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

Model Number	9-ASD-020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Shock (2072); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2026, a 20mm amplatzer septal occluder was chosen for implant using an unknown delivery system.No pericardial effusion had been noted prior to the procedure.The patient was in normal and constant rhythm at the time of the intervention.There was no transseptal puncture performed, as the procedure involved asd closure, and no multiple wire or delivery sheath exchanges occurred; the wire was positioned in the upper left pulmonary vein.During the procedure, the patient developed cardiac tamponade.The effusion was noted at the level of the aorta, in the form of a linear collection adjacent to the aorta, and was associated with shearing caused by the prosthesis, which led to bleeding at the level of the aortic wound in relation to the composite aortic prosthesis (cia prosthesis).The user believes that the abbott device was implicated, stating that the prosthesis caused the shearing at the aorta.The tamponade was managed intraoperatively with felted stitches and a reinforcement bandage.No abnormalities were observed on the aortic valve, and the prosthesis remained in appropriate position at the conclusion of the intervention.Postoperatively, the patient initially demonstrated favorable progress and was transferred out of the thoracic and cardiovascular surgery (ctcv) intensive care unit the same day.However, the patient subsequently developed obstructive shock secondary to recurrent cardiac tamponade.The effusion was managed with drainage followed by surgical repair, requiring an unplanned return to the operating room.
Event or Problem Description
It was reported that on (b)(6) 2026, a 20mm amplatzer septal occluder was chosen for implant using an unknown delivery system.No pericardial effusion had been noted prior to the procedure.The patient was in normal and constant rhythm at the time of the intervention.There was no transseptal puncture performed, as the procedure involved asd closure, and no multiple wire or delivery sheath exchanges occurred; the wire was positioned in the upper left pulmonary vein.During the procedure, the patient developed cardiac tamponade.The effusion was noted at the level of the aorta, in the form of a linear collection adjacent to the aorta, and was associated with shearing caused by the prosthesis, which led to bleeding at the level of the aortic wound in relation to the composite aortic prosthesis (cia prosthesis).The user believes that the abbott device was implicated, stating that the prosthesis caused the shearing at the aorta.The tamponade was managed intraoperatively with felted stitches and a reinforcement bandage.No abnormalities were observed on the aortic valve, and the prosthesis remained in appropriate position at the conclusion of the intervention.Postoperatively, the patient initially demonstrated favorable progress and was transferred out of the thoracic and cardiovascular surgery (ctcv) intensive care unit the same day.However, the patient subsequently developed obstructive shock secondary to recurrent cardiac tamponade.The effusion was managed with drainage followed by surgical repair, requiring an unplanned return to the operating room.
Additional Manufacturer Narrative
An event of a patient-device incompatibility (implant related tissue damage) was reported with pericardial effusion, cardiac tamponade, and shock.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.The reported pericardial effusion, cardiac tamponade, and shock are likely cascading effects from the event.An unexpected medical intervention and surgical intervention were a result of case specific circumstances, as a pericardiocentesis was performed and the tissue damage was repaired surgically.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: 24536340
• Report Number: 2135147-2026-01440
• Device Sequence Number: 21075736
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)271031(10)8755438
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 8755438
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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 Sex: Unknown