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

Model Number	BXA117901A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2021
Type of Reportable Event	Death
Event or Problem Description
Retroperitoneal bleed after vbx kissing stents placed in distal aorta extending into bilateral common iliacs.Vbx used as extensions of ibe device placed in distal aorta for aorto iliac occlusive disease.(aoid).After initial vbx inflation the plaque in the distal aorta was ruptured and subsequent blood pressure drop was noticed with retroperitoneal bleed appreciated on angiogram.Additional pta measures were taken and bleed and bp stabilized and patient stable and recovered.Once patient was admitted to her room after the procedure, a drop in hgb was noted as well as hypertension over next 48 hours.2 units of blood given, hgb went from 8.1 to 11.Acute renal failure also now diagnosed and 24hrs after index procedure the patient developed ischemic bowel.Patient expired (b)(6) 2021.Physician believes death was procedure related.
Additional Manufacturer Narrative
Revised.
Additional Manufacturer Narrative
H6: added component codes 515 and 788.
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.C1: added name and manufacturer/compounder h10: added 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.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11455128
• Report Number: 2017233-2021-01751
• Device Sequence Number: 11643721
• Product Code: PRL
• UDI-Device Identifier: 00733132637751
• UDI-Public: 00733132637751
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2022

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: 12/29/2022
• Device Model Number: BXA117901A
• Device Catalogue Number: BXA117901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021; 01/13/2022; 01/14/2022
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 07/07/2021; 01/13/2022; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BXA117901A/(B)(6).; BXA117901A/22675033
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Unknown