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

Model Number	VAMF4440C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
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 an unknown endovascular treatment.On the same date as the index procedure, it was reported that the patient was found slumped in a chair and taken back to hospital.A type a retrograde aortic dissection 250mm in length was observed.Aortic repair was carried out of the ascending aorta.It was reported that the event was resolved.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: the patient was found slumped in the chair two days post-index procedure.It was reported the type a retrograde aortic dissection was related to the index procedure.Film evaluation summary: the exact cause of the retrograde dissection reported post-implant could not be determined from the films provided.Review of pre-implant ct¿s and 3d-ct film report revealed that the patient had a type b thoracic dissection.The proximal tear was located ~20mm caudal to the innominate artery, and 12mm from the left carotid.The thoracic diameter at the innominate measured 40 x 41mm, and at the left carotid was 40mm in diameter.Just distal to the proximal tear near the top of the arch the thoracic diameter (tl+fl) measured ~37mm in diameter, and the diameter of the true lumen (tf) was ~ 21mm.From across the arch and along the essentially straight descending thoracic to the celiac artery, the tl diameter ranged from 22 ¿ 24 ¿ 22 ¿ 20mm.All the visceral vessels were being perfused by the true lumen.Films during implant were not available for review.Ct¿s returned from 6-days post-implant revealed that 3 valiant stent grafts had been implanted in the patient.The proximal free-flo device was positioned with the fabric just caudal to the left carotid artery, and the 2 overlapping distal valiant devices were positioned along the full length of the descending thoracic to just above the celiac artery.No stent graft issues were observed.Beginning near the bare spring of the proximal device a type a dissection was seen extending retrograde into the ascending thoracic.Analysis of the returned films did not reveal any stent graft anomalies that could explain the type a retrograde dissection.It is unclear if the bare spring seen in close proximity to the distal extent of the dissection may have contributed.It is possible that the patient¿s pre-existing condition,type b dissection, may have been a factor.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: 7922625
• Report Number: 2953200-2018-01367
• Device Sequence Number: 13866401
• Product Code: MIH
• UDI-Device Identifier: 00643169400191
• UDI-Public: 00643169400191
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• 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): 10/18/2018

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: 06/12/2020
• Device Model Number: VAMF4440C150TU
• Device Catalogue Number: VAMF4440C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 63