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

Model Number	9-ACP2-010-034
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6)2025 a 31mm amplatzer amulet left atrial appendage occluder was selected for implant.The patient had moderate to complex anatomy with a heavily pictinated left atrial appendage.The patient's landing zone measurements were measured under the following views: 24mm at 0 degrees, 25mm at 45 degrees, 23mm at 90 degrees, and 31mm at 135 degrees.Transesophageal echocardiogram (tee) was used during the procedure.During the procedure the occluder was determined to be too small in size.The occluder was removed from the patient and sized up to a 34mm amplatzer amulet left atrial appendage occluder.The second occluder showed adequate compression.Close criteria were met.A tension test was performed, however the occluder anchors were not engaged.The occluder was implanted.The following day the patient felt light-headed and presented with hypotension and intermitted premature ventricular contractions.Echocardiogram showed the occluder embolized to the mitral apparatus and caused a partial blockage leading to acute mitral regurgitation.The occluder was snared via transcatheter forceps and removed from the patient.On (b)(6)2025 a mitraclip was implanted.The patient status was stable.The user believed the occluder instability was the cause of the device embolization.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device embolization post amulet implant was reported.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.Based on the information received, and the cine review, the reported device embolization appears to be related to procedural conditions (occluder instability).The reported patient effects hypotension, arrythmia, obstruction/occlusion, mitral regurgitation could not be determined.It is possible that it was related to device embolized; however, this cannot be confirmed.There were no complaints associated with any other devices from the lot.The reported unexpected medical intervention and hospitalization were a result of case-specific circumstances as the device was snared.
Event or Problem Description
It was reported on (b)(6) 2025 a 31mm amplatzer amulet left atrial appendage occluder was selected for implant.The patient had moderate to complex anatomy with a heavily pictinated left atrial appendage.The patient's landing zone measurements were measured under the following views: 24mm at 0 degrees, 25mm at 45 degrees, 23mm at 90 degrees, and 31mm at 135 degrees.Transesophageal echocardiogram (tee) was used during the procedure.During the procedure the occluder was determined to be too small in size.The occluder was removed from the patient and sized up to a 34mm amplatzer amulet left atrial appendage occluder.The second occluder showed adequate compression.Close criteria were met.A tension test was performed, however the occluder anchors were not engaged.The occluder was implanted.The following day the patient felt light-headed and presented with hypotension and intermitted premature ventricular contractions.Echocardiogram showed the occluder embolized to the mitral apparatus and caused a partial blockage leading to acute mitral regurgitation.The occluder was snared via transcatheter forceps and removed from the patient.On (b)(6) 2025 a mitraclip was implanted.The patient status was stable.The user believed the occluder instability was the cause of the device embolization.

• 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: 23168567
• Report Number: 2135147-2025-05497
• Device Sequence Number: 18530478
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280430(10)9072053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 9072053
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male