BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 9935499 · Received April 8, 2020

    Report

    Report Number
    2024168-2020-03473
    Event Type
    Death
    Date Received
    April 8, 2020
    Date of Event
    March 2, 2020
    Report Date
    April 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227448
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND DEATH ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT FILED, ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN ASSESSED THE DEATH AS HAVING AN UNKNOWN RELATIONSHIP TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 ON (B)(6) 2020, THE PATIENT PRESENTED WITH A SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY LESION. PRE-DILATATION AND ATHERECTOMY WAS PERFORMED. A 3.5X28MM XIENCE SIERRA STENT (1550350-28, 9110641) WAS IMPLANTED WITHOUT COMPLICATIONS. STENT PLACEMENT WAS REPORTEDLY ACCEPTABLE WITH 0% DIAMETER STENOSIS AND TIMI FLOW III. ON (B)(6) 2020, THE PATIENT PASSED AWAY DUE TO A MYOCARDIAL INFARCTION (MI). NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404737 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550350-28 9110641 08717648227448

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death