MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-010-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Pericardial Effusion (3271)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage occlusion (laao) procedure using a amplatzer torqvue 45x45 delivery system.After the successful laao procedure it was noted that the patient was experiencing increasing chest tightness.A transesophageal echocardiogram (tte) was performed which showed a developing pericardial effusion.It was planned that the patient would have a tap (pericardiocentesis) later that day to alleviate symptoms.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage occlusion (laao) procedure using a amplatzer torqvue 45x45 delivery system.After the successful laao procedure it was noted that the patient was experiencing increasing chest tightness.A transesophageal echocardiogram (tte) was performed which showed a developing pericardial effusion.It was planned that the patient would have a tap (pericardiocentesis) later that day to alleviate symptoms.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of pericardial effusion and chest tightness 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported pericardial effusion could not be conclusively determined.The reported chest tightness appears to be cascading effect of the reported pericardial effusion.The reported serious injury/illness/impairment was a result of case-specific circumstances as no intervention was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 ; +1(651)756-5400
• MDR Report Key: 50614397
• Report Number: 2135147-2026-05997
• Device Sequence Number: 10573424
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300331(10)10802125
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/22/2026

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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 10802125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male