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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amplatzer amulet was chosen for implant using an unknown delivery system.During the procedure, the device was unsheathed into a ¿spear¿ configuration.It was communicated to the implanting physician that the device needed to be unsheathed into a ¿ball¿ configuration.The lobe was then deployed deep, and the device appearance was not as expected.The device was resheathed, after which it again appeared as a ¿spear.¿ landing zone measurements used to determine device size included ct lz min 19mm, max 21mm, avg 20mm; tee lz min 17mm, max 21mm; fluoroscopy appeared much larger; a 1,000ml saline bolus was given due to a left atrial pressure of 5mmhg.Device sizing was determined by fluoroscopy.Tee was used as the intraprocedural imaging modality.The lobe of the device was not deployed in the landing zone with correct alignment and compression.The physician attempted a ¿sandwich¿ technique, acknowledging this was against the ifu.No pericardial effusion was noted prior to the procedure.The transseptal puncture was inferior/mid.Contrast was subsequently injected, and contrast was observed within the pericardial sac.An imaging physician reviewed the findings and confirmed a pericardial effusion, which increased slowly.The effusion was circumferential.Pericardiocentesis was performed, and heparin was reversed with protamine.The patient was then taken to the operating room for sternotomy to repair the perforation, and chest tubes were placed.The user believes an abbott device caused the pericardial effusion, specifically the 28mm amplatzer amulet.Cardiac tamponade was not concluded by the physicians.The patient¿s act during the procedure was 281 seconds.There was only one partial release of the lobe.The patient was in atrial fibrillation at the time of the procedure.There were no multiple wire or delivery sheath exchanges.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
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 still images show a circumferential pericardial effusion.However, none of the uploaded images display the device itself or indicate its final position within the left atrial appendage (laa).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.Reported surgical intervention was under case specific circumstances as sternotomy was performed to repair the perforation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 24536413
• Report Number: 2135147-2026-01439
• Device Sequence Number: 21420231
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)280430(10)9070848
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 9070848
• 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: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male