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

Model Number	VNMC3434C223TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vnmc3737c223tu, serial/lot #: (b)(4), ubd: 16-dec-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion vnmc3434c223tu stent graft was intended to be implanted in the endovascular treatment of a thoracic ulcer.It was noted that this device would not de-air (flush) after multiple attempts.This use of this device was then abandoned.Another valiant navion vnmc3737c223tu (b)(4) was intended to be implanted in this procedure but it was found this device also would not de-air after multiple attempts and the patient had a replacement navion stent graft implanted instead.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
Additional info: it was confirmed there was there no bunching observed to the graft cover prior to attempting to flush and there was there no gap evident between the taper tip and the graft cover tip prior to flushing.It was reported that during flushing the physician did try releasing the vacuum at the edge of the graft cover because he could not get the air out.Device evaluation: the severe curvature observed to the catheter was likely due to lose coiling of the device in the return kit.Bunching of the graft cover was visible along the inner curve 37.5cm to 43.4cm proximal to the graft cover tip.A gap of 1.5mm was visible between the taper tip and the graft cover tip.The device was flushed via the luer connector with liquid visible exiting the taper tip.The device was flushed via the handle flush port, liquid was observed exiting the graft cover tip.No resistance was noted flushing the device vis the sideport.The reported flushing difficulties could not be confirmed through analysis of the device.The reported flushing difficulties could not be replicated and no abnormality which would have hindered flushing was observed during analysis.It is possible that the difficulties encountered when flushing the device may have been related to the technique used.The valiant navion thoracic stent graft system instructions for use (ifu) recommend holding the tapered tip of the valiant navion thoracic stent graft system higher than the handle, flush the graft cover using a syringe with heparinized saline solution via the flush port.Apply constant pressure to the syringe until fluid is observed exiting from the junction of the graft cover and the tapered tip.The cause of the difficulties flushing the device were likely procedural related.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9743924
• Report Number: 9612164-2020-00846
• Device Sequence Number: 11256249
• Product Code: MIH
• UDI-Device Identifier: 00763000101039
• UDI-Public: 00763000101039
• 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): 06/05/2020

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: 11/04/2021
• Device Model Number: VNMC3434C223TU
• Device Catalogue Number: VNMC3434C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR