BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930415 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04488
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    March 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART/LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: DEFLATE THE BALLOON BY PULLING NEGATIVE ON THE INFLATION DEVICE FOR 30 SECONDS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GENERAL COMMENT WAS RECEIVED FROM THE PHYSICIAN REPORTING THAT AFTER DEPLOYMENT AND DEFLATION OF XIENCE PRIME LL (33, 38 MM SIZES) BALLOONS, THERE IS RESISTANCE REMOVING THE DEVICES. THEY GET CAUGHT IN THE STENT STRUTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406313 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1