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

Model Number	VAMF4242C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Vascular Dissection (3160)
Date of Event	01/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that a follow up ct revealed a proximal type i endoleak present due to migration of the valiant stent graft.The physician elected to implant another valiant stent graft and performed a carotid to left subclavian bypass.Placement of the valiant proximal extension piece was done in a standard manner.While attempting to embolize the lsa origin with another manufacturer¿s plug, the plug was deployed, the sheath was withdrawn, a contrast injection demonstrated possible extravasation.Another manufacturer¿s covered stent was deployed in an attempt to cover a suspected vascular perforation, an angiogram demonstrated possible extravasation, therefore another manufacturer¿s plug and embolization coils were deployed inside the covered stent.No further extravasation was observed.It was reported that the patient presented emergently with chest pain.A ct demonstrated a suspected retrograde type a dissection on the lesser curve at the location of the proximal stent graft.The physician elected to perform a hemi-arch replacement with a surgical graft, however the event was not resolved.Per the physician, the cause of the dissection was related to the device.No additional clinical sequelae were reported and the patient is being 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: 6366280
• Report Number: 2953200-2017-00297
• Device Sequence Number: 10773717
• Product Code: MIH
• UDI-Device Identifier: 00643169347342
• UDI-Public: 00643169347342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2018
• Device Model Number: VAMF4242C100TU
• Device Catalogue Number: VAMF4242C100TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/28/2017
• 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: 73 YR