BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850778 · Received September 28, 2010

    Report

    Report Number
    2024168-2010-02031
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER THE PREDILATATION, THE XIENCE V STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO THE LAD. BUT, BEFORE REACHING THE LESION, THE STENT DISLODGED FROM THE SDS INTO THE LAD. THE SDS WAS PULLED BACK AND AN UNK BALLOON (1.5 MM X 15 MM) WAS INSERTED TO DEPLOY THE STENT. THE BALLOON WAS CHANGED TO AN UNK 2.5 MM X 15 MM BALLOON TO DILATE THE STENT IN THE LAD. THERE WAS NO REPORTED PT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0040841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention