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

Model Number	VNMC3737C182TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984)
Date of Event	02/12/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navon stent graft system was implanted in a patient for the endovascular treatment of a 60mm abdominal thoracic aneurysm.It was reported that during the index procedure the navion stent graft vnmc3737c182 was inadvertently deployed across the paravisceral segment.Conversion to open abdominal repair was carried out and the device was removed surgically, and an additional piece was placed.It was reported that the patient experienced occlusion of the renal arteries, celiac and sma after the case and expired the next day due to the complications.It was confirmed that the occlusion was due to the graft being placed over the paravisceral segment and that the graft was related to the occlusion.It was reported that the graft did what it is supposed to do (exclude flow outside the graft) but the placement and position of the graft was across those vessels.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is expired.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 9810655
• Report Number: 9612164-2020-01097
• Device Sequence Number: 3002224
• Product Code: MIH
• UDI-Device Identifier: 00763000101060
• UDI-Public: 00763000101060
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 03/10/2020

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: 12/17/2021
• Device Model Number: VNMC3737C182TU
• Device Catalogue Number: VNMC3737C182TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/10/2020
• 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: Death; Other; Required Intervention
• Patient Age: 55 YR