BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11305017 · Received February 9, 2021

    Report

    Report Number
    2024168-2021-01036
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    November 17, 2020
    Report Date
    February 9, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 THROMBOSIS IS LISTED IN THE XIENCE XPEDITION 48 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. 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 PROXIMAL LEFT ANTERIOR DESCENDING (LAD) 75% STENOSED LESION AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. A 3.0X48MM XIENCE XPEDITION STENT (1070300-48, 9082841) WAS IMPLANTED IN THE PROXIMAL LAD WITH ACCEPTABLE RESULTS. REPORTEDLY, POST-IMPLANTATION, THERE WAS INTRA-STENT PLAQUE PROTRUSION AND THROMBUS. AS TREATMENT, ADDITIONAL DILATATION WAS PERFORMED. 0% RESIDUAL STENOSIS AND TIMI GRADE III WAS OBSERVED POST-PROCEDURE. ON (B)(6) 2020, THE PATIENT STARTED EXPERIENCING CHEST PAIN. ON (B)(6) 2020, A CARDIAC MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. 5-10% ISCHEMIA WAS OBSERVED IN THE LAD TERRITORY. ON (B)(6) 2021, ANOTHER DIAGNOSTIC PCI WAS PERFORMED. REPORTEDLY, THE XIENCE XPEDITION STENT HAD REMAINED PATENT, WITHOUT ANY DISEASE PROGRESSION, AND THERE WAS NO DEVICE MALFUNCTION. NO TREATMENT WAS REQUIRED. PER PHYSICIAN, THE EVENT WAS UNRELATED TO THE XIENCE XPEDITION STENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196141 XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9082841

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention