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

Model Number ACH150

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

Patient Problems Death (1802); Perforation (2001)

Event Date 03/28/2019

Event Type  Death  

Manufacturer Narrative

Case-(b)(4).The atriclip ach150 device was not returned for evaluation but a device history review was obtained for lot number 78465.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.

Event Description

It was reported on (b)(6) 2019 that a male patient underwent an on-pump mitral valve repair with left atrial appendage management for improvement of left ventricular (lv) wall motion.After the mitral valve repair, an atriclip ach150 was placed on the laa.As the patient was being weaned from the cardiopulmonary bypass (cpb) bleeding was observed around the lung and an abnormal left ventricular wall movement was noted.Surgeon attempted to identify the source of bleeding, and then he removed the atriclip ach 150 as it was preventing the surgeon from finding the site of bleeding.Patient¿s left ventricular function grew worse and, in an attempt, to improve lv function, the surgeon did a coronary bypass graft.The surgeon was unable to determine the source of the bleeding and the chest was closed.The patient died the next morning on (b)(6) 2019.The surgeon stated that death was not related to the atriclip ach150.This was a procedural complication.There was no reported device malfunction.

• Brand Name: ATRICURE ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Type of Device: ATRICURE 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: 8539202
• MDR Text Key: 142730684
• Report Number: 3011706110-2019-00021
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: ACH150
• Device Catalogue Number: A000691-JP
• Device Lot Number: 78465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2017
• 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