BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER P.I. MUSCULAR VSD OCCLUDER

    MDR report key: 8500116 · Received April 10, 2019

    Report

    Report Number
    2135147-2019-00100
    Event Type
    Death
    Date Received
    April 10, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 29, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNSPECIFIED ISSUE AND PATIENT DEATH WAS REPORTED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL AND DIMENSIONAL 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 AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PER THE SITE THE PATIENT WAS VERY UNSTABLE DUE TO POST INFARCT VSD.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 18MM VSD MUSC PI OCCLUDER AND 20MM VSD MUSIC PI OCCLUDER WAS SELECTED FOR CLOSURE OF A MUSCULAR VSD. DURING PLACEMENT, OF THE 20MM VSD MUSC PI OCCLUDER, THE PATIENT BECAME UNSTABLE AND RESUSCITATION WAS ATTEMPTED WITHOUT SUCCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THREE WEEKS PRIOR TO THIS EVENT'S PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. ON (B)(6) 2019, THE PATIENT WAS VERY UNSTABLE DUE TO THE POST INFARCT VENTRICULAR SEPTAL DEFECT (PI VSD), SO A 18MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER (PI MVSO) AND 20MM PI MVSO WERE SELECTED FOR USE TO OCCLUDE THE PI VSD. THE 18MM PI MVSO WAS DEPLOYED BUT RESHEATHED FOR UPSIZING. DURING PLACEMENT OF THE 20MM PI MVSO, THE PATIENT'S UNSTABLE CONDITION WORSENED, AND RESUSCITATION WAS ATTEMPTED UNSUCCESSFULLY. THE PATIENT EXPIRED POST-PROCEDURE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294743 AMPLATZER P.I. MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSDMUSCPI-020 6086426

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R