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

Model Number BXAL083902A

Device Problem Human-Device Interface Problem (2949)

Patient Problems Calcium Deposits/Calcification (1758); Perforation of Vessels (2135)

Event Date 10/05/2021

Event Type  Death  

Event Description

The following was reported to gore: on (b)(6) 2021, a female patient required treatment due to aorto-iliac disease.As reported, the patient's vessels were calcified.A covered endovascular reconstruction of aortic bifurcation (cerab) procedure was performed using multiple gore® viabahn® vbx balloon expandable endoprostheses (vbx devices).The first vbx device (11x59) was placed in the aorta and post dilated to 16mm in the proximal section.Next, two vbx devices (8l x 39) were inserted and deployed using a kissing technique configuration into the iliac arteries.Two vbx devices (8x39) were also implanted at the overlap.Images reviewed showed good results.Using the ivus, it was observed the right side was not fully expanded.Two 10mm balloons were placed into the iliac arteries that had the 8lx39 vbx devices.Images revealed on the left side, piece of calcium appeared to have pushed through the left common iliac vbx device as bleeding was coming through the stent.Additional vbx devices (8lmm x 79mm) were deployed to reline the vbx devices.The patient¿s condition was stabilized and was transferred to surgery.During the surgical conversion, it was found the patient had more issues than the focal bleeding.Ultimately, patient expired with bleeding from the left common iliac artery.Two 8x29 vbx devices were utilized in each common iliac artery, which connected to the 8x39 vbx devices before the 8x79 vbx devices were deployed.Two 8x39 vbx device lot/serial numbers were entered as it is unknown which device was placed in the left common iliac artery.

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.Patient weight was requested, but not made available.(b)(4): review of device manufacturing record history is currently in progress.The affected devices remain implanted / were not returned to gore.Therefore, direct product analysis was not possible.

Manufacturer Narrative

H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.Further investigation was not possible as device remains implanted and no images were provided.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12754232
• MDR Text Key: 280440389
• Report Number: 2017233-2021-02513
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637829
• UDI-Public: 00733132637829
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: BXAL083902A
• Device Catalogue Number: BXAL083902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female