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

Model Number PRO V50

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 10/10/2019

Event Type  Death  

Manufacturer Narrative

(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 pro v50 device was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2019, a male patient with a history of clot, myocardial infarction, stent placement in lad, and right ventricular dysfunction, planned to undergo a convergent and left atrial appendage (laa) management procedure.Given the patients¿ history of clot, the surgeon decided first to manage the laa.Ports were placed in the normal fashion and pericardium was opened without incident.The laa was clipped with an atriclip pro v50 and within 5 minutes of placement, patient experienced sudden hypotension.The surgeon looked at the echo and noted it was right ventricular dysfunction.Compressions were started on the table and the pressure became stable.The surgeon made the decision to remove the clip, with the two forceps he pulled the clip apart and removed the clip without incident.Patient again became hypotensive; compressions were started, and pressure resumed after about 10 minutes.Patient became hemodynamically stable with short runs of ventricular tachycardia and had to be cardioverted 4 separate times and shocked once.The convergent part of the procedure was not completed.Then the port sites were closed, and the patient was brought to the cath lab for the coronary study.The coronary study showed no immediate causes for the hypotensive episodes.Post- procedure, the following day patient was due to be extubated, but the patient expired.The surgeon stated patients¿ events were associated with his pre-existing condition.This was a procedural complication, there was not reported device malfunction.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE PRO-V CLIP
• Type of Device: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE 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 ; 5137554563
• MDR Report Key: 9250828
• MDR Text Key: 164134995
• Report Number: 3011706110-2019-00051
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRO V50
• Device Catalogue Number: A000974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• 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): Death