MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP; ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ CLIP

Model Number PROV45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Tissue Breakdown (2681)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the prov45 was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2020 a patient with a fibroelastoma located in the left atrial appendage (laa), underwent a video assisted thoracoscopic laa procedure using the atriclip prov45.A pre- operative transesophageal echo cardiogram (tee) revealed that the fibroelastoma was located distally.The surgeon planned on placing the clip at the base of the laa without interfering with the fibroelastoma.After deploying the clip, an intra-operative tee revealed that the clip was not at the base and the clip was partially placed on a piece of the fibroelastoma.While the surgeon was attempting to reposition the clip a piece of the fibroelastoma separated and entered the left atrium.The patient was placed on pump and a sternotomy was performed.The surgeon removed the clip, sewed the laa and fibroelastoma was flushed out of the heart.The surgeon reported the patient is doing well.This was a procedural complication.There was no reported device malfunction.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP
• Type of Device: ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ 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: 9910811
• MDR Text Key: 189328138
• Report Number: 3011706110-2020-00016
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PROV45
• Device Catalogue Number: A000973
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening