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

Catalog Number JHJR050502J

Device Problem Partial Blockage (1065)

Patient Problem Stenosis (2263)

Event Date 01/11/2019

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2018, this patient underwent an endovascular repair for a pseudoaneurysm of the right renal artery using a gore® viabahn® endoprosthesis with heparin bioactive surface.The procedure was concluded with no issues, and the patient tolerated the procedure.On (b)(6) 2019, follow-up computed tomography (ct) showed that the endoprosthesis had stenosis.The patient was asymptomatic.On (b)(6) 2019, a reintervention was performed to repair the stenosis of the endoprosthesis.Angiography and intravascular ultrasound (ivus) confirmed that the middle portion of the endoprosthesis had the stenosis of 40-50 % stenosed.Reportedly, the proximal and distal ends of the endoprosthesis had slight intimal thickening, but not requiring treatment.An additional gore® viabahn® endoprosthesis with heparin bioactive surface was implanted inside the pre-existing endoprosthesis to repair the stenosis at the middle of the endoprosthesis.Post-ballooning was performed, digital subtraction angiography (dsa) and ivus showed good blood flow and expansion of the endoprosthesis.The procedure was concluded, and the patient tolerated the procedure.

Manufacturer Narrative

Conclusion code 1: updated.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8329726
• MDR Text Key: 135863989
• Report Number: 2017233-2019-00076
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 16108829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 45 YR