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

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Device serial number was requested but not made available., device remains implanted therefore a product evaluation is not possible.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 underwent treatment for an aneurysm in the left renal artery using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician advanced the vbx device through an 8fr tourguide¿ steerable sheath to the target zone and, upon ballooning, perforated the distal aspect of the left renal artery.The physician then performed a coil embolization of the aneurysm and deployed the vbx device at the treatment zone.The physician stated that there may have been an issue with the sizing of the vbx device.The patient tolerated the procedure.Patient information has been requested but is not available at this time.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient presented with an aneurysm in the left renal artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician advanced the vbx device through an 8fr tourguide¿ steerable sheath to the target zone and, upon ballooning, perforated the distal aspect of the left renal artery.The physician then performed a coil embolization of the aneurysm and deployed the vbx device at the target zone.The patient tolerated the procedure.

Manufacturer Narrative

H6 code: 3221- device serial number was requested but not made available., device remains implanted therefore a product evaluation is not possible.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: 10474664
• MDR Text Key: 205091636
• Report Number: 2017233-2020-01195
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization