BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 21397419 · Received February 18, 2025

    Report

    Report Number
    2024168-2025-01783
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    December 21, 2024
    Report Date
    February 17, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648226755
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE XIENCE PROA DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED AND THE PROXIMAL 80% STENOSED AT THE MID. PRE-DILATATION WAS PERFORMED USING A 3.0X12MM SEMI-COMPLIANT BALLOON. AN ATTEMPT WAS MADE TO TRAVERSE THE 3.50X15MM XIENCE PROA DRUG-ELUTING STENT (DES) THROUGH A NON-ABBOT GUIDE EXTENSION CATHETER (GEC), HOWEVER, THE XIENCE PROA DES COULD NOT PASS THROUGH THE GEC. RESISTANCE WAS NOTED WHEN ATTEMPTING TO PULL BACK THE XIENCE PROA DES, THEREFORE, THE GEC AND XIENCE PROA DES WERE WITHDRAWN AS A SINGLE UNIT. THE STENT OF THE XIENCE PROA WAS OBSERVED TO BE DISLODGED FROM THE BALLOON AND FOUND TO BE IN THE CATHETER ONCE REMOVED FROM THE ANATOMY. A NEW GEC, 3.5X18MM XIENCE PROA DES, AND NON-ABBOTT DES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478062 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1128350-15 3101641 08717648226755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown