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

Model Number	VAMF3434C200TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); Ischemia (1942); Occlusion (1984)
Date of Event	11/02/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Failure to follow instruction (positioned incorrectly).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 a patient for the endovascular treatment of a type b thoracic aortic dissection of 450 -500mm.It was reported that two days post procedure a follow up ct revealed that the visceral vessels had developed compromised blood flow.This led to limited blood flow to the visceral vessels, resulting in ischemia to the tissue and blood supply to the organs.It was reported that the patient expired 2 days post index procedure from abdominal ischemia.Per the physician, the cause of the event was due to inaccurate implantation of the stent graft, the proximal portion of the stent graft was in the true lumen; however the distal portion of the stent graft was in the false lumen.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Films review summary: the cause of the compromised blood flow reported two days post-implant could not be determined from the films provided.Films during implant were not provided.Pre-implant ct¿s revealed that the patient had a type b thoracic aortic dissection that extended from the lsa down to the distal abdominal aortic bifurcation.The true/false lumen boundaries along the descending thoracic were appreciably variable.The true lumen was seen perfusing the celiac, sma, and right renal artery, and the false lumen was perfusing the left renal artery.Films from 2-days post-implant revealed that a single valiant stent graft had been implanted in the patient from just caudal to the lsa, and extending across the arch and into the mid-descending thoracic aorta.The distal end of the stent graft was ~10 cm above the celiac artery origin.No stent graft issues were seen.The stent graft was patent, and was gradually angulated with no observed kinks or compression.The thoracic dissection appeared excluded along the length of the stent graft, and distal to the device a single lumen was visible extending to the visceral vessels.Beginning at the celiac artery the dissection was visible extending down to the abdominal aorta.The celiac artery and left renal were being perfused (possibly limited flow to the celiac compared to pre-implant); however, the sma and right renal artery both appeared occluded.It is possible that inaccurate implantation of the stent graft, implanting the proximal portion of the stent graft into the true lumen and the distal portion of the stent graft was in the false lumen, may have led to this event.The cause of this inaccurate placement could not be determined from the films provided.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: 7099281
• Report Number: 2953200-2017-01941
• Device Sequence Number: 1298031
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• 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): 01/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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
• Patient Age: 50 YR