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

Model Number	VAMF3434C200TU
Medical Device Problem Codes	Kinked (1339); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was inserted in a patient for the endovascular treatment of a 5.5 cm in diameter thoracic aortic aneurysm.An endurant stent graft system was implanted in the patient for use as a conduit in the right iliac limb.It was reported that the physician was unable to advance the valiant 34x34x150 delivery system to the intended landing zone due to calcification.The valiant 34x34x150 was removed from the patient.The physician elected to implant an endurant 16x10x124 right iliac limb in the right common and external iliac arteries as a conduit.The physician used another manufacturer¿s 12x4 balloon in the endurant stent graft and performed an angioplasty.The physician re-inserted the valiant 34x34x150 once again, but was unable to advance the device, the physician noticed that the nose cone had been damaged with what appeared to be a burr on the end.The device was discarded.The physician inserted a valiant 34x34x200 stent graft however while advancing the device up the left iliac artery there was some friction the device then kinked/buckled and then was unable to advance any further.The physician removed and discarded the device and aborted procedure.After closing the right and left arterial exposures the patient¿s right leg became ischemic and the physician performed a fem-fem bypass.Per the physician, the causes of the valiant related events are related to the patient¿s anatomy; calcified iliac arteries.The cause of the occlusion of the external iliac occlusion and endurant stent graft was the result of multiple passes of the valiant graft.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6599626
• Report Number: 2953200-2017-00888
• Device Sequence Number: 369914
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR