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

Catalog Number VAMF3838C100TJ

Device Problem Inaccurate Delivery (2339)

Patient Problems Death (1802); Occlusion (1984); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 01/14/2014

Event Type  Death  

Event Description

A valiant stent graft system was implanted in a patient for the endovascular treatment of a 60.2 x 123.5 mm fusiform thoracic aortic aneurysm in zone 2.The diameter of the non-aneurysmal proximal neck was 35.7mm.There was angulation of the external iliac artery.There were no complications at the time of implant.It was reported that six days post implant the patient was in a state of shock (level of consciousness was 300) and had an emergency operation.During open surgical repair there was acute bleeding which seemed to have had cardiac tamponade.The ascending aorta and aortic arch were replaced with a synthetic graft; however, cessation of cardiac activity was confirmed and the next day the patient expired.The physician commented that the dissection might have been due to a bare stent which would have touched ascending aorta.Review of several returned pre-implant images showed that the patient had 2 taa's; the proximal taa was just distal to the lsa, and the second was approximately several cm's distal and measured 6cm in diameter.There is a possible dissection seen near the renal arteries.Images during and post-implant were not provided.

Manufacturer Narrative

(b)(4).Evaluation, method: (film).Results: inherent risk of procedure (death, dissection, vessel occlusion).Patient¿s condition affected effectiveness of device (cardiac tamponade).Conclusion: 22inherent risk of procedure (death, dissection, vessel occlusion).Device failure/lack of effectiveness related to patient condition (cardiac tamponade).

Event Description

Additional films were received and review of cta's 5 days post-implant showed that the stent grafts were positioned from the lcca, and distally into the descending thoracic.The films show a possible type a dissection beginning at the bare springs and extending to the heart valve.The images in the ascending thoracic aorta contained multiple shadows and possible artifacts which made assessment of the dissection difficult.The shadows may have been caused by multiple neointimal tears or flaps which may have been in motion during the ct acquisition.A type b dissection is also seen near the celiac artery; this dissection was also seen in the pre-implant still images provided.No stent graft issues were observed.The cause of the type a dissection may be due the proximal bare springs.The patient's history and disease state (pre-existing type b dissection) may also have been a contributing factor.

• Brand Name: VALIANT CAPTIVIA
• 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: 3632091
• MDR Text Key: 4208009
• Report Number: 2953200-2014-00278
• 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,Followup
• Report Date: 02/27/2014

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: Other
• Device Expiration Date: 05/13/2015
• Device Catalogue Number: VAMF3838C100TJ
• Device Lot Number: V04045585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2014
• Date Device Manufactured: 05/14/2013
• 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; Required Intervention
• Patient Age: 00078 YR