BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10338735 · Received July 29, 2020

    Report

    Report Number
    2024168-2020-06280
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227295
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 EFFECT OF PROLAPSE IS LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM 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 OF THE DEVICE. THE ADDITIONAL XIENCE SIERRA DEVICE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI), ELEVATED TROPONIN, AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION AND A 2.75X33MM XIENCE SIERRA STENT (1550275-33, 0011041) WAS IMPLANTED. AN EDGE DISSECTION WAS OBSERVED, TREATED WITH A 3.0X33MM XIENCE SIERRA STENT (1550300-33, 0021841). POST-DILATATION WAS PERFORMED ON THE 3.0X33MM XIENCE SIERRA STENT WHEN A PLAQUE SHIFT WITH 100% OCCLUSION OCCURRED IN THE PROXIMAL DIAGONAL CORONARY ARTERY. ADDITIONAL ANGIOPLASTY WAS PERFORMED AS TREATMENT. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND THE EVENT RESOLVED. POST-PROCEDURE RESULTS WERE ACCEPTABLE, 0% RESIDUAL DIAMETER STENOSIS AND TIMI FLOW III. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802652 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550300-33 0021841 08717648227295

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention XIENCE SIERRA STENT