BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER P.I. MUSCULAR VSD OCCLUDER

    MDR report key: 10680653 · Received October 14, 2020

    Report

    Report Number
    2182269-2020-00091
    Event Type
    Death
    Date Received
    October 14, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 23, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF EMBOLIZATION WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE 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

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A 12MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, A COBRA-DEFORMATION WAS NOTED. THE DEVICE WAS PULL BACK INTO THE SHEATH AND DETACHED INTO THE SVC AND THE DEFORMATION WAS STILL NOTED. THE OCCLUDER WAS SNARED THOUGH A LARGE SHEATH. A 18MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND WAS UNSTABLE. A FEW HOURS POST PROCEDURE THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. IT WAS REPORTED THAT THE MUSCULAR VSD OCCLUDER HAD EMBOLIZED INTO THE RIGHT VENTRICLE AND THE PATIENT EXPIRED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141813 AMPLATZER P.I. MUSCULAR VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL 9-VSDMUSCPI-018 7371484

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R 9-ASD-012, 6077480| 9-ASD-012, 6077480