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

Model Number	9-ACP2-007-018
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	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a amulet¿ steerable delivery sheath.The appendage was very shallow.After multiple attempts with different sizes and sheaths the procedure was aborted.Shortly afterwards the patient developed an effusion and a pericardiocentesis was performed with removal of 800cc of blood.The patient was admitted to coronary care unit (ccu), blood stopped draining overnight.
Additional Manufacturer Narrative
An event of circumferential effusion shortly after amulet procedure was reported.A cardiac tamponade was also reported.Information from the field indicated that after multiple attempts with different sizes and sheaths the procedure was aborted.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.Requests were made for additional procedural details surrounding the case (e.G., operative notes, procedure imaging), however this information was not supplied by the site.Based on the limited information available, it is difficult to determine with certainty the exact cause of the reported event.It is possible that the reported procedural difficulties may have contributed to the observed pericardial effusion, however this cannot be conclusively determined.The unexpected medical intervention was result of pericardiocentesis performed due to pericardial effusion.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: health effect-clinical code: medical device problem code: 2993.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a amulet¿ steerable delivery sheath.The appendage was very shallow.During procedure, the left atrial pressure was 14mmhg.After multiple attempts with different sizes and sheaths the procedure was aborted.Shortly afterwards the patient developed a circumferential effusion and a pericardiocentesis was performed with removal of 800cc of blood.A cardiac tamponade was also noted.The physician mentioned the cause of pericardial effusion was amulet device.The patient was admitted to coronary care unit (ccu), blood stopped draining overnight.The patient was reported 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: 23809807
• Report Number: 2135147-2025-07373
• Device Sequence Number: 7732548
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)290930(10)10584474
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/03/2026

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-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 10584474
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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: 79 YR
• Patient Sex: Male