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

Model Number	VAMC4036C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
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 captivia stent graft system was implanted in a patient for the endovascular treatment of a 6 cm diameter thoracic aortic aneurysm.It was reported that the patient presented for a routine follow up.The ct revealed that the 44x44x100 valiant stent graft had a distal type i endoleak.The distal thoracic aorta had changed from 36 mm in diameter to 42 mm in diameter.The physician implanted a 40x36x150 valiant stent graft deploying it in the previously implanted proximal 40x40x100 valiant extending down in the native artery completely covering the 44x44x100 valiant.However, the distal type i endoleak did not resolve.The physician elected to monitor the patient.The physician stated that the cause of the distal type i endoleak was due to disease progression and distal aneurysm dilation.No clinical sequelae were reported and the patient is fine.
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: 6276395
• Report Number: 2953200-2017-00101
• Device Sequence Number: 19043563
• Product Code: MIH
• UDI-Device Identifier: 00643169346710
• UDI-Public: 00643169346710
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/09/2017

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: 10/04/2018
• Device Model Number: VAMC4036C150TU
• Device Catalogue Number: VAMC4036C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR