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

Model Number	VNMF2525C96TU
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an aortic ulcer.It was reported that during the index procedure prior to use of the device in the patient, the physician elected to modify the device on the back table, reducing the length of the stent graft by one stent ring.The delivery system sheath was retracted to expose the stent graft, and suture ties were applied to keep the stent graft from expanding.The distal stent ring was removed using an eye cautery to cut the material.The sheath was then advanced back over the stent graft, and the sutures holding the stent graft in place were cut as the sheath progressed.At this point, a snapping sound was heard by the physician and a split was noted on the proximal delivery system sheath, near the ro marker band.The physician then inserted the modified device via an 18 fr non-medtronic sheath to avoid having the split device move up through t he aorta.The stent graft was then successfully implanted in an infra-renal position with no complications.The device delivery system was then removed through the 18 fr sheath.As per the physician, the cause of the event could not be determined.The physician did not allege any malfunctions or deficiencies with the device, because they knew they were working off-label.No additional clinical sequelae were reported and the patient is fine.

• 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: 8522198
• Report Number: 2953200-2019-00520
• Device Sequence Number: 13924471
• Product Code: MIH
• UDI-Device Identifier: 00763000100551
• UDI-Public: 00763000100551
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: VNMF2525C96TU
• Device Catalogue Number: VNMF2525C96TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR