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

Catalog Number PAHR082502E

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting (b)(4).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

It was reported to gore that on (b)(6) 2022, the patient presented with an occlusion of the right distal superficial femoral artery (sfa).The rutherford clinical category classification for chronic limb ischemia was given as category iii and the tasc ii classification was given as type d.It was stated that a pre-dilation with an approximate balloon diameter of 8 mm was performed.The occlusion was treated successfully within an endovascular procedure with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device).It was reported that on (b)(6) 2022, the patient presented with an occlusion in the implanted vsx device until the middle popliteal artery.It was not stated that a treatment was performed.During a follow-up visit on (b)(6) 2022, ultrasound imaging indicated not patent right limb and no reintervention was required.

Manufacturer Narrative

C1: heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6-code b14 and c19: a review of the manufacturing records indicated the device met pre-release specifications.H6-code b13: additional information to the event has been requested and were provided.The provided information was captured in the event description.H6: code d12 - according to the gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use (ifu), complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to occlusion.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

It was reported to gore that on (b)(6) 2022, the patient presented with an occlusion of the right distal superficial femoral artery (sfa).The rutherford clinical category classification for chronic limb ischemia was given as category iii and the tasc ii classification was given as type d.It was stated that a pre-dilation with an approximate balloon diameter of 8 mm was performed.The occlusion was treated successfully within an endovascular procedure with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device).It was reported that on (b)(6), 2022, the patient presented with an occlusion in the implanted vsx device until the middle popliteal artery.It was not stated that a treatment was performed.During a follow-up visit on (b)(6) 2022, ultrasound imaging indicated not patent right limb and no reintervention was required.

• 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: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15994230
• MDR Text Key: 305584100
• Report Number: 2017233-2022-03582
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2024
• Device Catalogue Number: PAHR082502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2021
• 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 Age: 69 YR
• Patient Sex: Male