BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10362203 · Received August 4, 2020

    Report

    Report Number
    2024168-2020-06477
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    March 26, 2019
    Report Date
    August 4, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 99% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 2.75X33MM XIENCE SIERRA STENT (1500275-33, 8082141) WAS IMPLANTED. STENT PLACEMENT WAS DEEMED ACCEPTABLE WITH 0% RESIDUAL DIAMETER STENOSIS, TIMI FLOW III, AND NO COMPLICATIONS. POST-PROCEDURE THAT SAME DAY, ELEVATED TROPONIN WAS OBSERVED. ANOTHER TROPONIN WAS DRAWN WITH THE RESULTS TRENDED DOWNWARD. REPORTEDLY, THE EVENT WAS SERIOUS AS PROLONGED HOSPITALIZATION WAS REQUIRED. THERE WAS NO NEW MYOCARDIAL INFARCTION DIAGNOSED, NO TREATMENT REQUIRED, AND THERE WAS NO DEVICE MALFUNCTION. THE EVENT RESOLVED WITHOUT SEQUELA AND THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY, (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826691 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8082141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization