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

Catalog Number BXA082901J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

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

The following was reported to gore:on (b)(6) 2021, the patient underwent an endovascular treatment for an aortic arch aneurysm creating 2 debranch bypass and using the chimney technique for the brachiocephalic artery.In the procedure a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used.During the procedure, a vbx device (8x29) was implanted.After implantation, it was found that the vessel at the distal end of the vbx device (about 15 mm proximally from the right axillary anastomosis) was perforated, causing hypotension, and the patient went into shock.Manual hemostasis was performed and a blood transfusion (volume unknown) was required.An additional vbx device (8x59) was implanted at the injured site.The procedure was completed after confirming that the patient's condition had stabilized.

Manufacturer Narrative

A review of the manufacturing records indicated the device lots met all pre-release specifications.A direct device evaluation could not be performed as the device remains implanted.Communication revealed that the diameter of the blood vessel was not measured by ct prior to selection and use of the vbx device.Gore requested additional information on procedural details from the physician, but no additional information was provided.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there is an applicable precaution: ¿native vessel dimensions must be accurately measured, not estimated.¿ related statements are in the ifu under directions for use, imaging & measurement: ¿to achieve accurate measurement and ensure precise sizing and placement of the endoprosthesis, use image-centered, magnified-view contrast angiography, including a marker guidewire or catheter.¿ in addition, in directions for use, sizing and selection of the gore® viabahn® vbx balloon expandable endoprosthesis: ¿in selecting the appropriate size endoprosthesis, a careful assessment of the vessel is necessary.To reduce the potential for vessel damage, the final stent inner diameter (as indicated on the compliance chart on box label, the compliance chart is different per device size and it has more detailed information than table 2, stent graft sizing table) should approximate the diameter of the vessel just proximal and distal to the stenosis.¿.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12918040
• MDR Text Key: 284626862
• Report Number: 2017233-2021-02580
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Catalogue Number: BXA082901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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; Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male