BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 2153276 · Received July 1, 2011

    Report

    Report Number
    3002808486-2011-00025
    Event Type
    Death
    Date Received
    July 1, 2011
    Date of Event
    May 21, 2011
    Report Date
    June 13, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH UNKNOWN. PATIENT DIED 2-3 WEEKS AFTER PROCEDURE. EXPIRATION DATE IS UNK AS LOT NUMBER IS UNK. AGE OF DEVICE IS UNK AS LOT NUMBER IS UNK. (B)(4). NO DEVICE OR IMAGES HAVE BEEN AVAILABLE TO ASSIST THE INVESTIGATION. THIS EVALUATION WAS BASED SOLELY ON THE DESCRIPTION SINCE THERE ARE NO ANSWERS TO THE ADDITIONAL QUESTIONS ASKED ALREADY. EVALUATION WAS PERFORMED ON A MEETING (B)(6) 2011 WITH PARTICIPATION OF THE MEDICAL ADVISER AND THE DIRECTOR OF RESEARCH. BASED ON THE LIMITED INFORMATION A PRIMARY AND A SECONDARY FILTER LEG DID PERFORATE IVC AND THE FILTER DID MIGRATE CAUDALLY. HOWEVER, A LOT OF INFORMATION IS MISSING: "THE FILTER WAS PLACED AND SHORTLY LATER, THEY THOUGHT SHE HAD A RETRO PERITONEAL BLEED". HOWEVER, IT IS POSSIBLE THAT THE RETROPERITONEAL BLEEDING CAUSED THE EXPLORATIVE SURGERY. ALSO IT IS KNOWN THAT SURGERY AND MANIPULATION IN THE AREA CAN CAUSE THE FILTER PERFORATION OF IVC. WITH REFERENCE TO THE IFU, FILTER RETRIEVAL CAN BE PERFORMED INTERVENTIONALLY BY USING THE GUNTHER TULIP RETRIEVAL SET. NO LOT NUMBER IS AVAILABLE SO IT WAS NOT POSSIBLE TO INSPECT ANY MANUFACTURING DOCUMENTATION FOR THE DEVICE IN QUESTION. THE EXACT ROOT CAUSE FOR THIS EVENT IS UNKNOWN BASED ON THE LIMITED INFORMATION, BUT IT IS STATED THAT THE PATIENT'S DEATH WAS DUE TO A BLEEDING AND WAS NOT RELATED TO THE FILTER IMPLANT. NOTHING FURTHER IS INITIATED SINCE THE DESCRIPTION AND THE IMAGES DO NOT INDICATE PRESENCE OF DEVICE FAILURE AND THE ISSUE IS KNOWN FROM THE LITERATURE.

    Description of Event or Problem · 1

    THE FILTER WAS PLACED IN SHORTLY LATER, THEY THOUGHT THE PATIENT HAD A RETRO PERITONEAL BLEED. AN EXPLORATORY SURGERY WAS PERFORMED AND IT WAS DETERMINED THAT 1 SECONDARY STRUT AND 1 MAIN STRUT PERFORATED THE VENA CAVA WALL. THEY PROCEEDED TO CLIP THE STRUTS THAT WERE OUTSIDE OF THE WALL. THE FILTER WAS ALSO NOTED TO HAVE MIGRATED DOWN THE VENA CAVA, THE FACILITY NOT SURE AT WHAT POINT THE FILTER MIGRATED. THE FACILITY IS NOT SAYING THE PATIENT'S DEATH IS A DIRECT CORRELATION WITH THE FILTER. AUTOPSY WAS PERFORMED - NO ADDITIONAL INFO PROVIDED TO REP. PATIENT DIED 2-3 WEEKS AFTER THE FILTER WAS PLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death| R| S PATIENT DIED 2-3 WEEKS AFTER THE PROCEDURE.