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

Model Number	9-ACP2-010-031
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation (2001); Pericardial Effusion (3271)
Date of Event	07/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a 31 mm amplatzer amulet left atrial appendage occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (laa) closure.During the procedure, the left atrial pressure was 12 mmhg.Heparin was administered.Transseptal was made at the inferior and mid location.The non-abbott wire was positioned in the laa.One deployment of the device was made.The device was implanted.About 4 hours after the procedure the patient went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was initiated and a pericardial effusion (pe) developed during cpr.Cpr was unsuccessful and the patient expired.The physician suspected either a stroke or pulmonary emboli as the cause for cardiac arrest.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2026 a 31 mm amplatzer amulet left atrial appendage occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (laa) closure.Computed tomography (ct) measured the landing zone with a minimum of 19.7 mm and a maximum of 27.5mm.During the procedure, the left atrial pressure was 12 mmhg.Heparin was administered.Transseptal was made at the inferior and mid location.The non-abbott wire was positioned in the laa.One deployment of the device was made.The device was implanted.About 4 hours after the procedure the patient went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was initiated and a pericardial effusion (pe) developed during cpr.A pericardiocentesis was performed during cardiac arrest and approximately 1000 ml of fluid was removed.Cpr was unsuccessful and the patient expired.The autopsy report showed a large tear in the superior vena cava and device interaction with the pulmonary artery, resulting in a pulmonary artery injury.The physician believed the device in combination of the patient's comorbidities was the cause of death.
Additional Manufacturer Narrative
H11 the device is included in the correction notice issued by abbott on 04 sep 2026 for pulmonary artery injury with the amplatzer amulet.The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 50117649
• Report Number: 2135147-2026-05277
• Device Sequence Number: 18762027
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)271231(10)8827503
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8827503
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 99844
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Death
• Patient Age: 61 YR
• Patient Sex: Female