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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	09/18/2018
Type of Reportable Event	Death
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 implanted in the patient for the endovascular treatment of a 60mm diameter thoracic aortic aneurysm.It was reported the patients iliac arteries were very calcified it was reported during the index procedure that some resistance occurred while delivering the proximal stent graft to the target location, however, the device was able to pass to the thoracic proximal landing zone without having to remove the delivery system or perform any adjunctive procedures such as ballooning or stenting.Once the stent graft was deployed the delivery system was re-captured using the correct technique, however, it was reported when the physician pulled the device back through the iliac, the device would not pass.The device was pulled with slightly more force and was successfully removed through the femoral access point.A rupture was called at the time of the delivery system removal.The physician then placed an occlusion balloon in the proximal left common iliac through a large 18fr sheath and pushed contrast retrograde through the sheath to see extravasation from the external iliac artery.A covered stent was placed to gain hemostatic control of the iliac artery, and cutdown on the abdomen was also performed to gain hemostatic control of the distal aorta.It was reported that the patient expired due to a drop in blood pressure and blood loss caused by a ruptured artery, likely the external iliac artery.As per the physician ,the cause of the event was due to a calcified iliac artery which would not expand/ adjust to the delivery system.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
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: 7943154
• Report Number: 2953200-2018-01435
• Device Sequence Number: 19417631
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: 02/14/2020
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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: Death; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 60