BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11438630 · Received March 8, 2021

    Report

    Report Number
    2024168-2021-01819
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    November 26, 2018
    Report Date
    March 17, 2021
    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

    PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT AND RELABELED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF DISSECTION AND HEMATOMA, ARE LISTED IN THE XIENCE SIERRA 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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) 2018, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 2.75X33MM XIENCE SIERRA STENT (1500275-33, 8011941) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH ACCEPTABLE RESULTS AND NO COMPLICATIONS. THE OCT RUN SHOWED A DISTAL EDGE DISSECTION. AS TREATMENT, TWO ADDITIONAL XIENCE SIERRA STENTS, 2.5X12, 2.25X12MM WERE IMPLANTED. ANOTHER OCT RUN WAS PERFORMED SHOWING AN OBSTRUCTIVE RESIDUAL HEMATOMA. REPORTEDLY, THE RESIDUAL HEMATOMA WAS RELATED TO THE DISSECTION, NOTED AFTER THE FIRST STENT, THE 2.75X33MM XIENCE SIERRA STENT WAS IMPLANTED. DUE TO THE RESIDUAL HEMATOMA, ANOTHER XIENCE SIERRA STENT, 2.25X8MM WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH TIMI FLOW III AND NO FURTHER DISSECTION. POST-PROCEDURE, ELEVATED CARDIAC ENZYMES WERE OBSERVED. THERE WAS NO PROLONGED HOSPITALIZATION AND NO ADDITIONAL TREATMENT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328520 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8011941

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention