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	Anemia (1706); Angina (1710); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2024, a 16mm amplatzer amulet left atrial appendage occluder was implanted in a patient.No effusion was noted prior to procedure, however the patient did have a very large fluid-filled transverse sinus.(b)(4) units heparin given total during procedure.The patient's activated clotting time (act) levels at end of procedure was 283 seconds.There were multiple recaptures/repositioning due to shallow and small anatomy.40mg of protamine given at the end of procedure.No effusion was noted post procedure.Patient kept overnight and complained of atypical chest pain.Multiple surface echocardiogram (echo) performed on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024 were normal.On (b)(6) 2024, patient had drop in hemoglobin and hematocrit.Computer tomography (ct) of abdomen and pelvis performed which did not show any bleeds but did show moderate pericardial effusion.On (b)(6) 2024, patient received another echo which showed a small to moderate effusion.On (b)(6) 2024, echo showed an effusion larger than 2cm with beginning signs of cardiac tamponade, including right atrium (ra) collapse with increased heart rate.Patient taken to catheter lab for pericardiocentesis, which resulted in draining 320ml of bloody fluid.No residual effusion demonstrated on echo on (b)(6) 2024.The patient was reported as stable.
Additional Manufacturer Narrative
An event of chest pain, pericardial effusion lead to cardiac temponade post implant was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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.The patient's act was 283 seconds with in the expected range.It was indicated that multiple recaptures/repositioning due to shallow and small anatomy which could have contributed to the reported event.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 available information, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18811016
• Report Number: 2135147-2024-00940
• Device Sequence Number: 14281357
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)270531(10)8527458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/25/2024

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: 8527458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2022
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 52 KG