BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER P.I. MUSCULAR VSD OCCLUDER

    MDR report key: 11012820 · Received December 15, 2020

    Report

    Report Number
    2135147-2020-00541
    Event Type
    Death
    Date Received
    December 15, 2020
    Report Date
    December 29, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF THE DEVICE PREMATURELY DETACHING AND PATIENT DEATH WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED WAS NOT RETURNED FOR ANALYSIS. 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 · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2020, A 22MM AMPLATZER OCCLUDER WAS SELECTED FOR IMPLANT. THE DEVICE WAS ADVANCED THROUGH THE 12 FR DELIVERY SYSTEM FROM THROUGH THE DEFECT, WHICH WAS VERY APICAL. AS THE DEVICE WAS DEPLOYED, THE LEFT VENTRICULAR DISC DEPLOYED WITH NO ISSUE. AS THE DEVICE WAS BEING PULLED INTO THE DEFECT (DELIVERY SYSTEM AND DEVICE TOGETHER) THE DEVICE CAME OFF THE END OF THE DELIVERY CABLE AND BECAME FREE INTO THE LEFT VENTRICLE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE DEVICE DURING WHICH TIME THE PATIENT BECAME UNSTABLE, REQUIRING CPR, AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478534 AMPLATZER P.I. MUSCULAR VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION VSDMUSCPI-022-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Death