BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140774 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03426
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE FAULTY DEVICE WAS CONFIRMED; THERE WAS A TEAR/HOLE IN THE DEVICE. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND BY A STAFF MEMBER, HOWEVER, THERE IS NO INFORMATION AVAILABLE RELATED TO HOW THE DEVICE WAS USED IN A PROCEDURE, HOWEVER, THERE WAS NO REPORTED PATIENT ADVERSE EVENT OR INJURY. THE DEVICE WILL BE RETURNED FOR INVESTIGATION. RETURN DEVICE ANALYSIS REVEALED THAT THERE WAS BLOOD IN THE INFLATION LUMEN; A TEAR/HOLE IN THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242468 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2092241

    Patients

    Seq Age Sex Outcome Treatment
    1