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

Model Number	BXA067902A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/17/2022
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.Due to no device return, an investigation could not be performed.Due to no information as to which gore® viabahn® vbx balloon expandable endoprosthesis that were implanted occluded, a review off the manufacturing records for all devices implanted was performed.Lot/serial # of devices implanted in renal artery,(b)(4).A review of the manufacturing records for the devices implanted in renal arteries, indicated the lots met pre-release manufacturing specifications.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): site contact information obtained from the medrio clinical database and additional procedure and device details obtained from the medrio system administrator.Treating physician and facility: dr (b)(6); (b)(6).The following patient information was obtained from medrio system administrator: patient demographic info: male, dob (b)(6), comorbidities-hypercholesterolemia, weight (b)(6).Recvd: 3/17/2022 treated on (b)(6)2021.Adverse event date is not inputted in study database but was reported on 3/17/2022.Study pt: (b)(6).A/e: occlusion of bilateral renal artery stents.Lot/serial numbers implanted in rental arteries: (b)(4).
Event or Problem Description
On (b)(6) 2021, a study patient underwent a aaa procedure.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted as branch components in the renal arteries.Postoperative ct scan revealed widely patent stent system.Patient was known to have a small renal mass on the left kidney, which was going to require delayed intervention.Patient underwent laparoscopic robot-assisted nephrectomy on or about (b)(6) 2022.Since that procedure the patient has made little or no urine, and was emergently initiated on dialysis.The duplex ultrasound revealed some flow but the velocities were extremely low (about 30 com per second range).On (b)(6) 2022, renal artery occlusions were noted, but no intervention was performed.Findings: completed was abdominal and pelvic arteriogram, which revealed celiac artery stent was widely patent, the right and left renal artery stents were anatomically oriented correctly, with no signs of radiographic kinking.However, the angiography showed the stents were completely occluded from the branch point all the way into the distal aspect of the origin of the vessels.Because of the prolonged ischemia time, revascularization of the stents was not performed.Lot/serial numbers for vbx devices implanted in right rental arteries in overlapped fashion / one unit: (b)(6) (right renal; first distal extension) (b)(6) (right renal; most proximal within portal).
Additional Manufacturer Narrative
A5 - a6: patient ethnicity added b3: event description was updated b7: patient medical history updated.H6 - c19: review of device manufacturing record confirmed both devices met pre-release specifications.Two devices of same type/family were implanted in the right renal artery in an overlapped fashion.Second device has lot/serial (b)(6); udi (b)(4).Catalog #bxa075902a.H3: both devices remain in patient.Therefore, direct product analysis was not possible.Section g: contact name was updated.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14085465
• Report Number: 2017233-2022-02858
• Device Sequence Number: 2096141
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 06/07/2024
• Device Model Number: BXA067902A
• Device Catalogue Number: BXA067902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Life Threatening; Hospitalization; Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White