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	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown date, an unknown size amplatzer amulet left atrial appendage occluder was implanted in the patient.After the amulet procedure, a percutaneous coronary intervention (pci) was done on the right coronary artery (rca).The patient's blood pressure was dropped and had tenderness in abdomen.The patient was take for a computed tomography (ct) and went asystole.A cardiopulmonary resuscitation (cpr) was performed, patient stabilized and went back to cardiac catheterization lab for further testing.It was determined that patient had a retroperitoneal (rp) bleed from the arterial stick not the venous stick.As per physician this was not related to amulet implant.
Additional Manufacturer Narrative
An event of patient effects of cardiac arrest, low blood pressure, and hemorrhage was reported.A returned device assessment could not be performed as the device remains implanted.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 cardiac arrest, low blood pressure, and hemorrhage could not be confirmed.The unexpected medical intervention was a result of case-specific circumstances, as cpr was performed.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) 2025, a 16mm amplatzer amulet left atrial appendage occluder was implanted in the patient.After the amulet procedure, a percutaneous coronary intervention (pci) was done on the right coronary artery (rca).The patient's blood pressure was dropped and had tenderness in abdomen.The patient was take for a computed tomography (ct) and went asystole.A cardiopulmonary resuscitation (cpr) was performed, patient stabilized and went back to cardiac catheterization lab for further testing.It was determined that patient had a retroperitoneal (rp) bleed from the arterial stick not the venous stick.As per physician this was not related to amulet implant.The patient was reported stable.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23403997
• Report Number: 2135147-2025-06163
• Device Sequence Number: 15632890
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)290630(10)10423936
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/03/2025

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: 10423936
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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: Disability; Required Intervention
• Patient Sex: Male