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

Catalog Number BXA115902A

Device Problem Partial Blockage (1065)

Patient Problem Restenosis (4576)

Event Date 11/05/2023

Event Type  Death  

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.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

On (b)(6) 2023, this patient underwent endovascular treatment for a thoracic aortic dissection and penetrating aortic arch ulcer and was implanted with gore® tag® thoracic branch endoprostheses (tbe).An open surgical procedure was not an option due to patient condition and access was obtained in the abdominal aorta.The patient had previously received a procedure to bypass the lsa to the lcca and bca.The patient had an existing cabg coming off the mid-bca and a lima bypass off the lsa.Prior to placement of tbe, the patient was hypotensive with increased pressure in the left arm compared to the right.The tbe was placed with the side branch in the lsa and with intentional partial coverage of the bca proximally with the aortic component (ac).It was reported that the portal opening on the gore® tag® aortic component (tac123715a/25765796) had landed slightly distal to the lsa, leaving placement of the side branch (tsb121506a/26679693) a little compressed.Post operative cta demonstrated a moderate stenosis in the compressed portion of the side branch.A gore® tag® conformable thoracic stent graft with active control system (tgmr373710/23079450) was placed proximally to the tac to extend treatment into the ascending aorta.Due to this device configuration, all blood flow to the lcca and bsa was through a single side branch in the lsa.On (b)(6) 2023, the patient underwent reintervention on the tbe side branch and a gore viabahn vbx balloon expandable endoprosthesis (bxa115902a/27134726) was implanted to open the compressed region.The patient tolerated the procedure.The physician suspects (but was unable to confirm) that the patient may have experienced a small transient ischemic attack (tia) over the weekend due to the compressed side branch.No major stroke was reported, and the patient is reported to be doing better.On (b)(6) 2023, it was reported that the patient had expired on an unknown date, a cause of death was not provided.On december 7, 2023, the physician provided additional details.The patient expired on (b)(6) 2023.The physician listed the cause of death as cardiorespiratory failure likely related to the device.Compromised flow through the side branch was suspected to be a factor, although completion angiogram did not suggest this.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The device was not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18304092
• MDR Text Key: 330191345
• Report Number: 2017233-2023-04463
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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 Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male