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

Model Number	VAMC4036C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/02/2017
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 an 8.3 in diameter thoracoabdominal aortic aneurysm (taaa).Only the thoracic aneurysm component was treated and the physician planned for the second part of the staged procedure which was to implant another manufacturer¿s branch stent graft to treat the visceral and abdominal components.However, it was reported that, approximately 7 months post index procedure, prior to the planned second stage procedure, the patient presented emergently with abdominal pain.It was reported that the ct revealed that the abdominal aortic aneurysm had ruptured.The physicians performed a debranching from the left common iliac artery (lcia) to the celiac, sma and renal artery.Three additional valiant stent grafts were also implanted.Extending from the existing valiant thoracic stent graft to aortic bifurcation effectively excluding entire aorta.The ruptured aaa was excluded.Per the physician, the cause of the event was related to the patient¿s anatomy.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,gw
• MDR Report Key: 6990414
• Report Number: 2953200-2017-01649
• Device Sequence Number: 19003822
• Product Code: MIH
• UDI-Device Identifier: 00643169346710
• UDI-Public: 00643169346710
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/31/2017

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: 08/10/2018
• Device Model Number: VAMC4036C150TU
• Device Catalogue Number: VAMC4036C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/31/2017
• 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: 54 YR
• Patient Weight: 63