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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 06 july 2026 a 31 mm amplatzer amulet left atrial appendage occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (laa) closure.Imaging modalities used during the procedure were computed tomography (ct), angiography, and transoesophageal echocardiogram (toe).During the procedure the landing zone measurements averaged 17 mm to 24 mm in all dimensions.The left atrial pressure was 15 mmhg and minimal amount of fluid was given.No repositioning was required.No leak was detected.Close criteria were satisfied and a tension test was performed.The device was implanted.After 5 minutes, a rhythm change was noted.The device was found to have embolized into the left ventricle.A non-abbott sheath was inserted into the patient's left groin to snare the device.Multiple snare attempts were made.At one point during snaring, the snare capture was lost and the device traveled to the descending aorta.The device was retrieved and removed from the body.Additional heparin 3000 units was given maintain the activating clotting time (act) above 250 seconds.Both left and right groin were closed with closure devices.No pericardial effusion noted on final echocardiogram.Echocardiogram also showed small pectinate shadowing noted in left atrium post device removal.The patient status was stable.The physician believes that under sizing of the device may have caused the device embolization.
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.

• 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: 50070388
• Report Number: 2135147-2026-05177
• Device Sequence Number: 21412407
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)280531(10)9095534
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 9095534
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown