BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1800534 · Received August 12, 2010

    Report

    Report Number
    2024168-2010-01644
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS 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 OR DESIGN. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS REQUIRING INTERVENTION. TIME OF ADVERSE EVENT: APPROXIMATELY 22 MONTHS AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED UNSTABLE ANGINA THAT WAS TREATED WITH INTRAVENOUS NITROGLYCERIN. THE PATIENT UNDERWENT A DIAGNOSTIC CORONARY ANGIOGRAM THAT FOUND A NEW LESION PROXIMAL TO THE INDEX STENT THAT EXTENDED INTO THE PROXIMAL TIP OF THE STENT WITH AN APPROXIMATE 75% STENOSIS. THIS LESION WAS REVASCULARIZED WITH PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 8051461

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R