BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902010 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02439
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    January 22, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. ANGINA, MYOCARDIAL INFARCTION, RESTENOSIS AND NAUSEA ARE LISTED IN THE PRODUCTS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. IN THIS CASE, AND A NON-ABBOTT STENT WAS PLACED AS TREATMENT FOR THE STENOSIS REQUIRING ADD'L HOSPITALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROX 27 MONTHS POST XIENCE V STENT IMPLANTATION IN THE MID RIGHT CORONARY ARTERY (MRCA), THE PT EXPERIENCED CHEST PAIN, DIAPHORESIS, NAUSEA AND VOMITING WHICH WAS DIAGNOSED AS A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2010, 70-100% STENOSIS WAS SEEN AND A NON-ABBOTT STENT WAS PLACED AS TREATMENT. THERE WAS NO ADVERSE PT SEQUELA REPORTED AND ON (B)(6) 2010, THE EVENT RESOLVED. THERE WAS NO ADD'L INFO 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 70228P5

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S ASPIRIN| OTHER: CLOPIDOGREL