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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer amulet was chosen for implant using an 12f amulet delivery system.The procedure involved a difficult left atrial appendage (laa) closure due to a small, shallow appendage, which required a very anterior transseptal puncture to facilitate cannulation of the appendage with the delivery system.An 25 mm amplatzer amulet device was initially attempted; however, this device was assessed to be too large and was removed.The procedure was continued using a 22 mm amplatzer amulet, during which the device formed a cobra head configuration when transitioning from the ball position to the triangle configuration.The device was resheathed, and a second attempt was made to deploy the device in the ball position, but the cobra head configuration recurred.The deformed device was never released from the delivery cable.There was no interaction with the cardiac structures during deployment and no angulation/kink were noticed in the delivery system.The device was then exchanged for another new 22 mm amplatzer amulet, which was subsequently deployed successfully without event.
Additional Manufacturer Narrative
An event of device deformity was reported.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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the information received, the cause of the reported incident could not be conclusively determined.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: 25143475
• Report Number: 2135147-2026-03135
• Device Sequence Number: 9316086
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300731(10)11002327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 11002327
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 80 KG