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

Model Number ATRICURE CLIP DEVICE (UNKNOWN)

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

Patient Problem Stenosis (2263)

Event Type  Injury  

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 device was not reported or able to be subsequently ascertained.

Event Description

During a literature search this case was identified and reported on 18-dec-2020.A (b)(6)-year-old male patient underwent a mitral and tricuspid valve surgery with left atrial appendage occlusion.A transesophageal echocardiogram confirmed proper valve function without insufficiency.After patient was awake and stable, an ekg was performed and showed a third-degree atrioventricular block and blood levels of creatine kinase were within the normal range.On the first postoperative day patient showed indications of myocardial ischemia.A transthoracic echocardiogram showed patient's ejection fraction was reduced to 30%, and the patient was transferred to cardiac catheterization where stenosis of the left circumflex coronary artery was detected.Patient was referred for percutaneous coronary intervention where a stent was implanted into the affected coronary artery.The further course on the icu was uneventful.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 ; 5136448220
• MDR Report Key: 11170626
• MDR Text Key: 226836103
• Report Number: 3011706110-2021-00001
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191413
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ATRICURE CLIP DEVICE (UNKNOWN)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 79 YR