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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 01 december 2025, a 20mm amplatzer amulet was chosen for implant using a 12f amulet delivery sheath.During the procedure, it was noted that as the device went in, a small thread like or a filament-like structure was observed on the imaging on the lobe of the device.The device was retracted and the procedure was completed using a new 22mm amplatzer amulet device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of ptfe wire observed on the device under ice was reported.The device was returned to abbott for investigation.A long thread, consistent with the ptfe inner liner of the delivery sheath, was found to be entangled with the amplatzer amulet disc.The device met visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and that the product met all specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause of the reported exposed thread could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4641.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was chosen for implant using a 12f amulet delivery sheath.During the procedure, it was noted that as the device went in, a small thread like or a filament like structure was observed on the imaging coming out of the lobe while on ice.The device was not completely deployed and was never released from the cable.When the observation was made, the device was manipulated by recapturing it and was fully retracted into the delivery system.The patient¿s activated clotting time (act) was greater than 300.The procedure was then completed using a new 22 mm amplatzer amulet device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.

• 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: 23889296
• Report Number: 2135147-2025-07694
• Device Sequence Number: 9464540
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300630(10)10958239
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10958239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown