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

Model Number	9-ACP2-007-020
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	10/15/2025
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 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.During procedure, the doc's sheath came out of the appendage and accidentally went across mitral valve while in ball and hit the mitral annulus multiple times.The first deployment was so deep that it wasn't seen well on imaging.There were multiple redeployments and a new 18mm amplatzer amulet left atrial appendage occluder was chosen.During the first deployment of the second device, when the disc was deployed the lobe jumped up more proximally.The doc redeployed twice and they left a good implant.After release, a pericardial effusion was noted that grew bigger.A pericardiocentesis was performed and removed 458ccs of blood.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.During procedure, the doc's sheath came out of the appendage and accidentally went across mitral valve while in ball, and hit the mitral annulus multiple times.The first deployment was so deep that it wasn't seen well on imaging.There were multiple redeployments and a new 20mm amplatzer amulet left atrial appendage occluder was chosen with the same delivery system.During the first deployment of the second device, when the disc was deployed the lobe jumped up more proximally.The doc redeployed twice and they left a good implant.After release, a 16mm circumferential, but more localized posterior pericardial effusion was noted that grew bigger.A cardiac tamponade was also noted.A pericardiocentesis was performed and removed 458ccs of blood.The patient was reported stable.
Additional Manufacturer Narrative
An event of improper or incorrect procedure or method, pericardial effusion, and cardiac tamponade 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.There were no complaints associated with any other devices from the lot.Based on the available information and cine review, the cause for the reported pericardial effusion and cardiac tamponade could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as a pericardiocentesis was performed.The reported improper or incorrect procedure or method is related to the same delivery system being used with both amplatzer cardiac plugs.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: 23497988
• Report Number: 2135147-2025-06466
• Device Sequence Number: 8965735
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300131(10)10737611
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/04/2026

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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10737611
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH, 9-TV4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male