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

Catalog Number	9-ACP2-007-016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Pericardial Effusion (3271)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 16mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.During procedure, the left atrial pressure was >12mmhg and the amulet was successfully implanted after some manipulations.On (b)(6) 2024, the physician mentioned the patient presented to the emergency department on an unknown day with chest pain and a small pericardial effusion was detected and medication was administered.The physician mentioned the cause of effusion was abbott device, the patient was reported stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
An event of patient-device incompatibility (implant related to tissue damage-pericardial effusion) 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 specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the cause of the reported incident could not be determined.The patient effects of angina appears to be related to pericardial effusion.The reported hospitalization and unexpected medical intervention were resulted of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 16mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer torqvue 45x45 delivery sheath.The patient was on 48 hour hold of eliquis (5mg bid) prior to procedure.During procedure, the left atrial pressure was >12mmhg and the amulet was successfully implanted after some manipulations.On (b)(6) 2024, the physician mentioned the patient presented to the emergency department with chest pain and a pericardial effusion was detected and medication was administered.The patient was taking aspirin 81mg plavix 75mg at the time of pericardial effusion detected.The physician mentioned the cause of effusion was abbott device, the patient was reported stable.

• 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: 21126172
• Report Number: 2135147-2025-00257
• Device Sequence Number: 7676952
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)280131(10)8884102
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/25/2025

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 Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8884102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Male