MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR051502J

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

It should be noted the gore® viabahn® endoprosthesis instructions for use (ifu) recommends that the endoprosthesis overlap the native vessel at least 1 cm beyond the proximal and distal margins of the lesion when treating stenotic or occlusive lesions.Additionally, the ifu states ¿complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.¿.

Event Description

On (b)(6) 2019, the patient underwent an endovascular procedure whereby thrombectomy was performed, and a gore® viabahn® endoprosthesis was implanted in the right superficial femoral artery to treat acute limb ischemia.According to the report, patient had diffuse artery disease, and the condition of the vasculature including the right superficial femoral artery was poor.It was also reported that there was less than 1cm of healthy vessel seal zone on each side of the endoprosthesis.After the procedure on the same day, follow-up imaging reportedly identified occlusion of the right superficial femoral artery and the implanted endoprosthesis.On the same day, an additional thrombectomy was performed to repair the occlusion.Supplementary bare metal stents were also implanted at the both edges of the implanted viabahn® device to add radial force.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8613350
• MDR Text Key: 145214942
• Report Number: 2017233-2019-00351
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: JHJR051502J
• Device Lot Number: 18047230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR