BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2933600 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00457
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 22, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED, AND 60% STENOSED PROXIMAL CIRCUMFLEX ARTERY. A 3.5 X 8 MM XIENCE V STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, BEFORE IT COULD BE DEPLOYED, THE STENT IMPLANT DISLODGED. A TREK BALLOON CATHETER WAS ADVANCED TO THE LESION AND EXPANDED TO DEPLOY THE STENT IN THE INTENDED SITE. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39067 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1112941

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention