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

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/15/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: code ¿other¿ was selected as no device information (serial or lot number) is available and no device return.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following literature was reviewed.¿treatment results and problems about using viabahn to treat shunt trouble¿ ichiro morita, et al.The journal of japanese college of angiology, 2022: 62(suppl.) p.S147.Purpose: to consider about a cause of having poor outcomes for thirteen patients who were treated for graft shunt troubles using gore® viabahn® endoprostheses.Subjects: there were five males and eight females.The applications for using gore® viabahn® endoprosthesis were a repeated severe stenosis and occlusion.In 5 patients, bleeding was confirmed during pta treatment.Result: the patency of the gore® viabahn® endoprosthesis was confirmed in 4 cases (2 months after the viabahn® implantation, 6 months later, and 40 days until the patient died, 40 days until a graft was removed due to an infection).There was one case who experienced restenosis/re-occlusion within 1 months.There were 2 cases who experienced restenosis/re-occlusion within 1-3 months.There were 4 cases who experienced restenosis/re-occlusion within 3-6 months.The confirmation period of restenosis/re-occlusion was 4 days, and the longest period to confirm restenosis/re-occlusion was 5 months.It was confirmed that the interval of pta become longer in 8/11 cases.Regarding the medication after viabahn® implantation, no medication by 1 case, aspirin only by 3 patients, clopidogrel, effient or cilostazol by 6, only warfarin by 3 cases.The graft crossed the elbow in 1 case.The remaining stenosis in other that viabahn® treatment area was 1 case (the case who had significant stenosis in the terminal part of the cephalic vein was occluded a month after the viabahn® implantation) conclusion: it was considered that cause of having poor outcomes after gore® viabahn® endoprostheses was implanted are dapt is not performed appropriately, the stenosis remained before viabahn® implantation and the shunt is tortuous due to the graft crossing the elbow.

• 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: 16110625
• MDR Text Key: 306779612
• Report Number: 2017233-2023-03620
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• 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