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

Catalog Number BXA117902E

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem Aneurysm (1708)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.The results will be included in the final report.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

It was reported to gore that patient underwent endovascular treatment for an aneurysm in the iliac artery using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that to advance the vbx-device to the target lesion an 8fr terumo introducer sheath over a lunderquist guide wire was used.The insertion of the vbx catheter went smoothly without friction.Reportedly, the stent was positioned too high.It was tried to pull down the catheter, however the balloon went down too and the stent remained in the same position.It was stated that the vbx-device was disconnected from the catheter, however the catheter could easily be reinserted in the stent.It was reported that the balloon was a little bit inflated, the stent pulled down to the target lesion and finally inflated successfully.There was no report of patient harm.

Manufacturer Narrative

H6 result code: 213 - the review of the manufacturing records verified that this lot met all pre-release specifications.H3: other; there was no device returned; therefore, no physical evaluation of the device can be performed.A received image cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The image provided appears to demonstrate a deployed vbx and corresponding delivery system.The referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.Crush force is controlled through machine maintenance and calibration.The device history file was reviewed and no anomalies were identified.Machine history files were reviewed and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.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 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 an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.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: 10482029
• MDR Text Key: 215529656
• Report Number: 2017233-2020-01206
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: 01/10/2023
• Device Catalogue Number: BXA117902E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 60