MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/22/2021

Event Type  Injury  

Event Description

The following literature was reviewed: zhang, jason, et al.¿endovascular repair of traumatic axillosubclavian artery injuries.¿ journal of vascular surgery cases, innovations and techniques, vol.8, no.1, 22 nov.2021, pp.23¿27., https://doi.Org/10.1016/j.Jvscit.2021.11.006.On an unknown date between (b)(6) 2015 and (b)(6) 2020, a 38 year old male presented with a stab wound affecting the left subclavian artery and underwent treatment utilizing a 7mm x 5cm viabahn device.The viabahn device was placed without issue during the initial procedure.At 2 weeks post initial procedure, the patient presented with upper extremity numbness.Computed tomography angiography revealed an occluded subclavian viabahn stent despite dual antiplatelet therapy.An intravenous heparin infusion was started, and the patient underwent catheter-directed thrombolysis and thrombectomy with stent relining (6mm x 6cm viabahn device) and the patient was discharged.The stent was patent and patient asymptomatic at the 8 week follow-up period.When asked for input into why the occlusion may have occurred, the author stated they believed it was secondary to poor outflow from a size mismatch.As event date is unknown, date article accepted is being used.

Manufacturer Narrative

Information was obtained from the following article: zhang, jason, et al.¿endovascular repair of traumatic axillosubclavian artery injuries.¿ journal of vascular surgery cases, innovations and techniques, vol.8, no.1, 22 nov.2021, pp.23¿27., https://doi.Org/10.1016/j.Jvscit.2021.11.006.Device serial number remains unknown and device is not accessible for testing.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14989192
• MDR Text Key: 295720471
• Report Number: 2017233-2022-03108
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male