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

Catalog Number ECH060020W

Device Problems Partial Blockage (1065); Peeled/Delaminated (1454)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2, a3 and a4: patient age, gender, and weight is not available.C1: heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: device remains implanted and was not returned for evaluation.H6: c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.C21 - the imaging was returned and is under evaluation.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 was reported to gore: a patient was implanted with an acuseal vascular graft (vg) to create avg on (b)(6) 2023.On (b)(6) 2023, it was found thrombosis.On (b)(6) 2023, it was found thrombosis again after one session was punctured for dialysis treatment.It was noted that the delamination site was located near the axilla and was continuous to the vein-graft anastomosis.The delamination site had been dilated with prolonged balloon.

Manufacturer Narrative

Update h6, investigation conclusions - d16: engineering evaluation: the identity of the device was provided and is consistent with the device described in the case.The case description could not be confirmed, as no abnormalities were found in the dhr, and the provided images were not sufficient for evaluation.The reported failure modes reflect the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.

Manufacturer Narrative

Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.In the instruction for use for the gore® acuseal vascular graft the following is stated: warnings: when using the gore® acuseal vascular graft, avoid using traumatic instruments, handling the graft with excessive force or high rates of force, cutting the graft incorrectly, or placing the graft in an undersized tissue tunnel.These actions may lead to separation of graft layers.Potential consequences include partial or complete occlusion due to hemodynamically significant stenosis or thrombosis and related serious harms, including additional interventions to resolve.When cannulating gore® acuseal vascular graft puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may result in damage of the graft material that can lead to pain at the cannulation site, partial or complete occlusion, serious blood loss, pseudoaneurysm or additional interventions to resolve.Adverse events: potential device and procedure-related adverse events: complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: partial or complete occlusion due to hemodynamically significant stenosis or thrombosis; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; mechanical damage or tearing of the suture line, graft, and/or host vessel.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17786582
• MDR Text Key: 323894163
• Report Number: 2017233-2023-04291
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH060020W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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