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

Catalog Number BXA073902A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 the patient underwent emergency treatment for bowel ischemia where a 7 mm x 39 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was going to be used in the superior mesenteric artery (sma).It was reported the physician accessed the treatment area through direct cannulation because the abdomen was open, using a 7f sheath (brand unknown) and an 0.035" guidewire (brand unknown).Reportedly, when the delivery system catheter advanced to the target treatment site, it was determined the stent was slightly too long.The decision was made to withdraw the delivery system catheter from the patient.An attempt was made to pull the stent back into the introducer sheath.Resistance was met, and force was applied.The balloon was pulled into the introducer sheath, but the undeployed endoprosthesis dislodged and was left in the artery on the guide wire.The catheter and balloon were withdrawn from the patient.The physician pulled the endoprosthesis to a safe location and deployed it using another balloon.The endoprosthesis was then relined with a 7 mm x 59 mm vbx device to cover and pin it down so it would not migrate into the aorta.It was reported there was no impact to the patient.

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.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.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

Updated - investigation conclusion code.The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Engineering evaluation: the reported device failure, related to stent dislodgment during attempted withdrawal through the sheath, 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.As reported, the physician attempted to withdraw the vbx device into the sheath; resistance was met and force was applied, after which the reported endoprosthesis dislodgment occurred.Therefore, the stent dislodgment prior to deployment is consistent with use error as reported from the field.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) includes the following instruction: ¿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.¿.

• 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: 18623101
• MDR Text Key: 334326236
• Report Number: 2017233-2024-04583
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637270
• UDI-Public: 00733132637270
• 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
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: BXA073902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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 Age: 81 YR
• Patient Sex: Male