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

Catalog Number BXA115902A

Device Problems Premature Activation (1484); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2024, the patient underwent treatment for venous thrombosis in the common iliac using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).It was reported that the physician was not able to reach the common iliac due a fibrotic clot.The physician was able to go up a terumo 11fr pinnacle sheath and over a terumo guidewire advantage.035".While trying to advance the vbx device across the lesion, the proximal edge of the stent partially deployed.The physician attempted to withdraw the vbx device through the sheath and noticed the vbx device pulled off the balloon.It was decided to fully deployed and expanded where the vbx device came off the balloon in the external iliac vein.The procedure was completed by placing an additional device in order to treat the desired area, the common iliac vein.

Manufacturer Narrative

H6 code b20: the device remains implanted and was therefore not available for engineering evaluation.H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.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.

Manufacturer Narrative

The primary reported device failure, related to the inability to advance to the target treatment site, could not be independently confirmed.Reportedly, the target treatment site was tightly stenosed, and cause of the inability to advance is, therefore, attributed to the stenosed patient anatomy.The complaint also indicates the proximal edge of the device partially expanded during the attempts to pass the stenosis.No items were returned for evaluation so the reported proximal expansion could not be confirmed, but this expansion is consistent with a device interaction with the anatomy and/or sheath during the reported inability to advance the device.An additional reported device failure, related to stent dislodgment during attempted withdrawal, could not be confirmed due to no items being returned.However, users are instructed in the instructions for use (ifu) to withdraw the vbx device to a position close to the introducer sheath, rather than withdrawing it into the sheath, then removing both in tandem.Per the ifu, withdrawing the vbx device back into the sheath can lead to various issues including dislodgment of the endoprosthesis.Therefore, the root cause of the reported failure mode of stent dislodgment during attempted withdrawal is consistent with an unintended use error as reported from the field.Section a: added patient information under a1, a2, and a3.B4: updated description event.H6: removed code d16 and added codes d1001 and d1102 under investigation conclusions.

Event Description

The following was reported to gore: on (b)(6) 2024, the patient underwent treatment for venous thrombosis in the common iliac using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).It was reported that the physician was not able to reach the common iliac vein due a fibrotic clot.The physician was able to access the popliteal vein and used a terumo 11fr pinnacle sheath and a terumo guidewire advantage.035".Reportedly, the physician pushed the vbx through the common iliac vein without any sheath protection that had tight stenosis, the proximal edge of the stent partially deployed.The physician went to push the sheath up the vbx device to withdraw the vbx device through the sheath but noticed the vbx device pulled off the balloon.The physician decided to fully deploy the vbx device at the same location in which it came off the balloon.A coronary balloon was inserted through the vbx device to open it up, then, the delivery balloon was used to post dilated it.Implantation was at the external iliac vein, more distal to the disease they were planning to treat.The procedure was completed by placing additional vbx devices in order to treat the desired area, the common iliac vein.It was reported there was no impact to the patient.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19067076
• MDR Text Key: 339995705
• Report Number: 2017233-2024-04806
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• 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: 05/29/2024

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 Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2024
• 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 Age: 46 YR
• Patient Sex: Male