BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903722 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02468
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS A TIGHT LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND HAD A 95% STENOSIS. FOLLOWING PRE-DILATATION, A 2.5 X 18 XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYED. DUE TO THE HEAVY TORTUOSITY OF THE VESSEL; THE STENT CAUSED AN EDGE DISSECTION AT THE DISTAL EDGE OF THE STENT. THE DISSECTION REQUIRED TREATMENT WITH AN ADDITIONAL STENT (2.75 X 18 XIENCE V SDS) TO COVER THE DISSECTION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 0062541

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention