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

Model Number	VAMF4242C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s): vamf4444c150tu, sn (b)(4), expiration date: 2018-11-14, (b)(4).
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm on (b)(6) 2016.It was reported that the final angiogram after the initial procedure showed diffused contrast in the aneurysm.A recent routine follow up ct imaging demonstrated contrast in the aneurysm.The physician thought it was either a type ia or a type iii endoleak.Per the physician, the cause of the endoleak was unknown.No 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 - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6351624
• Report Number: 2953200-2017-00272
• Device Sequence Number: 977132
• Product Code: MIH
• UDI-Device Identifier: 00643169346536
• UDI-Public: 00643169346536
• 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): 02/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: VAMF4242C200TU
• Device Catalogue Number: VAMF4242C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2017
• Supplement Date Received by Manufacturer: 02/04/2017
• Initial Report FDA Received Date: 02/22/2017
• 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
• Patient Age: 82 YR