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

Catalog Number VAMF4040C150TJ

Device Problem Inaccurate Delivery (2339)

Patient Problems Death (1802); Occlusion (1984); Vascular Dissection (3160)

Event Date 01/06/2014

Event Type  Death  

Event Description

A valiant stent graft system was implanted for the endovascular treatment of a 6.8 cm diameter thoracic aortic aneurysm in zone one.The proximal neck was 37 mm and the distal neck was 32 mm in diameter.The aortic neck length was 42 mm.There was mild calcification at the superficial femoral artery.It was reported that approximately four months after the index procedure, the patient expired due to an ascending aortic dissection which was confirmed by a ct check.Two months post implant, a follow up ct was taken and no observations were seen.The physician commented that it is unknown the direct causality with the valiant devices.Film review analysis: review of returned angio images at implant showed the taa just distal to the lsa in the arch.The proximal main device was implanted just distal to the brachiocephalic, and a proximal cuff was placed several mm's proximal to the main device.The lsa was then coiled.Both sets of bare springs were positioned near to the level of the brachiocephalic ostium.No stent graft issues were observed.Cta's from 3-months post-implant showed no stent graft issues or endoleaks.No dissection was seen.The max diameter taa was approximately 6cm.Cta's from 5-months post-implant were non-contrast; the reported type a dissection could not be assessed due to the limited films.No obvious stent graft issues could be confirmed.The cause of the type a retrograde dissection could not be determined.It is possible that the implant of the stent graft into zone 1 may have contributed.

Manufacturer Narrative

(b)(4).Evaluation method: (film).Evaluation results and conclusion: (dissection, death).(unknown cause of event).(implanting in zone one).

• Brand Name: VALIANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3600917
• MDR Text Key: 4158410
• Report Number: 2953200-2014-00144
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2014

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
• Device Expiration Date: 03/01/2015
• Device Catalogue Number: VAMF4040C150TJ
• Device Lot Number: V04003489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 01/30/2014
• Date Device Manufactured: 03/05/2013
• 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
• Patient Age: 00069 YR