BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SIERRA

    MDR report key: 9835802 · Received March 16, 2020

    Report

    Report Number
    2024168-2020-02459
    Event Type
    Death
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227080
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE STENT REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B)(6) 2020. A 2.5X12MM XIENCE SIERRA STENT (1550250-12, 9100241) WAS SUCCESSFULLY IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM) CORONARY ARTERY LESION. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT HAD EXPIRED WHILE AT HOME. REPORTEDLY, THERE WAS NO IMAGING PERFORMED AFTER THE INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299431 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550250-12 9100241 08717648227080

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death