BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2861482 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07717
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ADDITIONAL XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO 2.75 X 38 MM XIENCE PRIME STENTS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2011. ON (B)(6) 2012, THE XIENCE PRIME STENTS WERE NOTED TO HAVE RESTENOSIS AND STENT FRACTURE WAS CONFIRMED UNDER ANGIOGRAPHY. TREATMENT WAS PERFORMED USING A DRUG-ELUTING BALLOON. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0091761

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention STENT: XIENCE PRIME