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

Catalog Number VBHR071502W

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.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.H6: code c19 - the manufacturing records were reviewed, and the device lot met all pre-release specifications.Code d15 - the primary reported device failure mode, related to excessive deployment force, is consistent with the inability to deploy the device using the deployment knob during attempted deployment of the returned device.Evaluation of the returned device confirms initiated deployment of the outer zipper, no deployment of the inner zipper, no expansion of the endoprosthesis, compression of the endoprosthesis toward the distal tip, and a kinked distal shaft.The distal shaft kink, bent struts, and endoprosthesis compression are consistent with a device interaction during withdrawal from the patient.Engineering evaluation was unable to confirm transmission of tension applied at the deployment knob to the zipper during the evaluation, but the device was returned with the outer zipper partially deployed which indicates the deployment line force was being transmitted to the zipper during the procedure.Deployment was unable to continue using the deployment knob, but deployment continued when pulling the deployment line at and along the endoprosthesis which indicates the zipper itself was not stuck.The cause for the stuck deployment line during the evaluation could not be established, and the cause for the excessive deployment force reported during the procedure could not be established with the available information.Procedural and benchtop deployment of the device can be impacted by different factors including but not limited zipper integrity, delivery system support or stiffness, or presence of dried fluid in/on the device.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

It was reported to gore that on ()(6) 2024, a patient was to be implanted with a 7mm x 15cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) to treat one of bilateral iliac artery occlusion.Bilateral use of ordinary guidewire vbhr081002w, vbhr081502w for ideal and smooth release of the kissing position in the abdominal main segment.Bilateral continuation of vbhr071002w and vbhr071502 stents, the left vbhr071002w was successfully released, while the right vbhr071502 stent had relatively high resistance and was not smooth.For safety reasons, vbhr071502w was withdrawn, and vbhr061502w was selected to reach the lesion site and the stent was successfully implanted.The treatment effect was ideal, and the patient was removed from the stage.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19141337
• MDR Text Key: 340694887
• Report Number: 2017233-2024-04849
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBHR071502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG