BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PERCLOSE

    MDR report key: 24676561 · Received March 24, 2026

    Report

    Report Number
    2024168-2026-01202
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    April 1, 2023
    Report Date
    March 24, 2026
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE PRODUCTION RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF HEMORRHAGE AND TISSUE INJURY AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A DEFINITIVE CAUSE FOR THE ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS LIKELY RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. B3: ESTIMATED DATE. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE, TITLED "SUITABILITY FOR TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT IN THE JAPANESE POPULATION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE ANATOMICAL CHARACTERISTICS OF THE COMMON CAROTID ARTERY (CCA) AND THE SUITABILITY OF PATIENTS FOR TRANS CAROTID (TC) TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). BETWEEN APRIL 2023 AND MARCH 2024, 336 PATIENTS WERE CATEGORIZED INTO A TOUGH-TRANSFEMORAL (TF) GROUP, WHO MAY REQUIRE AN ALTERNATIVE APPROACH, AND A VIABLE-TF GROUP. IN THE TF GROUP, TWO PERCLOSE DEVICES WERE PRE-PLACED. IT WAS REPORTED THE PERCLOSE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO VASCULAR INJURY, BLEEDING, AND MEDICAL INTERVENTION. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "SUITABILITY FOR TRANS CAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT IN THE JAPANESE POPULATION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256780 UNK PERCLOSE VESSEL CLOSURE SUTURE MGB ABBOTT VASCULAR UNK PERCLOSE CLOSURE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention