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

Model Number	VAMF3636C200TU
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
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 planned for implantation in a patient for the endovascular treatment of a 75mm diameter thoracic aortic aneurysm.It was reported that during the index procedure the surgeon tried to advance the device up the patients left side but the device would not advance.The right side was dilated to attempts to advance the device this side but it could not be advanced on the right either.The surgeon felt that the hydrophilic coating had come off the delivery system.It was noted that the physician had activated the hydrocoating as per the ifu with a saline soaked gauze.A new valiant stent graft was opened and was successfully deployed via the patients right side and the procedure completed.As per the physician, the cause of the event was anatomy related due to calcified vessels.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: 7572606
• Report Number: 2953200-2018-00814
• Device Sequence Number: 18868029
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2019
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR