BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1824808 · Received September 1, 2010

    Report

    Report Number
    2024168-2010-01810
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    May 11, 2010
    Report Date
    August 7, 2010
    Manufacturer
    ABBOTT VASCULAR-CLONMEL
    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). THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, DESIGN OR LABELING. THE XIENCE V 3.0 X 28 (PART 1009541-28, LOT 7112661) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: INSTENT RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: 22 MONTHS POST IMPLANTATION. IT WAS REPORTED VIA TRIAL THAT ON (B)(6) 2008, PREDILATATION WAS PERFORMED AND TWO XIENCE V STENTS WERE IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) OVERLAPPING EACH OTHER. ON (B)(6) 2010, THE PT PRESENTED TO THE EMERGENCY ROOM WITH LEFT-SIDED CHEST PRESSURE RADIATING TO THE LEFT ARM. THE LEFT HEART CATHETER REVEALED AN 80% IN-STENT RESTENOSIS IN THE MID RCA (BOTH STENTS), WHICH WAS SUCCESSFULLY RE-OPENED TO <10% STENOSIS USING A CUTTING BALLOON. AN ECG WAS PERFORMED AND THERE WERE NO FINDINGS SUGGESTIVE OF A MYOCARDIAL INFARCTION. THE PT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CLONMEL NA 7112141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R PERCLOSE| XIENCE V 3.0 X 28 (PART 1009541-28, LOT 7112661)