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

Model Number	VAMF4646C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Paralysis (1997)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: vamf4242c150tu sn (b)(4), use by date: 2019-05-02, udi # (b)(4).
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 71mm diameter thoracic aortic aneurysm.It was reported that the patient was paralyzed on an unknown date after the initial procedure.The physician stated that the cause of the event is unknown.No further information is available.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Additional information received reported that the patient experienced paralysis on the same day as the index procedure or early the next morning.The physician stated that the nurse failed to monitor the patient's blood pressure and drain pressures.The patient was hypotensive for a few hours.If information is provided in the future, a supplemental report will be issued.

• 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: 6711093
• Report Number: 2953200-2017-01133
• Device Sequence Number: 11028631
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2019
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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
• Patient Age: 76 YR