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

Model Number	VAMC3834C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant devices are: (b)(4), s/n: (b)(4); use by date: 03/20/2015; upn # (b)(4), s/n: (b)(4); use by date: 09/16/2016;upn # (b)(4).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 72mm diameter abdominal aortic aneurysm.It was reported that during the index procedure the graft was originally placed at the left common carotid artery.It was noted that the patient had a follow up ct and a type ia endoleak was observed.As per the physician, the cause of the endoleak was due to difficult patient anatomy.Intervention was performed on an unknown date in which a snorkel procedure was performed, and another manufacturers device was used to try and gain seal in the ascending arch.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 proximal type i endoleak could not be determined from the films provided.Pre-implant ct¿s revealed that the patient had a 7 ¿ 8 cm max diameter taa, which began in the proximal arch several cm¿s from the lcca.Images during implant were not available for review.Ct¿s returned from 3-months post-implant revealed that 3 valiant stent grafts had been implanted in the patient¿s thoracic aorta.The proximal device was positioned just caudal to the lcca, and the devices extended to just superior of the celiac artery.The maximum diameter taa measured ~8cm, and beginning 1 ¿ 2 cm from the proximal device contrast was seen within the sac from a likely proximal type i endoleak.It is possible that implanting within the patient¿s short proximal neck, with the taa beginning just past the lcca, may have contributed to the loss of the proximal seal.Images during the reported snorkel procedure and when an additional device was implanted to gain more proximal seal in the ascending arch were not provided.If information is provided in the future, a supplemental report will be issued.

• 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: 7276047
• Report Number: 2953200-2018-00239
• Device Sequence Number: 19151454
• Product Code: MIH
• UDI-Device Identifier: 00643169346727
• UDI-Public: 00643169346727
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 09/23/2016
• Device Model Number: VAMC3834C150TU
• Device Catalogue Number: VAMC3834C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/07/2018
• 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: 82 YR