MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR050502J

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Please note: an additional gore® viabahn® endoprosthesis (jhjr052502j/18397400) has been included in this report, as it is unknown which gore® viabahn® device may have contributed to this event.(b)(4).Per the gore® viabahn® endoprosthesis instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include, but are not limited to thrombosis or occlusion.

Event Description

On (b)(6) 2018, the patient was implanted with two gore® viabahn® endoprostheses with heparin bioactive surface (jhjr050502j/16466569 and jhjr052502j/18397400) to treat an occlusion of the right superficial femoral artery.On an unknown date in (b)(6) 2019, follow-up examination reportedly revealed occlusion in one gore® viabahn® device (it is unknown which device was occluded).There was reported collateral circulation approximately 7cm distal to the originally implanted stent graft.It was reported that the collateral circulation resulted in a competing blood flow, causing the occlusion.On (b)(6) 2019, the patient underwent endovascular treatment using an additional gore® viabahn® endoprosthesis with heparin bioactive surface and thrombectomy to treat the occlusion.The additional stent graft was placed to cover the collateral circulation.The patient tolerated the procedure.

Manufacturer Narrative

Please note correction to section g5.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8327816
• MDR Text Key: 135864510
• Report Number: 2017233-2019-00075
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 16466569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR