BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11632060 · Received April 7, 2021

    Report

    Report Number
    2135147-2021-00132
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 16, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010236
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY 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

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

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 2135147-2021-00131. ON (B)(6) 2021, AFTER BALLOON SIZING AT 34MM WITH LITTLE AORTIC RIM, A 38MM AMPLATZER SEPTAL OCCLUDER (LOT#5612973) WAS SELECTED FOR IMPLANT IN THE PATIENT USING AN AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#7302272). DURING THE PROCEDURE THE DEVICE DEPLOYED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW 38MM AMPLATZER SEPTAL OCCLUDER (LOT#6330319). USING THE SAME DELIVERY SYSTEM, THE 38MM DEVICE WAS DEPLOYED IN THE PATIENT, BUT WAS MISSIZED TOO LARGE. THE DEVICE AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND EXCHANGED FOR A 32MM AMPLATZER SEPTAL OCCLUDER(LOT#6140846) AND A NEW AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#707244). THE DEVICE DEPLOYED IN THE PATIENT IN A COBRA SHAPE AND THE PHYSICIAN EXCHANGED THE DEVICE FOR A NEW 32MM AMPLATZER SEPTAL OCCLUDER (LOT# 5933064). USING THE SAME DELIVERY SYSTEM, THE DEVICE WAS DEPLOYED WITH GOOD RESULTS IN THE PATIENT AND WAS RELEASED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE WITH NO ADVERSE EVENTS. THE PATIENT IS CURRENTLY DISCHARGED AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529581 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-032 6140846 00811806010236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 38MM AMPLATZER SEPTAL OCCLUDER.