BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR XIENCE XPEDITION LL

    MDR report key: 3750403 · Received March 18, 2014

    Report

    Report Number
    3750403
    Event Type
    Death
    Date Received
    March 18, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 13, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUCCESSFUL PTCA/STENT OF LM INTO LAD WITH XIENCE DES. SUCCESSFUL PTCA/STENT OF OSTIAL LCX WITH XIENCE DES. KISSING BALLOON INFLATIONS OF LM INTO BOTH LAD AND LCX PTCA/STENT OF THE DISTAL LAD WITH XIENCE DES. EVIDENCE OF POSSIBLE DISSECTION OF THE MID LAD. ATTEMPT TO PASS A 2.5 X 38 MM XIENCE DES INTO MID LAD WITH ASSISTANCE OF A BUDDY WIRE, BUT WAS UNSUCCESSFUL, ULTIMATELY RESULTING IN THE DISTAL SHAFT OF THE STENT FRACTURING, INCLUDING THE STENT/STENT BALLOON/DISTAL SHAFT, WITHIN THE LM. MULTIPLE ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL. ATTEMPTS TO USE A BALLOON TO HELP DRAG THE STENT BALLOON OUT OF THE CORONARY ARTERIES WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157851 ABBOTT VASCULAR XIENCE XPEDITION LL EXPEDITION MAF ABBOTT VASCULAR 1074250-38 3101941

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death