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

Catalog Number	9-ACP2-007-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a amplatzer amulet left atrial appendage (laa) occluder was chosen for implant, 14f amulet steerable delivery sheath.The patient was presented with small pericardial effusion prior to device attempt.Patient was in sinus rhythm with a contractile appendage and large transverse sinus.The patient's activated clotting time (act) levels was 378.Esmolol was administered to control heart rate during deployment.During the procedure, a second transseptal puncture was performed due to inability to get the steerable sheath coaxial enough for an orthogonal deployment.It was noted that there was difficulty implanting the amulet device, requiring multiple deployment attempts.About an hour post-procedure, the patient had a small blood pressure drop, which had also occurred during procedure.A transthoracic echocardiogram (tte) was done, and mildly larger pericardial effusion was noted.The patient was given colchicine and the pericardial effusion resolved on its own by the next day.The patient was reported to be stable and was discharged.
Additional Manufacturer Narrative
An event of small pericardial effusion present prior to implantation worsening post implantation was reported.There are multiple risk factors for pericardial effusion after a left atrial appendage closure procedure, including anticoagulation status of the patient, maneuvering of the guidewire or sheaths within the heart, the trans-septal puncture, or the stabilizing wires on the amulet puncturing the laa.Information from the field indicated that the patient's activated clotting time (act) levels was 378.Esmolol was administered to control heart rate during deployment.The field also indicated that a second transseptal puncture was performed due to inability to get the steerable sheath coaxial enough for an orthogonal deployment and that there was difficulty implanting the device.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 incident could not be conclusively determined.

• 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: 19011321
• Report Number: 2135147-2024-01399
• Device Sequence Number: 3825538
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)270930(10)8694698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/01/2024

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: 8694698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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: Other
• Patient Age: 79 YR
• Patient Sex: Female