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

Model Number	9-ACP2-007-022
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/10/2026
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) 2022, a 22mm amplatzer amulet was chosen for implant using a 14f amplatzer torqvue delivery sheath.The patient was in normal sinus rhythm at the start of the procedure and had taken eliquis the day before the procedure.A transseptal puncture was performed in the inferior mid location.The wire was positioned in the upper pulmonary vein, and there were no multiple wire or delivery sheath exchanges.The patient¿s left atrial pressure measured 22mmhg, and the activated clotting time (act) during the procedure was 289 seconds.The patient received 7,000 units of heparin, and no wire was ever placed in the left atrial appendage.The patient underwent the amulet procedure at approximately 9:30 a.M., during which a 0.6 cm pericardial effusion was noted.The device was successfully deployed on the first attempt.Following the procedure, the effusion was reassessed and again measured 0.6 cm.At the conclusion of the case, 50 units of protamine were administered.Approximately 1.5 hours later, the team was informed that the patient had developed cardiac tamponade, and a bedside pericardiocentesis was subsequently performed.
Event or Problem Description
It was reported that on (b)(6) 2022, a 22mm amplatzer amulet was chosen for implant using a 14f amplatzer torqvue delivery sheath.The patient was in normal sinus rhythm at the start of the procedure and had taken eliquis the day before the procedure.A transseptal puncture was performed in the inferior mid location.The wire was positioned in the upper pulmonary vein, and there were no multiple wire or delivery sheath exchanges.The patient¿s left atrial pressure measured 22 mmhg, and the activated clotting time (act) during the procedure was 289 seconds.The patient received 7,000 units of heparin, and no wire was ever placed in the left atrial appendage.The patient underwent the amulet procedure at approximately 9:30 a.M., during which a 0.6 cm pericardial effusion was noted, reported as circumferential pericardial (pr).The device was successfully deployed on the first attempt.Following the procedure, the effusion was reassessed and again measured 0.6 cm.At the conclusion of the case, 50 units of protamine were administered.Approximately 1.5 hours later, the team was informed that the patient had developed cardiac tamponade, and a bedside pericardiocentesis was subsequently performed.At the time the pericardial effusion was detected, the patient was reported to be on oral anticoagulation (oac).The user reported their belief that an abbott device, specifically the amplatzer amulet, caused the pericardial effusion.
Additional Manufacturer Narrative
An event of (implant-related tissue damage) pericardial effusion and cardiac tamponade 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 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 pericardial effusion and cardiac tamponade could not be determined.An unexpected medical intervention was a result of case specific circumstances, as a pericardiocentesis was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: medical device problem code: 2993.

• 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: 24536505
• Report Number: 2135147-2026-01441
• Device Sequence Number: 8895037
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)290831(10)10501871
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10501871
• 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: 04/23/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 78 KG