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

Catalog Number JHJR080502J

Device Problem Migration (4003)

Patient Problem Pseudoaneurysm (2605)

Event Date 08/10/2021

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent an endovascular treatment of a pseudoaneurysm which was located near the superior mesenteric artery (sma).A gore® viabahn® endoprosthesis was implanted in the sma.On an unknown date, it was observed that the gore® viabahn® endoprosthesis migrated distally.*below ctag event is captured in (b)(4).On (b)(6) 2021, a reintervention for the pseudoaneurysm was performed using gore® tag® conformable thoracic stent graft with active control system.The sma - the right external iliac artery bypass was created and the sma was coil embolized and branch near the pseudoaneurysm was coil embolized.Then, the gore® tag® conformable thoracic stent graft with active control system was implanted where the sma was located center with chimney procedure for the right and the left renal artery using two gore® viabahn® endoprostheses.There was no endoleaks and the blood flow of the bypass was well.On (b)(6) 2022, the patient vomited blood due to fistula between the stomach.And it was observed a distal type i endoleak of the initial gore® tag® conformable thoracic stent graft with active control system.A gore® tag® conformable thoracic stent graft with active control system was implanted distally.And a gore® viabahn® endoprosthesis was implanted to extend the gore® viabahn® endoprosthesis which had been implanted in the left renal artery on (b)(6) 2021 to near the terminal aorta.Then, nbca was injected into the pseudoaneurysm.No endoleaks were observed and the procedure was completed.The patient tolerated the procedure.

Manufacturer Narrative

(b)(4).

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.H6: investigation findings and conclusions updated h10: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.C1: name and manufacturer added.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13481075
• MDR Text Key: 289601520
• Report Number: 2017233-2022-02724
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: JHJR080502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female