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

Model Number	VAMC3232C150TU
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported inadvertently implanting the closed web valiant stent (distal component) as the proximal stent graft could not be conclusively determined from the two images provided.However, it was most likely user related.The exact cause of the proximal stent graft not apposing to the aorta along the inner curvature of the aortic arch (bird beaking) could not be conclusively determined from the two still angio images provided.Additional films during the implant procedure were not provided.The image provided showed that the aortic arch was steeply angulated ~ 90 deg.It is possible that implanting the closed web valiant stent graft as the most proximal device (not following ifu) in an angulated descending thoracic aorta may have contributed.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of an emergent thoracic aortic blunt force focal transaction transection.It was reported that a distal main was inadvertently implanted instead of a proximal main.It was noted that an assortment of devices were pulled to treat this patient.After ivus imaging a 32x32x150 valiant stent graft was decided upon.The staff reportedly pulled the distal main device by mistake and it was not noticed until the device was partially deployed.There was some slight bird beaking of the device due to the steep aortic angle of the aortic arch; but the device itself was placed perfectly distal to the left subclavian as planned.It was decided to leave the device as is and not extend proximally any further; as the angiogram showed that the transection was successfully excluded and the event had resolved.The cause of the event was noted as user error.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6168195
• Report Number: 2953200-2016-02096
• Device Sequence Number: 10931581
• Product Code: MIH
• UDI-Device Identifier: 00643169346581
• UDI-Public: 00643169346581
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2018
• Device Model Number: VAMC3232C150TU
• Device Catalogue Number: VAMC3232C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: 11/21/2016
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR