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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2019

Event Type  Injury  

Event Description

The following abstract was reviewed: "o-165 immediate access arteriovenous grafts decrease catheter days and complications" ellen dillavou et al.European journal of vascular and endovascular surgery volume 58, issue 6, supplement 2, december 2019.Introduction - immediate-access arteriovenous grafts (iaavg) can be used as peripheral access or in combination with outflow through the hemodialysis reliable outflow (hero) graft.This study compares iaavg to standard arteriovenous grafts (savg) as well as describing iaavg use with hero outflow.Methods - all patients who underwent placement of av graft from 1/2014 - 4/2016 at two large tertiary referral centers were retrospectively identified in the electronic medical record and through the vascular quality initiative (vqi).Patient comorbidities, graft configuration, operative characteristics and subsequent follow-up were collected and analyzed with respect to primary patency, primary assisted patency, and secondary patency.Results - 254 grafts were identified; 148 savg, 62 iaavg (50 of which are gore® acuseal vascular graft), 44 combined iaavg-hero.Patient characteristics were similar between groups, except for more pre-operative central venous occlusions in the iaavg vs savg (16.3% vs 6.8%, p<0.04) and these vs iaavg/hero (100%, p<.001).Of the iaavg group, 50 were gore® acuseal vascular graft and 12 were flixene (atrium).Iaavg/her0 patients all used gore® acuseal vascular graft.Standard avg were all gore-tex® vascular graft.There was no difference in graft infection (19.0% savg vs.12.0% iaavg, p=0.276).Conclusion - infection rates were similar between savg and iaavg, but with fewer secondary procedures performed in iaavg.The abstract notes an allegation of infection with reintervention involving the subset of patients iaavg using gore® acuseal vascular graft.Again, 50 of the 62 iaavg patients were implanted with gore® acuseal vascular graft, however, it is unknown which or how many device(s) that were infected required reintervention.

Manufacturer Narrative

Corrected data: h6.- conclusions code 1.Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Manufacturer Narrative

Additional manufacturing narrative: additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #unk.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10094668
• MDR Text Key: 197832844
• Report Number: 2017233-2020-00390
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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; Required Intervention