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

Model Number	VAMF4444C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	03/21/2018
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 a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that on a ct exam performed approximately 4 months post index procedure, a type ia endoleak was observed.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received; intervention was performed to address the type ia endoleak with the implantation of a 44x44x100 valiant stent graft proximally.It was reported that the stent graft was placed perfectly, but there was an endoleak proximally, either type ia or type ii endoleak.Film evaluation summary; the exact type and cause of the reported endoleak could not be determined from the films provided.Review of pre-implant ct¿s revealed that the patient had a 60mm max diameter taa located within the descending thoracic just past the arch.Other than the acutely angulated aortic arch (~90 deg), the thoracic was non-tortuous, and there was no appreciable calcification or thrombus.Ct¿s returned from ~4 months post-implant revealed that 2-valiant stent grafts had been implanted in the patient.The proximal free-flo device was positioned just distal to the lsa and extended across the arch.The distal device (closed web proximal) was positioned overlapping the proximal device ~3 stent rings (60mm¿s), with 3 stent rings extending distally from the end of the proximal device.Along the angulated stent graft inner curvature, near the start of the overlapping component junction, contrast was seen within the taa.The exact source/cause of the endoleak could not be determined.This most likely represented a type iiib fabric endoleak, possibly due to overlapping component abrasion which may have been exacerbated by stent graft angulation.However, it is also possible that this may have been a proximal type i endoleak due to an unknown cause.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7454341
• Report Number: 2953200-2018-00597
• Device Sequence Number: 13761965
• Product Code: MIH
• UDI-Device Identifier: 00643169346529
• UDI-Public: 00643169346529
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 05/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: VAMF4444C200TU
• Device Catalogue Number: VAMF4444C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/07/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/29/2018; 05/29/2018
• 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: 81 YR