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

Model Number	VAMF4242C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/01/2017
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 6.5 cm in diameter thoracic aortic aneurysm.It was reported that a recent ct revealed that there was remodeling of the thoracic aorta resulting in a distal type i endoleak.The distal end of the valiant stent graft is currently 5 cm above the celiac artery, compared to a ct performed on 7 months¿ post implant which the device was at the celiac artery.The physician elected to perform an intervention by extending coverage to the level of the celiac artery using a valiant [vamc4646b100tu] stent graft.The physician then elected to implant 4 aptus endoanchors in order to anchor it to the distal aorta.The patient was stable after the procedure and the distal type i endoleak was resolved.Per the physician, the causes of the events were related to the patient¿s anatomy.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6893711
• Report Number: 2953200-2017-01485
• Device Sequence Number: 116947
• Product Code: MIH
• UDI-Device Identifier: 00643169346536
• UDI-Public: 00643169346536
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: 05/28/2016
• Device Model Number: VAMF4242C200TU
• Device Catalogue Number: VAMF4242C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/26/2017
• 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: 69 YR