BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10391487 · Received August 11, 2020

    Report

    Report Number
    2024168-2020-06668
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY 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. THE XIENCE XPEDITION DEVICE, MENTIONED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN 80% STENOSED LESION WITHIN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A 2.5X48MM XIENCE XPEDITION (1070250-48, 7120741) AND A 3.5X12MM XIENCE SIERRA (1500350-12, 8111541) STENTS WERE IMPLANTED. THERE WAS NO DEVICE MALFUNCTION AND TIMI FLOW III WITH 0% RESIDUAL STENOSIS WAS OBSERVED. ON (B)(6) 2020, THE PATIENT PRESENTED TO AN OUTPATIENT CLINIC WITH ANGINA. MYOCARDIAL SCINTIGRAPHY WAS PERFORMED WITH NEGATIVE RESULTS. ON (B)(6) 2020, DIAGNOSTIC ANGIOGRAPHY AND THE FRACTIONAL FLOW RESERVE (FFR) OF THE LAD WAS PERFORMED. FFR LAD WAS 0.78 AND IN-STENT RESTENOSIS WITH HYPEREMIA WAS DIAGNOSED WITH BOTH LAD STENTS. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND NO TREATMENT WAS PROVIDED. A CORONARY ARTERY BYPASS GRAFT IS A POSSIBILITY IN THE FUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855589 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8111541

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other