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

Model Number	VAMF4040C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/27/2018
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 stent graft system was implanted in a patient for the endovascular treatment of a 78mm diameter thoracic aortic aneurysm.It was reported that the patient presented emergently after being found unresponsive due to a cardiac arrest approximately 5 years post the index procedure.The patient was revived and transferred to icu.On cta which was performed at the hospital, a type ib/type ia endoleak was demonstrated.As per the physician, the cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7453456
• Report Number: 2953200-2018-00581
• Device Sequence Number: 1373537
• Product Code: MIH
• UDI-Device Identifier: 00613994797667
• UDI-Public: 00613994797667
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 08/27/2014
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/24/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 89 YR