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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) of Esophagus (2398)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.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) 2026, a 31mm amplatzer amulet was chosen for implant using a 14f amplatzer amulet delivery system.Heparin was administered as per usual procedural indications; however, the physician did not provide the exact activated clotting time (act) levels.The mitraclip procedure was performed first, followed by the left atrial appendage occlusion (laao) procedure.At the end of the procedures, the patient developed bleeding from the mouth at the site where the transesophageal echocardiography (tee) probe had been positioned.The bleeding resolved within approximately ten minutes.The patient was subsequently admitted to the intensive care unit as per standard post-procedural practice and was reported to be stable.On the following morning, the patient was transferred urgently to the surgical operating unit with a diagnosis of esophageal laceration with hemodynamic compromise.The patient underwent esophageal reconstruction surgery.According to the physician, the esophageal laceration was believed to have resulted from scraping during intubation and tee probe insertion, and there was no allegation of malfunction against the abbott device or the procedure.The only information available regarding the patient's condition is that they remained in the intensive care unit following the surgical esophageal reconstruction.
Event or Problem Description
It was reported that on (b)(6) 2026, a 31mm amplatzer amulet was chosen for implant using a 14f amplatzer amulet delivery system.Heparin was administered as per usual procedural indications; however, the physician did not provide the exact activated clotting time (act) levels.The mitraclip procedure was performed first, followed by the left atrial appendage occlusion (laao) procedure.At the end of the procedures, the patient developed bleeding from the mouth at the site where the transesophageal echocardiography (tee) probe had been positioned.The bleeding resolved within approximately ten minutes.The patient was subsequently admitted to the intensive care unit as per standard post-procedural practice and was reported to be stable.On the following morning, the patient was transferred urgently to the surgical operating unit with a diagnosis of esophageal laceration with hemodynamic compromise.The patient underwent esophageal reconstruction surgery.According to the physician, the esophageal laceration was believed to have resulted from scraping during intubation and tee probe insertion, and there was no allegation of malfunction against the abbott device or the procedure.The only information available regarding the patient¿s condition is that they remained in the intensive care unit following the surgical esophageal reconstruction.
Additional Manufacturer Narrative
An event of bleeding and laceration of the esophagus 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.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 laceration of esophagus is likely related to scraping during intubation and transesophageal probe insertion.The reported bleeding is a cascading effect from the event.A prolonged hospitalization and surgical intervention are a result of case specific circumstances, as the patient underwent esophageal reconstruction.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: 24666584
• Report Number: 2135147-2026-01820
• Device Sequence Number: 5118026
• Product Code: NGV
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/14/2026

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: 10828585
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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 Sex: Male