BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1830885 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01874
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    April 17, 2010
    Report Date
    July 28, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), 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 MFR, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL, THAT APPROX 6 MONTHS POST A MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY STENTING PROCEDURE WITH A XIENCE V STENT, THE PT EXPERIENCED A SELF LIMITING EPISODE OF ANGINA WITH SOME SHORTNESS OF BREATH. A NUCLEAR STRESS TEST WAS NEGATIVE. ON (B)(6) 2010, THE PT WAS ADMITTED FOR A CARDIAC CATHETERIZATION. IN-STENT RESTENOSIS AND NEW LESIONS WERE FOUND. BALLOON ANGIOPLASTY AND TWO ADDITIONAL XIENCE STENTS WERE PLACED IN THE MID AND PROXIMAL LAD. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ON (B)(6) 2010, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9080641

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R