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

Device Problem Material Separation (1562)

Patient Problem Stenosis (2263)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.The instructions for use state: the gore® acuseal vascular graft can be cannulated early (within 24 hours after implantation).Patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 publishment was reviewed by gore: title: delamination of acuseal early cannulation arteriovenous graft months after implantation.Source: j vasc access.2021 sep;22(5):840-844, corresponding author: kotaro suemitsu.Abstract: arteriovenous fistula is recommended, but arteriovenous graft is acceptable when a fistula is not possible.Acuseal is an early cannulation graft with a trilayer structure.Although primary patency rates of acuseal appear to be similar to those of other standard grafts, few studies have investigated long-term results and complications.In our series, delamination of the wall structure occurred in 5.1% (6/115) by 21 months after acuseal implantation.The causes could be divided into cannulation-related and cannulation-unrelated.Here, we describe the six cases in which delamination of the wall structure occurred in the medium term after acuseal implantation.Case: patient 1: a 43-year-old female had been on regular hemodialysis for 27 years.A 6.0 mm acuseal (loop graft; inflow, proximal radial artery; outflow, basilic vein) was implanted in her right forearm.Ultrasound examination was performed every 3 months.The postoperative course was uneventful for 2 years.Although delamination of the posterior wall of the venous puncture site was detected by ultrasound, intervention was not performed because graft flow was maintained.Three weeks after detection, however, the avg was suddenly occluded.The avg was perfused after thrombolysis with urokinase, and the delamination was treated with a stent (smart 6.0 mm ¬ 80 mm; cordis, usa).(captured by psts# (b)(6)).In addition, delamination of the anterior wall of the arterial puncture site occurred with pseudoaneurysm 3 months later.This delamination was also treated with a stent (epic 6.0 mm ¬ 80 mm; boston scientific, usa).The post-procedure course has been uneventful.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14863107
• MDR Text Key: 295108965
• Report Number: 2017233-2022-03073
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female