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

Device Problems Collapse (1099); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; endovascular repair of blunt thoracic aortic trauma: is postimplant hypertension an incidental finding - konstantinos tigkiropoulos, fragiska sigala, diamantis i.Tsilimigras ,2demetrios moris, konstantinos filis, nikolaos melas, dimitrios karamanos, christos kontogiannis, ioannis lazaridis, and nikolaos saratzis, thessaloniki and athens, greece, and durham, north carolina ann vasc surg 2018; 50: 160e166 doi.Org/10.1016/j.Avsg.2018.01.100.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in 23 patients for the endovascular treatment of blunt thoracic aortic trauma between (b)(6) 2005 and (b)(6) 2016.The following device malfunction was observed; proximal collapse of endograft.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7693414
• MDR Text Key: 114690167
• Report Number: 2953200-2018-01038
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/11/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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