MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE SYNERGY ABLATION SYSTEM

Model Number OLL2

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

Patient Problem Pulmonary Valve Stenosis (2024)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event was discovered during a literature search >16 months post procedure.There was no reported device malfunction at the time of the procedure and no lot number was able to be ascertained.

Event Description

A literature search reported that a 55-year-old male underwent a coronary artery bypass graft (cabg) and concomitant surgical ablation using an isolator synergy ablation clamp (oll2) and a left atrial appendage exclusion device.At 16-months post-operation, the left superior pulmonary vein (lspv) was confirmed to have mild stenosis.Pulmonary vein recanalization was attempted but unsuccessful.Patient has dyspnea on exertion without significant progression.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY ABLATION SYSTEM
• 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: 15764089
• MDR Text Key: 303392344
• Report Number: 3011706110-2022-00039
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• 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
• Treatment: ATRICLIP
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Sex: Male