BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10165400 · Received June 17, 2020

    Report

    Report Number
    2024168-2020-05121
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 17, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OF PERFORATION IS LISTED IN THE XIENCE ALPINE (PRO-A) EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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) 2020, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. A 4.0X28MM XIENCE PROA STENT (1128400-28 8022341) WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION WITHOUT A DEVICE ISSUE. FOLLOWING, A PERFORATION OCCURRED. DILATATION WAS PERFORMED AND A 4.0X33MM XIENCE PRO STENT (1128400-33 8011941) WAS IMPLANTED. TWO COVERED, NON-ABBOTT STENTS (PAPYRUS, BIOTRONIK) WERE IMPLANTED, SEALING THE PERFORATION. THE EVENT RESOLVED WITHOUT SEQUELA. POST-PROCEDURE, TIMI FLOW 3 WITH 0% RESIDUAL STENOSIS WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629091 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8022341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention