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

Model Number	VAMC3434C150TU
Medical Device Problem Codes	Device Damaged by Another Device (2915); Power Problem (3010)
Health Effect - Clinical Codes	Intimal Dissection (1333); Death (1802); Occlusion (1984); Injury (2348)
Date of Event	08/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: v amf3636c100tu, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 100mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, it was reported that the guide wire was mis-located.The guidewire was re-advanced and passed through a small sub-intimal flap.The stent graft systems were then delivered and deployed over this wire leading to a thoracic dissection and partial occlusion.The patient received bypass treatment on the same date but patient expired due to thoracic injury and occlusion.Per the physician, the cause of the event was tortuous anatomy and user error.No additional clinical sequelae were reported.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7836936
• Report Number: 2953200-2018-01250
• Device Sequence Number: 2446681
• Product Code: MIH
• UDI-Device Identifier: 00643169346574
• UDI-Public: 00643169346574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 03/28/2019
• Device Model Number: VAMC3434C150TU
• Device Catalogue Number: VAMC3434C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2018
• Initial Report FDA Received Date: 08/31/2018
• 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; Required Intervention