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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pericardial Effusion (3271)
Date of Event	09/09/2025
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 on (b)(6) 2025 a 22mm amplatzer amulet left atrial appendage occluder was selected for implant to treat a left atrial appendage (laa).The patient had a pre-existing pericardial effusion.Transseptal access was inferior in the bicaval, and mid on the short axis.The patient's activated clotting time (act) level was 317 seconds.The patient's left atrial pressure was 18mmhg.Fifteen thousand units of heparin were administered.During the procedure three attempts were made to deploy the occluder.It was determined that the occluder was too big in size.The occluder was removed and sized down to a 20mm amplatzer amulet left atrial appendage.The second occluder was re-captuered twice.Upon deployment, the patient's blood pressure dropped.The pericardial effusion appeared to be unchanged from baseline.It was discovered that there was a small pericardial effusion and a larger pleural effusion.A pericardiocentesis was performed.It was then noted that the patient's left lung collapsed.A drain was placed in the left lung.The patient continued to bleed, and a thoracotomy was performed to control the bleeding.On (b)(6) 2025 the patient passed away.The cause of death was the pericardial and pleural effusion.
Additional Manufacturer Narrative
An event of patient-device incompatibility (implant related to tissue damage-perforation, pericardial effusion, pleural effusion, low blood pressure/hypotension, pericardiocentesis death) was reported.The device remains implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Reportedly, the patient had a pre-existing condition pericardial effusion.Based on cine and medical review performed at abbott ¿the exact cause of death two days post-implant is unknown but likely is procedure related due to complications from the thoracotomy used to control the bleeding associated with multiple device deployments.¿ based on the information received, the cause of the reported implant related to tissue damage associated with perforation and pericardial effusion resulted in hypotension and appeared to be related to procedural circumstances (pericardiocentesis).The reported unexpected medical interventions and surgical intervention resulted of case-specific circumstances as pericardiocentesis was performed.Based on the information received and medical review, the cause for the reported death could not be conclusively determined.It is possible that the cause is related to the procedure and the patient's comorbidities.However, this cannot be confirmed.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: 23192363
• Report Number: 2135147-2025-05559
• Device Sequence Number: 13260054
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)270331(10)8445147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 8445147
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 79 KG