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

Catalog Number PAH090502B

Device Problem Complete Blockage (1094)

Patient Problem Stenosis (2263)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Patient was treated with two devices.Device # 2 pah090502b lot # and udi information not available.It is not known whether both or one device exhibited stenosis.A second report, # 2017233-2020-00186 is being sent to capture patient no.(b)(6).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 two 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.(b)(6) developed 50-60% in-stent restenosis at the annual follow-up ct and 6 months after the annual follow-up progressed to severe stenosis seen on color doppler ultrasound.Balloon angioplasty was performed to achieve assisted primary stent patency.

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.1 developed 50-60% in-stent restenosis at the annual follow-up ct and 6months after the annual follow-up progressed to severe stenosis seen on color doppler ultrasound.Balloon angioplasty was performed to achieve assisted primary stent patency.

Manufacturer Narrative

Patient #4 is being reported under mfr report # 2017233-2020-00249.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9832875
• MDR Text Key: 196422727
• Report Number: 2017233-2020-00185
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAH090502B
• 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; Other; Required Intervention
• Patient Age: 68 YR