MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 24 mm amplatzer septal occluder was chosen for implant using 10f amplatzer trevisio delivery system.Complex anatomy with large atrial septal defect.A discrepancy was observed between tee and fluoroscopy measurements when sizing the defect with a balloon.The 24 mm device was deployed first; however, a peri-device leak was noted around the waist, and the device was subsequently retrieved.The device was then upsized to a 28 mm amplatzer septal occluder.During deployment, a portion of the left disc was released into the right atrium, prompting the operator to fully recapture the device.During recapture, a structure resembling a clot was visualized, appearing attached to the septum and floating within the right atrium.The device and delivery system were carefully removed and inspected, and no clot was identified on either component.The physician sought a second opinion from colleagues, and the team concluded that the structure was likely a partially detached piece of septal tissue.No asd device was implanted, and the plan was to continue monitoring the patient.The patient remained hemodynamically stable for the duration of the procedure and was discharged the following day.
Event or Problem Description
It was reported that on (b)(6)2026, a 24mm amplatzer septal occluder was chosen for implant using 10f amplatzer trevisio delivery system.Complex anatomy with large atrial septal defect.A discrepancy was observed between tee and fluoroscopy measurements when sizing the defect with a balloon.The 24 mm device was deployed first; however, a peri-device leak was noted around the waist, and the device was subsequently retrieved.It was confirmed that there was no additional product experience other than the mis-sizing.The device was then upsized to a 28 mm amplatzer septal occluder.During deployment, a portion of the left disc was released into the right atrium, prompting the operator to fully recapture the device.During recapture, a structure resembling a clot was visualized, appearing attached to the septum and floating within the right atrium.It was confirmed that it was not a thrombus , but a structure that seemed to be a thin layer of septum was in the right atrium.The physicians (interventional cardiologist and echographists) confirmed that the structure is a thin piece of septum still attached to the main septum.The device and delivery system were carefully removed and inspected, and no clot was identified on either component.The physician sought a second opinion from colleagues, and the team concluded that the structure was likely a partially detached piece of septal tissue.The cause was reported to be not clear, it could have been during device positioning attempts and/or passage of the delivery system though the asd.No asd device was implanted, and the plan was to continue monitoring the patient.The patient remained hemodynamically stable for the duration of the procedure and was discharged the following day.
Additional Manufacturer Narrative
An event of unspecified tissue injury was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The physician mentioned there was no clot found on the delivery system and on the device.The physician concluded that it was a piece of septum partially detached.A more comprehensive assessment of the device or the unspecified tissue could not be performed as the device was not returned for analysis.Based on the 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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24689631
• Report Number: 2135147-2026-01915
• Device Sequence Number: 9903327
• Product Code: MLV
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8544880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female