{ "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": 308977 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3002808486-2020-00446", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K121629", "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": "", "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": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466784", "implant_date_year": "2017", "date_removed_year": "2019", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "COOK CELECT® PLATINUM NAVALIGN 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": "20191027", "model_number": "", "catalog_number": "IGTCFS-65-1-FEM-CELECT-PT", "lot_number": "E3512416", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DTK", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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", "Device Tipped Over", "Insufficient Device Problem Information", "Difficult to Remove", "Structural Problem", "Device Tipped Over", "Insufficient Device Problem Information" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/13/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250817", "health_professional": "", "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": "", "patient_weight": "111", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Thrombosis", "Perforation of Vessels", "No Information", "Pain", "Thrombosis", "Perforation of Vessels", "No Information" ] } ], "distributor_city": "", "date_report": "20200529", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000201", "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": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "316714048", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2017 VIA THE RIGHT GROIN DUE TO POST DEEP VEIN THROMBOSIS (DVT). AN (B)(6) 2019 SUCCESSFUL FILTER RETRIEVAL DUE TO DEVICE FAILURE WAS REPORTED. PATIENT IS ALLEGING DEVICE TILT, VENA CAVA PERFORATION COMPLEX REMOVAL, DVT. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING \"DAMAGE TO VEINS, SEVERE CHRONIC SWELLING AND PAIN, LEG DISCOLORATION, MULTIPLE DVT'S, CHRONIC CELLULITIS INFECTIONS, RESTLESS LEG SYNDROME\", PHYSICAL LIMITATIONS AND ANXIETY. PER A (B)(6) 2019 COMPUTED TOMOGRAPHY (CT) ABDOMEN: \"INFERIOR VENA CAVAL FILTER IS NOTED. APEX IS JUST BELOW THE LEFT RENAL VEIN IVC CONFLUENCE. THE APEX IS TILTED ANTEROMEDIALLY AND ADJACENT TO THE VENA CAVAL WALL. METALLIC STRUTS ARE INTACT. THERE IS PENETRATION OF THE IVC WALLS WITH THE MAJOR 4 CORNER STRUTS. NO IMPINGEMENT UPON ADJACENT ORGANS IS SEEN. NO EXTRAVASATION IS SUGGESTED. MEDIAL STRUT IS APPROXIMATELY 2 MM FROM THE LATERAL WALL OF THE DISTAL AORTA\". (B)(6) 2019 SUCCESSFUL IVC FILTER RETRIEVAL: \"SUCCESSFUL RETRIEVAL OF A CONICAL IVC FILTER\"." }, { "mdr_text_key": "316714049", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA (VC) PERFORATION, DEEP VEIN THROMBOSIS (DVT), DIFFICULT TO RETRIEVE, TILT, PAIN, VEIN INJURY, SWELLING LEG DISCOLORATION, CHRONIC CELLULITIS INFECTIONS, RESTLESS LEG SYNDROME, PHYSICAL LIMITATIONS AND ANXIETY. 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. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. 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. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED PAIN, VEIN INJURY, SWELLING, LEG DISCOLORATION, CHRONIC CELLULITIS INFECTIONS, RESTLESS LEG SYNDROME, PHYSICAL LIMITATIONS AND ANXIETY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 DEVICES IN LOT. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THE LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED." }, { "mdr_text_key": "189620741", "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": "189620742", "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) 2017. 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": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/29/2020" } ] }