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

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

Patient Problem Aortic Dissection (2491)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the article treatment of renal arteries utilizing balloon expandable stent grafts appears to be more durable than historical experience with bare stents or balloon angioplasty.

Event Description

Received an article titled "balloon-expandable stent grafts for in stent restenosis in atherosclerotic renal artery stenosis with prior clinical response".The purpose of the article was to determine the functional and anatomical outcome of managing bare-stent in stent restenosis (isr) utilizing balloon expandable stent grafts (icast) in patients who had a positive clinical response to the initial bare stent placement.Per the article one patient had a type-b aortic dissection.

• Brand Name: ATRIUM ICAST COVERED 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: 7538354
• MDR Text Key: 109064084
• Report Number: 3011175548-2018-00512
• 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: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

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
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/23/2018
• 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