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

Model Number	VAMF2626C100TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/19/2018
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 attempted to be implanted in a patient for the endovascular treatment of a 46 mm thoracic aortic aneurysm.The diameter of the left iliac artery was 6 mm and 7 mm at the right iliac artery.It was reported that the patient had small access anatomy and a narrow calcified distal aorta.Other manufacturer's dilators, sheaths and the dotter technique were used in the left groin in order to make space for the delivery system.The physician advanced the device however the device could not be passed beyond the aorta iliac bifurcation.The device was removed and the patient's blood pressure dropped.Rupture had occurred of the left common iliac artery.A reliant balloon was passed through a sheath in the right groin to the abdominal aorta and the balloon was inflate to occlude and tamponade the blood loss.The procedure was converted to open repair and the rupture was repaired with aorto bifemoral bypass.The taa was not treated at this time.The valiant device was not implanted.As per the physician the cause of the event is anatomy related and was due to the small calcified distal aorta.No clinical sequelae were reported and the patient is alive.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the ruptured lcia and inability to advance the device to the target could not be determined from the pre-implant films provided.Films during implant were not provided.However, it appears very likely that attempting to implant into the small and calcified distal aorta and small/calcified common iliac arteries, likely contributed to the reported events.It is also possible that other manufacturer's dilators and sheaths utilized prior to advancing the delivery system also may have contributed to the vessel rupture.If information is provided in the future, a supplemental report will be issued.

• 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: 7262962
• Report Number: 2953200-2018-00208
• Device Sequence Number: 16402920
• Product Code: MIH
• UDI-Device Identifier: 00643169347106
• UDI-Public: 00643169347106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2019
• Device Model Number: VAMF2626C100TU
• Device Catalogue Number: VAMF2626C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/06/2018
• 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: 73 YR
• Patient Weight: 37