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

Catalog Number PAHR111002B

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/05/2022

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.Patient gender and weight were requested but not made available.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 was reported to gore: on (b)(6) 2022, a patient was implanted with two gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) for treatment of a popliteal artery aneurysm.The vsx devices were overlapped and implanted in the patient's leg, from the superficial femoral to popliteal artery.On (b)(6) 2022, a bypass procedure was performed because the vsx devices had occluded.As reported, heparin-induced thrombocytopenia (hit) was also suspected by the physician.The type of hit test performed was not specified, and test results were not made available.The vsx devices were ligated at either end, and both vsx devices remain implanted.The patient was reported to be recovering well following the bypass procedure.

Manufacturer Narrative

H6 - c19: review of device manufacturing record history confirmed devices met pre-release specifications.Both devices remain implanted; therefore, direct product analysis was not possible.During procedure, two gore devices that were overlapped and deployed in same treatment area in patient's leg.The second gore® viabahn® endoprosthesis with heparin bioactive surface lot/serial number is b)(6); udi #(b)(4); catalog #pahr131002b.

Manufacturer Narrative

A3: patient gender was 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15756542
• MDR Text Key: 303295844
• Report Number: 2017233-2022-03457
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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,Followup
• Report Date: 11/22/2022

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: 02/10/2024
• Device Catalogue Number: PAHR111002B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 11/18/2022
• Supplement Dates FDA Received: 11/09/2022; 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male