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

Model Number BXAL087902A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Perforation (2001)

Event Date 11/16/2020

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) 2020, the patient presented with an aneurysm beginning in the right common iliac artery and extending to the right internal iliac artery and underwent treatment utilizing two gore® excluder® iliac branch endoprosthesis (ibe, ceb231010, hgb161007), a gore® excluder® aaa endoprosthesis (rlt231416) , and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician began by advancing and deploying the first ibe (ceb231010) device successfully and a 12fr sheath was advanced into the ibe device.The physician then cannulated the right internal iliac artery with a terumo glidewire advantage® guidewire and then exchanged the guidewire for a 1cm tip amplatz wire through a kumpe catheter.An ibe (hgb161007) internal component was then successfully deployed in the ibe gate.A vbx device was chosen based on a 7mm vessel diameter, and was delivered successfully and deployed to nominal pressure at 12atm.The balloon was deflated and removed and a 10mmx20mm armada balloon was delivered to the overlap of the ibe internal component and the vbx device and expanded to 6 atm.The physician then noticed a drop in pressure and a perforation was observed with an ante grade angiogram through the 12fr sheath.The 10mm balloon was expanded inside the limb to maintain pressure and 9 nester coils (10-15mm) were delivered into the distal branch and distal graft.Then 14mm and 12mm amplatz plugs were also deployed into the mid limb.The limb was occluded and confirmed by an angiogram, and pressure rose and stabilized.A gore® excluder® aaa endoprosthesis was delivered on the right and the ipsilateral limb was deployed into the right external ibe graft to exclude the right hypogastric.The patient tolerated the procedure.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11007935
• MDR Text Key: 221547347
• Report Number: 2017233-2020-01525
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR