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

Model Number	VAMF3838C200TU
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2018
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
Two valiant thoracic stent graft systems were implanted in the patient for the endovascular treatment of an intramural hematoma with dissection and penetrating atherosclerotic ulcer.A 24 fr sentrant sheath was used as an accessory device after the second stent graft had been delivered successfully (b)(4), the physician attempted to remove the delivery system out of the 24 fr sentrant sheath.The physician reported that while removing the delivery system from the sheath the physician met resistance, it was noted by the rep that ¿the physician was pulling on the graft cover instead of the grey handle to extract the system from the sheath¿.Once the physician removed the delivery system from the sheath he noticed that the tip of the graft cover was moved over and caught on the side of the spindle that houses the free flow stents.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: review of a pre-implant 3d-ct film report of the thoracic aorta confirmed that the patient had an intramural hematoma that measured 53mm maximum diameter.The thoracic diameter just caudal to the lsa measured 34mm, and 29mm distal to the lsa the proximal tear and penetrating ulcer was observed and the imh diameter measured 38mm in diameter.The distal tear and 2nd pau was located 132mm from the lsa, and the imh diameter (maximum) measured 53mm in diameter.Within the descending thoracic, which was essentially straight, the imh diameter ranged from 37 ¿ 32 ¿ 33 ¿ 32mm along the 175mm length to the celiac artery.No thrombus/calcification was noted at either the proximal or distal implant sites.The exact cause of the reported delivery system removal difficulties could not be determined from the pre-implant films provided.Images during implant and delivery system removal were not provided, and the reported event could not be assessed.Analysis of the returned films did not reveal any anatomical characteristics that could explain the reported event.This appeared most likely to be a user related issue; pulling on the graft cover instead of the grey handle to extract the system from the sheath.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: visual inspection did not reveal anything which might explain the issues seen during removal.The stent graft cover was flush with the tip and no gap was noted when stent graft cover was fully seated.No other issues were seen with the device.It is possible that the reported use related issue with pulling back on the graft cover during removal may have lead to the resistance noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7205053
• Report Number: 2953200-2018-00123
• Device Sequence Number: 13824469
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 10/25/2019
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 07/19/2018; 08/08/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 03/06/2018; 07/20/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR