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

Model Number	VAMF4646C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a thoracoabdominal aneurysm.It was reported that the physician successfully implanted the valiant stent graft along with superior mesenteric artery (sma) and left renal artery with the snorkel technique.The physician modelled the valiant stent graft with ballooning however the aortogram revealed a type ia endoleak.The physician elected to snorkel the celiac artery, lengthen the sma stent and the left renal artery stent and implanted a 2nd valiant stent graft higher in the descending thoracic aorta.All devices were placed successfully.Ballooning was completed however the aortogram revealed that the type ia endoleak was still present.Per the physician, the cause of the proximal type i endoleak was due to the patient¿s anatomy, thoracoabdominal aneurysm.No additional clinical sequelae were reported and the patient will be monitored by the 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: 6967940
• Report Number: 2953200-2017-01610
• Device Sequence Number: 16468983
• Product Code: MIH
• UDI-Device Identifier: 00643169346918
• UDI-Public: 00643169346918
• 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): 10/23/2017

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: 08/24/2019
• Device Model Number: VAMF4646C150TU
• Device Catalogue Number: VAMF4646C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/23/2017
• 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: 78 YR