MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number BXA067902A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Renal Failure (2041); Thrombus (2101)

Event Date 04/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Devices were not returned to gore.Therefore, direct product analyses was not possible.One gore® viabahn® vbx balloon expandable endoprosthesis was placed in sma, which had no reported issues.Additional medwatch report was submitted for one gore® viabahn® vbx balloon expandable endoprosthesis used in same procedure and placed in renal artery: device lot#16142813, medwatch reported number 2017233-2017-00265.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore that on (b)(6) 2017, an aaa endovascular repair using a chimney technique was performed due to failure of a previously implanted medtronic device and failing renal arteries.A cook device was used to reline the medtronic device and three gore® viabahn® vbx balloon expandable endoprostheses were implanted during the procedure.One gore® viabahn® vbx balloon expandable endoprosthesis was placed in the superior mesenteric artery, and a gore® viabahn® vbx balloon expandable endoprosthesis was placed in each renal artery.On (b)(4) 2017, a ct scan was performed without contrast dye as the patient' renal arteries were already compromised and to avoid further damage to the kidneys.As a result, possible clotting of the renal arteries was not observed.On (b)(6) 2017, it was found the two gore® viabahn® vbx balloon expandable endoprostheses that were placed in the renal arteries had clotted.The patient was not on the anti-platelet therapy.It was reported the patient is now in renal failure.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6578003
• MDR Text Key: 75534705
• Report Number: 2017233-2017-00264
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2020
• Device Catalogue Number: BXA067902A
• Device Lot Number: 16142822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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 Outcome(s): Other
• Patient Age: 62 YR