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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/22/2020

Event Type  Injury  

Event Description

Within the article ¿application and implications of a standardized reporting system for arteriovenous access graft infection¿ published by david kingsmore et al in the journal of vascular access, volume 23(3), received on 22 september 2020.The following was published: a key factor in the debate regarding the optimal modality for provision of haemodialysis is the perceived rate of infection in arteriovenous grafts (avg).Whilst it is recognized that the long-term patency outcomes can match those of an arteriovenous fistula (avf) though requiring repeated interventions to maintain patency, there is a perception that avg have a high risk of infection.Whilst the concerns regarding patency have been previously considered in other reviews, contemporary data on avg infection in newer devices such as early-cannulation avg has been limited.The aim of this article is to use this proposed classification of avg infection to report the frequency, management and long-term outcomes of avg infection in a consecutive case series of 277 early-cannulation avg (ecavg) with long-term follow-up.A single-center prospectively-maintained electronic database was used to identify a consecutive cohort of patients with a prosthetic arteriovenous graft.Of 320 who had an avg, 277 had an early-cannulation eptfe grafts (ecavg) placed in the 9-year period between january 2012 and december 2019.In all cases, a non-tapered 6 mm eptfe gore® acuseal vascular graft was implanted by a single operating team (dbk/ks/aj).Additional data was extracted including baseline demographics, laboratory data, haemodialysis data, complications and outcomes.There were 51 infections (avgi) in 45 ecavg in 43 patients (two patients had two separate ecavg, one ecavg experienced three infections, and four ecavg experienced two infections) giving a crude incidence of infection in an ecavg of 16.3% (45/276).The rate of avgi varied by time of ecavg use, with ½ of all infections occurring by 215 days (figure 1).Primary avgi occurred in nine patients and accounted for 18% of all episodes of avgi (9/51).Secondary avgi occurred 33 times and accounted for 65% of all avgi (33/51).One patient had an avg that was removed for systemic fungaemia, although subsequent graft culture failed to demonstrate the ecavg as the source for this the clinical impact of avgi was considered as either failure (vascular access loss due to infection) or not (vascular access not required ¿ tertiary infections; not lost ¿ successful graft preservation; or expedited previously planned conversion to alternative modality such an avf from arterialised outflow that was used immediately).Access failure occurred in 25/51 (49%) episodes of avgi.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided additional information in regard to the event and images of the case were requested from the physician.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Attachment update.

Manufacturer Narrative

Manufacturing site update.

Manufacturer Narrative

H6: corrected imdrf codes.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15595111
• MDR Text Key: 301661990
• Report Number: 3007284313-2022-02158
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male