BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10995665 · Received December 12, 2020

    Report

    Report Number
    2024168-2020-10416
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    September 20, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 STENOSIS AND ANGINA ARE LISTED IN THE XIENCE ALPINE, EVEROLIMUS ELUTING CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE, AS KNOWN PATIENT EFFECTS OF CORONARY STENTING 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 OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (MI) AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE RIGHT CORONARY ARTERY (RCA) LESION. PRE-DILATATION WAS PERFORMED AND A 3.0X38MM XIENCE ALPINE (1120300-38, 7121941) STENT WAS IMPLANTED IN THE PROXIMAL RCA AND A 3.5X38MM XIENCE ALPINE (1120350-38, 7111441) STENT WAS IMPLANTED IN THE MID RCA. REPORTEDLY, THE STENTS WERE SUCCESSFULLY IMPLANTED, OVERLAPPING, WITH 0% RESIDUAL STENOSIS OBSERVED. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXPERIENCING PRECORDIAL CHEST TIGHTNESS THE DAY BEFORE ON (B)(6) 2020. THE CHEST TIGHTNESS WAS PAROXYSMAL AND WOULD RESOLVE ON ITS OWN WITH REST. CORONARY IMAGING WAS PERFORMED. THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY HAD 40% STENOSIS, THE MID RCA HAD ABOUT 70% RESTENOSIS. REPORTEDLY, ONLY THE 3.5X38MM XIENCE ALPINE HAD RESTENOSIS. MEDICATION WAS PROVIDED AND BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460898 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 7111441

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R