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

Model Number	9-ACP2-010-034
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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 (b)(6) 2025, a 28mm amplatzer amulet was selected for use in an implant procedure.During the procedure, it was found that the device wasn't able to fit and was removed.The decision was to upsize to 34mm amplatzer amulet with the same ds being used.It was noted that a back bleeding was performed on the ds.The 34mm device was prepped and delivered to the implant site.Once in the ball formation, something unknown was noted on tee.The decision was to resheath the device and abandon the procedure.Examination of the 34mm device revealed a thin strand of stringy material.There were no adverse events to the patient and their act was noted to be 326.There was 2 resheath attempts on the 28mm device and 1 resheath attempt on the 34mm device.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer amulet was selected for use in an implant procedure.During the procedure, it was found that the device wasn't able to fit and was removed.The decision was to upsize to 34mm amplatzer amulet with the same ds being used.It was noted that a back bleeding was performed on the ds.The 34mm device was prepped and delivered to the implant site.Once in the ball formation, something unknown was noted on tee.The decision was to resheath the device and abandon the procedure.Examination of the 34mm device revealed a thin strand of stringy material.There were no adverse events to the patient and their act was noted to be 326.There was 2 resheath attempts on the 28mm device and 1 resheath attempt on the 34mm device.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Additional Manufacturer Narrative
An event of foreign material noted (a thin strand of stringy material) on tee during procedure was reported.Information from filed indicated that 34 mm amulet device was implanted using same delivery system that was used with 28 mm device.There was 2 re-sheath attempts on the 28 mm device and 1 re-sheath attempt on the 34 mm device.Please note that per the amulet instructions for use, "if the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced.Failure to replace both the device and the sheath may result in sheath and/or device malfunction." 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 specifications, including inspection records for exist of foreign material.Based on the information received and cine review, the re-use of the same sheath with a new occluder device could have lead to the inner lining of the sheath being transferred onto the 34 mm occluder device when being re-used, thus causing the reported incident.However, the exact cause of reported incident could not be conclusively determined.The patient status was reported as stable.There were no complaints associated with any other devices from the lot.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: 21885852
• Report Number: 2135147-2025-02135
• Device Sequence Number: 3530754
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)270831(10)8650869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/09/2025

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 Model Number: 9-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 8650869
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• 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 Sex: Male