BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1505502 · Received September 15, 2009

    Report

    Report Number
    3004742046-2009-00229
    Event Type
    Malfunction
    Date Received
    September 15, 2009
    Date of Event
    August 28, 2009
    Report Date
    August 31, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): OFF LABEL VASCULAR USE. (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. DEVICE 2: THE ABSOLUTE .035 SELF EXPANDING STENT SYSTEM (PART #1010557-40, LOT#8041452) IS BEING FILED UNDER ANOTHER MEDWATCH MFR #.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: PREMATURE, PARTIAL STENT DEPLOYMENT. TYPE OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING THE STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, AFTER THE ABSOLUTE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, THE STENT WAS NOTED TO BE PREMATURELY, PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED AND A SECOND ABSOLUTE STENT WAS USED, BUT THIS STENT ALSO PREMATURELY, PARTIALLY DEPLOYED AFTER IT WAS ADVANCED TO THE LESION. THE DEVICE WAS REMOVED FROM THE ANATOMY. A THIRD ABSOLUTE DEVICE WAS SUCCESSFULLY DEPLOYED. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9032651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYSTEM (PART#1010557-40, LOT#8041452)| DEVICE #2: ABSOLUTE .035 SELF EXPANDING STENT