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

Model Number	9-ACP2-007-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Heart Block (4444)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
T was reported that on (b)(6) 2025, a 25mm amplatzer amulet was implanted using an unknown delivery system.During the procedure, following administration of angiographic contrast, the patient developed hypotension and a slowing heart rate.Electrocardiogram monitoring revealed st-segment elevation in leads ii and iii.Supplemental oxygen was provided, and 100 mcg of phenylephrine was administered to support blood pressure, resulting in brief improvement.No air was observed in the sheath.The physician proceeded with device implantation.A 16 mm device was deployed successfully without recapture attempts.No pericardial effusion was noted at any time during the procedure.The patient subsequently experienced transient heart block and required three chest compressions.Endotracheal intubation was performed, and the patient was stabilized.Transesophageal echocardiography (tee) was then conducted, confirming the device was in place and stable, with no evidence of pericardial effusion.Tee also demonstrated severely reduced left ventricular ejection fraction (approximately 10%) and the presence of aortic and mitral stenosis.On (b)(6) 2025, pericardiocentesis was performed, and the patient was transferred to the intensive care unit (icu) in stable condition.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 16 mm amplatzer amulet was implanted using an 14f amulet delivery system.The clinical indication for implanting the amplatzer amulet in this patient was high bleeding risk.The patient was reported to be stable immediately prior to the implant procedure, and the baseline rhythm was normal sinus rhythm (nsr) at the beginning of the procedure.Idevice sizing measurements were obtained using intracardiac echocardiography (ice) and angiography, supporting selection of a 16 mm amplatzer amulet device.During the procedure, following administration of angiographic contrast, the patient developed hypotension and a slowing heart rate.Electrocardiogram monitoring revealed st-segment elevation in leads ii and iii.The st elevation and onset of heart block occurred prior to device insertion.The timing of the myocardial infarction was reported as st-segment elevation noted after contrast injection through the pigtail during angiography of the appendage, with the patient having been stable until this point.Supplemental oxygen was provided, and 100 mcg of neo (phenylephrine) was administered to support blood pressure, resulting in brief improvement.Although the physician considered an air embolism as a potential cause, no air was visualized on imaging.No air was observed in the sheath.The physician proceeded with the device implantation, and a 16 mm device was deployed successfully without recapture attempts.No pericardial effusion was noted throughout the procedure.The patient subsequently experienced transient third-degree heart block and required three chest compressions.The intervention performed to treat the heart block consisted of subcutaneous pacing followed by placement of a temporary pacer.It was further reported that no permanent pacemaker was required, as the third-degree heart block was temporary, and no pacemaker implant or cardiac ablation was necessary.Endotracheal intubation was performed, and the patient was stabilized.Transesophageal echocardiography (tee) was then conducted, confirming that the device was in place and stable, with no evidence of pericardial effusion.Regarding the patient¿s comorbidities, it was reported that there was no known history of heart attack, with some narrowing of vessels observed on angiography.The patient was later reported to be stable.
Additional Manufacturer Narrative
An event of hypotension and arrhythmia 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported hypotension and arrhythmia could not be determined.An unexpected medical intervention was a result of case specific circumstances, as cpr was performed and temporary pacemaker was used.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 3271.Health effect- impact code: 4607.

• 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: 23824973
• Report Number: 2135147-2025-07450
• Device Sequence Number: 20100669
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)300228(10)10773538
• 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): 04/09/2026

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-ACP2-007-016
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 10773538
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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: 54 YR
• Patient Sex: Female