BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA

    MDR report key: 9491712 · Received December 18, 2019

    Report

    Report Number
    2024168-2019-14710
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    November 27, 2019
    Report Date
    February 6, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION, HEMATOMA, ARRHYTHMIA, ANGINA, AND OCCLUSION 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. D4: UDI NUMBER.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT HAD ALSO RECEIVED MORPHINE AS TREATMENT.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. THE DEVICE 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) 2019, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 3.5X33MM (1500350-33, 9091641) XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION WITH ACCEPTABLE RESULTS. THERE WAS 0% DIAMETER STENOSIS, TIMI FLOW III, AND NO COMPLICATION. ON (B)(6) 2019, THE PATIENT PRESENTED WITH RETROSTERNAL PAIN WITH RADIATION TO THE LEFT ARM, DYSPNEA, AND PALPITATIONS. ELEVATED CARDIAC ENZYMES WERE OBSERVED AND A ST ELEVATED MI WAS DIAGNOSED. CORONARY IMAGING WAS PERFORMED AND A NEW OCCLUSION (99%) OF THE MID LAD WAS SEEN. REPORTEDLY, THE OCCLUSION WAS DUE TO AN INTRAMURAL HEMATOMA. ANOTHER STENT WAS IMPLANTED AS TREATMENT. PER PHYSICIAN, THERE WAS NO DEVICE DEFICIENCY. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283318 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9091641

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R| S