BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 9835392 · Received March 16, 2020

    Report

    Report Number
    2024168-2020-02453
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 7, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THE REPORTED PATIENT EFFECT(S) OF DISSECTION, THROMBOSIS AND MYOCARDIAL INFARCTION 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. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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 ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE PATIENT PRESENTED WITH A LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, CHRONIC TOTAL OCCLUSION (CTO). PREDILATATION WAS PERFORMED AND A 2.5X28MM XIENCE SIERRA STENT (1500250-28, 9100741) WAS IMPLANTED. POST-STENT OCT WAS PERFORMED. A PROXIMAL EDGE DISSECTION AND AN INTRA-STENT THROMBUS WERE OBSERVED. THROMBUS ASPIRATION AND THROMBOLYTICS WERE PROVIDED. POST-DILATATION WAS PERFORMED. THE END RESULT WAS TIMI FLOW III AND 0% STENOSIS. REPORTEDLY, THE STENT WAS FULLY APPOSED TO THE VESSEL WALL. NO ADDITIONAL TREATMENT WAS PROVIDED. POST-PROCEDURE, THERE WAS A MODERATE INCREASE IN CREATININE KINASE-MYOCARDIAL BAND (CK-MB), 40.1NG/ML, AND A MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. PROLONGED HOSPITALIZATION WAS REQUIRED AND THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298255 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9100741

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S