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

Model Number	VAMF3838C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft was implanted in the patient for the endovascular treatment of 60mm diameter thoracic aortic aneurysm.It was reported that the patient presented emergently under the care of another physician and was found to have a dissection extending proximally from the stent graft to the subclavian artery.The physician stated that they would medically manage the patient and determine if an lsa bypass is needed along with a proximal stent graft extension.Per the physician the cause of the event is due to uncontrolled hypertension.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Film review summary: the exact cause of the dissection flap seen just above the proximal bare spring could not be determined from the post-implant films provided.The pre-implant anatomy is unknown and films during implant were not available.Ct¿s returned from 3 months post-implant revealed that a single valiant captivia stent graft had been implanted in the patient¿s descending thoracic.The proximal bare spring was positioned just past the aortic arch ~12cm caudal to the lsa, in an essentially straight segment of the descending thoracic.A thoracic dissection flap was seen extending ~15mm above the bare spring.It is possible that this dissection flap may have been related to a pre-existing anatomical condition, caused by the reported uncontrolled hypertension, or was possibly related to the implant of the stent graft.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: 6829545
• Report Number: 2953200-2017-01355
• Device Sequence Number: 1523058
• Product Code: MIH
• UDI-Device Identifier: 00643169346956
• UDI-Public: 00643169346956
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/22/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2018
• Device Model Number: VAMF3838C150TU
• Device Catalogue Number: VAMF3838C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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: 83 YR