BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 11135551 · Received January 7, 2021

    Report

    Report Number
    2024168-2021-00244
    Event Type
    Death
    Date Received
    January 7, 2021
    Date of Event
    January 1, 2014
    Report Date
    January 7, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: AVERAGE. THE UDI IS UNKNOWN AS INDIVIDUAL PART AND LOT NUMBERS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE XACT. THE REPORTED PATIENT EFFECTS OF DEATH, IS LISTED IN THE XACT INSTRUCTIONS FOR USE AS KNOWN POSSIBLE ADVERSE EVENT THAT MAY BE ASSOCIATED WITH CAROTID STENTS AND EMBOLIC PROTECTION SYSTEMS. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH, 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 ADDITIONAL PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. REPORTED ATTACHED: ¿VASCULAR QUALITY INITIATIVE, MEDICAL DEVICE REPORT PREPARED FOR ABBOTT VASCULAR, X.ACT CAROTID STENT SYSTEM.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP (PMCF) REPORT THAT THE XACT CAROTID ARTERY STENT MAY BE RELATED TO STROKE, MI, ACCESS SITE COMPLICATION, POST-PROCEDURAL TIA, RECURRENT CAROTID RESTENOSIS, RE-TREATMENT (PERCUTANEOUS AND SURGICAL), AND DEATH. A DEVICE MALFUNCTION WAS NOT REPORTED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE PROVIDED IN THE PMCF REPORT, VASCULAR QUALITY INITIATIVE, MEDICAL DEVICE REPORT PREPARED FOR ABBOTT VASCULAR, X.ACT CAROTID STENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26811 XACT CAROTID STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death