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

Model Number	VAMC3838C100TU
Medical Device Problem Codes	Difficult to Insert (1316); Difficult To Position (1467)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	03/27/2018
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 captivia stent graft system was planned to be implanted in a patient to treat a 67 mm thoracic abdominal aortic aneurysm.The patient was being treated for a thoracic co-abdominal repair with another investigational device.It was reported that the valiant stent graft system was inserted through the right common femoral artery but would not pass through the right external iliac artery.The diameter of the right external iliac artery was 6 mm.The physician then used sequential dilators to dilate the eternal iliac artery.While removing the dilators, the patient's blood pressure dropped and the external iliac artery ruptured and emergency treatment was started.A balloon was inflated in the distal aorta to occlude the artery and an angiogram was taken to see the extent of the rupture.An endurant ii limb was then deployed into the right common iliac artery down to the right common femoral to cover the injury.However, the injury was too extensive, and the physician then cut down on the common femoral site and reteroperitoneal to assess the injury and clamped off the bleeding artery.A 10mm graft was used to bypass the right common iliac artery down to the right common femoral artery.The bleeding was controlled and the patient left the operating room in a stable condition.It was also reported that the endurant ii limb was explanted during the procedure.It was reported that the procedure was subsequently completed s uccessfully approximately 8 days post the index procedure.The physician reported that the cause of the event was anatomy related and that the right external iliac (6mm) was too small for the valiant captivia device.No additional clinical sequelae were reported, and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the valiant positioning difficulties and resulting external iliac rupture could not be determined from the pre-implant films provided.Images during implant were not available for review and the reported events could not be assessed.Pre-implant ct¿s and 3d-ct film report confirmed that the common iliac arteries were non-tortuous and mildly calcified.The right common iliac ranged in diameter from 14 ¿ 11 ¿ 10mm, and both the right and left external iliacs measured 6mm in diameter with no appreciable calcification.It is possible that implanting via the small right external iliac artery may have contributed to the events.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: 7453464
• Report Number: 2953200-2018-00583
• Device Sequence Number: 806710
• Product Code: MIH
• UDI-Device Identifier: 00643169347168
• UDI-Public: 00643169347168
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 07/06/2019
• Device Model Number: VAMC3838C100TU
• Device Catalogue Number: VAMC3838C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 69 YR