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

Catalog Number BXAL087901J

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020, the patient presented with an occlusion of the left common iliac artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a bare metal stent.The physician pre ballooned the target site in the left common iliac artery and attempted to advance the vbx device to the treatment target zone.The physician met resistance while advancing the vbx device to the target treatment zone and decided to withdraw the vbx device in order to balloon the target site a second time.While removing the vbx device the physician felt a resistance and the endoprosthesis dislodged from the delivery catheter separated completely in the left external iliac artery, but remained on the guidewire.Reportedly, the physician inserted the vbx balloon into the stent graft and deployed the vbx device in the left external iliac artery.An additional vbx device was placed in the left common iliac artery with the "kissing stent" technique.A bare metal stent was deployed between the two vbx devices since there was no overlap.Further information has been requested but is not available at this time.

Event Description

On (b)(6) 2020, the patient presented with an occlusion of the left common iliac artery and underwent treatment using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a bare metal stent.The physician pre ballooned the target site in the left common iliac artery and attempted to advance the vbx device to the treatment target zone.The physician met resistance while advancing the vbx device to the target treatment zone and decided to withdraw the vbx device in order to balloon the target site a second time.While removing the vbx device the physician felt a resistance and the endoprosthesis dislodged from the delivery catheter in the left external iliac artery, but remained on the guidewire.Reportedly, the physician inserted the vbx balloon into the stent graft and deployed the vbx device in the left external iliac artery.An additional vbx device was placed in the left common iliac artery with the "kissing stent" technique.A bare metal stent was deployed between the two vbx devices since there was no overlap.The patient tolerated the procedure and is doing well.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10382508
• MDR Text Key: 208788028
• Report Number: 2017233-2020-01097
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: BXAL087901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization