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

Model Number BXA117902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Viabahn vbx came off delivery system undeployed inside the body.The stent was retrieved intact using a snare.Catalog number bxa117902a.During the procedure, they tried to get a 11 x 79 vbx in from the arm.This would not go at first.They switched wires.Then went with an amplatz wire, and then tried to put the stent again.This was ballooned, and after that, they realized that the stent was not on this.They looked to see where the stent was and saw the stent was actually in the 8-french sheath that was coming from the arm, the stent was sticking just a little bit into the sheath, and the rest was into the abdominal aorta.A right common femoral artery cutdown was performed, got a 16-french sheath up, got a snare up, actually snared the 11 x 79 stent and pulled it out with the sheath.Once they did this, they got access again in, into the left internal iliac artery and then were able to deploy 11 x 79 vbx stent.At the end of the procedure, there was no evidence of any endoleak at all, and after everything was closed, the patient had palpable radial pulse, and doppler signals in the feet.Patient was transferred to pacu in stable condition.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDO
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth st; flagstaff AZ 86004
• MDR Report Key: 10017032
• MDR Text Key: 189587031
• Report Number: 10017032
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BXA117902A
• Device Catalogue Number: BXA117902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA