BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1652954 · Received March 29, 2010

    Report

    Report Number
    2024168-2010-00628
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE OTHER MULTI-LINK 8 (P.N. 1012168-08, LOT # 9111861) IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: SHAFT SEPARATION. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT WHEN THE DEVICE WAS ADVANCED TO THE CALCIFIED LESION THERE WAS RESISTANCE AND THE SHAFT SEPARATED. THIS OCCURRED WITH TWO DEVICES DURING THE SAME CASE. FINALLY, THE PATIENT RECEIVED A NON-ABBOTT STENT. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9111861

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 X 8 MM MULTI-LINK 8 (P.N. 1012168-08| LOT # 9111861)| STENT: DRIVER