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

Catalog Number BXA083901J

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore; on (b)(6) 2020, the patient presented with a calcification lesion beginning in the left common iliac artery and ending in the external iliac artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a non-gore device.The physician advanced and deployed the non-gore device in the external iliac artery without issue.The physician then began advancing the vbx device to the treatment zone.After passing through the non-gore device, the physician met resistance while advancing into the common iliac artery due to tortuous anatomy.The physician applied additional force to advance further but was ultimately unsuccessful.The physician decided to remove the vbx device and when approximately thirty percent of the catheter was inside of the sheath the vbx device dislodged.The physician advanced the catheter and recaptured the endoprosthesis.The physician then advanced the vbx device to the common iliac artery and attempted to push through the calcification once more, but was unsuccessful.The physician then decided to withdraw the device to the external iliac artery and deploy the vbx within the non-gore stent.The physician then used another vbx device to complete the procedure without issue.The patient tolerated the procedure.

Event Description

The following was reported to gore; on (b)(6) 2020, the patient presented with a calcification lesion beginning in the left common iliac artery and ending in the external iliac artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) and a non gore device.The physician advanced and deployed the non gore device in the external iliac artery without issue.The physician then began advancing the vbx device to the treatment zone.After passing through the non-gore device, the physician met resistance while advancing into the common iliac artery due to tortuous anatomy.The physician applied additional force to advance further but was ultimately unsuccessful.The physician decided to remove the vbx device and when approximately thirty percent of the catheter was inside of the sheath the vbx device dislodged.The physician advanced the catheter and recaptured the endoprosthesis.The physician then advanced the vbx device to the common iliac artery and attempted to push through the calcification once more, but was unsuccessful.The physician then decided to withdraw the device to the external iliac artery and deploy the vbx within the non-gore stent.The physician then used another vbx device to complete the procedure without issue.The patient tolerated the procedure.

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: 10985058
• MDR Text Key: 220722878
• Report Number: 2017233-2020-01519
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Catalogue Number: BXA083901J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization