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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Pericardial Effusion (3271)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 14f delivery system.The sizing was selected based on transesophageal echocardiogram (tee) measurements.The laa anatomy was a shallow broccoli.During procedure, the left atrial pressure was 12mmhg.The patient's activated clotting time (act) levels were 300 sec and heparin was administered.It was a single deployment single device laao.The amulet was successfully implanted.That night the patient got short of breath and received at chest echocardiogram (echo), which showed a pericardial effusion.The patient underwent pericardiocentesis.The physician mentioned the cause of effusion was amulet.The patient recovered and subsequently discharged.
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.
Additional Manufacturer Narrative
An event of pericardial effusion and dyspnea was reported.A returned device assessment could not be performed as the device remains implanted and 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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.The reported unexpected intervention is a case-specific circumstance as a pericardiocentesis 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 18mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 14f delivery system.The sizing was selected based on transesophageal echocardiogram (tee) measurements.The laa anatomy was a shallow broccoli.During procedure, the left atrial pressure was 12mmhg.The patient's activated clotting time (act) levels were 300 sec and heparin was administered.It was a single deployment single device laao.The amulet was successfully implanted.That night the patient got short of breath and received at chest echocardiogram (echo), which showed a pericardial effusion.The patient underwent pericardiocentesis.The physician mentioned the cause of effusion was amulet.The patient recovered and subsequently discharged.

• 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: 23037420
• Report Number: 2135147-2025-05145
• Device Sequence Number: 13125460
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)300228(10)10763364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 10763364
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: Required Intervention
• Patient Sex: Unknown