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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) a 22mm amplatzer amulet was implanted using 14f amplatzer torqvue delivery system.During the procedure, no pericardial effusion had been noted prior to the intervention, and heparin was administered per procedural practice.A transseptal puncture was performed in the inferior anterior location, and access to the left atrium was achieved.The non-abbott wire was placed in the left atrial appendage, after which the procedure proceeded with advancement of the delivery system.There were no multiple wire or sheath exchanges, and the wire position remained in the mid left atrium throughout device preparation and deployment.Hemodynamic assessment showed a left atrial pressure of 10 mmhg at the time of the procedure.The occluder device was then introduced and deployed without immediate complication.On (b)(6) 2026, the patient presented to the emergency room, where a circumferential pericardial effusion was identified.A total of 300cc was drained, and it was noted that there was no presence of tamponade.The patient remained stable.The user later reported a belief that the effusion was caused by an abbott device, specifically identifying the amulet.
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 patient-device incompatibility was reported with pericardial effusion.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.The available quad-view image showing side-by-side pre- and post-implant comparisons is insufficient to confirm the presence of an effusion.Based on the available information, the cause for the reported patient-device incompatibility could not be determined.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.
Event or Problem Description
It was reported that on (b)(6) a 22mm amplatzer amulet was implanted using 14f amplatzer torqvue delivery system.During the procedure, no pericardial effusion had been noted prior to the intervention, and heparin was administered per procedural practice.A transseptal puncture was performed in the inferior anterior location, and access to the left atrium was achieved.The non-abbott wire was placed in the left atrial appendage, after which the procedure proceeded with advancement of the delivery system.There were no multiple wire or sheath exchanges, and the wire position remained in the mid left atrium throughout device preparation and deployment.Hemodynamic assessment showed a left atrial pressure of 10 mmhg at the time of the procedure.The occluder device was then introduced and deployed without immediate complication.On (b)(6) 2026, the patient presented to the emergency room, where a circumferential pericardial effusion was identified.A total of 300cc was drained, and it was noted that there was no presence of tamponade.The patient remained stable.The user later reported a belief that the effusion was caused by an abbott device, specifically identifying the amulet.

• 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: 24536301
• Report Number: 2135147-2026-01444
• Device Sequence Number: 9026598
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300531(10)10923163
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 10923163
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male