BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8562855 · Received April 29, 2019

    Report

    Report Number
    2024168-2019-03401
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    April 5, 2019
    Report Date
    April 29, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648227097
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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 EFFECTS OF ANGINA AND THROMBOSIS ARE LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 2.5X23MM (9011541) XIENCE SIERRA STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN OF 7 DAYS AND DYSPNEA OF 4 DAYS. CORONARY ANGIOGRAPHY WAS PERFORMED, AND THROMBUS WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A MYOCARDIAL INFARCTION WAS DIAGNOSED. INTERVENTION WAS PERFORMED AND TWO XIENCE SIERRA STENTS (2.5X15 MM (8102442), 2.5X23MM (9011541)) WERE IMPLANTED IN OVERLAPPING FASHION IN THE LAD. THE ACTIVATED CLOTTING TIME (ACT) WAS 260 ON A FIRST MEASUREMENT AND 400 ON A SECOND MEASUREMENT. THE PATIENT WAS ADMINISTERED ASPIRIN AND PLAVIX; HOWEVER, IT WAS NOTED THAT THE PATIENT WAS PLAVIX-RESISTANT. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN OF 1 DAY. THE LAD WAS NOTED TO BE OCCLUDED WITH THROMBUS IN THE STENTED SEGMENT. THE PATIENT WAS REFERRED FOR SURGICAL CONSULT AND UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE ON AN UNSPECIFIED DATE. POST-SURGICAL PROCEDURE, THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355651 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8102442 08717648227097

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R| S