MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENT; STENT, RENAL

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

Patient Problems Hemorrhage, Cerebral (1889); Respiratory Failure (2484)

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 ch-tevar with a balloon-expandable chimney stent graft can be complicated by incomplete chimney deployment due to balloon perforation.Relining of the chimney stent graft with a self-expanding stent improved the deployment with acceptable patency.

Event Description

Ahttp://emdr.Fda.Gov/emdr/forminbox/rticle received: katsargyris, a.E.(2017).Incomplete expansion of chimney stent graft during chimney-thoracic encovascular aneurysm repair.Annals of vascular surgery, 293.E1 - 293.E5.Purpose: to report a technical complication during a chimney-thoracic endovascular aneurysm repair procedure.Per the article adverse events included respiratory insufficiency and ischemic stroke.

• Brand Name: ADVANTA V12 VASCULAR STENT
• Type of Device: STENT, RENAL
• 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: 7921904
• MDR Text Key: 122164683
• Report Number: 3011175548-2018-01065
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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?: Yes
• 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: 77 YR