BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1964273 · Received January 19, 2011

    Report

    Report Number
    2024168-2011-00378
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    January 20, 2010
    Report Date
    December 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.5 X 12 MM XIENCE V (1009545-12, 8062361) ON THE INITITAL MEDWATCH IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    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. ANGINA, RESTENOSIS, ADDITIONAL THERAPY/NONSURGICAL TREATMENT, AND HOSPITALIZATION ARE FORESEEABLE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY 14 MONTHS POST XIENCE STENT IMPLANTATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY THE PATIENT EXPERIENCED EXERTIONAL ANGINA. THE PATIENT UNDERWENT A (B)(6) WHICH WAS POSITIVE. ON (B)(6) 2010 THREE STENTS WERE PLACED IN THE INDEX TARGET LESION DUE TO 100% IN-STENT RESTENOSIS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATING THAT BOTH INDEX PROCEDURE STENTS HAD IN-STENT RESTENOSIS.

    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-TEMECULA-CT 8060661

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R STENT: 2.5 X 12 XIENCE V