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	Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
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 that on (b)(6) 2025, a 22mm amplatzer amulet was chosen for implant using an unknown delivery sheath.Following the amulet procedure, the patient was found to be non-responsive, and a code was initiated.The patient was noted to have pulseless electrical activity.Cardiopulmonary resuscitation (cpr) was performed, and pericardiocentesis was conducted, with 280 cc of fluid drained.The patient was stabilized and intubated.Extubation was planned for (b)(6) 2025.No additional information was provided.
Additional Manufacturer Narrative
An event of patient device incompatibility was reported with pericardial effusion, cardiac tamponade, and cardiac arrest.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 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, cardiac tamponade, and cardiac arrest, are likely cascading effects from the event.Medical interventions were a result of case-specific circumstances, as cpr, pericardiocentesis, and surgical removal of device were 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) 2025, a 22mm amplatzer amulet was chosen for implant using an unknown delivery sheath.No pericardial effusion was noted prior to the procedure.A transseptal puncture was performed in the mid/mid position.The device was manipulated during the procedure, including two partial recaptures and no full recaptures.There were multiple wire or delivery sheath exchanges, with wire positioning in the left atrium.The patient¿s rhythm at the time of the procedure was sinus rhythm.The patient received heparin via drip, with an activated clotting time of greater than 350 seconds, and was on oral anticoagulant therapy with aspirin (oac + asa) at the time the event occurred.Following the amulet procedure, the patient was found to be non-responsive, and a code was initiated.The patient was noted to have pulseless electrical activity.Cardiopulmonary resuscitation (cpr) was performed, and pericardiocentesis was conducted, with 280 cc of fluid drained, resolving the pericardial effusion.The effusion was described as circumferential, and the physician concluded that cardiac tamponade was present.A reversal agent (protamine) was administered.The user believes the amulet device caused the effusion.The patient was stabilized and intubated.On (b)(6) 2026, the device was explanted surgically.

• 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: 23950635
• Report Number: 2135147-2026-00039
• Device Sequence Number: 18830780
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)291231(10)10699268
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/19/2026

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: 10699268
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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: Disability; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female