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

Model Number PRO240

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

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombus (2101)

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 pro240 device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.There was no reported device malfunction.

Event Description

It was reported on (b)(6) 2019 that a patient underwent an atrial valve replacement (avr) and left atrial appendage management procedure with an atriclip pro240 device.The procedure date is unknown.Pre-procedure, the physician performed a transesophageal echocardiogram (tee) and tee was clear of clots in the left atrial appendage.The patient went onto bypass and was heparinized with an unknown amount.The avr portion was completed, and the surgeon placed the atriclip pro240.While the patient was being weaned off bypass, another tee was performed, and a large clot was visualized in the atrium.Patient was put back on bypass and the surgeon removed the clot from the atrium.The surgeon completed the procedure.It was reported that post procedure, the patient expired.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 ; 5137554563
• MDR Report Key: 8519549
• MDR Text Key: 142108750
• Report Number: 3011706110-2019-00018
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160454
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRO240
• Device Catalogue Number: A000966
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• 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