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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet occluder was selected for implant in a patient using a 14f amplatzer torqvue 45x45 delivery sheath.The patient was administered 8,000 units of heparin for procedure.The patient's activated clotting time (act) level was 298 seconds before implanting the occluder.It was noted during the procedure, that the 31mm amplatzer amulet occluder was too small.The decision was made to fully recapture the 31mm amplatzer amulet occluder and replace it with a 34mm amplatzer amulet occluder to complete the procedure, using the same delivery sheath.The patient remained hemodynamically stable throughout the procedure.The 14f amplatzer torqvue 45x45 delivery sheath was not in the patient for a significant period of time.There was no clinically significant delay in procedure reported.Post-implant, it was noted via transesophageal echocardiogram that a potential new thrombus was seen adhering to the disc of the occluder in the left atrium.The patient's international normalized ratio (inr) closest to the time of the reported thrombus is unknown.It's noted that the patient was on eliquis prior to the procedure.The decision was made to place the patient back on a 45 day regimen of eliquis.The patient does not receive any treatment (medications) that could contribute to thrombus formation.There is no allegation of malfunction against the abbott device or procedure.The patient was stable at the time of report.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that post-implant of amulet occluder a transesophageal echocardiogram showed a potential new thrombus adhering to the disc of the occluder in the left atrium.Information from field indicated that the 34 mm amplatzer amulet occluder selected after recapturing 31 mm amulet device as it was too small, using the same delivery sheath.Please note that per the instructions for use, arten600142796 -e, "if the device is retracted farther than the radiopaque markers (fully recaptured), 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 remains implanted and 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.It is possible that the reported re-use of the delivery sheath may have contributed to the potential thrombus formation, however this cannot be conclusively determined.Based on the information received, the exact cause of the reported thrombus could not be conclusively determined.The reported intervention is a case-specific circumstance as a decision was made to place the patient back on a 45 day regimen of eliquis.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 north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22066444
• Report Number: 2135147-2025-02679
• Device Sequence Number: 18490375
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)290831(10)10512802
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 10512802
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 31MM AMPLATZER AMULET OCCLUDER, 9-ACP2-010-031; AMPLATZER TORQVUE 45X45, 9-TV45X45-14F-080
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male