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

Catalog Number PAHR061002E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

The hospital has not made the device available until now.The hospital was contacted to ask for further details like possible root cause, allegation of malfunction against our device, lot-/ serial no.Of second device, patient outcome and if images are available.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 the patient underwent endovascular treatment for a stent angioplasty in the left arteries of the thigh with a gore® viabahn® endoprosthesis with propaten bioactive surface.It was stated that after desobliteration of the superficial femoral artery a perforation was noticed.Two gore® viabahn® endoprosthesis with propaten bioactive surface were implanted over a 18" terumo guidewire.Reportedly, after removal of the guidewire, a femoro-popliteal occlusion occurred.The stents could no longer be passed and were therefore explanted.

Manufacturer Narrative

Evaluation coded investigation findings 213 refers to the product history review.A review of the manufacturing records indicated the device met pre-release specifications.The hospital has not made the device available until now.The hospital was contacted again to ask for further details like possible root cause, allegation of malfunction against our device, lot-/ serial no.Of second device, patient outcome and if images are available.Until now no further information was provided.

Manufacturer Narrative

Neither clinical images enabling direct assessment of product performance nor the explanted product itself were returned to gore for evaluation despite multiple requests.Multiple attempts were made to obtain additional information about this incident, such as further clarification of the procedure steps, as the reported information appears to be incomplete, the most probable cause of the occlusion, allegations against our device, and patient outcome.No further information was provided, therefore the connection between the usage of the device, guidewire removal and the femoro-popliteal occlusion remains unknown.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface.The following is stated: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: thrombosis, occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

• 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: 12922385
• MDR Text Key: 281653663
• Report Number: 2017233-2021-02585
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Catalogue Number: PAHR061002E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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
• Treatment: 18" TERUMO GUIDEWIRE.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male