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

Model Number	VNMF4040C223TU
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	10/29/2019
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 navion stent graft system was implanted in a patient for the endovascular treatment of an unknown diameter thoracic aortic aneurysm.It was reported that during the implant procedure, the physician had to push the delivery system to deliver it to the landing zone, due to the patient's severe tortuosity distal to a previously placed stent graft.After successful delivery and placement of the navion stent graft, the patient's blood pressure dropped.Angiography distal to the stent graft showed a thoracic rupture.The patient expired during the procedure.As per the physician, the cause of the event was related to the patient's tortuous anatomy.No additional clinical sequelae were reported and the patient is expired.
Additional Manufacturer Narrative
Analysis summary: the exact cause of the reported thoracic rupture occurring during the planned intervention could not be determined from the returned pre-implant film report.Complete ct¿s prior to implant were not returned, and a thorough evaluation of the patient¿s anatomy could not be performed.Films during implant were not available for return and the reported event could not be assessed.The returned films confirmed a severely tortuous bend just distal to the previously implanted devices.It was reported that the physician had to push the delivery system in order to deliver it to the landing zone.Therefore it is possible that the thoracic rupture, leading to the patient's death, was most likely procedure and anatomy related due to implanting across the tortuous thoracic.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: 9283703
• Report Number: 9612164-2019-04654
• Device Sequence Number: 16722124
• Product Code: MIH
• UDI-Device Identifier: 00763000100735
• UDI-Public: 00763000100735
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 12/05/2019

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: 08/11/2021
• Device Model Number: VNMF4040C223TU
• Device Catalogue Number: VNMF4040C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: Death
• Patient Age: 74 YR