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

Model Number	BXAL087902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism (1829); Perforation (2001)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11007935
• Report Number: 2017233-2020-01525
• Device Sequence Number: 17048391
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR