BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 11135525 · Received January 7, 2021

    Report

    Report Number
    2024168-2021-00242
    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
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE. MAJORITY. ESTIMATED. 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 RX ACCULINK. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF A STENT IN CAROTID ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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, RX ACCULINK CAROTID STENT SYSTEM.¿NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP (PMCF) REPORT THAT THE ACCULINK 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 ATTACHED PMCF REPORT, VASCULAR QUALITY INITIATIVE, MEDICAL DEVICE REPORT PREPARED FOR ABBOTT VASCULAR, RX ACCULINK CAROTID STENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29130 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT NIM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death