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

Model Number VAMF3636C150TJ

Device Problems Inability to Irrigate (1337); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

A valiant stent graft system was selected for in a patient for the endovascular treatment of a 5.5 cm thoracic aortic aneurysm.It was reported that when the delivery system was inserted into the patient¿s body, strong resistance was noted.The delivery system was thus removed and flushing was attempted; however, flushing was unsuccessful.The physician decided to discontinue using it.The device was replaced with another manufacturer¿s product and the treatment was completed without further issues.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received reported that the device was flushed prior to use, but it was reported that it was hard to flush.After the device was removed and flushing attempted for a second time, the guidewire lumen could not be irrigated, and no fluid could be pushed through the system.Film evaluation summary: the cause of the device positioning difficulties and flushing issues could not be determined from the single pre-implant ct/3d-recon image and sizing information provided.Complete pre-implant ct¿s and films during implant were not available for return, and the device was discarded.The single image provided showed the thoracic aorta which was scattered with calcification, but was not tortuous or otherwise noteworthy.Between the lsa and celiac arteries the thoracic diameter ranged from 32.6mm max to 30mm minimum.The sizing report noted that the diameter at the origin of the right and left common iliac arteries (d6r <(><<)>(><(>&<)><(><<)>)> d6l) were 15mm and 12mm respectively, and the diameter of the access vessel diameter (d7r <(><<)>(><(>&<)><(> <<)>)> d7l) measured 7.4mm and 7.6mm respectively; which is small for the 24fr thoracic device.The morphology of the access and iliac vessels was not reported and were not visible on this single returned image.It is possible that patient anatomy at the access site (possible tortuous, calcified, and small diameter access vessels) may have contributed to the event.It is also possible that this was related to the device; however, the device was discarded and no analysis could not be performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6879234
• MDR Text Key: 87873417
• Report Number: 2953200-2017-01463
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: VAMF3636C150TJ
• Device Catalogue Number: VAMF3636C150TJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR