MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP; IMPLANTABLE CLIP AND CLIP APPLIER

Model Number	PROV45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A patient underwent a convergent procedure with concomitant video-assisted thoracoscopic (vats) left atrial appendage exclusion (laae) using a prov45 atriclip device.During placement of the clip device, an injury occurred at the base of the left atrial appendage (laa).The procedure was converted to sternotomy and the injury was repaired with suture.The prov45 was then successfully placed at the base of the laa.The patient is reportedly recovering.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP
• Common Device Name: IMPLANTABLE CLIP AND CLIP APPLIER
• 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 45140 ; 5136448220
• MDR Report Key: 20043425
• Report Number: 3011706110-2024-00050
• Device Sequence Number: 7998353
• Product Code: PZX
• UDI-Device Identifier: 10840143907647
• UDI-Public: (01)10840143907647(17)270101(10)136668
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K210293
• 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): 08/22/2024

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 Model Number: PROV45
• Device Catalogue Number: A000973-4
• Device Lot Number: 136668
• 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: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Male