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

Model Number	VNMC4343C55TU
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/31/2019
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 65mm thoracic aneurysm.It was noted the patient had a previous open aortic bi femoral repair and there were stents placed in the limbs of the open repair graft.It was reported during the index procedure several attempts were made to advance the device through the patients left limb due to resistance.A 22fr sheath was then advanced as far as possible through the limb and the device was reinserted through the sheath into the aorta.The device was deployed without difficulty but the middle of the stent graft failed to open.The delivery system was removed and the physician attempted to balloon the device to get it to open but there appeared to be a 5mm section that was constrained to about 16mm.Under fluoroscopy a section of the iliac stent was observed to be stuck on the stent graft leading to the graft being constrained.Several attempts were made to balloon out the stent to break it away from the graft but they were unsuccessful.Due to the stent constraining the graft, the distal end of the graft did not land in the intended place.The physician elected to implant a 43x55 navion stent to extend the distal end of the graft however this device misdeployed.It appeared as if the distal part of the graft auto-deployed causing the left side of the graft to slide out of the delivery system landing well above the intended landing zone.A (46x95) valinat navion stent was then used to extend the graft successfully.Per the physician the cause of the constrainment was due to the iliac stent fracturing and which was not observed until fluoroscopy.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: 8361152
• Report Number: 2953200-2019-00256
• Device Sequence Number: 1915237
• Product Code: MIH
• UDI-Device Identifier: 00763000101121
• UDI-Public: 00763000101121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/22/2019

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: 11/20/2020
• Device Model Number: VNMC4343C55TU
• Device Catalogue Number: VNMC4343C55TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: 78 YR