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

Model Number	VAMF3434C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Vascular Dissection (3160)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was implanted into a patient for the emergent endovascular treatment of a leaking descending thoracic aortic ulcer.It was reported that the patient presented with chest pain.An angiogram revealed that there was a retrograde type a dissection from the suprarenal struts extending into the ascending aorta down to the level of the sinotubular junction.The patient has uncontrolled hypertension and this was controlled with nicardipine.The physician preformed open surgical repair for the type a dissection.A dacron graft was sewn into the aorta, then the aorta was cut and trimmed proximally to the sinotublar junction which was reconstructed with a double felt sandwich that was sewn in place and with bypass of the innominate artery and the left carotid artery.Per the operative report that cause of the retrograde type a dissection was due to the combination of the patient¿s tissue quality that was particularly friable and very poor and to the barbs of the stent graft.Per the physician, the cause of the event may have been due to over sizing of the valiant stent graft.No additional clinical sequelae were reported and the patient is fine.

• 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: 6964301
• Report Number: 2953200-2017-01607
• Device Sequence Number: 16411319
• Product Code: MIH
• UDI-Device Identifier: 00643169346970
• UDI-Public: 00643169346970
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/20/2017

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: 01/05/2019
• Device Model Number: VAMF3434C150TU
• Device Catalogue Number: VAMF3434C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/20/2017
• 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: 61 YR