MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. STENT GRAFT VIABAHN SX HEPARIN 18 RO; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBJR050702A
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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: STENT GRAFT VIABAHN SX HEPARIN 18 RO
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 11709841
• Report Number: 2017233-2021-01887
• Device Sequence Number: 4330907
• Product Code: NIP
• UDI-Device Identifier: 00733132624089
• UDI-Public: 00733132624089
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: 06/07/2023
• Device Model Number: VBJR050702A
• Device Catalogue Number: VBJR050702A
• 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: 03/25/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female