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

Catalog Number BXAL087901J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Aneurysm (1708)

Event Date 08/05/2022

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2022, this patient underwent endovascular treatment of a bilateral iliac artery aneurysm using gore® viabahn® vbx balloon expandable endoprosthesis(vbx), and a gore® dryseal flex introducer sheath(dsf) as an accessory in the procedure.The vbx device was advanced to the left internal iliac artery from right common femoral artery.The device reportedly was difficult to advance due to the tortuous anatomy.After the deployment, the physician attempted to remove the delivery catheter but was unable to remove the balloon from the stent graft.Attempts were made to re-inflate and re-deflate the balloon, push and pull the delivery catheter, but it was not successful.It was observed that the distal side of the stent graft migrated proximally approximately 20mm, hence, the balloon was burst at 20atm and the delivery catheter was removed.The procedure was continued, but the left external iliac artery was ruptured by non-gore device.To treat the vessel rupture, the 16fr dsf sheath was inserted from the left common femoral artery; however, additional vessel rupture occurred by the 16fr dsf sheath.Subsequently, the procedure was changed to a surgical procedure, where a y-graft replacement was performed.The patient tolerated the procedure.(balloon ruptured to remove catheter).

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Imaging evaluation: gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Unable to confirm: difficult/inability for the balloon to separate from the fully deployed stent.Difficulty with insertion of delivery system through the introducer sheath/valve/catheter.Inability to accurately position/deploy the stent.The device was not returned for evaluation, and evaluation of the provided clinical images was unable to confirm the reported device failure modes.The cause for the reported complaint could not be established with the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.The vbx device ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified as related to the primary device failure mode in the complaint.Introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis using fluoroscopic guidance, advance the delivery system over the stiff guidewire via the angiographic introducer sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery system and introducer sheath together as a unit.Deployment of the gore® viabahn® vbx balloon expandable endoprosthesis maintaining proper sheath support, very slowly withdraw the balloon.Observe under fluoroscopy to ensure that the balloon disengages from the stent.If resistance is encountered upon attempted removal, do not force removal, use fluoroscopy and conventional techniques to determine and remedy the cause of resistance before proceeding.The balloon needs to be fully deflated to ensure it disengages fully from the endoprosthesis.Precautions related to directions for use: if excessive resistance is felt as the gore® viabahn® vbx balloon expandable endoprosthesis is introduced through the hemostasis valve of introducer sheath, remove and inspect the delivery system for damage.Do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis if damaged or if the covered stent is fluoroscopically observed to be displaced relative to the radiopaque markers on the delivery catheter.Ensure a compatible introducer sheath size (table 1 and table 2) is used, and that the introducer sheath is free of kinks.Do not insert the shrink sleeve or the hub assembly into the introducer sheath.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15271730
• MDR Text Key: 300885732
• Report Number: 2017233-2022-03256
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male