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

Model Number	VNMF3737C174TU
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/26/2019
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 for the endovascular treatment of a saccular thoracic aneurysm.Calcification of the renal arteries and infrarenal aorta was noted with a narrow distal aorta measuring 15mm.It was reported during the index procedure after the stent graft was deployed, the distal aspect of the graft infolded.An additional graft was implanted to cover the infolded part and the procedure completed successfully.Per the physician the cause of the infolding is undetermined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary; the reported stent graft infolding/malposition of the distal aspect of the implanted device was confirmed; however, the exact cause could not be determined from the films provided.Complete ct¿s prior to implant were not returned and a comprehensive review of the patient¿s anatomy could not be performed.Complete angiograms during implant, including cine¿s during stent graft positioning, deployment & removal of the delivery system, and flow lumen assessment, were also not returned for review.A single still angiogram and an ivus video after the navion free-flo stent graft had been implanted confirmed that an area of potential stent infolding/malposition was seen having occurred on the most distal stent of the device.It is possible that this was anatomy related.Implanting within a calcified and/or thrombus filled vessel may have led to infolding during deployment.This also may have been user/procedure related.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: 9254685
• Report Number: 9612164-2019-04542
• Device Sequence Number: 13923085
• Product Code: MIH
• UDI-Device Identifier: 00763000100681
• UDI-Public: 00763000100681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2019

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: 10/14/2020
• Device Model Number: VNMF3737C174TU
• Device Catalogue Number: VNMF3737C174TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/26/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 74 YR