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

Catalog Number VBJR080502A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.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: migrations.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient was undergoing treatment of a left arm av access proximal graft to distal subclavian vein thrombotic occlusion with apparent extravasation seen on contrast angio.A gore® viabahn® endoprosthesis with heparin bioactive surface was advanced over a.035" glidewire through a 7fr sheath.On (b)(6) 2017 it was reported imaging showed no viabahn in the area expected.Further imaging showed the viabahn in the superior vena cava.The patient is reportedly stable and there are no current plans for reintervention.

Manufacturer Narrative

Updated.

Event Description

On (b)(6) 2017 a patient was undergoing treatment of a left arm av access procedure.A gore® viabahn® endoprosthesis with heparin bioactive surface was advanced over a.035" glidewire through a 7fr sheath and deployed in the axillary vein, across the anastomosis with the av graft.Following the procedure, the viabahn was well-apposed to the both the axillary vein and the av graft.On (b)(6) 2017 it was reported imaging showed no viabahn in the area expected.Further imaging showed the viabahn in the pulmonary artery.On an unknown date the viabahn was explanted by an interventional radiologist through the internal jugular vein.The patient is reportedly doing well and is receiving dialysis treatments via a permacath.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7144564
• MDR Text Key: 95915196
• Report Number: 2017233-2017-00674
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: VBJR080502A
• Device Lot Number: 16519337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• 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; Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 114