BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001720 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01205
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ISCHEMIA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROXIMATELY 5 YEARS POST XIENCE V STENT IMPLANTATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT HAD A POSITIVE FUNCTIONAL STRESS TEST. THE PATIENT WAS HOSPITALIZED AND PER A DIAGNOSTIC CORONARY ANGIOGRAM, 75% STENOSIS WAS SEEN. A XIENCE STENT WAS PLACED AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ONE DAY POST-PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 51108P1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R