BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10003018 · Received April 27, 2020

    Report

    Report Number
    2024168-2020-03932
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    December 1, 2013
    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-030866.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 MYOCARDIAL INFARCTION AND THROMBOSIS 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 OF MYOCARDIAL INFARCTION AND THROMBOSIS, 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 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 TO DISTAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X20MM BALLOON AT 14 ATMOSPHERES (ATMS), AND THE 3.5X10MM XIENCE STENT WAS IMPLANTED AT 18 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X18MM BALLOON AT 14 ATMS. ANOTHER 2.75X28MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED AGAIN WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 8 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI ON THE SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE 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
    466473 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S 2.75X28 XIENCE STENT