MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP® PRO-V® LAA EXCLUSION SYSTEM; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	PROV50
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	11/25/2025
Type of Reportable Event	Death
Event or Problem Description
A patient underwent a video-assisted thoracoscopy (vats) for standalone left atrial appendage exclusion using a prov50 atriclip device.Due to lungs being adhered to pericardium and chest wall the procedural approach was converted to a thoracotomy.The prov50 device was advanced through 12mm port at the sixth intercostal space.The prov50 was removed and reintroduced via the thoracotomy at the fourth intercostal space.While positioning device around the left atrial appendage (laa) a tear at the base of the laa and dome of the atrium occurred.An attempt to deploy the clip was unsuccessful.After approximately one hour, the patient was placed on cardiopulmonary bypass, and the tear was sutured via thoracotomy.Despite these measures, the patient expired in the operating room.

• Brand Name: ATRICLIP® PRO-V® LAA EXCLUSION SYSTEM
• 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 ; 5136448220
• MDR Report Key: 23852097
• Report Number: 3011706110-2025-00041
• Device Sequence Number: 9958757
• Product Code: PZX
• UDI-Device Identifier: 10840143913556
• UDI-Public: (01)10840143913556(17)280801(10)157154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/17/2025

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 Model Number: PROV50
• Device Catalogue Number: A000974-4
• Device Lot Number: 157154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2025
• 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: Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 105 KG