BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11279522 · Received February 4, 2021

    Report

    Report Number
    2024168-2021-00871
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 4, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227271
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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 MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 2.5X12MM (1550250-12, 0022741) XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. FOLLOWING, A 3.0X23MM (1550300-23, 0021241) XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD. A DEVICE MALFUNCTION WAS NOT REPORTED AND 0% RESIDUAL STENOSIS WITH TIMI FLOW GRADE III WAS OBSERVED POST-PROCEDURE. ON (B)(6) 2021, THE PATIENT PRESENTED LEFT SIDED CHEST PAIN, RADIATING TO THE LEFT SCAPULA, AND SHORTNESS OF BREATH. PER IMAGING, THE PROXIMAL LAD WAS 80% RESTENOSED, WITHOUT A DEVICE MALFUNCTION OBSERVED. AS TREATMENT, ANOTHER STENT WAS IMPLANTED IN THE PROXIMAL LAD, TARGET LESION. THE EVENT DID NOT REQUIRE HOSPITALIZATION AND RESOLVED WITHOUT SEQUALA THAT SAME DAY. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175628 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550300-23 0021241 08717648227271

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention XIENCE SIERRA STENT