BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER P.I. MUSCULAR VSD OCCLUDER

    MDR report key: 7734934 · Received July 31, 2018

    Report

    Report Number
    2135147-2018-00096
    Event Type
    Death
    Date Received
    July 31, 2018
    Date of Event
    July 4, 2018
    Report Date
    July 31, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A PERICARDIAL EFFUSION AND PATIENT DEATH WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT HAD A PROCEDURE WITH A RESIDUAL PERICARDIAL EFFUSION THAT THE USER ATTRIBUTES TO THAT PROCEDURE. ON (B)(6) 2018, A 24 MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS SELECTED FOR CLOSURE OF A POST-INFARCT VSD. A 1 MM LV PERICARDIAL EFFUSION WAS NOTED INITIALLY ON FLUOROSCOPY AT THE START OF THE PROCEDURE. DURING THE PROCEDURE, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND EXPERIENCED HYPOTENSION AT WHICH TIME A LARGE EFFUSION WAS DETECTED. THE PHYSICIAN DEPLOYED THE DEVICE IN THE 1 MM DEFECT AND DID NO FURTHER INTERVENTION FOR THE REMAINING DEFECTS DUE TO THE PATIENT CONDITION. DESPITE EFFORTS MADE TO STABILIZE THE PATIENT; IT IS REPORTED THE PATIENT DIED IN THE ICU THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576874 AMPLATZER P.I. MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSDMUSCPI-024 6246609

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R