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	Dyspnea (1816); Pericardial Effusion (3271)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer amulet was chosen for implant using a 12f amplatzer torqvue delivery system.Earlier in the procedure, the device was implanted with one recapture during deployment, and fluid was observed in the transverse sinus on transesophageal echocardiography (tee) imaging; however, no worsening was identified at that time.A few hours after the amulet implant, a pericardial effusion was noted in the patient.A pericardiocentesis (tap) was subsequently performed successfully, and the patient was reported to be doing well following the intervention.
Additional Manufacturer Narrative
An event of patient-device incompatibility was reported with pericardial effusion, and dyspnea.A returned device assessment could not be performed as the device remains implanted.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 patient-device incompatibility could not be determined.The reported pericardial effusion, and dyspnea are likely cascading effects from the event.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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer amulet was chosen for implant using a 12f amplatzer torqvue delivery system.He patient presented with a localized pericardial effusion in the transverse sinus prior to the procedure.A transseptal puncture was performed at a mid-mid/posterior location, after which the left atrial pressure was noted to be 15 mmhg.Ositioning of the delivery sheath was initially challenging due to the higher transseptal puncture influencing the angle into the laa, and one partial recapture and redeployment of the device was performed.During deployment, fluid was observed in the transverse sinus on tee imaging; however, no worsening was identified at that time.The effusion location was confirmed to be in the transverse sinus, and the user believes the effusion was potentially caused by manipulation of the delivery sheath or delivery system during positioning, or by an anchor of the amulet implant.A few hours following the implant, the pericardial effusion progressed from its initial localized state to becoming circumferential, and a pericardiocentesis (tap) was performed successfully.The patient was reported to be doing well following the intervention.

• 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: 24490278
• Report Number: 2135147-2026-01317
• Device Sequence Number: 10676701
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300131(10)10730947
• 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): 03/26/2026

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: 10730947
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male