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

Model Number	VAMF3030C200TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 280 mm thoracic aorta type b dissection.Deployment of thoracic grafts was successful landing just distal to left common carotid artery.It was reported that after the valiant stent graft had laser fenestration performed for access to the left subclavian artery a completion angiogram was performed demonstrating that the valiant stent graft had partially encroached the left common carotid artery.An attempt was made to pull the proximal portion of the valiant stent graft back slightly by use of balloon but was unsuccessful.The physician made the decision to stent the left common carotid with another manufacturer¿s 8 x 27 mm balloon expandable stent to alleviate encroachment.The left common carotid was cannulated and successfully stented.A completion angiogram showed gross patency of the origin of the left common carotid.Per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6392468
• Report Number: 2953200-2017-00353
• Device Sequence Number: 13578208
• Product Code: MIH
• UDI-Device Identifier: 00643169346901
• UDI-Public: 00643169346901
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 01/21/2018
• Device Model Number: VAMF3030C200TU
• Device Catalogue Number: VAMF3030C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 65 YR
• Patient Weight: 94