BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 5743926 · Received June 23, 2016

    Report

    Report Number
    3002808486-2016-00573
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    October 20, 2015
    Report Date
    June 7, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. (B)(4). INVESTIGATION: 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 ¿TILT, DEVICE UNABLE TO BE RETRIEVED, PAIN, ANXIETY/STRESS". COOK WILL REOPEN ITS INVESTIGATION AFTER FURTHER INFORMATION CONCERNING ALLEGED PATIENT SUFFERINGS IS RECEIVED AND WILL SUPPLEMENT IN ACCORDANCE WITH 21 C.F.R.803.56 WHEN APPROPRIATE. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER. UNKNOWN IF THE REPORTED PATIENT DEATH IS RELATED TO THE FILTER. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. 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. UNKNOWN IF THE REPORTED PAIN DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED ANXIETY/STRESS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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.

    Description of Event or Problem · 0

    THIS ADDITIONAL INFORMATION RECEIVED ON 20MAR2018 AS FOLLOWS: ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PULMONARY EMBOLISM. [PT] IS ALLEGING TILT, DEVICE UNABLE TO BE RETRIEVED. [PT] FURTHER ALLEGES PAIN AROUND FILTER AREA, ANXIETY/STRESS. IT WAS REPORTED [PT] EXPIRED ON (B)(6) 2017 WITHOUT FURTHER DETAILS. FILTER RETRIEVAL WAS ATTEMPTED ON (B)(6) 2015 AND (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PATIENTS MEDICAL RECORDS ARE UNKNOWN AND NO IMAGING IS PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON THE SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE IVC FILTER, WHICH PATIENT ALLEGEDLY SUFFERED APPROX. 4 MONTHS AFTER PLACEMENT OF A CELECT FILTER, BECAUSE THE FILTER BECAME "IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." ALSO, IT IS NOT POSSIBLE TO COMMENT ON THE MEDICAL EXPENSES, WHICH PATIENT ALLEGEDLY HAS INCURRED AND WILL INCUR IN THE FUTURE, THE PAIN AND SUFFERING AND LOSS OF ENJOYMENT OF LIFE, THE PATIENT HAS ENDURED AND WILL ENDURE, AS WELL AS THE PATIENT OTHERWISE BEING DAMAGED IN A PERSONAL AND PECUNIARY NATURE. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING FILTER PLACEMENT OR DURING FILTER IMPLANTING PERIOD. UNDER NORMAL CONDITIONS, I.E. IVC < 30 MM, THE RADIAL FORCE OF THE FILTER WILL ENSURE PROPER ATTACHMENT OF THE FILTER LEGS TO IVC. HOWEVER, FILTER MIGRATION IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. MANIPULATION IN THE AREA OF THE FILTER IMPLANT OR A BLOOD CLOT CAPTURED INSIDE THE FILTER MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. 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. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. RPN AND LOT# ARE UNKNOWN, BUT THERE IS 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT [PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2015 IN (B)(6). IN OR AROUND (B)(6) 2015, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." 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 OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT [PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2015. IN OR AROUND (B)(6) 2015, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT ET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398898 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening