BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 16897452 · Received May 9, 2023

    Report

    Report Number
    2135147-2023-02001
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 19, 2022
    Report Date
    August 1, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    UDI-DI
    00811806010397
    PMA / PMN Number
    K071699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF RESIDUAL SHUNT AFTER PLACEMENT OF THE DEVICE AND EXPLANT WAS REPORTED. INFORMATION FROM THE FIELD INDICATED THAT AFTER THE DEVICE IMPLANTED IT POPPED OUT OF THE PVL. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE FIELD. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. 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

    CLINICAL INFORMATION: CRD_1008 - AV-MDR, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO PLUG A PARAVALVULAR LEAK (PVL). PRIOR TO 12MM DEVICE IMPLANT, A 10MM AMPLATZER VASCULAR PLUG II (8372531) WAS SUCCESSFULLY IMPLANTED IN ANOTHER NEARBY PVL. WHILE ATTEMPTING TO IMPLANT THE 12MM DEVICE (8368984), DEVICE DEPLOYMENT WAS SUCCESSFUL. HOWEVER, LEAKAGE WAS SEEN AROUND THE PLUG AND AFTER THE DEVICE WAS IN PLACE, IT POPPED OUT OF THE PVL. AFTERWARDS, THE DEVICE WAS EXPLANTED AND A SECOND 10MM AMPLATZER VASCULAR PLUG II (7810738) WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED AS STABLE.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: CRD_1008 - AV-MDR, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT. PRIOR TO 12MM DEVICE IMPLANT, A 10MM AMPLATZER VASCULAR PLUG II (8372531) WAS SUCCESSFULLY IMPLANTED. WHILE ATTEMPTING TO IMPLANT THE 12MM DEVICE (8368984), DEVICE DEPLOYMENT WAS SUCCESSFUL, HOWEVER, AFTER THE DEVICE WAS IN PLACE, IT CAME OUT. LEAKAGE WAS SEEN AROUND THE PLUG AND CONSIDERED CLINICALLY ACCEPTABLE. AFTERWARDS, A SECOND 10MM AMPLATZER VASCULAR PLUG II (7810738) WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854273 AMPLATZER VASCULAR PLUG II DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL 9-AVP2-012 8368984 00811806010397

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male