MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

Model Number	ACH235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case: (b)(4).The ach235 device was not returned for evaluation; however, the device history record was reviewed.There are no non-conformance or reworks that were noted during the manufacturing process that relate to the reported issue.
Event or Problem Description
A patient underwent an on-pump aortic root replacement with concomitant left atrial appendage exclusion (laae) via median sternotomy.After placing the atriclip, the medial end of the clip came in contact with the button of the left mainstem artery where it was reattached to the aortic graft.The patient went into ventricular fibrillation (vf), and the clip was removed.The vf self-resolved and the patient is recovering.This was a procedural complication with no reported device malfunction.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 16862164
• Report Number: 3011706110-2023-00020
• Device Sequence Number: 17512518
• Product Code: PZX
• UDI-Device Identifier: 30840143900093
• UDI-Public: (01)30840143900093(17)250801(10)122874
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 05/03/2023

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 Expiration Date: 08/01/2025
• Device Model Number: ACH235
• Device Catalogue Number: A000916
• Device Lot Number: 122874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2022
• 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: Life Threatening; Required Intervention
• Patient Sex: Male