MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982)

Event Date 11/10/2017

Event Type  Death  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; thoracic aortic transection resulting in a type b dissection following blunt trauma lance fogleman, terrell caffery, jeffrey gruner, danielle tatum (bmj case rep 2017.Doi:10.1136/bcr-2016-218766.Information references the main component of the system.Other relevant devices are: endurant stent graft cat number: unknown, s/n: unknown; use by date: unknown; upn # unknown endurant stent graft cat number: unknown, s/n: unknown; use by date: unknown; upn # unknown.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Three endurant stent graft systems were implanted in the patient for the endovascular treatment of a blunt thoracic aortic transection that resulted in a type b dissection.A (b)(6) -year-old man sustained an acute grade iii aortic injury resulting in a type b aortic dissection in the setting of severe traumatic brain injury, cervical spine injury and multiple orthopaedic injuries following a motorcycle crash.The patient underwent an emergent thoracic endovascular aortic repair, complicated by a thoracic pseudoaneurysm rupture and ongoing exsanguination from a persistent type 1 endoleak.Additional stent grafts were required to gain control of the endoleak.The patient ultimately progressed to brain death post procedure in the intensive care unit.This case reviews treatment considerations in the context of a blunt thoracic aortic transection and distal dissection with concomitant polytrauma.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7198682
• MDR Text Key: 97467397
• Report Number: 2953200-2018-00097
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/17/2018
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 39 YR