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

Model Number	VNMC3131C223TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/07/2020
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 was implanted in the endovascular treatment of a aortic intramural hematoma (imh).It was reported that on the date of the ct, just under a year post the index procedure, a type ia endoleak was observed with aortic dilation.It was noted there was 25mm of proximal seal zone available to extend coverage to the left common carotid.Intervention was performed on the same date, and a vnmf 37x37x174mm stent graft was implanted as treatment in a good proximal position to the left common carotid artery.Final angiogram showed the endoleak had resolved.As per the physician the cause of the event was anatomy and noted there to be significant aortic remodeling.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
Conclusion: the reported endoleak event could not be assessed on the films provided.The cause of the event could not be fully determined.Lack of post-implant ct¿s or angiograms showing the endoleak or anatomical remodelling were not provided.Although a type ia endoleak cannot be ruled out, analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported type ia endoleak.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: 10173299
• Report Number: 9612164-2020-02266
• Device Sequence Number: 17037307
• Product Code: MIH
• UDI-Device Identifier: 00763000100995
• UDI-Public: 00763000100995
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/07/2020

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: 01/16/2021
• Device Model Number: VNMC3131C223TU
• Device Catalogue Number: VNMC3131C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 06/07/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: 57 YR