BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4619475 · Received March 17, 2015

    Report

    Report Number
    3002808486-2015-00023
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    June 13, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG# UNK BUT REFERRED TO AS A COOK CELECT VENA CAVA FILTER. EXPIRATION DATE: UNK AS LOT# IS UNK. SINCE CATALOG IS UNK THE 510(K) COULD BE EITHER K090140 OR K073374 BASED ON THE DATE OF IMPLANT. UNK AS LOT# IS UNK. INVESTIGATION STILL IN PROGRESS. SINCE CATALOG IS UNK THE 510(K) COULD BE EITHER K090140 OR K073374 BASED ON THE DATE OF IMPLANT. DEVICE EXPIRING DATE IS UNK AS LOT# IS UNK. INVESTIGATION STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG: UNKNOWN BUT REFERRED TO AS A COOK CELECT VENA CAVA FILTER SINCE CATALOG IS UNKNOWN THE 510(K) COULD BE EITHER K090140 OR K073374 BASED ON THE DATE OF IMPLANT. (B)(4). INFORMATION REGARDING THE EVENT HAS NOT BEEN PROVIDED. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE THIS EVENT BASED ON THE LIMITED INFORMATION, AND WE ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4) CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT AND PRODUCT PROBLEM TO ADVERSE EVENT. 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 "THE PLAINTIFF ALLEGES DEVICE TILT, VC PERFORATION, THROMBOSIS AT IVC FILTER, BLEEDING, AND ORGAN PERFORATION". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. 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. 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.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] HAD A COOK CELECT VENA CAVA FILTER IMPLANTED ON (B)(6) 2011 AT (B)(6) BY IMPLANTING SURGEON (B)(6). " PT OUTCOME: IT IS ALLEGED THAT "[PT] SUFFERED LOSS OF CONSORTIUM AND PUNITIVE DAMAGES." ADDITIONAL INFO REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

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

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 11/11/2015 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2011 VIA THE JUGULAR VEIN DUE TO PROPHYLAXIS OF BLOOD CLOT FORMATION WHILE BEDRIDDEN AFTER 2 ABDOMINAL SURGERIES. THE PLAINTIFF ALLEGES DEVICE TILT, VC PERFORATION, THROMBOSIS AT IVC FILTER, BLEEDING, AND ORGAN PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182644 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening