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

Device Problems Material Invagination (1336); Positioning Problem (3009)

Event Date 07/01/2023

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records for the device could not be conducted because the serial / lot number remains unknown.Without a lot number or device serial number, the manufacturing date and / or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.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

On an unknown date, the patient underwent endovascular treatment using gore® viabahn® endoprosthesis with heparin bioactive surface.The viabahn device was implanted in the superficial femoral artery.Date and application of the procedure and the device detail were unknown.On an unknown date in (b)(6) 2023 (few days before july 26), occlusion of the superficial femoral artery and deep femoral artery were observed.Reportedly it was suspected that the edge of the viabahn device covered the entrance of the deep femoral artery.As a treatment, a part of the viabahn device was surgically transected.Treatment detail was unknown.On (b)(6) 2023, acute occlusion of the superficial femoral artery was confirmed.Thrombectomy was performed but it was not successful.Reintervention was scheduled at a later date.During this treatment, it was observed that the edge of the transected the viabahn device had infolding.The physician commented that the device infolding may have caused occlusion of the superficial femoral artery.He questioned whether it was necessary to transect the viabahn device.

Manufacturer Narrative

Updated investigation conclusions to d15 to cause not established.The investigation findings did not lead to a clear conclusion about the cause of the reported adverse event.The gore® viabahn® endoprosthesis with heparin bioactive surface instruction for use (ifu), section hazards and adverse events states, complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17466630
• MDR Text Key: 320479634
• Report Number: 2017233-2023-04171
• 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: 08/14/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other