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

Model Number	VAMF3434C100TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: v amf3838c100tu, serial/lot #: (b)(4), ubd: 02-mar-2018, 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 non mdt stent graft system for the treatment of a type iiib endoleak.Taa diameter measures 67 x 65mm thoracic aneurysm.It was reported that approximately 9 months post implant, follow up ct revealed the endograft construct displaced caudally causing a type ia endoleak with subsequent aneurysm sac expansion.Intervention was performed.The main body of the endograft construct was explanted and a tube graft sewed in its place resolving the event.It was not possible to identify which device had the type ia endoleak.It was reported that during the explant there was grumous material present, but no new blood.A distinct endoleak wasn't identifiable on pre-operative scans.Per the physician the cause of the event was due to multiple failures in the non mdt stent graft resulting in overall failure of the endograft construct.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported type ia endoleak was confirmed.The exact cause of the detachment of the non-mdt bifurcate proximal stent, leading to the type ia endoleak and aaa expansion, could not be determined from the films provided.Other than caused by failure of the non-mdt bifurcate, it is also possible that disease progression and challenging anatomy may have contributed to the events.The cause of the thrombus seen within the devices placed within the aaa sac also could not be determined; however, significant pre-existing thrombus and severely angulated anatomy was previously observed.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: 8508213
• Report Number: 2953200-2019-00495
• Device Sequence Number: 13861555
• Product Code: MIH
• UDI-Device Identifier: 00643169347069
• UDI-Public: 00643169347069
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 01/04/2017
• Device Model Number: VAMF3434C100TU
• Device Catalogue Number: VAMF3434C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: 73 YR
• Patient Weight: 66