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

Model Number	VNMF4040C223TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in a patient for the endovascular treatment of a 180mm dissection and 58 mm thoracic aortic aneurysm.It was reported that during the procedure while deploying the stent graft vnmf4040c223tu the device ¿slipped¿ 15-20mm distally of the intended landing zone.The stent graft was 25% deployed at this point.It was reported that the stent graft was deployed according to the ifu with forward pressure maintained on the stiff wire and the delivery system.The mean blood pressure was also dropped to 45mhg.The freeflow stent was also released after the rest of the stent graft had been deployed.A second valiant navion stent graft vnmf4040c183tu was then placed proximally.It was reported that this stent graft was also deployed in the same manner as the first stent graft, but this also deployed 5mm lower than intended.It was reported that the physician pushed forward quite a bit but still could not keep the device from migrating during deployment.Post deployment angiogram showed no endoleak.As per the physician, the cause of the event was likely due to the location of the aneurysm on the greater curve of the aortic arch.The physician also reported that he didn¿t think it was the device and there was probably nothing that could have been done to prevent the device form prolapsing into the aneurysm.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary; the cause of the reported inaccurate delivery of both implanted devices, the proximal end of the devices slipping 15 ¿ 20mm distal to the intended target, could not be determined from the pre-implant films provided.Images during implant were not available for review; therefore, the reported events could not be assessed.Post-implant ct¿s were also not provided and the implanted stent graft in-vivo configuration could not be reviewed.Analysis of the returned films did not reveal any anatomical characteristics that could explain the reported event.It is unclear if the location of the taa on the greater curve of the aortic arch may have contributed to the events.This may have been caused by an unknown anatomical and/or procedural issue.A device issue cannot be ruled out as a potential cause.However, the delivery systems were discarded and a product investigation could not be performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8762242
• Report Number: 9612164-2019-02684
• Device Sequence Number: 11336830
• Product Code: MIH
• UDI-Device Identifier: 00763000100735
• UDI-Public: 00763000100735
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: VNMF4040C223TU
• Device Catalogue Number: VNMF4040C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 70 YR