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

Model Number	VAMF2828C150TU
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Ischemia (1942); Occlusion (1984); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 captivia stent graft system was implanted in a patient for the endovascular treatment of a 25.0 cm thoracic aortic dissection.It was reported that the left common carotid artery was unintentionally covered during the initial procedure.An intra-operative retrograde type a dissection also occurred; which caused malperfusion to the celiac artery, renal arteries, superior mesenteric artery, and right leg.A carotid-carotid bypass and ascending aortic open repair were performed.The metal struts had punctured through the aorta circumferentially.The physician had to bypass the innominate artery and replace the ascending aorta by sewing to the fabric of the stent graft and stent struts.The physician stated that the cause of the event could not be determined.The patient is alive and still in the hospital.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
Film review the cause of the events occurring during implant could not be determined from the pre-implant films provided.Images during and post-implant were not available, and the stent graft in-vivo configuration could not be assessed.Pre-implant ct¿s confirmed that the patient had a type b dissection that extended from just caudal to the lsa, down to just above the celiac artery.The dissection then resumed down the abdominal aorta, from just below the orifice of the right renal artery and down to the mid-level of the left common iliac artery.The descending thoracic was essentially straight, with no appreciable calcification of thrombus.The diameter of the ascending thoracic measured 28 ¿ 30mm and no dissection was observed.The thoracic flow lumen (tl +fl) diameter along the descending thoracic ranged from 30 ¿ 27mm.It is possible that the patient¿s pre-existing type b dissection may have contributed to the events.Unintentional stent graft coverage of the left common carotid artery was likely procedure/user related.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: 6827064
• Report Number: 9612164-2017-01188
• Device Sequence Number: 13467706
• Product Code: MIH
• UDI-Device Identifier: 00643169347007
• UDI-Public: 00643169347007
• 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): 09/01/2017

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: 10/10/2018
• Device Model Number: VAMF2828C150TU
• Device Catalogue Number: VAMF2828C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/25/2017
• 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; Disability
• Patient Age: 34 YR