BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 20429231 · Received October 11, 2024

    Report

    Report Number
    2135147-2024-05032
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B2: DATE OF DEATH IS ESTIMATED AS (B)(6) 2024 AS THIS WAS THE DATE THE EVENT WAS REPORTED TO ABBOTT. B3: DATE OF EVENT IS ESTIMATED AS 17 SEPTEMBER 2024 AS THIS WAS THE DATE THE EVENT WAS REPORTED TO ABBOTT. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH: THE DEATH DATE WAS ESTIMATED AS (B)(6) 2024 AS THIS WAS THE DATE THE DEATH WAS REPORTED TO ABBOTT. IT WAS REPORTED THAT A PATIENT UNDERWENT ASD CLOSURE USING THE AMPLATZER SEPTAL OCCLUDER ON AN UNKNOWN DATE SOMETIME IN THE PAST TWO YEARS AND SUBSEQUENTLY WAS REPORTED TO HAVE EXPIRED FROM A DEVICE EROSION. ALSO REPORTED THAT THE AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PEDIATRIC PATIENT WITH A DEFICIENT RETRO-AORTIC RIM. HOWEVER, SOMETIME FOLLOWING HOSPITAL DISCHARGE THE PATIENT HAD A CARDIAC ARREST AND ULTIMATELY DIED. A MORE COMPREHENSIVE ASSESSMENT, COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. BASED ON MEDICAL REVIEW PERFORMED AT ABBOTT, THE EXACT CAUSE FOR THE REPORTED EROSION IS UNKNOWN AND IT WAS NOT POSSIBLE TO CONFIRM THE EVENT. A DEVICE EROSION IS A RARE POTENTIAL ADVERSE EVENT THAT MAY OCCUR FOLLOWING IMPLANTATION OF THE ASO. DEVICE OVERSIZING AND A DEFICIENT RETRO AORTIC RIM HAVE PREVIOUSLY IDENTIFIED AS POTENTIAL RISK FACTORS FOR A DEVICE EROSION; HOWEVER, IN THIS CASE SINCE THERE IS NO INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF ANY OF THESE RISK FACTORS WERE PRESENT. THE DEVICE BATCH/LOT NUMBER WAS NOT PROVIDED, AND THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. NO IMPLANT-RELATED FACTORS COULD BE CONFIRMED AS INFORMATION RELATED TO THE IMPLANT PROCEDURE WAS NOT PROVIDED FROM THE ACCOUNT. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT DIED DUE TO AORTIC EROSIONS AFTER THE IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT DIED DUE TO AORTIC EROSIONS AFTER THE IMPLANT PROCEDURE. IT WAS NOTED THAT THE AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED IN A PEDIATRIC PATIENT WITH A DEFICIENT RETRO-AORTIC RIM. HOWEVER, SOMETIME FOLLOWING HOSPITAL DISCHARGE THE PATIENT HAD A CARDIAC ARREST AND ULTIMATELY DIED. AUTOPSY FINDINGS FOR BOTH CASES DEMONSTRATED EVIDENCE OF DEVICE EROSION. THE DEVICE SIZES AND EXACT IMPLANT DATES AND DATES OF DEATH ARE UNKNOWN. IT IS ESTIMATED THAT THE IMPLANTS OCCURRED SOMETIME IN THE PAST TWO YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293358 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death