BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930369 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04476
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    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). 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. A SIMILAR INCIDENT QUERY IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS NOT PERFORMED AS THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 3.0 X 28 XIENCE V ON (B)(6) 2014 IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT RETURNED (B)(6) 2014 WITH CHEST PAIN. AN ANGIOGRAPHY WAS COMPLETED AND REVEALED A PROXIMAL EDGE RESTENOSIS. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12MM NC TREK BALLOON DILATATION CATHETER (BDC). A 3.5 X 28 XIENCE V WAS PLACED TO COVER THE RESTENOSIS. POST DILATATION WAS PERFORMED WITH A 3.5 X 9MM BCD AT 26-28 ATMOSPHERES. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405856 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2081541

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R