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

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

Patient Problems Hematoma (1884); Pain (1994)

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 this technique extends the reach of endovascular therapy to the most severe subcategory of tasc iid aiod and is a viable alternative to aortobifemoral bypass for ciao.(b)(4).

Event Description

Article received: pepe, r.E.(2016).Endovascular reconstruction for chronic infrarenal aortoiliac occlusive disease.Annals of vascular surgery, 263.E11-263.E16.Purpose: to describe the use and short term outcomes of an endovascular technique that allows for successful revascularization of the chronically occluded infrarenal aorta, aortic bifurcation and the iliac system.Per the article adverse events included abdominal back pain and retroperitoneal hematoma.

• 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: 7921897
• MDR Text Key: 122165272
• Report Number: 3011175548-2018-01062
• 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: 09/11/2018
• 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: 55 YR