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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: information references the main component of the system.Other relevant device(s) are: product id: v amc3232c200tu, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (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 thoracic aortic aneurysm.It was reported that during a follow up performed approximately 1.5 year post index procedure, a type ib endo leak was detected.Per the physician, the cause of the event was due to disease progression and distal aorta dilated beyond size of the endograft.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Films review summary: the exact cause of reported type ib endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant ct¿s were not available for review and comparison.Ct¿s returned from 14 months post-implant revealed that the patient had been implanted with 2 valiant stent grafts.The proximal free-flo device was positioned with the proximal covered stent ~3cm caudal to the lsa, and the second closed web device extended 5 ¿ 6 cm from the proximal device and was positioned ~4cm above the celiac artery.The 7cm diameter taa was seen within the descending thoracic, and contrast was observed outside the stent graft within the distal taa sac most likely coming from a distal type i endoleak.The distal stent graft od measured ~32mm and there was 1cm of remaining distal seal zone length.It is possible that disease progression due to distal thoracic diameter dilatation along with distal seal length decrease may have led to the type ib endoleak.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7654401
• Report Number: 2953200-2018-00921
• Device Sequence Number: 1652465
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 06/30/2018
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/08/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1