{
  "meta": {
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-05",
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          "manufacturer_d_address_2": "",
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          "openfda": {
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      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
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      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "sequence_number_treatment": [
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      "manufacturer_contact_city": "",
      "mdr_report_key": "1000545",
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20080213",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "adverse_event_flag": "N",
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      "single_use_flag": "",
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      "mdr_text": [
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          "mdr_text_key": "794835",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, FOUR HEARTSTRING SEALS DID NOT DEPLOY CORRECTLY OUT OF THE DELIVERY TUBE INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A SIDE CLAMP. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP AS A RESULT. THIS REPORT IS FOR THE FIRST SEAL."
        },
        {
          "mdr_text_key": "8093475",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "AFTER THE PROCEDURE, THE HOSP DISCARDED THE PROD. SINCE THE PROD WAS NOT RETURNED TO CARDIAC SURGERY FOR EVAL IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW WAS COMPLETED FOR THE PROD. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}