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

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problem Blood Loss (2597)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed 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.The article accepted date is (b)(6) 2019.Therefore the event date will be listed as (b)(6) 2019.67% of patients were males with a mean average age of 73.

Event Description

The following article was reviewed: "outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms" (aleem mirza, m.D.; emanual tenorio,m.D.; jussi kärkkäinen, m.D.; keouna pather, b.S.C.; jarin kratzberg, phd; bernardo mendes, m.D.; randall demartino, m.D.; gustavo oderich, m.D.; journal of vascular surgery 2019; 0741-5214; copyright © 2019 by the society for vascular surgery.Published by elsevier inc.; https://doi.Org/10.1016/j.Jvs.2019.09.058).The aim of the study was to evaluate the technical feasibility, procedure metrics and outcomes of endovascular repair of thoracoabdominal aneurysm (taaas) using a novel patient-specific low profile (lp) preloaded guidewire systems (pgs) compared with the standard off-the-shelf multibranch stent graft (t-branch; cook medical).The study was a prospective study conducted between january 2014 and february 2018.The study reported that the target vessels were sequentially stented using the gore® viabahn® vbx balloon expandable endoprosthesis for all directional branches.Technical success, defined by implantation of the aortic device and all intended side branch stents, was achieved in all 54 cases.A total of 206 renal-mesenteric arteries were incorporated by fenestrations or directional branches.Table iv reports primary target vessel patency at 98%; secondary target vessel patency 98%, freedom from branch instability 95%.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9946781
• MDR Text Key: 196628589
• Report Number: 2017233-2020-00242
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR