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

Model Number	VAMC4444C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Thrombus (2101)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: vamc4444c200tu, serial/lot #: (b)(4), ubd: 23-may-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant stent graft systems were implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm of 57mm.It was reported that during the index procedure, upon removal of the 26fr sheath from the right common femoral artery, intimal stripping of the distal external iliac and proximal common femoral artery had occurred.This was confirmed by an angiography.It was also reported that on an unknown date the patient had a right femoral thrombus.The physician placed a 9x5 viabahn covered stent graft and a 9x37 express stent graft in the patient and repaired the anterior surface of the right common femoral artery with a bovine pericardial patch.Completion angiography revealed patent right femoral iliac system and palpable pulse in the right foot.It was reported the patient tolerated the procedure well and the event was resolved.The intimal femoral stripping is assessed by the investigator as not related to the device but related to the procedure.The sponsor has reported the cause of the event to be procedure and device related.The thrombus has not been assessed.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; after review, the sponsor has corrected its assessment of this event as not related to the device but related to the procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7845225
• Report Number: 2953200-2018-01260
• Device Sequence Number: 1573585
• Product Code: MIH
• UDI-Device Identifier: 00643169346819
• UDI-Public: 00643169346819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 06/10/2020
• Device Model Number: VAMC4444C150TU
• Device Catalogue Number: VAMC4444C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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: 62 YR
• Patient Weight: 97