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

Model Number	VAMF3232C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captiva stent graft was intended for use in the endovascular treatment of an aortic transection.It was reported that during the index procedure, the device could not be flushed.A new device was used successfully to complete the procedure.As per the physician, the cause of the event was device related.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: it was not possible to flush the device via the side port extension during decontamination and analysis.There was no damage to or blockage in the side port which would have prevented flushing.A gap of 2.0mm (fail) was observed between the taper tip and graft cover tip, specification is 0.5mm.There was no damage observed to the device which would have prevented flushing.The cause of the flushing difficulties could not be determined through analysis.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: 8454991
• Report Number: 2953200-2019-00409
• Device Sequence Number: 10851281
• Product Code: MIH
• UDI-Device Identifier: 00643169347076
• UDI-Public: 00643169347076
• 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): 06/07/2019

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: 06/27/2020
• Device Model Number: VAMF3232C100TU
• Device Catalogue Number: VAMF3232C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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