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

Model Number	VAMF3434C200TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was planned to be implanted in a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that the physician was unable to pass the valiant captivia stent graft system (b)(4) into the main right femoral artery and was unable to get the device to the desired location.The access vessel size was reported to be 8-9mm and non-calcified.Multiple attempts were made but the graft could not pass.Another manufacturers 24 french sheath was then passed through the access vessel and the vessel dissected.A non-mdt stent graft was implanted to resolve the dissection and the case was aborted.The physician attributed the cause of the event to the patients anatomy and reported that access was extremely difficult.The difficulty with access was not expected due to the size of the access vessels.No additional clinical sequelae were reported and the patient is being monitored.

• 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: 7510015
• Report Number: 2953200-2018-00696
• Device Sequence Number: 13859020
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 05/24/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/14/2018
• 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: 88 YR