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

Catalog Number VBC060502

Device Problem Off-Label Use (1494)

Patient Problems Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Intended use / indications the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 ¿ 12 mm.Warnings ¿ w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral or iliac arteries.

Event Description

This information was received through "the 12th asian-oceanian congress of neuroradiology " the title is "carotid bifurcation blowout syndrome post cover stent placement with recurrent pseudoaneurysm:a case report of special retreatment technique¿ the author: dr.Chang hsien ou, dr.Sun jay lee, dr.Te yuan chen, dr.Wan ching lin, pei ling lin.The purpose of the study to report a case of emergent carotid bifurcation blowout syndrome post cover stent(viabahn)placement, but later recurrent bleeding from collateral circulations causing pseudoaneurysm formation.With sonographic guided direct puncture of the pseudoaneurysm and injection of nbca, the pseudoaneurysm and connection collateral circulations were completely embolised.The result: a (b)(6)-year-old male with a history of hypopharyngeal and esophageal cancer post operation and ccrt.This time, massive oral bleeding occurred and emergent angiography was performed.Massive active bleeding and hypovolemic shock took place during the procedure.A gore® viabahn® endoprosthesis was placed for life saving measures and the patient's condition was stabilized.One month later, rebleeding was occurred and emergent angiogram revealed patent common carotid artery (cca) and internal carotid artery (ica) without endoleak but retrograde filling of carotid bifurcation with enlargement of pseudoaneurysm from vertebra-occipital anastomosis collaterals were noted.Therapeutic options such as operation, anastomosis embolization,retrograde sta puncture or direct puncture of pseudoaneurysm embolization were considered.Due to difficulty reopening the previous operative necrotic tissue and no suitable target vessels can be chosen for embolization, direct puncture of the bifurcation pseudoaneurysm was done and then injected nbca to completely occlude the pseudoaneurysm and connecting collaterals.Three months follow to now, the patient's condition has been stable.

Manufacturer Narrative

Review of the file determined this event to be non-reportable due to the complications mentioned in the article was not related to gore device.This medwatch will be voided.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8886645
• MDR Text Key: 154303880
• Report Number: 2017233-2019-00621
• 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
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VBC060502
• 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): Required Intervention
• Patient Age: 60 YR