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

Catalog Number ECH060040J

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Title: short- to midterm results of early cannulation arteriovenous grafts (gore acuseal) for hemodialysis: experience with the acuseal in a japanese cohort source: the journal of vascular access, 2020.Author: kenichi honma.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.

Event Description

The following publication was reviewed: title: short- to midterm results of early cannulation arteriovenous grafts (gore acuseal) for hemodialysis: experience with the acuseal in a japanese cohort source: the journal of vascular access, 2020 background: in patients without suitable vasculature for autologous arteriovenous fistula, vascular access using a prosthetic graft is an option for hemodialysis.Gore® acuseal vascular graft is an early cannulation arteriovenous graft (avg) that allows early puncture within 24 h after surgery.We aimed to report the outcomes of using this graft in patients from a single center.Methods: this study included 113 patients who underwent surgery for a new avg using acuseal, between december 2015 and december 2017, and were followed up.Acuseal 6mm×40cm was used as the graft for all patients.The primary outcomes were primary patency, assistedprimary patency, and secondary patency.Secondary outcomes were postoperative complications such as graft infection and steal syndrome.Results: of the 113 patients, 60 were male and 53 were female.The average age was 74.4±10.7 years.We could cannulate 69.1% of patients within 24 h.The average follow-up period was 20.1±10.8months.The primary patency rates after 3months, 6months, and 1 year were 76.2%, 60.4%, and 33.8%, respectively.The assisted-primary patency rates after 3months, 6months, and 1year were 88.8%, 73.2%, and 58.9%, respectively.The secondary patency rates after 3months, 6months, and 1year were 100%, 100%, and 98.8%, respectively.Postoperative complications: -graft infection 14 (12.4%) early infection (within 30days after surgery) 3 (2.7%) late infection (more than 30days after surgery) 11 (9.7%) -steal syndrome 2 (1.8%) -early occlusion due to technical failure 1 (0.9%) one patient developed occlusion the next day, due to suturing of the venous valve in the venous anastomosis.-death 34 (30.1%) pneumonia in six, sepsis in five, heart failure in three, cancer in two, gastrointestinal bleeding and leg gangrene in two each, and acute myocardial infarction, ruptured internal iliac artery aneurysm, and multiple organ failure in one patient each.Three patients died within 30days after surgery.The first patient died of sepsis 5days after surgery.The second patient died of acute myocardial infarction 11 days after surgery.The third patient died of a ruptured internal iliac artery aneurysm 26days after surgery.No patients developed major adverse cardiovascular events within 30days after surgery other than the patient who died of acute myocardial infarction.The overall 1-year and 2-year survival rates were 81.4% and 72.3%, respectively conclusion: in our study, acuseal showed satisfactory patency and acceptable complication rates in the short to medium term, similar to previous studies.Acuseal is beneficial for surgeons who are familiar with using avg and for medical staff who control bleeding after dialysis.However, due to the large outer diameter of the graft, surgical wounds might become dehiscent, and careful designing of the subcutaneous graft route is necessary.It might be possible to reduce the rate of graft infection by planning the site and skin incision.

• 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 WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15514937
• MDR Text Key: 300893981
• Report Number: 2017233-2022-03367
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR