MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Model Number	9-ACP2-007-020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
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 on (b)(6) 2025 a 20mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath to treat a left atrial appendage (laa).The patient had a pre-existing atrial fibrillation.It was noted that there was limited visualization with transesophageal echocardiogram (tee).Transseptal puncture was posterior and medial.The patient's activated clotting time (act) level was 220-250 seconds.The patient's left atrial pressure was 10mmhg.During the procedure the occluder was partially re-capture twice.There was difficulty assessing deployment of the occluder's lobe.The occluder was manipulated in a ball configuration in an attempt to properly orient it within the landing zone, however the lobe could not be visualized.The patient then presented with a circumferential pericardial effusion was noted on echocardiogram.The effusion developed into a cardiac tamponade.The procedure was suspended, and the occluder was not implanted.An injury was noted at the left atrioventricular junction.The left atrioventricular junction was surgically repaired.The patient was transferred to the intensive care unit (icu) for monitoring.The patient status was stable.The user believed the transseptal puncture caused the pericardial effusion, and the occluder may have contributed to it.
Event or Problem Description
It was reported on (b)(6) 2025 a 20mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath to treat a left atrial appendage (laa).The patient had a pre-existing atrial fibrillation.It was noted that there was limited visualization with transesophageal echocardiogram (tee).Transseptal puncture was posterior and medial.The patient's activated clotting time (act) level was 220-250 seconds.The patient's left atrial pressure was 10mmhg.During the procedure the occluder was partially re-capture twice.There was difficulty assessing deployment of the occluder's lobe.The occluder was manipulated in a ball configuration in an attempt to properly orient it within the landing zone, however the lobe could not be visualized.The patient then presented with a circumferential pericardial effusion was noted on echocardiogram.The effusion developed into a cardiac tamponade.The procedure was suspended, and the occluder was not implanted.An injury was noted at the left atrioventricular junction.The left atrioventricular junction was surgically repaired.The patient was transferred to the intensive care unit (icu) for monitoring.The patient status was stable.The user believed the transseptal puncture caused the pericardial effusion, and the occluder may have contributed to it.
Additional Manufacturer Narrative
An event of patient-device incompatibility (implant-related tissue damage), pericardial effusion, cardiac tamponade, and perforation was reported.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 specifications.Based on the information received, the cause of the reported implant-related tissue damage-pericardial effusion results in cardiac tamponade could not be determined.The reported perforation could not be determined.The reported hospitalization and surgical intervention were the result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER AMULET
• Common Device Name: CARDIAC PLUG
• 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: 23359898
• Report Number: 2135147-2025-06043
• Device Sequence Number: 15671451
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)280731(10)9177861
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P200049
• 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): 12/22/2025

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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 9177861
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG