MAUDE Adverse Event Report: AtriCure, Inc. AtriClip® Flex-V® LAA Exclusion System with Preloaded V Clip¿; Left Atrial Appendage Clip, Implantable

Model Number	ACHV45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent aortic valve repair/replacement (avrr) via median sternotomy with concomitant surgical ablation and left atrial appendage exclusion (laae) using achv45 atriclip device.That evening, the patient was returned to the or for bleeding.Reoperation identified that laa was torn at the base, proximal to clip device.The surgeon repaired the tear with suture from within the atrium.The patient¿s chest was packed and they were observed overnight.No further bleeding was noted and the chest was closed the following day.The patient is recovering without further reported incident.While direct cause or contribution by the device was not confirmed, it cannot be ruled out; therefore this event is being reported per part 803.There was no reported device malfunction and this event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was not returned for evaluation however, a device history review was conducted and there is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the subject complaint.

• Brand Name: AtriClip® Flex-V® LAA Exclusion System with Preloaded V Clip¿
• Common Device Name: Left Atrial Appendage Clip, Implantable
• Manufacturer (Section D): AtriCure, Inc.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): AtriCure, Inc.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: patricia craft ; 7555 innovation way; mason, OH 45040 ; +1(513)664-1909
• MDR Report Key: 50240903
• Report Number: 3011706110-2026-00030
• Device Sequence Number: 10273113
• Product Code: PZX
• UDI-Device Identifier: 10840143914294
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K233407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/13/2026

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: ACHV45
• Device Catalogue Number: A001019-4
• Device Lot Number: 166473
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2026
• 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: Suture
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 171 LB