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

Model Number	9-ACP2-007-016
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on an unknown date, a 16mm amplatzer amulet was selected for implant.During the procedure, the occluder was found to not take the proper shape.The device wasn't implanted and the patient was converted for surgical closure.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.However, it could not be confirmed during the returned device analysis.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: 21561302
• Report Number: 2135147-2025-01197
• Device Sequence Number: 9261717
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)250228(10)7429765
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 02/28/2025
• Device Model Number: 9-ACP2-007-016
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 7429765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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