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

Model Number	VAMC3232C150TU
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A valiant captivia stent graft system was opened for the endovascular treatment of a 20.0 cm thoracic aortic dissection.It was reported that while prepping the device it was noticed that saline was not reaching the stent graft inside the delivery system and instead was introducing air into the system.A leak was then noticed coming from the side port.The physician decided to use another device and the procedure was completed.The physician stated that the cause of the event was device related.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the complaint was confirmed as water was unable to be flushed through the sideport.The reported sideport leakage could not be confirmed as no leakage could be recreated during flushing.The root cause of the event could not be conclusively determined during analysis.Inspection of the components found that all the individual components met with material specification.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.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: 6229145
• Report Number: 2953200-2017-00025
• Device Sequence Number: 967464
• Product Code: MIH
• UDI-Device Identifier: 00643169346581
• UDI-Public: 00643169346581
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 02/02/2017

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: 04/12/2018
• Device Model Number: VAMC3232C150TU
• Device Catalogue Number: VAMC3232C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 02/02/2017
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 01/26/2017; 02/03/2017; 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: 88 YR