BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3942578 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04613
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY; THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE DEFLATION DIFFICULTIES WERE UNABLE TO BE CONFIRMED. THE DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION 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. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DEFLATION ISSUES OR DIFFICULT TO REMOVE FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE NON-CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 2.75 X 18 MM XIENCE PRIME STENT WAS IMPLANTED AT 8 ATMOSPHERE (ATM) FOR 10 SECONDS. IT WAS NOTED THAT USING NEGATIVE PRESSURE THE BALLOON COULD NOT BE REMOVED FROM THE STENT. EVENTUALLY THE BALLOON WAS REMOVED FROM THE ANATOMY PARTIALLY DEFLATED, HOWEVER, THE PATIENT EXPERIENCED ANGINA AND UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED AS OK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418661 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3062741

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention