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

Catalog Number PAJR060502B

Device Problem Complete Blockage (1094)

Patient Problem Stenosis (2263)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Additional reports submitted: 2017233-2020-00186, 2017233-2020-00185.The date the article was accepted is being used as the date of event.

Event Description

The following information was reported to gore: in an article titled technical considerations and clinical outcomes in the endovascular management of celiac arterial aneurysms it states some patients who underwent treatment of celiac artery aneurysms who were treated with either gore® viabahn® endoprosthesis with propaten bioactive surface or gore® viabahn® vbx balloon expandable endoprosthesis had device related post-procedural complications: patient no.4 was treated with an atrium and a gore® viabahn® endoprosthesis with propaten bioactive surface.This patient exhibited rebleeding angiomyolipoma and 80% in-stent restenosis sir grade c.

Event Description

The following information was reported to gore: in an article titled technical considerations and clinical outcomes in the endovascular management of celiac arterial aneurysms it states some patients who underwent treatment of celiac artery aneurysms who were treated with either gore® viabahn® endoprosthesis with propaten bioactive surface or gore® viabahn® vbx balloon expandable endoprosthesis had device related post-procedural complications: patient no.4 was treated with an atrium and a gore® viabahn® endoprosthesis with propaten bioactive surface.This patient exhibited rebleeding angiomyolipoma and 80% in-stent restenosis sir grade c.Complete stent graft thrombosis with good collateral flow through the gda into the pha was demonstrated on follow-up ct angiogram imaging in patient #4, despite prior angioplasty of the stenosed segment with a drug-coated balloon.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9957525
• MDR Text Key: 194035810
• Report Number: 2017233-2020-00249
• 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
• Report Date: 04/15/2020

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 Catalogue Number: PAJR060502B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR