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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/03/2025
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) 2025, a 22mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath in a reverse chicken wing anatomy.The transseptal puncture was performed in an inferior and medial position of posterior-anterior orientation, as this approach is recommended for reverse chicken wing anatomy.During the procedure, at the point of deploying the device, the sheath was positioned very deep, and the preferred strategy was to withdraw the sheath rather than advance the cable.Despite this adjustment, the first contrast injection revealed the presence of pericardial effusion, indicating that the left atrial appendage had been perforated by the distal tip of the device (distal screw).The pericardial effusion was noted intraprocedural at the moment of delivering the ball inside the left atrial appendage.It was located in the left atrial appendage and resolved with pericardiocentesis.The operator believed the effusion was caused by an abbott device, specifically the distal screw.The patient¿s activated clotting time (act) during the procedure was 250.Heparin was administered, though the exact amount is pending confirmation.The greatest difficulty encountered was the chicken wing anatomy with limited depth before the wing turn.There were no multiple wire or delivery sheath exchanges, and the wire was not placed in the left atrial appendage.The device was implanted successfully on the first attempt, with no partial recaptures.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath in a reverse chicken wing anatomy.The patient was in sinus rhythm at the start of the procedure and had been taking aspirin prior to the procedure.A transseptal puncture was performed in an inferior and medial position with a posterior-anterior orientation, consistent with recommendations for reverse chicken-wing morphology.Imaging confirmed a reverse chicken-wing left atrial appendage (laa) with a short neck, and the chosen strategy was a sandwich-technique implantation.During the procedure, at the point of deploying the device, the sheath was positioned very deep, and the preferred strategy was to withdraw the sheath rather than advance the cable.Despite this adjustment, the first contrast injection revealed the presence of pericardial effusion, indicating that the left atrial appendage had been perforated by the distal tip of the device (distal screw).The effusion measured 17 mm at its largest dimension and was circumferential.Hemodynamic evaluation indicated cardiac tamponade.The left atrial pressure at this time measured 22 mmhg and the patient became heparinized at the time the pericardial effusion was detected, with an activated clotting time (act) of 250 seconds.The pericardial effusion was noted intraprocedural at the moment of delivering the ball inside the left atrial appendage.It was located in the left atrial appendage and resolved with pericardiocentesis.To reverse anticoagulation, 80 mg of protamine was administered for complete reversal.There were no multiple wire or delivery sheath exchanges, and the wire was not positioned in the laa.Despite the complication, the device was implanted successfully on the first attempt with no partial recaptures.The operator believed the effusion was caused by an abbott device, specifically the distal screw.The greatest difficulty encountered was the chicken wing anatomy with limited depth before the wing turn.There were no multiple wire or delivery sheath exchanges, and the wire was not placed in the left atrial appendage.The device was implanted successfully on the first attempt, with no partial recaptures.The patient was discharged six days later in stable condition on apixaban.
Additional Manufacturer Narrative
An event of patient-device incompatibility, pericardial effusion, perforation and cardiac tamponade 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.Based on the information received, the cause of the reported patient-device incompatibility, pericardial effusion, and cardiac tamponade could not be determined.The transesophageal echocardiogram included six images demonstrating a circumferential effusion measured at multiple points.Because no procedural imaging was available, the underlying cause of the effusion cannot be determined.Reported unexpected medical intervention was a result of case-specific circumstances as the pericardiocentesis was performed.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: 23881944
• Report Number: 2135147-2025-07642
• Device Sequence Number: 9605770
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)290930(10)10582630
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10582630
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female