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

Model Number BXA112902A

Device Problem No Flow (2991)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially non-eluting.

Event Description

'outcomes of small renal artery targets in patients treated by fenestrated- branched endovascular aortic repair' jussi m.Kärkkäinen, emanuel r.Tenorio, keouna pather, bernardo c.Mendes, thanila a.Macedo, jean wigham, alisa diderrich, gustavo s.Oderich.The aim was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (ra) during fenestrated-branched endovascular aortic repair (f-bevar).A total of 215 consecutive patients enrolled in a prospective f-bevar trial were reviewed.The kaplane-meier estimates of one and two year ra related outcomes are presented in table 4.At one year, primary patency was 79 ± 9% in the study group and 94 ± 1% in the control group (p <.001); secondary patency was 84 ± 8% vs.97 ± 1% (p <.001), respectively (fig.3a).Freedom from ra instability was 79 ± 9% vs.93 ± 2% at one year (p ¼.005, fig.3b), and freedom from renal function deterioration was 90 ± 7% vs.90 ± 3% (p ¼.09), respectively.There were no differences in freedom from reintervention and survival between the groups.No device allegations of deficiencies specific for gore devices.

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.No information about the device availability.Consequently, a direct product analysis was not possible.Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11709214
• MDR Text Key: 261808434
• Report Number: 2017233-2021-01886
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: BXA112902A
• Device Catalogue Number: BXA112902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female