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

Catalog Number BXA072902A

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/14/2024

Event Type  malfunction  

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.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: the dislodged vbx stent was maneuvered to the external iliac artery and deployed.The device remains implanted; therefore, direct product analysis was not possible.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.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

The following was reported to gore: patient presented for endovascular treatment in the superior mesenteric artery (sma) due to a high-grade stenosis and ischemic symptoms.During treatment, 7fr tourguide sheath and a 260cm.035 advantage glidewire were used to advance a 7mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent).While attempting to track the vbx device through a very steep and curved vessel into the sma, the delivery catheter was pushed and pulled multiple times.Attempts to get the vbx device into the sma ostium was unsuccessful.Consequently, the vbx device was being back out through the sheath when the constrained vbx device caught on the edge of the sheath.The constrained vbx stent was dislodged from the delivery catheter.Balloons of various sizes and brands and different wires were used to pull the vbx stent into the right external iliac artery and the device was deployed at that location.Over an.035 rosen wire, a new vbx device (6mm x 29mm) was implanted in the sma without any issues.As reported, the patient was doing well following the procedure.

Manufacturer Narrative

Engineering evaluation: the primary reported device failure (inability to advance the catheter to the target site) could not be independently confirmed as no items were returned for evaluation.Although it was noted the vbx device was pushed and pulled multiple times across the origin of the sma to track the vbx device on a very steep curve into the sma, it was not explicitly reported that the inability to advance the catheter was due to excessively tortuous anatomy.Therefore, the root cause of the primary reported device failure could not be established with the available information.The secondary reported device failure (stent dislodgment during attempted withdrawal) could not be confirmed due to no items being returned.However, users are instructed in the 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.The root cause of the reported failure mode of stent dislodgment during attempted withdrawal is consistent with use error as reported from the field.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18837776
• MDR Text Key: 336956704
• Report Number: 2017233-2024-04679
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637515
• UDI-Public: 00733132637515
• 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: 04/04/2024

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: BXA072902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 42 KG