MAUDE Adverse Event Report: ATRIUM MEDICAL ATRIUM ICAST STENTS; PROSTHESIS, TRACHEAL

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The article concluded that further research is warranted on whether emergent traumatic cases with contraindications can be performed in a similar fashion to safely reduce the morbidity and mortality associated with aortic disruptions.

Event Description

Article received: abi-chaker, a.E.(2017).Successful revascularization of aortic arch in a (b)(6) blunt trauma patient with acute diffuse axonal injury without the use of systemic anticoagulation.Annals of vascular surgery, 418.E1 - 418.E5.Purpose: to demonstrate the viability of a hybrid vascular repair of a complex aortic disruption without the use of systemic anticoagulation in the setting of contraindicated or unknown risk of systemic anticoagulation.Per the article adverse events included: carotid/vagus nerve injury.

• Brand Name: ATRIUM ICAST STENTS
• Type of Device: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7921907
• MDR Text Key: 122165450
• Report Number: 3011175548-2018-01078
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/01/2018
• 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): Required Intervention
• Patient Age: 39 YR