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

Model Number	9-ASD-017
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning 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) 2026, a 18mm amplazter septal occluder was chosen for implant using an 8f amplatzer torqvue delivery system for a closure of a post-infarct ventricular septal defect (vsd) in a patient who had experienced a myocardial infarction approximately 10 days earlier.During the procedure, the left disc of the occluder was deployed in the left ventricle as intended.However, transesophageal echocardiography (tee) imaging was limited due to interference attributed to an impella pump positioned in the aorta, resulting in difficulty visualizing and guiding the device to an optimal position.It was stated that the physician elected to recapture the left disc and attempt redeployment closer to the ventricular septum.Upon redeployment, the left disc formed a ¿cobra head¿ configuration.The deformed device was never released from the delivery cable.There was no interaction with the cardiac structures during deployment and no angulation/kink were noticed in the delivery system.The device was then recaptured and removed without incident.Because the delivery sheath remained positioned across the defect within the left ventricle, the physician exchanged and upsized the delivery system to a 9f amplatzer trevisio delivery system and selected a 17mm amplatzer septal occluder.When advancing this second device, the left disc again assumed a cobra head configuration and the device had some interactions with the mitral leaflets.The physician subsequently recaptured and redeployed the disc two additional times.It was then reported that tee imaging demonstrated a developing pericardial effusion.During the procedure the patient¿s activated clotting time (act) was above 250 and had a sinus rhythm.Pericardial effusion was noted on the outside of atriums.The pericardial effusion was localized near atria and the physician believes it might have been due to recapturing and re-deploying the device multiple times near the lv apex.Pericardiocentesis was performed, and although fluid was initially drained, reaccumulation was observed.Based on these findings and concern for a possible perforation, the physician recommended transferring the patient to surgery for vsd repair.
Additional Manufacturer Narrative
An event of device deformity and 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 information received, the cause of the reported device deformity could not be conclusively determined.The reported implant related tissue damage could have been due to procedural circumstances (interference with the lv apex) contribute to the event; however this cannot be determined.The pericardial effusion and cardiac tamponade are likely cascading effects from the event.Medical and surgical interventions were a result of case specific circumstances, as a pericardiocentesis was performed and the suspected perforation was attempted to be closed, 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: 24335061
• Report Number: 2135147-2026-00889
• Device Sequence Number: 21277443
• Product Code: MLV
• UDI-Device Identifier: 00811806010144
• UDI-Public: (01)00811806010144(17)271231(10)8868444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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-017
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 8868444
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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: 63 YR
• Patient Sex: Female