BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 17413651 · Received July 28, 2023

    Report

    Report Number
    2135147-2023-03298
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    March 25, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A LITERATURE ARTICLE, A PATIENT WAS DIAGNOSED WITH RIGHT AORTIC ARCH (RAA) AND ASSOCIATED WITH KOMMERELL DIVERTICULUM (KD). FIVE YEARS POST-PROCEDURE, PATIENT'S ANEURYSM DIAMETER HAD NOT INCREASED AND THE PATIENT WAS UNDER FOLLOW UP AS AN OUTPATIENT. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE ABSTRACT, "TREATMENT STRATEGIES FOR KOMMERELL DIVERTICULURN", WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF A 75-YEAR-OLD MALE WAS DIAGNOSED WITH RIGHT AORTIC ARCH (RAA) · KOMMERELL DIVERTICULURN (KD) AFTER UNDERGOING A MEDICAL EXAMINATION ON AN UNKNOWN DATE 5 YEARS AGO. THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH 2-DEBRANCHING PROCEDURES ON THE LEFT CAROTID ARTERY (LCA) INCLUDED BYPASS ON THE -BILATERAL SUBCLAVIAN ARTERY (SCA) AND AN AMPLATZER VASCULAR PLUG II IMPLANT ON THE +BILATERAL SCA. ACCESS WAS PERFORMED AT THE RIGHT FEMORAL ARTERY APPROACH. THE PATIENT HAD A TYPE II ENDOLEAK BUT WAS STABLE AND DISCHARGED SAME DAY. IT WAS REPORTED 5 YEARS POST-PROCEDURE, PATIENT'S ANEURYSM DIAMETER HAD NOT INCREASED AND THE PATIENT WAS UNDER FOLLOW UP AS AN OUTPATIENT. [THE PRIMARY AUTHOR WAS KEISUKE NAKAMURA, SHOWA UNIVERSITY NORTHERN YOKOHAMA HOSPITAL, 35-1 CHIGASAKICHUO, TSUZUKI WARD, YOKOHAMA, KANAGAWA 224-0032, JAPAN].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968431 AMPLATZER VASCULAR PLUG II DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other