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

Model Number PROV40

Device Problem Malposition of Device (2616)

Patient Problem Low Cardiac Output (2501)

Event Date 03/07/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 312800151
• Report Number: 3011706110-2023-00014
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10840143901225
• UDI-Public: (01)10840143901225(17)240701(10)112045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female