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

Model Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of migration or expulsion of device (device migration) was reported.A returned device assessment could not be performed as the device was not returned for analysis.It was indicated that during the procedure the occluder was partially re-captured twice.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the reported device migration could not be determined.It is possible due to incorrect device sizing or positioning issue due to patient's complex anatomy; however, this cannot be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 a 34mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amulet delivery sheath.The dimensions of the left atrial appendage (laa) under transesophageal echocardiogram (tee) were a 20mm minimum and a 32mm maximum.Angiography and tee were used during the procedure.During the procedure the occluder was partially re-captured twice.The patient had complex anatomy.The occluder was implanted.Three months post-procedure during a follow-up it was noted that the occluder rotated in the left atrium and approximately 50% of the occluder was outside the left atrium.The physician believed the axis of the occluder may not have been completely aligned due to the patient's complex anatomy.Some of the hooks may have not been properly anchored, however this was unable to be seen through tee during the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.

• 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: 21733096
• Report Number: 2135147-2025-01665
• Device Sequence Number: 14502439
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)250831(10)7662817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 03/31/2025

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 Expiration Date: 08/31/2025
• Device Model Number: 9-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 7662817
• 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: 03/06/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• 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 Sex: Unknown