BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 18641863 · Received February 5, 2024

    Report

    Report Number
    2024168-2024-01406
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 11, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648205835
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    C8 - #1 EVENT ABATED AFTER USE STOPPED: CHANGE TO DOESN'T APPLY C9 - #1 EVENT REAPPEARED AFTER REINTRO: CHANGE TO DOESN'T APPLY THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LABELING ISSUE WAS NOT CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED LABELING PROBLEM AS THE DEVICE WAS RETURNED AND THE LABELING ON CHIPBOARD BOX, FOIL POUCH, INNER POUCH AND DEVICE ALL MATCHED. THERE WAS NO DISCREPANCY ON THE LABELING OF ANY OF THE COMPONENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REMOVING THE XIENCE ALPINE DRUG ELUTING STENT SYSTEM (DES) FROM THE PACKAGE, IT WAS NOTED THE DEVICE LABEL (3.50X33MM)(LOT 3060641) DID NOT MATCH THE PACKAGING LABELED SIZE, 3.50X28MM (LOT 3081041). THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439311 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 3081041 08717648205835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown