BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1725468 · Received June 11, 2010

    Report

    Report Number
    2024168-2010-01161
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 18, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE 3.0 JOSTENT GRAFTMASTER REFERENCE IN B5 AND D11 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT MIGRATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: DEATH. IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS POST A LIVER TRANSPLANT, THE PATIENT DEVELOPED A GASTROINTESTINAL BLEED. ON (B) (6) 2010, ANGIOGRAM REVEALED A PERFORATION IN THE HEPATIC ARTERY PROXIMAL TO THE HEPATIC ARTERY ANASTOMOSIS. A 3.5 MM JOSTENT GRAFTMASTER WAS DEPLOYED OVER THE PERFORATION RESULTING IN A MARKED DECREASE IN BLEEDING; HOWEVER, THERE WAS STILL SOME BLEEDING. A 3.5 X 2 CM UNSPECIFIED BALLOON WAS ADVANCED INTO THE STENT GRAFT. WHEN THE BALLOON WAS REMOVED, THE STENT GRAFT HAD MIGRATED INTO THE COMMON HEPATIC ARTERY AND THE GRAFT NO LONGER COVERED THE PERFORATION. A 3.0 JOSTENT GRAFTMASTER WAS ADVANCED TO THE PERFORATION, BUT COULD NOT BE VISUALIZED. THE DEVICE WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND UNDEPLOYED IN THE HEPATIC ARTERY. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO CAPTURE THE STENT, RESULTING IN A DISSECTION OF THE HEPATIC ARTERY. THE PATIENT'S HEMODYNAMIC STATUS BEGAN TO DECLINE. THE HEPATIC ARTERY WAS EMBOLIZED WITH MICROCOILS. THE FEMORAL SHEATH WAS LEFT IN UNTIL (B) (6) 2010. UPON REMOVAL, HEMOSTASIS WAS DIFFICULT TO ACHIEVE. A FEMSTOP WAS PLACED AND THE PATIENT WAS TAKEN TO CT. WHILE IN CT, THE HEMORRHAGE WORSENED. THE PATIENT WAS ACTIVELY RESUSCITATED WITH BLOOD PRODUCTS AND FLUID AND TAKEN TO SURGERY TO OBTAIN CONTROL OF THE HEMORRHAGE. IN SURGERY, THE PATIENT DECLINED AND A CODE WAS INITIATED. A TRANSTHORACIC ECHOCARDIOGRAM WAS DONE REVEALING A LARGE CLOT IN THE RIGHT SIDE OF THE HEART. THE PATIENT EXPIRED IN THE OPERATING ROOM. AN AUTOPSY WAS DECLINED BY THE FAMILY. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 519581

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death DIL CATH: 3.5 X 2 CM BALLOON| 3.0 JOSTENT GRAFTMASTER