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

Model Number	VNMF3737C229TU
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/12/2020
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 was implanted in the endovascular repair of a 50mm thoracic aortic aneurysm.It was reported that during the index procedure the physician deployed the device at the target location but due to the length of the graft used the distal end was not in the field of view on the monitor of the fluoroscopy unit.It was thought that the physician deployed the entire stent graft by rotating the deployment handle to the end.Unfortunately the deployed handle was not rotated to the end and as a result there was approximately 1-2cm that remained constrained within the graft cover of the delivery system.When the physician went to remove the delivery system that was thought to have been previously completely deployed, the stent graft was inadvertently pulled down from the target location approximately 4-5cm.The consequence from this was the distal end of the stent graft was now covering the patient's celiac, sma and renal arteries.An open thoracotomy was performed in order to explant the valiant navion and repair the thoracic aneurysm as per the physician the cause of the event was user error.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported removal difficulties and resulting inaccurate placement of the device could not be confirmed from the pre-implant films provided.Procedural images or videos showing deployment and removal of the device were not provided for a thorough analysis of the reported event.Analysis of the 3d report received did not show any obvious anatomic characteristics that may have contributed to the event.The most likely cause of the reported event was the user error described, by attempting to remove the device from the patient before complete deployment of the device had been achieved, and by not continuously visualizing of the entire device via fluoroscopy during the procedure.The delivery system and explanted devices are not returning for analysis and so potential device issues cannot be evaluated.Device code changed at completion of film evaluation- from deployment issue to difficult to remove.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: 9848777
• Report Number: 9612164-2020-01215
• Device Sequence Number: 2967696
• Product Code: MIH
• UDI-Device Identifier: 00763000100698
• UDI-Public: 00763000100698
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 11/04/2021
• Device Model Number: VNMF3737C229TU
• Device Catalogue Number: VNMF3737C229TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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: Other; Required Intervention
• Patient Age: 73 YR