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

Model Number	BXA115902A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	03/05/2021
Type of Reportable Event	Death
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
On (b)(6) 2021, the patient underwent a covered endovascular reconstruction of the aortic bifurcation to treat aortoiliac occlusive disease.Three gore® viabahn® vbx balloon expandable endoprostheses (vbx) were implanted in the patients aortoiliac bifurcation.A dissection was then noted and was suspected to be originating from the aortoiliac bifurcation (exact location unknown).The dissection was suspected by the physician to have been caused by the ballooning of the stents as the patients anatomy was extremely friable.Two additional vbx devices were implanted, one proximal and one distal of the previously implant vbx devices for extension to treat the dissection.The dissection was still present and the patient continued to experience blood loss.A medtronic covered stent was implanted to reline the previously implanted devices.The dissection was still present with noted blood loss continuing to occur.A conformable gore® tag® thoracic endoprosthesis was implanted in the distal aorta to treat the dissection.The patient underwent a blood transfusion.The patient expired due to exsanguination.
Additional Manufacturer Narrative
As it is unknown which device(s) may have contributed to the dissection, two additional gore® viabahn® vbx balloon expandable endoprostheses have been included in this report: (b)(4).
Additional Manufacturer Narrative
Added h6 investigation findings and investigation conclusion.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11596061
• Report Number: 2017233-2021-01834
• Device Sequence Number: 11636661
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2021

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: 01/02/2024
• Device Model Number: BXA115902A
• Device Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021; 03/31/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 03/31/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 113 KG