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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Shock (2072)
Date of Event	03/06/2026
Type of Reportable Event	Death
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) 2026, a 22mm amplatzer amulet was implanted using a 14f amplatzer amulet delivery system.Prior to the implant, the patient¿s condition was reported as good, with no symptoms, atrioventricular (av) block iii, and stable circulation.Pre-procedural sizing was determined via transesophageal echocardiography (tee) using the manufacturer¿s sizing chart, with landing zone measurements recorded as 17mm at 0°, 18mm at 45°, 16mm at 90°, and 18mm at 135°.Tee was utilized as the imaging modality throughout the procedure.The device was deployed with a tire-shaped configuration, and a tension test was performed, after which no peri-device leak was detected around the lobe.Approximately 250ml of fluid was administered during the procedure.The implanter reported that the close criteria were met, and all criteria were verified multiple times.The implantation was considered successful, and no symptoms were noted at the conclusion of the procedure despite the absence of sinus rhythm.On (b)(6) 2026 (day 10 post-implant), the patient was admitted to the hospital with malaise and dyspnea/shortness of breath.A transthoracic echocardiogram subsequently confirmed embolization of the implanted device, and angiography was identified as the imaging study that confirmed the migration/embolization.It was reported that the device completely dislodged from the implant site and traveled to the mitral valve.The patient was transferred to the german heart center berlin (dhzc) for device explantation, and surgical retrieval was performed.The explantation procedure was reported to be successful.Following explantation, the implanter reported finding no identifiable cause for the embolization.Despite the reported procedural success, the patient later developed further symptoms, including cardiogenic shock, which led to death.The implanter did not classify the death as related to the performance of the implanted device and did not consider it likely related to the procedure, attributing it instead to other factors, including the patient¿s comorbidities.
Additional Manufacturer Narrative
An event of device embolization, dyspnea, fatigue, shock, and death were 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 defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported device embolization could not be determined.The reported dyspnea, fatigue, and shock are likely cascading effects from the event.Prolonged hospitalization and a surgical intervention are a result of case specific circumstances, as the device was removed surgically.A cause for the reported death cannot be determined; however, it is possible that patient comorbidities contributed to the event.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer amulet was implanted using a 14f amplatzer amulet delivery system.Prior to the implant, the patient¿s condition was reported as good, with no symptoms, atrioventricular (av) block iii, and stable circulation.Pre-procedural sizing was determined via transesophageal echocardiography (tee) using the manufacturer¿s sizing chart, with landing zone measurements recorded as 17 mm at 0°, 18 mm at 45°, 16 mm at 90°, and 18 mm at 135°.Tee was utilized as the imaging modality throughout the procedure.The device was deployed with a tire-shaped configuration, and a tension test was performed, after which no peri-device leak was detected around the lobe.Approximately 250 ml of fluid was administered during the procedure.The implanter reported that the close criteria were met, and all criteria were verified multiple times.The implantation was considered successful, and no symptoms were noted at the conclusion of the procedure despite the absence of sinus rhythm.On (b)(6) 2026 (day 10 post-implant), the patient was admitted to the hospital with malaise and dyspnea/shortness of breath.A transthoracic echocardiogram subsequently confirmed embolization of the implanted device, and angiography was identified as the imaging study that confirmed the migration/embolization.It was reported that the device completely dislodged from the implant site and traveled to the mitral valve.The patient was transferred to the (b)(6) (dhzc) for device explantation, and surgical retrieval was performed.The explantation procedure was reported to be successful.Following explantation, the implanter reported finding no identifiable cause for the embolization.Despite the reported procedural success, the patient later developed further symptoms, including cardiogenic shock, which led to death.The implanter did not classify the death as related to the performance of the implanted device and did not consider it likely related to the procedure, attributing it instead to other factors, including the patient¿s comorbidities.

• 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: 24749648
• Report Number: 2135147-2026-02066
• Device Sequence Number: 8780099
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)290430(10)10356084
• 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
• 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): 06/22/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10356084
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Death
• Patient Sex: Male