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

Model Number	VAMC3838C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported distal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not provided for comparison.Additional films during the most recent intervention, when an additional valiant along with 8 aptus endoanchors were implanted resolving the endoleak, were also not available for review.Ct¿s at 15 months post-implant revealed an endoleak along the distal 3cm¿s of the device and down to the celiac artery origin.There appeared to be a marginal distal seal length as the bottom of the taa was near the level of the distal stent graft.This was most likely a distal type i endoleak but could not rule out type iii fabric endoleak.Review of ct¿s from 18 months post-implant revealed that since the previous study, an additional valiant stent graft had been implanted into the distal valiant device, extending down to the celiac artery.Contrast was again seen within the distal taa sac which appeared most likely to have been a distal type i endoleak.It is possible that the likely distal type i endoleak was caused by disease progression.Between the bottom of the stent graft and the celiac artery the thoracic was moderately calcified, which may have also contributed to the endoleak.A good faith effort will be made to obtain the applicable information relevant to the report.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 distal type i endoleak of a valiant stent graft.It was reported that the patient presented emergently with back pain.The ct revealed a distal type i endoleak.The physician decided to implant a valiant 38x38x100 along with 8 aptus endoanchors.The final angiogram revealed that the distal type i endoleak was resolved.The physician could not determine the cause of the event.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6429426
• Report Number: 2953200-2017-00453
• Device Sequence Number: 780626
• Product Code: MIH
• UDI-Device Identifier: 00643169347168
• UDI-Public: 00643169347168
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/27/2017

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: 06/16/2018
• Device Model Number: VAMC3838C100TU
• Device Catalogue Number: VAMC3838C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 83 YR