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

Model Number	VNMC4343C95TU
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
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 system was implanted in a patient for the endovascular treatment of a 53 mm diameter thoracic aortic aneurysm.It was reported that during the implant procedure, after full deployment of the stent graft, the physician had difficulty recapturing the delivery system prior to removal.It was reported that retracting the trigger on the slider was not disengaging it from the screw gear threads.After the physician moved the slider back and forth and retracted and released the trigger multiple times, the delivery system was eventually recaptured and removed from the patient.It was noted that during troubleshooting, the physician made sure that the delivery system was being held straight and that the front grip and slider were not being squeezed too tightly.As per the physician, the cause of the event could not be determined.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: 8887885
• Report Number: 9612164-2019-03372
• Device Sequence Number: 16772795
• Product Code: MIH
• UDI-Device Identifier: 00763000101138
• UDI-Public: 00763000101138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/13/2019

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: 03/27/2021
• Device Model Number: VNMC4343C95TU
• Device Catalogue Number: VNMC4343C95TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR