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

Model Number	VAMC4440C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft was implanted in the patient for the endovascular treatment of 250mm length thoracic aortic dissection.The dissection had spread distal to the superior mesenteric artery prior to the procedure.The distal aorta measured 36mm in diameter.It was reported that the thoracic dissection appeared to be sealed both proximal and distal after the final angio at the time of the index procedure.The patient returned to the hospital and the physicians found the distal seal above the celiac artery to be compromised allowing dye to flow retrograde into aneurysm sac.The physician made multiple inflations with an aortic balloon distally not obtaining a seal.No further intervention was performed.Per the physician the cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6933743
• Report Number: 2953200-2017-01551
• Device Sequence Number: 19184631
• Product Code: MIH
• UDI-Device Identifier: 00643169346697
• UDI-Public: 00643169346697
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: VAMC4440C150TU
• Device Catalogue Number: VAMC4440C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• 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: Required Intervention
• Patient Age: 76 YR