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

Model Number	VAMF4242C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis # (b)(4): (b)(6): became aware that films are available in the anchor registry for subject: 198-011: (b)(6) pre-cta; (b)(6) implant angio; (b)(6) post-cta.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 the endovascular treatment of an asymptomatic thoracic aortic aneurysm.The physician elected to implant six heli-fx endoanchors in one endograft to another endograft to the distal neck out of concern for late failure.The aneurysm extended from the visceral aorta to the suprarenal abdominal aorta.The maximum aneurysm diameter measured 66 mm.The diameter of the aorta at the superior mesenteric artery measured 32 mm in diameter.The diameter immediately proximal to the aneurysm measured 32 mm.The proximal neck length measured 45 mm and the distal neck length measured 20 mm.There was no vessel tortuosity, there was no thrombus at the proximal seal zone, and there was no calcium at the proximal seal zone.There was localized calcium at the distal seal zone that covered 40% of the circumference with a maximum thickness of 1.5 mm.It was reported that, a ct revealed that the valiant stent graft had a proximal type i endoleak.The maximum diameter of the aneurysm measured 62 mm.The patient was hospitalized and, the physician elected to implant a valiant 42x42x200 stent graft proximally.The stent graft extension was advanced up to the subclavian artery and was successfully deployed without left subclavian artery coverage.A reliant balloon was then used to balloon the overlap of the previous stents.The proximal seal zone was not ballooned.A completion aortogram revealed perfect position of the aortic stent graft with no impingement of flow on the brachiocephalic vessels.No further endoleak was visualized, the physician was satisfied with the result, and the procedure was completed.The investigator assessed that the event was related to the aneurysm.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i endoleak could not be determined from the films provided.However, it is possible that disease progression with vessel dilation at the proximal seal zone, and proximal neck calcification, may have contributed to the type ia endoleak.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: 6992599
• Report Number: 2953200-2017-01660
• Device Sequence Number: 1496321
• 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): 11/16/2017

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: 06/28/2019
• Device Model Number: VAMF4242C150TU
• Device Catalogue Number: VAMF4242C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 60