BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ABBOTT

    MDR report key: 5306067 · Received December 15, 2015

    Report

    Report Number
    MW5058559
    Event Type
    Injury
    Date Received
    December 15, 2015
    Manufacturer
    ABBOTT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, A MEDICATED STENT WAS INSERTED IN MY LEFT LEG. I HAD MANY SIDE EFFECTS FROM THE ANTIPLATELET MEDS REQUIRED WITH THIS STENT. EVENTUALLY THE STENT FAILED CAUSING 90% BLOCKAGE LEFT LEG. DIFFICULT AMBULATION, WOUND IN LEFT FOOT REQUIRED CONTINUING TREATMENT AND PAIN. I HAVE SINCE LEARNED THAT THIS PRODUCT WAS NOT APPROVED BY THE FDA FOR USE IN LEGS, ONLY ACUTE CARD, AS SYND. I AM NOT ABLE TO PERFORM MY ADL'S WITHOUT PAIN AND IT HAS LIMITED MY R. O. M., AND INDEPENDENCE. SIDE EFFECTS ASSOCIATED WITH THE MEDS REQUIRED FOR USE THIS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825639 XIENCE ABBOTT XIENCE XPEDITION LL 3.0 MMX38 MM MAF ABBOTT 4082041

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S