MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Occlusion (1984); No Information (3190)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

The following abstract was reviewed: "performance of viabahn balloon-expandable stent compared with self-expanding covered stents for fenestrated-branched endovascular aortic repair" (fernando motta, m.D.; frederico e.Parodi, m.D.; jason r.Crowner, m.D.; luigi pascarella, m.D.; katharine l.Mcginigle, m.D.; william a.Marston, m.D.; melina r.Kibbe, m.D.; mark a.Farber, m.D.; savs22; journal of vascular surgery, january 2020, volume 71, number 1; page e28 & e29.The objective of the physician sponsored investigational device exemption trial was to compare the performance between gore® viabahn® vbx balloon expandable endoprosthesis and self-expanding covered stents (gore® viabahn® endoprosthesis & fluency¿ plus endovascular stent graft) (ses) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms.The median patient age was 71 with 70% male.Total number of vessels incorporated to repair was 977 of which 179 were branch vessels (54 celiac artery, 56 superior mesenteric artery, 38 right renal artery, and 31 left renal artery).Primary patency rates at 24 months for vbx was 98.1%, and,98.6 for ses.Freedom from endoleaks (vbx - 97.3, ses 98.6%), freedom from secondary intervention (vbx - 91.5%, ses 95%), and freedom branch instability (vbx - 95.5%, ses 97.3%).The abstract reports the vbx demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death.

Manufacturer Narrative

Method code 1.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9740711
• MDR Text Key: 188375354
• Report Number: 2017233-2020-00119
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR