BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902115 · Received November 10, 2010

    Report

    Report Number
    2024168-2010-02406
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    May 25, 2010
    Report Date
    October 20, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. ANGINA, MYOCARDIAL INFARCTION (MR), AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED,THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURER OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRAIL THAT ON (B)(6) 2008, THE PT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2010, THE PT EXPERIENCED EARLY MORNING CHEST PAIN OF MODERATE INTENSITY. THE PT TOOK SUBLINGUAL NITROGLYCERIN AND PHONED THE AMBULANCE. THE ELECTROCARDIOGRAM SHOWED A Q WAVE AND ST ELEVATION MYOCARDIAL INFARCTION. THE PT WAS HOSPITALIZED AND UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION ON (B)(6) 2010 IN THE TARGET LESION AND IN THE NON-TARGET PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PATIENT'S CONDITION RESOLVED AND WAS DISCHARGED ON (B)(6) 2010. THOUGH REQUESTED, NO ADDITIONAL INFO WAS 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 8051361

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S VESSEL CLOSURE: MANUAL COMPRESSION