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

Catalog Number JHH100502J

Device Problem Partial Blockage (1065)

Patient Problems Occlusion (1984); Claudication (2550)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted because the lot numbers remain unknown.It is unknown which of the two implanted devices were involved in the reported occlusion.The device information of the additional device is jhh100502j/unknown.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to thrombosis or occlusion.As the exact date of the device occlusion is unknown and based on the incoming information that "within a week the endoprostheses were occluded", (b)(6) 2018 will be used as an event date.

Event Description

On (b)(6) 2018, an iatrogenic right external iliac artery injury was developed during a thoracic endovascular aortic repair with non-gore device.Two gore® viabahn® endoprostheses with heparin bioactive surface were implanted in the right external iliac artery to repair the injury.Final angiography showed hemostasis and good blood flow.The procedure was concluded, and the patient tolerated the procedure.Medication (antiplatelet drug) was not started after the procedure as the indication was the vessel injury with bleeding.Within a week (exact date unknown), the endoprostheses were occluded.A watch-and-wait approach was elected.The physician reportedly considered as follows regarding cause of the occlusion: medication was not started, and condition of run-off vessel was not good.It was also possible that anastomosis of the right common femoral artery was not moderately done during the initial procedure.These conditions might have caused flow-limitation of the artery and the thrombotic occlusion.On (b)(6) 2018, it was decided to perform a re-intervention as the patient experienced claudication due to the occluded lesion included the whole length of the endoprostheses.Thrombectomy was performed to treat the occluded endoprostheses.The plain old balloon angioplasty (poba) was performed from the proximal right superficial femoral artery to the right common femoral artery, and a bare metal stent was implanted in the right superficial femoral artery.Final angiography showed a blood flow, and the procedure was concluded.

• 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: nataliya baramzina ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7887832
• MDR Text Key: 120692464
• Report Number: 2017233-2018-00563
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHH100502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR