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

Catalog Number JHJR081002J

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Date 10/27/2021

Event Type  Injury  

Event Description

On an unknown date, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a non-gore manufactured stent graft.On (b)(6) 2021, the patient underwent endovascular treatment of thoracic aneurysm enlargement using a gore® tag® conformable thoracic stent graft with active control system.During the procedure, a 22fr gore® dryseal flex introducer sheath was inserted from the left femoral artery.According to the report, resistance was felt while advancing the sheath.The reason for the resistance felt while advancing the sheath was unknown.The diameter of the access vessel from the left femoral artery to the external iliac artery measured a reported 6.1mm to 8.2mm.After all gore® tag® devices were implanted, the left external iliac artery (eia) was reportedly ruptured upon removal of the sheath.A gore® viabahn® endoprosthesis (8mm x 10cm) was implanted with coverage of the left internal iliac artery to treat the left eia rupture.Distal bleeding was reportedly observed, and the physician opted to implant a second gore® viabahn® endoprosthesis (8mm x 5cm) distally.Procedural imaging reportedly revealed a suspected proximal type i endoleak, and a gore® viabahn® vbx balloon expandable endoprosthesis was then implanted proximally.It was reported that bleeding was also observed at the sheath insertion area.The gore® viabahn® endoprosthesis was clamped using a forceps (it was unknown whether the clamped area included the distal gore® viabahn® endoprosthesis, or the junction of the two gore® viabahn® devices).The area of sheath insertion was surgically repaired; however, the bleeding reportedly was not resolved.Additionally, blood flow was reportedly impaired distal to the midpoint of the proximal gore® viabahn® endoprosthesis.A femoro-femoral bypass was performed, and blood flow to both peripheral arteries was restored.The procedure was concluded, and the patient tolerated the procedure.The physician commented it was unknown whether the clamped gore® viabahn® endoprosthesis was related to the disappearance of blood flow in the device.It was reported that when the gore® viabahn® endoprosthesis was clamped, the device was compressed.Percutaneous transluminal angioplasty (pta) was performed, and the blood flow was reportedly observed at that time.However, the gore® viabahn® endoprosthesis was reportedly clamped several times, which may have contributed to the two gore® viabahn® devices becoming occluded.

Manufacturer Narrative

The gore® dryseal flex introducer sheath in this event has been reported in mfr report #3007284313-2021-01672.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Corrections to sections d1/d2 and g4.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12855099
• MDR Text Key: 281105023
• Report Number: 2017233-2021-02559
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: JHJR081002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female