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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet left atrial appendage occluder was chosen for a procedure.During procedure, it was noted that one metal wire of the lobe was broken.The patient was reported good.
Additional Manufacturer Narrative
It was reported that during device preparation the nitinol wire of the device was noted to be fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There were no complaints associated with any other devices from the lot.One picture from field showed the device to expose the broken wire on the proximal mesh.The investigation of returned device at abbott found that a broken nitinol wire in the lobe and the stabilizing wires was seen out of place.The device was sent to science & technology lab (s&t) for further analysis.The fracture was examined using scanning electron microscopy (sem).The fracture appeared to occur as a result of a shear deformation with swaging suggested as a potential source.The cause of the reported incident could not be conclusively determined.The device was further investigated by cross-functional teams at abbott, and it was decided to initiate an exception to further evaluate final inspection requirements for wire damage and ¿broken wire¿ identification.
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet left atrial appendage occluder was chosen for a procedure.During exhaust operation, it was noted that one metal wire of the lobe was broken.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported good.

• 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: 23746019
• Report Number: 2135147-2025-07217
• Device Sequence Number: 9583815
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)261130(10)8796980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8796980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG