BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT JUGULAR VENA CAVA FILTER SET

    MDR report key: 5002801 · Received August 14, 2015

    Report

    Report Number
    3002808486-2015-00095
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Report Date
    September 16, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 K073374, K061815 OR K090140. INVESTIGATION IS STILL IN PROGRESS. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815 OR K090140. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815 OR K090140. SUMMARY OF INVESTIGATION FINDINGS: NO IMAGING PROVIDED AND CONSEQUENTLY IT IS NOT POSSIBLE TO COMMENT ON THE REPORTED TWO UNSUCCESSFUL RETRIEVAL ATTEMPTS APPROXIMATELY THREE WEEKS AND THREE MONTHS AFTER FILTER PLACEMENT. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. 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 VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    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

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6), 2011 AT (B)(6)." 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

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6) 2011 AT (B)(6)." JANUARY 04, 2016 ADDITIONAL INFORMATION RECEIVED: IT IS ALLEGED THAT "RETRIEVAL WAS SCHEDULED APPROXIMATELY 3 WEEKS AFTER IMPLANTATION OF DEVICE BECAUSE [PT] "COULD NOT BREATHE PROPERLY." TWO RETRIEVAL ATTEMPTS PERFORMED ON (B)(6) 2011 AND (B)(6) 2011. THE IVC FILTER WAS REMOVED ON (B)(6) 2011 VIA A SURGICAL PROCEDURE." PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] SUFFERED SHORTNESS OF BREATH AND BREATHING CUT IN HALF CAUSED BY THE FILTER, FILTER TILT AND CLOTS GREW AROUND THE DEVICE" [PT] DIED IN 2013 PRESUMABLY RELATED TO CANCER.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 12/29/2015 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED THE FILTER IMPLANT ON (B)(6) 2011 DUE TO PE. TWO UNSUCCESSFUL RETRIEVAL ATTEMPTS ALLEGEDLY OCCURRED ON (B)(6) 2011, RESPECTIVELY. RECORDS FROM THE SECOND RETRIEVAL ATTEMPT ALLEGES A ¿(L)ARGE THROMBUS ENCASING THE FILTER AND PROJECTING ABOVE THE FILTER.¿ DURING OPEN SURGERY ON (B)(6) 2011, THE FILTER WAS SUCCESSFULLY REMOVED, THE GALLBLADDER WAS REMOVED, THORACIC SURGERY WAS PERFORMED, AND LEFT RENAL VEIN STUMP RESECTED. RECORDS FROM THE SURGERY NOTE ¿THE PATIENT HAD THROMBOSIS INTO THE FILTER AND EXTENDING INTO THE ATRIUM. FURTHER STUDYING DEMONSTRATED THAT THIS WAS AN EXTENSION OF THE RENAL CELL CARCINOMA. FOR THAT REASON, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR THE ABOVE-MENTIONED PROCEDURES.¿ THE PATIENT INVOLVED WAS REPORTED TO HAVE DIED IN 2013, PRESUMABLY FROM CANCER. THE PLAINTIFF ALLEGES DEVICE TILT, THROMBUS, AND SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539101 COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening