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

Model Number	VAMF3838C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	01/23/2018
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 stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm (300mm in length from the lsa to sma).It was reported that on follow up ct a type ia endoleak was observed.As per the physician, the cause of the event was anatomy related due to angulation of the vessel.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the reported proximal type i endoleak could not be determined from the pre-implant films provided.Images during implant and post-implant were not available, and the reported endoleak could not be assessed.A returned pre-implant 3d-ct film report confirmed the taa within the proximal portion of the descending thoracic, beginning just below the steeply angulated <(><<)>(><(>&<)><(><<)>)> short aortic arch.The thoracic diameter along the 25mm proximal seal length ranged from 31.8 to 29.7mm.It is possible that implanting within the short length seal and angulated arch may have contributed to the reported type ia endoleak.Additional information was received for this case: intervention was performed.A proximal extension was implanted and the endoleak has resolved.

• 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: 7282112
• Report Number: 2953200-2018-00258
• Device Sequence Number: 16178738
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/21/2018

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: 11/20/2019
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: 71 YR