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

Catalog Number VBH130502W

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing phr ¿ the following manufacturing records were reviewed in tungsten/mdis: 22439544; 22439543; 22439541; qc testing batch 9/16/2020-b; zipper components 22307231, 22300344, 22382714, 22284874.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Ncr117928 was initiated due to a standard deviation failure for the distal shaft to distal tip tensile test.The investigation evaluated the reliability levels.All product was dispositioned as accept.Based on the nature of the complaint and the investigation of ncr117928, there is no indication of a relationship between this ncr and the reported complaint because the complaint does not indicate distal tip separation.Two photos related to images were returned.The images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.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.Images received via (email) with no patient identifier or date of acquisition in image.Images provided do not allow for evaluation in relationship to this event.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient was to be implanted with a 13mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat iliac aneurysm.When the physician pulled the deployment line, he found it was difficult to pull out during the middle of stent.Then the physician used a balloon dilatation and pulled the deployment line with large force.Finally, the viabahn device was successfully expanded.The patient tolerated the procedure.

Manufacturer Narrative

Update: h6 component code was added.G4: date received by manufacturer.The investigation including evaluation of images, could not confirm the cause of the reported issue of this event.

Manufacturer Narrative

The investigation including evaluation of images, could not confirm the cause of the reported issue of this event.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12427136
• MDR Text Key: 270319792
• Report Number: 2017233-2021-02335
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: VBH130502W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 03/12/2022; 03/25/2022
• Supplement Dates FDA Received: 03/11/2022; 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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