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

Model Number	VAMF3838C150TU
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm (1708); Pleural Effusion (2010)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: vamc4036c150tu, serial/lot #: (b)(4), ubd: 13-nov-2014, 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 to treat a thoracic aortic aneurysm of unknown size.It is reported that the patient presented with a left pleural effusion approximately five years later.A ct was carried out which showed that the aneurysm had increased proximally and the stent graft had migrated distally into the aneurysm.An intervention was carried out with debranching of the greater vessels.A landing zone was created and two valiant navion stent grafts (vnmc4343c225 and vnmc4343c93) were implanted to realign the existing stent graft from the ascending aorta to distal of the existing stent graft.The physician stated that the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary; the reported events were confirmed; however, the amount of migration and exact cause could not be determined from the films provided.The pre-implant films and more recent post-implant films were not available for review.Ct¿s returned from 5+ years post-implant revealed that the patient had been implanted with two (2) valiant stent grafts within the tortuous and aneurysmal thoracic aorta.Left pleural effusion was confirmed.The proximal device was positioned ~8cm from the lcca and there was a proximal type i endoleak.Between the lcca and proximal device the thoracic aneurysm measured ~ 5cm in flow lumen diameter.The devices were severely angulated measuring ~160deg from the proximal ¿ distal end, and at this stent graft angulation near the top of the arch the devices were compressed to ~18mm min id.Several cm¿s distal to the devices the thoracic was acutely angulated ~100deg as it coursed down to the celiac artery.The devices were patent.It appears likely that disease progression and morphology changes contributed to the stent graft migration, leading to the type ia endoleak and taa expansion.The cause of the left pleural effusion could not be determined.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: 8068889
• Report Number: 2953200-2018-01578
• Device Sequence Number: 2190712
• Product Code: MIH
• UDI-Device Identifier: 00613994797674
• UDI-Public: 00613994797674
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 05/15/2015
• Device Model Number: VAMF3838C150TU
• Device Catalogue Number: VAMF3838C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 70 YR