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

Model Number	VAMF3030C150TU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: a still image of the broken barb adaptor was received.The delivery system is within the tray with the sideport facing upwards.The side port extension is broken off at the base of the barbed adaptor.The break appears clean however, there is a small surface area that appears brittle.There appears to be no damage to the tray in the area of the sideport extension.From the returned still image, the cause of the broken barb adaptor cannot be determined.
Event or Problem Description
A valiant stent graft system was selected for use, but not inserted in the patient, for the second part of a scheduled staged endovascular treatment of thoracic aortic dissection.It was reported that the side arm flush port detached from the delivery system during prepping of the device.When the technician attempted to attach the syringe to the side arm flush port the side arm flush port detached.Upon removal of the device from the packaging there was no obvious delivery system issues noted.The outer box packaging and the inner packaging did not have any damage.The physician used another device and the case was successfully completed.The physician does not know the cause of the event, maybe related device issue or possible damage during shipping.No 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 - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6280189
• Report Number: 2953200-2017-00109
• Device Sequence Number: 19114744
• Product Code: MIH
• UDI-Device Identifier: 00643169346994
• UDI-Public: 00643169346994
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2017

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: 11/10/2018
• Device Model Number: VAMF3030C150TU
• Device Catalogue Number: VAMF3030C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2017
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR