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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Hemothorax (1896); Pericardial Effusion (3271)
Date of Event	12/12/2025
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 that on (b)(6) 2025, a 28mm amplatzer amulet was implanted using a 14f amulet delivery sheath in a complex left atrial appendage (laa).Two recaptures were required due to anatomical complexity.A satisfactory implant was achieved, and no change in effusion was noted following device release.On (b)(6) 2025, it was further reported that the patient returned to the hospital with chest pain.Diagnostic evaluation revealed a hemopneumothorax and a small pericardial effusion.The effusion was not drained as intervention was deemed unnecessary.The patient was stabilized and subsequently discharged.The physician did not attribute the hemopneumothorax to the device but was uncertain regarding the exact cause of the sequelae.
Additional Manufacturer Narrative
An event of angina, pericardial effusion, and hemothorax 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 angina, pericardial effusion, and hemothorax could not be determined.A prolonged hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer amulet was implanted using a 14f amulet delivery sheath in a complex left atrial appendage (laa).A pericardial effusion was not noted prior to the procedure.Due to the anatomical complexity, two partial recaptures were required before satisfactory device positioning was achieved.The transseptal puncture site was inferior/anterior, and the patient was in normal sinus rhythm at the time of the procedure.Following device release, no change in effusion was observed.During the procedure, the activated clotting time (act) was 230 seconds, at which point an additional 5,000 units of heparin were administered without reassessment, for a total of 15,000 units given.A pigtail wire was used for crossing into the left atrium, and two partial recaptures were performed as part of the implantation process.On (b)(6) 2025, it was reported that the patient returned to the hospital with chest pain.Diagnostic evaluation identified a hemopneumothorax and a small, localized apical pericardial effusion.The largest dimension of the effusion was described as ¿small.¿ the effusion was not drained, as intervention was deemed unnecessary, and the patient was stabilized without treatment of the effusion.The physician did not believe the pericardial effusion or hemopneumothorax was related to the abbott device, and the cause of the sequelae could not be definitively determined.The user indicated that the hemothorax may have been related to anesthesia, although no specific cause was identified.Cardiac tamponade was not present.The patient was reported to be stable and discharged.

• 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: 24035584
• Report Number: 2135147-2026-00225
• Device Sequence Number: 21457216
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)280430(10)9045489
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 9045489
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male