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

Model Number	VAMF3434C200TU
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Blood Loss (2597)
Date of Event	01/19/2019
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 planned to be implanted in a patient for the emergent endovascular treatment of a contained 60mm ruptured thoracic aneurysm.The patient had a known thoracic aneurysm.The access vessel was reported to be very narrow.It was reported during the index procedure due to tight access the physician elected to perform a endoconduit with 3 non mdt stents placing them from the mid right common iliac to just above the inguinal ligament.It was noted bilateral iliac stents were previously implanted and one stent was placed inside an existing stent and ballooning completed.The physician attempted to insert the valiant stent graft but it would not pass any further than the tip of the nose cone due to size of external iliac.At this point of the procedure, the patient's blood pressure dropped.The physician performed a retrograde injection through the 11fr.Sheath in place and observed extravasation from the external iliac where the non mdt stents had been placed.Uncontrollable blood loss was reported and cpr commenced.While cpr was in progress the physician made a longer incision and observed that the entire external iliac was torn up to the area of the right cia with the bare metal stent.The patient expired during the procedure.Per the physician the cause of the event was anatomy related due to small calcified right external iliac artery.

• 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: 8270734
• Report Number: 2953200-2019-00143
• Device Sequence Number: 16568756
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 12/11/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 01/23/2019
• 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
• Patient Age: 84 YR