BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6282326 · Received January 27, 2017

    Report

    Report Number
    3002808486-2017-00182
    Event Type
    Death
    Date Received
    January 27, 2017
    Report Date
    May 17, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    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). INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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 "DEVICE FAILURE(S) RESULTING IN FATAL PULMONARY EMBOLISM." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. IT IS UNKNOWN, IF REPORTED PATIENT DEATH IN ANY WAY 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. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: POTENTIAL ADVERSE EVENTS: ¿ DAMAGE TO THE VENA CAVA ¿ PULMONARY EMBOLISM ¿ FILTER EMBOLIZATION ¿ VENA CAVA PERFORATION ¿ VENA CAVA OCCLUSION OR THROMBOSIS ¿ HEMORRHAGE ¿ EXTRAVASATION OF CONTRAST MATERIAL AT TIME OF VENA CAVAGRAM ¿ HEMATOMA AT VASCULAR ACCESS SITE ¿ INFECTION AT VASCULAR ACCESS SITE ¿ THROMBOSIS OR STENOSIS AT IMPLANT SITE ¿ DEATH. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). 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 · 1

    MANUFACTURER REF# (B)(4). THE 510(K) K090140. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED. PATIENT CODE : DEATH (1802) (LISTED IN IFU). PATIENT CODE : PULMONARY EMBOLISM (1498) (LISTED IN IFU). DEVICE CODE : MIGRATION OF DEVICE OR DEVICE COMPONENT (1395) (NOT LISTED IN IFU). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT/GUNTHER TULIP FILTER ON (B)(6) 2014." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT ON (B)(6) 2014, VIA RIGHT COMMON FEMORAL VENOUS ACCESS, A "CELECT TULIP" IVC FILTER WAS DEPLOYED IN THE RIGHT GROIN. PATIENT WAS ADMITTED TO ER ON (B)(6) 2015, WHERE HE EXPIRED. ESTATE ALLEGES PATIENT SUFFERED FATAL PULMONARY EMBOLISM DUE TO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66671 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death