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

Model Number	9-ACP2-010-025
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was implanted using an 12f delivery system.Prior to the amulet implant, a trivial pericardial effusion was noted.A transseptal puncture was performed in an inferior/mid location, with a reported left atrial pressure of 11 mmhg at the time of the procedure.During the procedure, heparin was administered at a dose of 15,000 units, achieving an activated clotting time (act) of 310 seconds.The device required one repositioning during implantation, with no multiple wire or delivery sheath exchanges reported and wire position not changing between pulmonary veins.Protamine was administered directly after sheath removal.On (b)(6) 2026, it was discovered that the patient experienced pericardial effusion.The user reported the belief that the pericardial effusion was caused by the amulet device.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was implanted using an 12f delivery system.Prior to the amulet implant, a trivial pericardial effusion was noted.A transseptal puncture was performed in an inferior/mid location, with a reported left atrial pressure of 11mmhg at the time of the procedure.During the procedure, heparin was administered at a dose of 15,000 units, achieving an activated clotting time (act) of 310 seconds.The device required one repositioning during implantation, with no multiple wire or delivery sheath exchanges reported and wire position not changing between pulmonary veins.Protamine was administered directly after sheath removal.On (b)(6) 2026, it was discovered that the patient experienced pericardial effusion.The user reported the belief that the pericardial effusion was caused by the amulet device.
Additional Manufacturer Narrative
An event of pericardial effusion post procedure was reported.A returned device assessment could not be performed as the device remains implanted and 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 available, the cause of the reported pericardial effusion cannot be conclusively determined.The reported serious injury/illness/impairment were due to case-specific circumstances as no further intervention or treatment was performed.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.

• 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: 24749772
• Report Number: 2135147-2026-02072
• Device Sequence Number: 18449109
• Product Code: NGV
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/25/2026

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: 10419285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: Other
• Patient Sex: Unknown