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

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 03/17/2018

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.The article indicated both gore® viabahn® vbx balloon expandable endoprosthesis & gore® viabahn® endoprosthesis were involved.However, the article did not provide specifics.Reference mdr #2017233-2020-00145 for gore® viabahn® endoprosthesis report.

Event Description

The following published article was reviewed: 'outcomes of an iliac branch endoprosthesis using an ¿up-and-over¿ technique for endovascular repair of failed bifurcated grafts'; emanuel r.Tenorio, md, phd, gustavo s.Oderich, md, giuliano a.Sandri, md, jussi m.Kärkkäinen, md, phd, manju kalra, mbbs, randall r.Demartino, md, jill k.Johnstone, md, and fahad shuja, mbbs, rochester, minn; presented at the forty-sixth annual symposium of the society for clinical vascular surgery, las vegas, nev, march 17-21, 2018; 0741-5214; copyright 2018 by the society for vascular surgery.Published by elsevier inc.; https://doi.Org/10.1016/j.Jvs.2018.10.098.The aim of this study was to evaluate outcomes of the ibe using an ¿up-and-over¿ transfemoral technique in patients with prior aortic repair compared with the standard technique in patients with de novo iliac aneurysms.There were 53 patients (51 male; avg.74 years old) treated by 62 ibes.The article reported secondary intervention was required because of seroma.The article is unclear about which device was used.Note: the article reports that the bridging stent of choice was preferentially an 8l viabahn balloon-expandable endoprosthesis (vbx; w.L.Gore & associates), which was advanced over the amplatz guidewire.When that was not available, the icast (atrium medical, (b)(4)) stent graft was selected.Gore® viabahn® endoprosthesis was also used as a bridging stent in the iia.

Manufacturer Narrative

Corrected data: medwatch #2017233-2020-00144 was sent in error.Additional received information determined that the seroma identified in the article is unrelated to the performance of the gore® viabahn® vbx balloon expandable endoprosthesis so this event is not reportable to the fda.Therefore this medwatch and supplemental will be retracted.

• 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: 9795138
• MDR Text Key: 190765024
• Report Number: 2017233-2020-00144
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR