BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11324240 · Received February 12, 2021

    Report

    Report Number
    2024168-2021-01170
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 12, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 EFFECT(S) OF STENOSIS AND ANGINA ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A MID-RIGHT CORONARY ARTERY (RCA), 80% STENOSED LESION AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE MID RCA AND A 2.5X23MM (1500250-23, 9080641) AND 3.0X28MM (1500300-28, 9081641) XIENCE SIERRA STENTS WERE IMPLANTED WITH ACCEPTABLE RESULTS. ON (B)(6) 2020, THE PATIENT HAD PRESENTED WITH ANGINA AND A POSITIVE STRESS TEST WITH ST DEPRESSION IN V4-V6 LEADS. ON (B)(6) 2021, A DIAGNOSTIC CORONARY ANGIOGRAM WAS PERFORMED WITH MODERATE (40%) STENOSIS JUST BEFORE THE PREVIOUSLY IMPLANTED, MID RCA 3.0X28MM XIENCE SIERRA STENT. THE MID RCA 2.5X23MM XIENCE SIERRA STENT REMAINED PATENT. ADDITIONAL HOSPITALIZATION WAS NOT REQUIRED, AND NO TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221027 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9081641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other