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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC Back to Search Results
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%.
 
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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 Key9946781
MDR Text Key196628589
Report Number2017233-2020-00242
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160021
Number of Events Reported1
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 Received04/09/2020
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 Number1
Patient Outcome(s) Other;
Patient Age73 YR
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