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

Model Number	BXA082901A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypovolemic Shock (1917); Cardiogenic Shock (2262)
Date of Event	01/26/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: liver cancer currently being treated with tace, aaa, alcohol dependence, hypertension, joint pain, left leg pain, liver lesion, left lobe, liver mass, pad.Concomitant medical products: patient medications include but are not limited to: acetaminophen.The instructions for use (ifu) for the gore® viabahn® endoprosthesis states the following: hazards and adverse events, procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: death.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of a symptomatic abdominal aortic aneurysm with short distance claudication of both lower extremities and bilateral iliac artery occlusions; with complete occlusion of the right external iliac artery (rcia) and left common iliac artery (lcia).Post dissection of the bilateral cia¿s a gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) was advanced and deployed within the rcia and extended with a gore® viabahn® endoprosthesis with heparin bioactive surface down to the reia and inflated to 12mmhg.A 16 fr sheath was then advanced through the right iliac viabahn® system and a gore® excluder® trunk ipsilateral leg component featuring c3® delivery system was advanced and deployed just distal to the renal arteries.A second trunk ipsilateral leg component of the same size was then advanced and deployed to overlap the first one.Angioplasty of the entire system was performed all the way down to the common and external iliac¿s.Completion angiography demonstrated no endoleak and a widely patent graft system and a femoral to femoral artery bypass was performed.An angiograph was performed and showed two areas of sluggish flow within the bypass system and a gore® viabahn® endoprosthesis was implanted and dilated with a 8mm diameter balloon.Completion imaging was performed and demonstrated inline and brisk, pulsatile flow.The patient tolerated the procedure and was transferred to recovery in fair condition.On (b)(6) 2021, the patient expired from a likely combination of cardiogenic shock and hypovolemic shock.The patient suffered hepatocellular carcinoma and presume to develop hepatic coagulopathy on top of arteriosclerotic cardiovascular disease.
Additional Manufacturer Narrative
H6: corrected code.
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.H6: corrected information, lot number was provided and a device history review was conducted.
Additional Manufacturer Narrative
H6: added component code h6: code(s): 4117, 3331: a review of the manufacturing records for the device was unable to be conducted as the lot number(s) was not available, as such no udi was able to be generated.Previous medwatch indicated an analysis was performed; no analysis was performed.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11440247
• Report Number: 2017233-2021-01744
• Device Sequence Number: 3243416
• Product Code: PRL
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2021

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: 05/31/2023
• Device Model Number: BXA082901A
• Device Catalogue Number: BXA082901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 02/15/2021; 02/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 09/01/2021; 11/12/2021; 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 54 KG