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

Catalog Number VAMF3838C200TU

Device Problem Inaccurate Delivery (2339)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 01/09/2014

Event Type  Injury  

Event Description

A valiant captivia stent graft system was implanted for the endovascular treatment of a 290 mm descending dissection in zone two.The maximum aneurysm diameter was 37.4 mm.The diameter from the caudal to the left carotid artery measured 36 mm.The diameter from the caudal to te left subclavian artery measuring 35.4 mm.It was reported that 37 days post implant, the patient presented to the emergency room with pain.It was discovered that the patient had a type a retrograde dissection so, the physician decided to do an open repair.A cortex graft was sewn into the existing stent graft.The physician stated the cause of the event was due to the bare springs had perforated the aorta in several locations.The physician decided to clip off the proximal portion of the springs that had perforated the aorta.No clinical sequelae were reported and the patient is fine.Film review analysis: review of returned films pre-implant showed that the patient had a type b dissection extending from the bottom of the arch, distally down to just proximal to the celiac.Images during implant or post-implant showing the type a dissection were not provided, and the cause of the type a dissection could not be determined.

Manufacturer Narrative

(b)(4).Evaluation method/results/ conclusion: inherent risk of procedure (dissection, aortic perforation, removal of implant), other (unknown cause of event), unapproved use of device (pre-implant dissection) evaluation codes.

Manufacturer Narrative

Conclusion: pre-implant dissection.

• 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: 3604827
• MDR Text Key: 16916168
• Report Number: 2953200-2014-00168
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

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: 10/08/2015
• Device Catalogue Number: VAMF3838C200TU
• Device Lot Number: V04130985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2014
• Date Device Manufactured: 10/09/2013
• 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): Required Intervention
• Patient Age: 00050 YR