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

Model Number	VAMC4040C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/23/2017
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 80mm diameter thoracic aortic aneurysm.It was reported that on follow up ct performed there was suspicion of type 1b or type ii endoleak.A distal extension(40x40x150) was implanted.It was reported that the patient sustained a fall and a ct was performed.An incidental finding on the ct performed, revealed the type ib and/or a type ii endoleak had not resolved.The physician planned to extend farther distally to the celiac artery.A 40x40x100mm valiant stent graft was implanted successfully with satisfactory results and the event was resolved.As per the physician, the cause of the event was due to tortuous distal aorta anatomy.No additional clinical sequelae were reported, and the patient is fine.

• Brand Name: VALIANT CAPTIVIA ENDOVASCULAR GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7127928
• Report Number: 9612164-2017-02006
• Device Sequence Number: 19302785
• Product Code: MIH
• UDI-Device Identifier: 00643169346833
• UDI-Public: 00643169346833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/19/2017

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: 05/17/2019
• Device Model Number: VAMC4040C150TU
• Device Catalogue Number: VAMC4040C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: 84 YR