BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 10842853 · Received November 16, 2020

    Report

    Report Number
    2135147-2020-00476
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 19, 2020
    Report Date
    December 14, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010090
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEFORMATION DURING DEPLOYMENT COULD NOT BE CONFIRMED. 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. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE ARTMT100116885 REV. A, "THE AMPLATZER¿ SEPTAL OCCLUDER IS A PERCUTANEOUS, TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE DEVICE INTENDED FOR THE OCCLUSION OF ATRIAL SEPTAL DEFECTS (ASDS) IN SECUNDUM POSITION OR PATIENTS WHO HAVE UNDERGONE A FENESTRATED FONTAN PROCEDURE AND WHO NOW REQUIRE CLOSURE OF THE FENESTRATION." AN INITIAL REVIEW OF COMPLAINTS DATA WAS REVIEWED ON (B)(6) 2020 AS A COMPONENT OF THE COMPLAINT HANDLING RISK REVIEW PER WI 90591806. THE MEDICAL DEVICE PROBLEM AND AHO CODES ARE CONSISTENT WITH THE HAZARDS/HARMS IDENTIFIED FOR THIS PRODUCT FAMILY, AND NO NEW HAZARDS OR HARMS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    AN 12MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS SELECTED FOR VSD IMPLANT. THE USER TRIED A 12MM AMPLATZER SEPTAL OCCLUDER (LOT NO: 6240039),AND IT FORMED A SHAPE OF A COBRA AND WOULDN¿T SIT APPROPRIATELY. WE DECIDED WE WOULD TRY A 14MM AMPLATZER SEPTAL OCCLUDER(LOT NO: 7266691), THAT TOO ALSO FORMED A SHAPE OF A COBRA, BUT IN THIS CASE AFTER A COUPLE OF TRIES IT WOULDN¿T GO BACK TO ORIGINALLY SHAPE AS GOOD AS IT SHOULD HAVE, THE SAME THING HAPPENED WITH 13MM AMPLATZER SEPTAL OCCLUDER (LOT NO: 6791191). IT WAS DECIDED TO TRY A MUSCULAR VSD, THEREFORE WE CLOSED THE SECOND HOLE WITH AN AVP2. THE PATIENT WASN¿T HARMED AT DURING PROCEDURE. THE CASE JUST TOOK A LITTLE LONGER THAN HOPED. ADDITIONAL REPORTS FOR 9-ASD-014 (MDR-2020-48416), 9-ASD-013 (MDR-2020-48435).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310919 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-012 6240039 00811806010090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization