BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1822889 · Received August 25, 2010

    Report

    Report Number
    2024168-2010-01763
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 31, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS LISTED IN THE PRODUCT 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.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): STENOSIS WITHIN 5 MM OF THE PREVIOUSLY PLACED XIENCE V STENT. ONSET OF AE: APPROXIMATELY 7 MONTHS AFTER STENT IMPLANTATION. IT WAS REPORTED VIA TRIAL THAT APPROX 7 MONTHS POST A MID RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE WITH A XIENCE V STENT, THE PATIENT EXPERIENCED UNSTABLE ANGINA AND WAS TAKEN TO THE CATHETER LAB WHERE STENOSIS WAS NOTED BOTH PROXIMAL AND DISTAL TO THE PREVIOUSLY PLACED XIENCE V STENT. PROXIMALLY, THE STENOSIS WAS WITHIN 5 MM OF THE STENT. TWO STENTS WERE PLACED TO COVER THE NEW AREAS OF STENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ONE DAY POST-PROCEDURE THE PATIENT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, 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 9010761

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R ANGIO-SEAL