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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Occlusion (1984); Injury (2348)

Event Date 02/03/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted because the lot numbers remain unknown.Further information was requested and will be provided.Please note that the poster "effects of viabahn® stent on segmental patency with peripheral obstructive arterial disease: a retrospective study¿, presented by sidnei jose galego, keller silva sontos, carine marianne melo araujo, marina raphe mattarleonardo cardoso bringel de olinda, daniel santos costa, diego lucena joao antonio correa, department of vascular surgery, faculdade de medicina do abc, santo andre, brazil/rede d¿or - hospital brazil, santo andre, brazil on iset conference: international symposium on endovascular therapy (iset) 2018 february 3 - 7, 2018 - is attached to the medwatch report.The date of presentation was used as the date of incident.

Event Description

Within the poster ¿effects of viabahn® stent on segmental patency with peripheral obstructive arterial disease: a retrospective study¿, presented by sidnei jose galego, keller silva sontos, carine marianne melo araujo, marina raphe mattarleonardo cardoso bringel de olinda, daniel santos costa, diego lucena joao antonio correa, department of vascular surgery, faculdade de medicina do abc, santo andre, brazil/rede d¿or - hospital brazil, santo andre, brazil on iset conference: international symposium on endovascular therapy (iset) 2018 february 3 - 7, 2018 , the published results indicated the following: the aim of this study was to describe the patency of the femoral-popliteal segments up to 24 months after endovascular treatment using the gore® viabahn® endoprostheses with heparin bioactive surface.All sixty nine (69) patients were treated with gore® viabahn® endoprostheses with heparin bioactive surface between 2012 and 2017 (5 years) with device lengths ranging from 5 to 25cm.The majority of patients had ischemic symptoms.These vessel occlusion cases were treated by means of (12) mechanical devices and fibrinolytic agents.About 50% had long occlusion of the femoral artery.The majority of the gore® viabahn® endoprostheses with heparin bioactive surface devices were 15 cm in length.Technical success was achieved in the limbs of 68 patients.It was reported that 1 limb was lost due to occlusion with an ischemic infection lesion 30 days after procedure.Stent graft patency was estimated by kaplan-meyer curve 93% in the first 6 months, 86% at 12 months, 81.0% 84% at 2 years after placement.A 94% limb salvage rate was achieved (65) during 2 year follow-up.The cause of infection is unknown.

Manufacturer Narrative

This report is being sent as a retraction to the initial report.Due to the investigation and information provided from the hospital, it was recognized that the infection was caused by the trophic lesion in the extremity and not related with the gore® viabahn® endoprosthesis with heparin bioactive surface.As there is no allegation against the gore® viabahn® endoprosthesis, this event is not reportable as a serious injury.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7273564
• MDR Text Key: 100176585
• Report Number: 2017233-2018-00103
• 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,litera
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention