BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION

    MDR report key: 9759037 · Received February 26, 2020

    Report

    Report Number
    2024168-2020-01809
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 26, 2020
    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 · 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 DISSECTION IS LISTED IN THE XIENCE PRO 48 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(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 80% STENOSED LESION AND A 3.0X48MM (1017300-48, 9080641) XIENCE PRO STENT WAS IMPLANTED. FOLLOWING, A DISSECTION OCCURRED, TREATED AND OVERLAPPED WITH ANOTHER STENT, A 3.5X8MM (1500350-08, 8010541) XIENCE PRO STENT. THE DISSECTION RESOLVED. REPORTEDLY, THE ANGIOGRAPHIC RESULTS WERE ACCEPTABLE, 0% STENOSIS AND TIMI FLOW III. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217003 XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9080641

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention