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

Model Number	VAMC4238C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597)
Date of Event	03/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: vamf4040c100tu, (b)(4) expiration date: 2014-08-20, (b)(4).
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 37.2 cm in length thoracic aortic dissection.It was reported that the patient presented with chest and abdomen pain.The ct found a proximal type i endoleak.The investigator elected to surgical perform medial sternotomy with replacement of ascending aorta, aortic debranching and graft placement with separate stents to the left carotid and innominate arteries.Subject handled procedure well.It was reported that a three weeks later the patient presented with post-operative massive chest bleed and the patient expired.Per the investigator, the causes of the events were related to the pre-existing dissection and not related to the study device or the study procedure.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6622837
• Report Number: 2953200-2017-00949
• Device Sequence Number: 10915811
• Product Code: MIH
• UDI-Device Identifier: 00613994802903
• UDI-Public: 00613994802903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 08/20/2014
• Device Model Number: VAMC4238C150TU
• Device Catalogue Number: VAMC4238C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/08/2017
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68