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

Device Problem Insufficient Information (3190)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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.

Event Description

Abstract reviewed: outcomes of the gore excluder iliac branch endoprosthesis using self-expanding or balloon-expandable stent grafts for the internal iliac artery component.Nicholas s.Cortolillo, eric murphy, andres guerra, andrew hoel, mark k.Eskandari, tadaki tomita.Northwestern university feinberg school of medicine, chicago, il.Objectives: stent graft repair for aortic and iliac artery aneurysms has largely replaced open surgery, and modifications in the design that preserve flow to the pelvis with the gore excluder (w.L.Gore & associates, flagstaff, az) iliac branch endoprosthesis (ibe) device has led to improved outcomes.The ibe was developed for use in combination with a self-expanding stent graft for the internal iliac component (se-iic).Balloon-expandable stent grafts are an alternative for the internal iliac component (be-iic), offering advantages in sizing, device tracking, precision, and lower profile delivery.We compared the performance of the se-iic and be-iic in patients undergoing ibe implantation.Methods: this was a retrospective review of consecutive patients who underwent ibe implantation at a single center from october 2016 to may 2021.The anatomic and procedural characteristics were recorded via medical record review and computed tomography postprocessing software.The devices were assigned to se-iic vs be-iic groups according to the type of device landing in the most distal internal iliac artery (iia) segment.Analysis was performed per device to account for patients undergoing bilateral ibe placement.The primary end point was iia patency, and the secondary end point was ibe-related endoleak.Results: during the study period, 48 ibe devices were implanted in 41 patients (mean age, 71.1 years).There were 24 devices each in the se-iic and be-iic groups.The anatomic and procedural characteristics are listed in table i.The mean follow-up was 525 days.The se-iic cohort showed larger diameter iia target vessels (11.6 6 2.0 mm vs 8.4 6 1.7 mm; table i).Loss of iia patency occurred in two se-iic devices (8.33%) at 73 and 180 days after the procedure and in no be-iic device.However, this difference was not statistically significant (p ¼.16).The patency over time in each cohort is presented in fig.Only one be-iic device required reintervention to treat a type ic endoleak at 284 days.Conclusions: we found no significant differences in outcomes between the se-iic and be-iic groups, although the be-icc devices were deployed in smaller vessels.Given these comparable findings and coupled with the improved deliverability, tracking, and precision of the be-iic, consideration should be given to its broader application to streamline the procedure.This case captures one unplanned readmission that occurred within 30 days due to thrombosis of the right external iliac limb of the ibe device in the se-iic and also captures a type 3 endoleak that occurred in one patient in be-iic that required reintervention at 284 days.

• 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: 16897153
• MDR Text Key: 314851172
• Report Number: 2017233-2023-03917
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2023
• 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): Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male