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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 Problem Patient Device Interaction Problem (4001)
Patient Problem No Code Available (3191)
Event Date 03/16/2019
Event Type  Injury  
Manufacturer Narrative
Patient age: not provided in the poster.Patient gender: not provided in the poster.Date the event occurred is unknown, so the date the abstract was published was used as date of event.(b)(4).The information available relating to the reported event is not sufficient to identify the device, because manufacturer/lot number of the device have not been provided.It remains unclear if a gore® viabahn® vbx balloon expandable endoprosthesis is involved in the incident.The device remains implanted, so an engineering evaluation could not be performed.Requests have been sent to author to clarify the incident, for example lot/sn/item number, summary of the initial procedure and the reintervention, dicom images of the procedures and the diagnosis of the endoleak.
 
Event Description
The following literature poster was reviewed: "an alternative way to treat iliac aneurysm" graziana derone, david barilla, domenico spinelli et al.2066; jacc march 12, 2019; volume 73; issue 9 poster contributions poster hall, hall f saturday, march 16, 2019, 10:00 a.M.-10:45 a.M.Session title: vascular medicine: endovascular therapy 1 abstract category: 39.Vascular medicine: endovascular therapy presentation number: 1136-465.Background: isolated iliac aneurysms or combined with aortic aneurysms can be treated through implantation of three balloon expandable polytetrafluoroethylene-covered stents in order to create a new iliac bifurcation.We present nine patients, unfit for open surgery and anatomically non suitable for conventional endovascular approaches, in which covered stent endovascular reconstruction of the iliac bifurcation (cerib) was performed.Methods: we treated nine patients with cerib technique.Five patients were treated for concomitant abdominal aortic aneurysm.The mean diameter and length of the common iliac artery (cia) were 10.44 mm and 52.12 mm respectively; iliac axes had calcifications and angulations which did not allow conventional techniques.All patients had contraindications for commercially available iliac branch devices.This technique consists in the deployment of two covered stents in external iliac artery and internal iliac artery in kissing stent configuration, after the deployment and overlapped into a larger covered stent in the cia, such to reconstruct the iliac bifurcation.The stents we used were begraft® and vbx viabahn® stents, delivered from a low profile delivery system.The cia stent was introduced and deployed from the ipsilateral side.A femoral femoral through and through wire or an axillary femoral through and through wire were performed to gain access to the internal iliac artery.Four patients received, as adjunctive procedure, a post dilatation of the stents.Results: technical success was achieved in all procedures.None of the patients had endoleak at the end of the surgery or developed thrombosis of the stent neither pelvic or leg ischaemia.All patients underwent computed tomography (ct) angiography one month after the surgery.We reported only one case of endoleak type iii four months after the procedure which was resolved with a further balloon dilatation of the stents.Conclusion: the cerib technique allows to extend the possibility to treat isolated iliac aneurysms and aorto iliac aneurysms with endovascular approach to cases with a narrow or short common iliac artery.
 
Manufacturer Narrative
The following literature poster was reviewed: "an alternative way to treat iliac aneurysm" graziana derone, david barilla, domenico spinelli et al.2066; jacc march 12, 2019; volume 73; issue 9 poster contributions poster hall, hall f saturday, march 16, 2019, 10:00 a.M.-10:45 a.M.Session title: vascular medicine: endovascular therapy 1 abstract category: 39.Vascular medicine: endovascular therapy presentation number: 1136-465.H6-code 3221: the requests to the author remain unanswered.The lot numbers remain unknown.Without additional information, gore was unable to do further investigation of this event.
 
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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
MDR Report Key9809181
MDR Text Key194930093
Report Number2017233-2020-00171
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
PMA/PMN Number
P160021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Device Operator Health Professional
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 Number1
Patient Outcome(s) Hospitalization;
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