BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242213 · Received November 19, 2008

    Report

    Report Number
    2024168-2008-01185
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 24, 2008
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ANGINA AND STENOSIS, AS LISTED IN THE XIENCE V IFU, ARE KNOWN RISKS ASSOCIATED WITH CORONARY STENTING. THESE PT EFFECTS ARE NOT NECESSARILY AN INDICATION OF PROD QUALITY ISSUE. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYS QUALITY PROBLEM. THE REPORTED PT ISSUE OF ANGINA APPEARS TO BE A RESULT OF THE RESTENOSIS AND THEREFORE REQUIRED ADD'L HOSPITALIZATION. A CONCLUSIVE ROOT CAUSE FOR ALL REPORTED PT ISSUES, AND THE RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE ISSUE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT A XIENCE V STENT WAS IMPLANTED IN 2007, IN THE PROXIMAL LAD. THE FOLLOWING YEAR, THE PT BEGAN TO EXPERIENCE CHEST PAIN/ANGINA. THE PT WAS HOSPITALIZED AND A DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED; HOWEVER, NO TREATMENT WAS PERFORMED AT THAT TIME. THREE MONTHS LATER, THE PT WAS HOSPITALIZED AGAIN FOR ANGIOGRAPHY WHICH RESULTED IN REVASCULARIZATION WITH THE DEPLOYMENT OF ANOTHER CO'S STENT DUE TO RESTENOSIS. NO ADD'L EVENT OR PT 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-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R