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 Codes	Fever (1858); Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Sepsis (2067)
Date of Event	10/13/2025
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that on (b)(6) 2025 (friday), a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer amulet delivery sheath.The sizing of the device was determined by transesophageal echocardiogram (tee) and angiography.The landing zone measurements were 24-28mm.During procedure, the v\ left atrial pressure was 11-12mmhg and fluids were given.There was some difficulty with implanting the device due to the angle of the puncture was difficult during the anatomy lesson.The occluder was successfully implanted after satisfying close criteria and tension test was performed.The device compression was normal.On (b)(6) 2025 (monday), on ultrasound probe showed that the occluder was embolized and noted free in the left atrium.On (b)(6) 2025 (tuesday), the explanation procedure started and the anesthesia began, the patient's blood pressure dropped sharply, and after several attempts to stabilize it, the patient died.The physician mentioned, patient developed severe pneumonia with severe sepsis over the weekend.During the night from monday to tuesday, he developed a high fever.Ultimately, the patient suffered right heart failure.The cause of death was sepsis due to patient's pneumonia and right heart failure.
Event or Problem Description
It was reported that on (b)(6) 2025 (friday), a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer amulet delivery sheath.The sizing of the device was determined by transesophageal echocardiogram (tee) and angiography.The landing zone measurements were 24-28mm.During procedure, the v\ left atrial pressure was 11-12mmhg and fluids were given.There was some difficulty with implanting the device due to the angle of the puncture was difficult during the anatomy lesson.The occluder was successfully implanted after satisfying close criteria and tension test was performed.The device compression was normal.On (b)(6) 2025 (monday), on ultrasound probe showed that the occluder was embolized and noted free in the left atrium.On (b)(6) 2025 (tuesday), the explanation procedure started and the anesthesia began, the patient's blood pressure dropped sharply, and after several attempts to stabilize it, the patient died.The physician mentioned, patient developed severe pneumonia with severe sepsis over the weekend.During the night from monday to tuesday, he developed a high fever.Ultimately, the patient suffered right heart failure.The cause of death was sepsis due to patient's pneumonia and right heart failure.
Additional Manufacturer Narrative
An event of device embolization and death was reported with patient effects of low blood pressure, fever, pneumonia, and sepsis.A medical review was completed and concluded that the reported event is procedure related and related to patient medical conditions.Not related to a device malfunction.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 and death with patient effects of low blood pressure, fever, pneumonia, and sepsis could not be determined.A surgical intervention was a result of case-specific circumstances, as the device was planned to be removed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23496586
• Report Number: 2135147-2025-06451
• Device Sequence Number: 9115420
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)271031(10)8745674
• 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: 2025
• Device Explanted Year: 2025
• 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): 01/13/2026

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8745674
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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; Death
• Patient Sex: Unknown