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

Model Number	PROV40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Low Cardiac Output (2501)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent an on-pump, heparinized mini mitral valve repair with concomitant maze procedure and left atrial appendage exclusion.A prov40 clip was placed successfully.Post-operative heart catheterization indicated that the left anterior descending artery (lad) was occluded.Patient was returned to the operating room where the surgeon performed a left thoracotomy and removed the prov40 and placed a balloon pump.Heart catheterization the next day showed the lad had normal flow.The patient is doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
(b)(4): the device was not returned for investigation as there was no reported device malfunction.The device history record was reviewed for lot 112045.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V 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: 16691483
• Report Number: 3011706110-2023-00014
• Device Sequence Number: 20353593
• Product Code: FZP
• UDI-Device Identifier: 10840143901225
• UDI-Public: (01)10840143901225(17)240701(10)112045
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: 07/01/2024
• Device Model Number: PROV40
• Device Catalogue Number: A000973-4
• Device Lot Number: 112045
• 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: 03/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female