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

Model Number	VNMC4040C55TU
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
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 a cadaver as part of an r <(>&<)>d pre-clinical trial at a medtronic physiological research lab.It was reported that during the procedure when the device was removed from its packaging and prepared for use it was noted that the tapered tip was separated from the graft cover radiopaque marker (i.E there was a gap noted).The space between the tapered tip and the distal extent of the graft cover was approximately 5-7mm.It was decided to continue to implant the device and the device was successfully introduced, tracked and deployed as expected, with the procedure observed by an attending physician.The cause of the event is unknown.
Additional Manufacturer Narrative
Device analysis summary: the delivery system returned with the external slider and rapid release trigger in the home position.A gap of 2.5mm was visible between the taper tip and the graft cover tip (fail); specification is 1.0mm.A kink was observed on the graft cover 5.3mm from the tip.The graft cover was retracted, and the kink was visible on the middle and inner members.The reported dimensional deviation could not be confirmed through analysis.If information is provided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: 9762593
• Report Number: 9612164-2020-00905
• Device Sequence Number: 14147876
• Product Code: MIH
• UDI-Device Identifier: 00763000101084
• UDI-Public: 00763000101084
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 12/18/2020
• Device Model Number: VNMC4040C55TU
• Device Catalogue Number: VNMC4040C55TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1