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

Model Number	9-ASD-022
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer septal occluder was implanted using an unknown delivery system.The aortic rim measured 2.9 mm, and the original atrial septal defect was 13 mm × 16 mm.Balloon sizing indicated a diameter of 21 mm, and based on this measurement, a 22 mm device was selected for implantation.It was noted that there were no difficulties implanting the device.At the four month follow-up on (b)(6) 2025, transthoracic echocardiography (tte) revealed pericardial effusion, although the patient remained asymptomatic.Transesophageal echocardiography (tee) demonstrated device protrusion toward the aorta with a 1.4-mm dent, along with asd effusion and cardiac tamponade extending up to the atrium.It was noted that the tamponade had not reached the aorta (ao), but the device was in a state of rubbing against the aortic wall.According to the operative record, the amplatzer device protruded into the atrium toward the non-coronary cusp (ncc) of the valsalva sinus.Contusion was observed on the adventitia of the aortic wall, and a known thrombus was identified between the aortic wall and the atrium.On (b)(6) 2025, minimally invasive cardiac surgery (mics) was performed by the cardiovascular surgery team.On the atrial side, surgicel sheet, autologous pericardium, and hydrofit were applied for hemostasis.On the aortic side, tachosil was pressed in place for reinforcement, and hemostasis was confirmed.The device was not removed; instead, autologous pericardium was used to support the area of abrasion on the aortic wall.A right thoracic drainage tube was placed, and the chest wall and wound were closed to complete the procedure.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer septal occluder was implanted using an unknown delivery system.The aortic rim measured 2.9 mm, and the original atrial septal defect was 13 mm × 16 mm.Balloon sizing indicated a diameter of 21 mm, and based on this measurement, a 22 mm device was selected for implantation.It was noted that there were no difficulties implanting the device.At the 4-month follow-up on (b)(6) 2025, transthoracic echocardiography (tte) revealed pericardial effusion, although the patient remained asymptomatic.Transesophageal echocardiography (tee) demonstrated device protrusion toward the aorta with a 1.4-mm dent, along with asd effusion and cardiac tamponade extending up to the atrium.It was noted that the tamponade had not reached the aorta (ao), but the device was in a state of rubbing against the aortic wall.According to the operative record, the amplatzer device protruded into the atrium toward the non-coronary cusp (ncc) of the valsalva sinus.Contusion was observed on the adventitia of the aortic wall, and a known thrombus was identified between the aortic wall and the atrium.The thrombus was not weird in shape.The patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability and the patient did not receive any treatment (medications), including over-the-counter medications, that could contribute to thrombus formation.On (b)(6) 2025, minimally invasive cardiac surgery (mics) was performed by the cardiovascular surgery team.On the atrial side, surgicel sheet, autologous pericardium, and hydrofit were applied for hemostasis.On the aortic side, tachosil was pressed in place for reinforcement, and hemostasis was confirmed.The device was not removed; instead, autologous pericardium was used to support the area of abrasion on the aortic wall.A right thoracic drainage tube was placed, and the chest wall and wound were closed to complete the procedure.
Additional Manufacturer Narrative
An event of a patient-device incompatibility (implant related tissue damage) was reported with pericardial effusion, and cardiac tamponade.A returned device 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported patient-device incompatibility could not be determined.It is possible that anatomical factors contributed to the event, however this cannot be determined.The reported pericardial effusion, and cardiac tamponade are likely cascading effects from the event.A surgical intervention was a result of case specific circumstances, as surgical treatment was performed to treat perforation.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): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24122513
• Report Number: 2135147-2026-00377
• Device Sequence Number: 5987356
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: (01)00811806010182(17)270531(10)8536422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 8536422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 43 KG