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

Catalog Number	VBHR101002A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Thrombocytopenia (4431); Thrombosis/Thrombus (4440)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records including additional heparin coating review indicated the lot met pre-release manufacturing specifications.The device was not returned to gore for direct analysis.Therefore, an engineering evaluation could not be performed.According to the instructions for use, contraindications: do not use the gore® viabahn® endoprosthesis with heparin bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of heparin-induced thrombocytopenia (hit) type ii.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 or Problem Description
The following information was reported to gore: on (b)(6) 2024, two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn devices) were implanted to repair a popliteal aneurysms.It was reported on an unknown date after the implant procedure thrombosis of the repaired site was noted.Reportedly, the physician believes, due to time of onset and aggressiveness of thrombosis that the patient had heparin induced thrombocytopenia (hit).Additionally, on an unknown date a reintervention occurred (bypass repair) in which both viabahn devices were explanted.At an unknown time shortly after the bypass repair the site was thrombosed as well.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn devices) were implanted to repair a popliteal aneurysms.It was reported on an unknown date after the implant procedure thrombosis of the repaired site was noted.Reportedly, the physician believes, due to time of onset and aggressiveness of thrombosis that the patient had heparin induced thrombocytopenia (hit).Additionally, on an unknown date a reintervention occurred (bypass repair) in which both viabahn devices were explanted.At an unknown time shortly after the bypass repair the site was thrombosed as well.Reportedly, on an unknown date after procedure a platelet factor 4 (pf4) test was completed with the result of positive antibodies in the patient.It is unknown what treatment the patient received after the positive pf4, however, the patient is doing well and the symptoms of hit have resolved.
Additional Manufacturer Narrative
Revised b5: additional information.Revised h6: investigation conclusions.Removed d15.Revised h10: remove statement, " according to the instructions for use, contraindications: do not use the gore® viabahn® endoprosthesis with heparin bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of heparin-induced thrombocytopenia (hit) type ii." added to h10: this event had two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn devices).The other viabahn device is captured in medwatch number 2017233-2024-04824.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19111896
• Report Number: 2017233-2024-04823
• Device Sequence Number: 15235836
• Product Code: NIP
• UDI-Device Identifier: 00733132646043
• UDI-Public: 00733132646043
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Catalogue Number: VBHR101002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown