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

Catalog Number BXA057902E

Device Problem Patient-Device Incompatibility (2682)

Event Date 02/09/2021

Event Type  Injury  

Event Description

The following was reported to gore on 1/31/24 from a retrospective study: on (b)(6) 2021, this 77 year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm.The patient was treated with a cook t-branch device, five gore® viabahn® vbx balloon expandable endoprosthesis devices to the superior mesenteric artery (2), right renal artery (1), and left renal artery (2), and a bare metal stent to the left renal artery.The vbx devices were successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.The patient was noted to have an endoleak type 1c for insufficient landing of both renal stents on february 9, 2021.Endovascular reintervention in the right and left renal arteries occurred on june 14, 2021 in which two gore® viabahn® vbx balloon expandable endoprosthesis devices were placed.Gore® viabahn® vbx balloon expandable endoprosthesis (bxa055902e/ni) was implanted in the right renal artery and gore® viabahn® vbx balloon expandable endoprosthesis (bxa053902e/ni) was implanted in the left renal artery.The devices were patent at the end of the procedure.The patient was noted to have recovered/adverse event resolved without sequelae.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.H3 other code: as the device remains implanted, no further investigation can be performed.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Further details were requested from the study coordinator such as lot-/serial no's, possible root cause and if fluoroscopic images are available for further evaluation.No further information was provided yet.Please notice that upon further review of this case this report was sent for the endoleak in the left renal artery where 2 vbx-devices and a bare metal stent were implanted (second proximal implanted device bxa057902e/ni).For the primary proximal implanted device in the left renal artery manufacturer report number 2017233-2024-04649 was sent.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

B5 describe event or problem was updated.The reported endoleak type 1c in the left renal artery is related to the most distal vbx-device which was identified based on the catalogue number provided to gore.This incident was reported with manufacturer report number 2017233-2024-04649 (gore reference number (b)(4)).The present report is related to the most proximal vbx-device in the left renal artery which was neither involved in the incident nor is there an allegation against the device.Therefore the present report is being retracted.

Event Description

The following was reported to gore on 1/31/24 from a retrospective study: on (b)(6) 2021, this 77 year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm.The patient was treated with a cook t-branch device, five gore® viabahn® vbx balloon expandable endoprosthesis devices to the superior mesenteric artery (2), right renal artery (1), and left renal artery (2), and a bare metal stent to the left renal artery.The vbx devices were successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.The patient was noted to have an endoleak type 1c for insufficient landing of the most distal stent in the left renal artery on (b)(6) 2021.Endovascular reintervention in the left renal artery occurred on (b)(6) 2021 in which a gore® viabahn® vbx balloon expandable endoprosthesis device (bxa053902e/ni) was implanted in the left renal artery.The device was patent at the end of the procedure.The patient was noted to have recovered/adverse event resolved without sequelae.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18758009
• MDR Text Key: 335998223
• Report Number: 2017233-2024-04650
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA057902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COOK T-BRANCH DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG