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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.See mfr report #2017233-2020-00284 for intervention for bilateral groin seroma investigation.See mfr report #2017233-2020-00286 for pulmonary embolus investigation.See mfr report #2017233-2020-00285 for pseudoaneurysm.

Event Description

The following article was reviewed: 'hybrid revascularization combining iliofemoral endarterectomy and iliac stent grafting for transatlantic inter-society consensus c and d aortoiliac occlusive disease'; juliet j.Ray, sarah a.Eidelson, charles a.Karcutskie, jonathan p.Meizoso,hilene deamorim, lee j.Goldstein, john karwowski, and arash bornak; ann vasc surg 2018; 50: 73¿79; https://doi.Org/10.1016/j.Avsg.2017.11.061; published by elsevier inc.; manuscript received: july 24, 2017; manuscript accepted: november 19, 2017; published online: 24 february 2018.The purpose of the study was a retrospective review examining the outcomes of hybrid revascularization combining iliofemoral endarterectomy and iliac artery stenting using covered stents in transatlantic inter-society consensus (tasc) c and d aortoiliac occlusive disease (aiod) involving the common femoral artery (cfa).All external iliac arteries were treated using a gore® viabahn® endoprosthesis.The article identifies on page 77 an explant of the infected iliac stent and in-situ femoral vein bypass revascularization, this infection presented 2 months after an initial surgical site seroma.

Manufacturer Narrative

H6: conclusions code 1: code 4315 - as the device was not available for return, and no evaluation of the device could be performed, cause was unable to be established.H6: device code 1: updated device code.Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.No further information was able to be obtained, therefore this event is being closed with the available information.It should be noted that the gore® viabahn® endoprosthesis instructions for use addresses the following adverse reactions among others: "complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.".

Manufacturer Narrative

Additional manufacturer narrative: no actual event date was provided.Therefore, date of event is an estimate based on publication date of the article (02/24/2018).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10049838
• MDR Text Key: 193650361
• Report Number: 2017233-2020-00355
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Other
• Patient Age: 64 YR