BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 6685308 · Received July 4, 2017

    Report

    Report Number
    3002808486-2017-01370
    Event Type
    Death
    Date Received
    July 4, 2017
    Report Date
    January 16, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). D4) CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE #(B)(4). EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). COOK INC./ WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH, UNCLEAR THE REASON FOR DEATH. H11) CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: B1: <NONE> TO ADVERSE EVENT. H1: <NONE> TO DEATH. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'CELECT, PE (DEATH), SHORTNESS OF BREATH '. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF THE REPORTED PATIENT DEATH IS RELATED TO THE FILTER. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. 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. 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.

    Description of Event or Problem · 0

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013." PATIENT OUTCOME: [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 20NOV2017 AS FOLLOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 DUE TO A BLOOD CLOT IN THE LEG. PATIENT'S ESTATE IS ALLEGING, SHORTNESS OF BREATH, THE DEVICE DID NOT WORK AND THE DEVICE DID NOT INHIBIT BLOOD CLOTS FROM TRAVELLING TO THE LUNGS. THE PATIENT HAS BEEN REPORTED TO HAVE EXPIRED ON (B)(6) 2013, CAUSE OF DEATH IS DUE TO CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465750 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death