BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 1643760 · Received March 26, 2010

    Report

    Report Number
    3004742046-2010-00114
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 2, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE ABSOLUTE PRO .035 (PART #1011922-080, LOT #8061651) IS BEING FILED UNDER A SEPARATE MFR NUMBER. THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT FRACTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: FOREIGN BODY UNRETRIEVED IN THE ANATOMY. TIME OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A REVASCULARIZATION OF A PREVIOUSLY PLACED 7.0 X 80 CM ABSOLUTE PRO STENT IN A MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY, THE NEW STENT REACHED THE LESION WITHOUT RESISTANCE. THE THUMBWHEEL TURNED EASILY TO RELEASE THE STENT. DURING DEPLOYMENT, THE FIRST ONE-THIRD OF THE STENT WAS PLACED INSIDE THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THE REMAINING TWO-THIRDS OF THE STENT TOTALLY DETACHED FROM THE REST OF THE STENT AND MIGRATED INTO THE ILIAC ARTERY. ANOTHER ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE. THE DETACHED SEGMENT OF THE STENT REMAINS IN THE ILIAC ARTERY. THERE WAS NO ADVERSE PT SEQUELAE REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9111151

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R| S ABSOLUTE PRO .035 (PART #1011922-080 LOT #8061651)