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

Catalog Number BXA115901J

Device Problems Patient-Device Incompatibility (2682); Activation, Positioning or Separation Problem (2906); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/14/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent an endovascular treatment of an aortic arch aneurysm using gore® tag® conformable thoracic stent graft with active control system (ctagac).Prior to the procedure, the right axillary artery ¿ the left axillary artery ¿ the left common carotid artery bypass was created.The physician planned to perform pta ballooning within the brachiocephalic artery (bca) to prevent cerebral infarction.A gore® viabahn® vbx balloon expandable endoprosthesis was planned to be implanted into the bca prior to the ballooning in order to protect the native vessel.The right femoral artery was cut down for access.After plug embolizing the left subclavian artery, a vbx was delivered to the bca.The vbx balloon was inflated while the 1/3 of the stent graft remained inside the sheath.The vbx catheter was removed and a gekira pta balloon (cosmotec co., ltd, tokyo) was delivered to the leading end of the vbx.The gekira balloon was inflated to post-dilate the vbx from its distal end to the proximal end while removing the sheath at the same time.Reportedly, the implanted vbx moved distally along with the blood flow, and the distal end of the vbx entered the right subclavian artery for about 5 mm.As a result, right common carotid artery (rcca) was covered.The flow to the rcca was persisting due to the vbx being undersized against the native vessel, therefore, the procedure was continued.A 24fr gore® dryseal flex introducer sheath was delivered from the right femoral artery.Reportedly, the physician felt resistance during the sheath advancement, however, continued to push it by force.The sheath reached the target site and two ctags were implanted from zone 1 to the descending aorta.Coils were placed at the ostium of the left subclavian artery and within the implanted plug.Final angiography confirmed a type iii endoleak from the joint of two ctags.Balloon touch-up was performed at the joint, however, the leak remained slightly.The physician presumed the leak would disappear at a later point in time and no further treatment was given for the leak.Subsequently, angiography for the access vessel confirmed a dissection at the distal end of the right common iliac artery, which, 24fr sheath advancement attributed to.The dissection was small, therefore, was left to be monitored.No further event was reported.The patient tolerated the procedure.The reporting physician commented as follows: as the diameter of the bca measured about 15 mm, the vbx was inflated to 16 mm diameter.However, the vbx seemed to have been undersized and migrated after the deployment.The size of the vbx could have been inappropriate.Since the flow of the rcca was persisting, no future ischemic event was expected.The patient will be monitored to assess if an additional treatment will be required.The dissection at the right common iliac artery was anticipated preoperatively as the vessel was narrow.Reportedly, the narrowest diameter of the right common iliac artery was measured at 7.8 mm.

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17487097
• MDR Text Key: 320664811
• Report Number: 2017233-2023-04185
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA115901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2023
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male