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

Model Number	VAMC3232C150TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Codes	Occlusion (1984); Paralysis (1997)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vamf3232c200tu, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was planned for implantation in a patient for the endovascular treatment of a 65mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, after placement of wires and catheters, the most proximal 24fr valiant stent graft to be implanted was inserted; however, while trying to advance, although the physician was pushing as hard as possible, the delivery system could not be advance.After removal of the device, angiogram showed an occlusion of the distal aorta and proximal common iliac arteries.The physician used a balloon expandable stent in the area and then sequential dilators up to 22 fr to dilate the vessels.The physician then attempted to pass the device again, however, it still would not advance.A 22fr valiant stent graft was then attempted to pass and this was successfully advanced proximally to land just before the left subclavian artery to treat the taa.Another valiant stent graft was placed just above the celiac artery more distally.It was reported the next day, the patient was paralyzed from the waist down.Attempts to place a spinal drain and fluoroscopy drain were not successful.Additionally, a csf drain had also been placed prior to the stent graft procedure.The physician noted a 3-5% risk of paralysis with the taa repair procedure.As per the physician, the cause of the crossing difficulties was due to advanced occlusive disease leading to inability to advance the device.The cause of the paralysis as per the physician cannot be determined.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 7521895
• Report Number: 2953200-2018-00732
• Device Sequence Number: 16568082
• Product Code: MIH
• UDI-Device Identifier: 00643169346581
• UDI-Public: 00643169346581
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 09/11/2019
• Device Model Number: VAMC3232C150TU
• Device Catalogue Number: VAMC3232C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: Disability
• Patient Age: 69 YR