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

Catalog Number PAH131002E

Device Problems Difficult or Delayed Activation (2577); Activation Failure (3270)

Patient Problem Aneurysm (1708)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

As the device remains implanted, a further investigation of the device cannot be performed.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

It was reported to gore that patient underwent endovascular treatment for a saccular aneurysm in the right common iliac artery with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that an additional procedure has taken place, namely a right hypogastric artery embolization with coils.It was reported that there were difficulties pulling the deployment line of the viabahn-device (13mm x 100mm).Therefore, an attempt was made to remove the prosthesis through the dryseal 12fr introducer sheath, which was impossible.It was stated that the viabahn-device was released with great difficulties and with several pulls in an unwanted area between the right common iliac artery and the right external iliac artery.Reportedly, the procedure was completed with an additional viabahn-device (13mm x 50mm) which was implanted proximal to the previous one in the correct place.

Manufacturer Narrative

Product history review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.As the device remains implanted, no further investigation can be performed.With the information provided to gore, this investigation is considered complete, and the cause of the complaint was unable to be determined.According to the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is mentioned: hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: deployment failure and device failure.

Manufacturer Narrative

Report # 2017233-2021-01869 is being retracted.After further evaluation, this complaint was deemed not reportable.The device successfully deployed, no reported vessel coverage reported with deployment in an unintended location and no patient harm indicated by the report.The procedure ended successfully with additional device deployment.H1: update to 'other' for report retraction.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11684191
• MDR Text Key: 246016312
• Report Number: 2017233-2021-01869
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2022

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: 09/10/2023
• Device Catalogue Number: PAH131002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 03/15/2022; 07/20/2022
• Supplement Dates FDA Received: 04/13/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 80 KG