BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1773871 · Received July 23, 2010

    Report

    Report Number
    3004742046-2010-00332
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - OFF LABEL VASCULAR USE. THE CUSTOMER REPORTED THAT THE DEVICE IS BEING RETAINED AND NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ABSOLUTE PRO (PART 1011932-080, LOT 9081151), INDICATED IS BEING FILED UNDER A SEPARATE MFR #.

    Description of Event or Problem · 1

    DEVICE ISSUE: OUTER SHEATH SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING USE OF THE ABSOLUTE PRO (LOT 9051451) IN THE PATIENT VASCULATURE, THE OUTER SHEATH SEPARATED FROM THE HANDLE. A CONTRALATERAL APPROACH WAS USED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. A SECOND ABSOLUTE PRO (LOT 9081151) WAS USED AND THE STENT WAS DEPLOYED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY LESION; HOWEVER, THE DISTAL SEGMENT OF THE DELIVERY SYSTEM SEPARATED INSIDE THE PATIENT. A SNARE WAS INSERTED AND SUCCESSFULLY REMOVED THE SEPARATED SEGMENT OF THE ABSOLUTE PRO. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9051451

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR STENT: ABSOLUTE PRO (PART 1011932-080,LOT 9081151)| OMNILINK