BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 7085968 · Received December 6, 2017

    Report

    Report Number
    3002808486-2017-02336
    Event Type
    Death
    Date Received
    December 6, 2017
    Report Date
    February 3, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 OR K090140. (B)(4). 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 FILTER IMPLANTED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER.

    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). 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, MIGRATION, UNABLE TO RETRIEVE, OCCLUSION (SVC SYNDROME), DEATH, ATTENDANT PAIN / SUFFERING'. 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. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. 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 OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A CELECT FILTER ON (B)(6) 2009". PATIENT OUTCOME: [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (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 (B)(6) 2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2009 VIA THE FEMORAL VEIN DUE TO PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS DESPITE ANTICOAGULATION. PT IS ALLEGING MIGRATION, DEVICE UNABLE TO BE RETRIEVED, SUPRAVENTRICULAR VENA CAVA SYNDROME, DEATH, ATTENDANT PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866983 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death