MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAHR130502E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Obstruction/Occlusion (2422); Ruptured Aneurysm (4436)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

Patient information (id) including preexisting medical condition(s) and medications was requested but remains unavailable.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: code: a27 was used as the device problem is not adequately described by any other term in order to capture unintentional obstruction of the internal iliac artery.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

Reportedly on (b)(6) 2023 , this patient underwent an endovascular repair of an aneurysmal rupture which was treated with a fenestrated and branched stent graft component (zenith® t-branch® thoracoabdominal endovascular graft, cook medical).Reportedly, the aortic access was successfully gained, device deployed as intended, catheters were successfully removed and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.According to reports, on the same day which is (b)(6) 2023 , an adverse event termed "internal iliac stented this migrated with the top end only just within the branch.A 2nd viabahn was placed, it landed slightly high, partially covering the external iliac artery".After completion of deployment of the iliac branch device, the internal iliac was stented using a 13 mm x 10 cm gore® viabahn® endoprosthesis with propaten bioactive surface.The viabahn migrated forwards during deployment, with the top end only just within the branch.A second 13 mm x 5 cm gore® viabahn® endoprosthesis with propaten bioactive surface was placed, but unfortunately landed slightly high, and was partially covering the origin of the external iliac artery.Reportedly, the external iliac artery was extended with a zsle-16-39-zt.Due to the poor flow down the external iliac artery and risk of subsequent external iliac occlusion the physician decided to place a 12 mm x 49 mm bentley stent parallel with the internal iliac stents to protect flow down the external iliac artery as a means of resolving the unintentional partial covering of the external iliac artery.It is likely that this will result in occlusion of the internal iliac artery stent graft but this was felt preferable to loss of the external iliac artery.Further additional information revealed that the distance migrated by the gore® viabahn® endoprosthesis with propaten bioactive surface was unknown as it was not recorded and the migration was not resolved because no reintervention was performed.The cause of the event is unknown according to the physician.2203-a:-other (used to capture: unintentional obstruction of the internal iliac artery).

Manufacturer Narrative

The present event was checked with the clinical database provider and the study coordinator.Some forms have been dropped for this patient, since related data have been moved from one database to another.It was determined that this event is a duplicate of (b)(4) (manufacturer report number 2017233-2023-03789) and is therefore withdrawn.Please refer to (b)(4) (manufacturer report number 2017233-2023-03789) for investigation results and conclusion.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 17580836
• MDR Text Key: 321512079
• Report Number: 2017233-2023-04214
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR130502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: 80 YR
• Patient Sex: Male