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

Catalog Number BXA083901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Exsanguination (1841); Rupture (2208)

Event Date 01/10/2021

Event Type  Death  

Manufacturer Narrative

As the following devices were used as an overlapping system they will be included in this report : (bxa085901j/ (b)(4)) udi - , (b)(4), (bxa085901j/ (b)(4)) udi - , (b)(4), and (bxal085901j/(b)(4)) udi - , (b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using non-gore stent for the right external iliac artery lesion.The post-ballooning was performed using non-gore pta balloon, then the blood vessel ruptured, and bleeding occurred.The first gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn) (jhjr071502j/(b)(4)) was deployed.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx) (bxa083901j/(b)(4)) was deployed to extend the device proximally, and the second viabahn (jhjr060502j/(b)(4)) was deployed to extend the device distally.It was reported that hemostasis was obtained, and vital signs were stable.The patient tolerated the procedure.On (b)(6) 2021, in the morning, the patient¿s condition suddenly changed.The patient underwent reintervention.Re-bleeding was observed, and it was suspected due to type ii endoleak.Two additional viabahn (jhjr071502j/(b)(4), jhjr060502j/(b)(4)) and three additional vbx (bxa085901j/(b)(4), bxa085901j/(b)(4), bxal085901j/(b)(4)) were deployed from the aorta to the bilateral iliac arteries, using the covered endovascular reconstruction of the aortic bifurcation (cerab) technique to cover the lumbar artery and contralateral internal iliac artery, these may be communicating near the bleeding site.It was reported no endoleak was observed.The patient tolerated the procedure.On (b)(6) 2021, it was reported the patient expired.No cause of death, the presence of autopsy, and the physician comment were available.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The device(s) remained in the patient.Consequently, a direct product analysis was not possible.H6 - component code, 515 (stent) updated.H6 - investigations findings, 213 (no device problem found) updated.H6 - investigation conclusions, 4315 (cause not established) updated.

Manufacturer Narrative

C1 - name (give labeled strength and mfr/labeler), corrected (cbas® heparin surface).C1 - manufacturer/compounder, corrected (w.L.Gore & associates, inc.).

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11298523
• MDR Text Key: 230910922
• Report Number: 2017233-2021-01658
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: BXA083901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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: 74 YR
• Patient Sex: Male