BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 9772695 · Received March 1, 2020

    Report

    Report Number
    2135147-2020-00086
    Event Type
    Malfunction
    Date Received
    March 1, 2020
    Date of Event
    January 30, 2020
    Report Date
    April 2, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806011813
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6, AND H10. AN EVENT OF INABILITY TO RETRACT THE OCCLUDER INTO THE SHEATH COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE OCCLUDER MET DIMENSIONAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER 2135147-2020-00087. ON (B)(6) 2020, AN 8MM AMPLATZER MUSCULAR VSD WAS ATTEMPTED TO BE IMPLANTED. IT WAS MIS-SIZED TOO SMALL AND EXCHANGED FOR A 10MM AMPLATZER MUSCULAR VSD OCCLUDER (LOT # 6925807) WITH A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. WHEN POSITIONING THE DEVICE, IT WAS DETERMINED TO BE MI-SIZED TOO SMALL. WHEN ATTEMPTING TO RETRACT THE DEVICE, THE DEVICE WOULD NOT RE-SHEATH NOR RETRACT INTO THE 6F DELIVERY SHEATH AND A VASCULAR ISSUE OCCURRED WITH HEMATOMA AT THE GROIN. THE DEVICE AND THE DELIVERY SYSTEM WAS REMOVED AND THE DELIVERY SYSTEM WAS EXCHANGED FOR AN 8F TORQVUE 45/80 DELIVERY SYSTEM (LOT # UNKNOWN) AND A NEW 10MM MUSCULAR VSP (LOT # 6942246). THE PHYSICIAN NOTED THAT THE PATIENT HAD A TORTUROUS ANATOMY AND THERE WAS NO KINKS NOTED ON THE FIRST DELIVERY SYSTEM (LOT # 6271477). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS STABLE DURING AND POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236326 AMPLATZER MUSCULAR VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-010 6925807 00811806011813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AMPLATZER TORQVUE DELIVERY SYSTEM