MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Case # 2 is being reported under mfr report # 2017233-2020-00372.

Event Description

The following information was reported to gore: in an article titled "arteriovenous graft delamination and dissection as a cause of graft dysfunction" it states a woman receiving hemodialysis presented with av graft thrombosis 3 months after implantation of a gore® hybrid vascular graft.Thrombectomy was performed with an arrow-trerotola percutaneous thrombectomy device.After flow was restored angiography showed several mild focal intragraft stenoses and filling defects within the venous limb, which were treated with repeated thrombectomy and balloon-angioplasty.Repeated angiography showed greater prominence of these lesions with no improvement in appearance.Thrombectomy was then attempted with a compliant balloon, but after balloon deflation the original filling defect was still there.Color doppler ultrasonography showed dissection, infolding and stagnant flow within the false lumen.Overlapping fluency and smart stents were deployed across these flow-limiting dissections.Four weeks after hemodialysis was removed, the av graft rethrombosed.After percutaneous thrombectomy, additional lucent areas compatible with graft dissections in the venous limb were identified and treated with stent deployment.Although hemodialysis was resumed, the graft subsequently thrombosed and was then abandoned.Literature citation: dai r, broadwell sr, lessne ml, kim cy.Arteriovenous graft delamination and dissection as a cause of graft dysfunction.Journal of vascular & interventional radiology 2020;31(5):852-854.E1.

Event Description

The following information was reported to gore: in an article titled "arteriovenous graft delamination and dissection as a cause of graft dysfunction" it states a woman receiving hemodialysis presented with av graft thrombosis 3 months after implantation of a gore® hybrid vascular graft.Thrombectomy was performed with an arrow-trerotola percutaneous thrombectomy device.After flow was restored angiography showed several mild focal intragraft stenoses and filling defects within the venous limb, which were treated with repeated thrombectomy and balloon-angioplasty.Repeated angiography showed greater prominence of these lesions with no improvement in appearance.Thrombectomy was then attempted with a compliant balloon, but after balloon deflation the original filling defect was still there.Color doppler ultrasonography showed dissection, infolding and stagnant flow within the false lumen.Overlapping fluency and smart stents were deployed across these flow-limiting dissections.Four weeks after hemodialysis was resumed, the av graft rethrombosed.After percutaneous thrombectomy, additional lucent areas compatible with graft dissections in the venous limb were identified and treated with stent deployment.Although hemodialysis was resumed, the graft subsequently thrombosed and was then abandoned.Literature citation: dai r, broadwell sr, lessne ml, kim cy.Arteriovenous graft delamination and dissection as a cause of graft dysfunction.Journal of vascular & interventional radiology 2020;31(5):852-854.E1.

Manufacturer Narrative

Event updated.

• Brand Name: GORE HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10072646
• MDR Text Key: 194964051
• Report Number: 2017233-2020-00373
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 25 YR