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

Catalog Number BXA113902A

Device Problems Material Fragmentation (1261); Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda 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.

Event Description

On (b)(6) 2022, the patient with small bowel motility issues underwent treatment in the superior vena cava (svc) where an 11 mm x 39 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was placed as a conduit for catheter access used during administration of total parenteral nutrition (tpn).Reportedly, the physician has used the vbx device in this manner 4-5 times previously.They selected the biggest diameter vbx device they could; length did not need to be long.The vbx device was not post-dilated after placement.They were not concerned about wall apposition because the svc was occluded, and they felt the vbx device was not going to move.On (b)(6) 2023, the patient was having a non-stent related echocardiogram for bacteremia when there was an incidental finding of stent-graft material located in the heart.A chest x-ray was then performed and additional pieces of stent-graft material was found in the lung.This piece looked like three of the stainless steel "diamonds".It is unknown if there was eptfe as well.The x-ray also showed the proximal and distal portions of the vbx device were still located in the svc.The fractured part of the stent-graft was located in the top third of the device.The decision was made to not remove any of the pieces.The physician suspects the stent fracture was due to the manipulation of accessing and putting a catheter though the device.It was reported that there was no impact to the patient.

Manufacturer Narrative

A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: the reported primary failure mode of broken stent-graft components was confirmed with the clinical images provided for review.The images demonstrate time points indicated as ¿implant date¿ and ¿two weeks, three months and four months post implant.¿ a deployed vbx device is visualized on the image designated as ¿implant date.¿ there is subsequent progression of a gap visualized in the stent row pattern in the upper half of the device followed by a separation and a break in the vbx device stent pattern.A metallic density with a shape consistent with the vbx device stent row pattern was identified in the lung.The physician suspected catheter access and manipulation caused or contributed to the reported device failure.Procedure-related considerations that may have impacted product performance could neither be independently confirmed nor dismissed, and the root cause of the broken stent-graft could not be established with the available information.The field reported treatment of an occluded superior vena cava (svc).Use of the vbx device to treat venous occlusive disease is a reasonably foreseeable misuse consistent with the secondary failure of migration of stent-graft components to the heart and lungs.The migration of ¿stainless steel diamonds¿ was confirmed with the clinical images submitted for review, and the root cause is consistent with the off-label use of the device.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) states the following: ¿intended use / indications the gore® viabahn® vbx balloon expandable endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.¿.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17410267
• MDR Text Key: 319917292
• Report Number: 2017233-2023-04150
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637720
• UDI-Public: 00733132637720
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA113902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female