BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10009396 · Received April 29, 2020

    Report

    Report Number
    2024168-2020-03984
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 6, 2017
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-030878.PDF].

    Additional Manufacturer Narrative · 1

    EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND CARDIAC ARREST ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 6 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED WENT INTO CARDIAC ARREST 1222 DAYS LATER AND THROMBOSIS WAS IDENTIFIED. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472621 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S