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

Model Number	VAMF4040C200TU
Medical Device Problem Codes	Difficult To Position (1467); Difficult to Remove (1528)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was inserted in a patient for the endovascular treatment of a 50mm diameter thoracic aortic aneurysm.T here was severe thrombus in the descending aorta and the external iliac arteries were tortuous.It was reported that during the index procedure the physician was unable to deliver the device through the 6mm iliac artery.The physician was unable to remove the device so, a retroperitoneal incision was performed to expose the common and external iliac artery.An 8mm conduit was sewn proximally and the device was removed with approximately 3-4cm of the intima layer on the graft cover.A new device was opened and successfully advanced through the 8mm conduit resolving the event.Per the physician the cause of the event was due to attempting to advance a 24fr valiant sheath (8mm) into a 6mm external iliac artery.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6281691
• Report Number: 2953200-2017-00114
• Device Sequence Number: 10915695
• Product Code: MIH
• UDI-Device Identifier: 00643169346543
• UDI-Public: 00643169346543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2017

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: 05/26/2018
• Device Model Number: VAMF4040C200TU
• Device Catalogue Number: VAMF4040C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 68 YR