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 ACH150

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

Patient Problem Thrombus (2101)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Case (b)(4) the device was not returned for evaluation, however a device history review was conducted for ach150 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 that on (b)(6) 2019 an off-pump stand-alone left atrial appendage (laa) closure was performed with left approach of right lateral decubitus position.Prior to procedure, a transesophageal echo (tee) confirmed that there was no thrombus in the laa.A follow-up tee (date unknown) revealed presence of thrombus and confirmed that the clip was placed on the proximal laa.On (b)(6) 2019 the surgeon performed an on-pump thrombectomy with minimally invasive cardiac surgery.A surgical patch was attached on laa ostium.Anticoagulant therapy (warfarin) was prescribed after re-operation.

• 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: 9363676
• MDR Text Key: 168058859
• Report Number: 3011706110-2019-00056
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Distributor Facility Aware Date: 10/29/2019
• Date Manufacturer Received: 10/29/2019
• Date Device Manufactured: 10/26/2017
• 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): Life Threatening; Required Intervention