MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-010-028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 a 28 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.Transesophageal echocardiogram (tee), x-ray, and 2-d tee were used during the procedure and to determine the device size.The landing zone measurements were 21 mm at 0 degrees, 19 mm at 45 degrees, 22 mm at 90 degrees, and 25 mm at 135 degrees.During the procedure fluid was given.Two partial recaptures were performed to achieve greater depth.No leak was detected, close criteria were met, and a tension test was performed.The device was implanted.Two hours after the procedure while in recovery, transthoracic echocardiogram (tte) confirmed the device embolized to the mitral valve apparatus.The device was snared using a mitralclip guide and removed from the body.The lateral leaflets of the mitral valve sustained damage from the retrieval process.Mitral regurgitation and mild atrial septal defect were observed but resolved over time.The patient status was stable and discharged to home.The physician suspects the embolization may be related to the change in heart rhythm from atrial fibrillation to normal sinus.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50178175
• Report Number: 2135147-2026-05404
• Device Sequence Number: 12850690
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)310228(10)11319126
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 11319126
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 182 LB