{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 686374 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "BJAEVERSKOV", "manufacturer_contact_address_1": "SANDET 6, DK-4632", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3002808486-2020-00447", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K073374", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "WALMANN", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "LISSI", "device_date_of_manufacturer": "20091209", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466957", "implant_date_year": "2010", "date_removed_year": "2019", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "COOK CELECT FEMORAL VENA CAVA FILTER SET", "generic_name": "DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR", "manufacturer_d_name": "WILLIAM COOK EUROPE", "manufacturer_d_address_1": "SANDET 6", "manufacturer_d_address_2": "", "manufacturer_d_city": "BJAEVERSKOV", "manufacturer_d_state": "", "manufacturer_d_zip_code": "4632", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "DA", "manufacturer_d_postal_code": "4632", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20111209", "model_number": "", "catalog_number": "IGTCFS-65-FEM-CELECT-PERM", "lot_number": "E2487871", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DTK", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3002808486" ], "fei_number": [ "3002808486" ], "device_name": "Filter, Intravascular, Cardiovascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3375", "device_class": "2" } } ], "product_problems": [ "Difficult to Remove", "Structural Problem", "Unintended Movement", "Insufficient Device Problem Information", "Difficult to Remove", "Structural Problem", "Unintended Movement", "Insufficient Device Problem Information" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/02/2020;05/30/2023", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "78 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Vessel Or Plaque, Device Embedded In", "Internal Organ Perforation", "Perforation of Vessels", "No Information", "Vessel Or Plaque, Device Embedded In", "Internal Organ Perforation", "Perforation of Vessels", "No Information" ] } ], "distributor_city": "", "date_report": "20230613", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "BJAEVERSKOV", "mdr_report_key": "10000214", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200413", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "WILLIAM COOK EUROPE", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "316697351", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA RIGHT COMMON FEMORAL VEIN DUE TO POST TRAUMA. THE PATIENT ALLEGES ORGAN/VENA CAVA PERFORATION, EMBEDMENT, AND OPEN REMOVAL. THE PATIENT FURTHER ALLEGES MEDICAL INTERVENTION WITH SPINAL CORD INJECTIONS AND MICRO DECOMPRESSION SURGERY ON L3-L4, PAIN, LIMITED MOBILITY, DEPRESSION, ANXIETY, POST TRAUMATIC STRESS DISORDER (PTSD). OPEN ABDOMINAL RETRIEVAL ON 29AUG2019 DUE TO DEVICE FAILURE. (B)(6) 2019, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿THERE IS AN INFERIOR VENA CAVA FILTER PRESENT. THE FILTER IS LOCATED STRAIGHT ALONG THE COURSE OF THE PATIENT'S INFERIOR VENA CAVA. THE FILTER STRUTS ARE INTACT. THERE IS NO BENDING. THERE IS PERFORATION BEYOND THE INFERIOR VENA CAVA OF MANY OF THE STRUTS. THIS IS MOST PRONOUNCED AT THE 12, 3, 6 AND 9 O'CLOCK POSITIONS OF THE FILTER. AT THE 12 O'CLOCK POSITION, THERE IS 3 MM OF PERFORATION INTO THE ANTERIOR CAVAL RETROPERITONEAL FAT. AT THE 3 O'CLOCK POSITION, THE STRUT EXTENDS POSTEROLATERALLY BY 8 MM. THE TIP OF THIS STRUT IS LOCATED JUST ANTERIOR TO THE L3 VERTEBRAL BODY. AT THE 6 O'CLOCK POSITION, THE STRUT EXTENDS POSTERIORLY IN BETWEEN THE PSOAS AND L3 VERTEBRAL BODY. THIS IS PERFORATED BY A DISTANCE OF 8-9 MM. AT THE 9 O'CLOCK POSITION, THE STRUT EXTENDS LATERALLY INTO THE RETROPERITONEAL FAT PERFORATED BY A DISTANCE OF 6 MM.¿ (B)(6) 2019, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); ¿WE THEN REMOVED THE VENA CAVA FILTER IN ITS ENTIRETY. THE ANTERIOR VENA CAVA WAS INSPECTED AND APPEARED TO BE INTACT.¿" }, { "mdr_text_key": "316697352", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN/VENA CAVA PERFORATION, EMBEDMENT, COMPLEX REMOVAL, INTERVENTION, PAIN, ANXIETY/DEPRESSION, LIMITED MOBILITY, POST TRAUMATIC STRESS DISORDER. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PE IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION; THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS). FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. SPECIFIC FOR ¿EMBEDDED¿ A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. UNKNOWN IF THE REPORTED INTERVENTION, PAIN, ANXIETY/DEPRESSION, LIMITED MOBILITY, POST TRAUMATIC STRESS DISORDER ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED." }, { "mdr_text_key": "336555975", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: B5, B7, H6. INVESTIGATION THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: MIGRATION. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED." }, { "mdr_text_key": "336555976", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED WHICH ALLEGES MIGRATION." }, { "mdr_text_key": "189621930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56." }, { "mdr_text_key": "189621931", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT \"[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010. IT IS ALLEGED THAT THE [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "SANDET 6, DK-4632", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;06/13/2023" } ] }