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

Device Problem Peeled/Delaminated (1454)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2023

Event Type  malfunction  

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.Patient dob, weight, medical history and medication information was requested but not made available.(b)(4).Publication reviewed: delamination in acuseal.Journal of japanese society for dialysis therapy 2022: 55(suppl.1) p.457 instructions for use for gore® acuseal vascular graft - vascular access procedures 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.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: delamination in acuseal.Journal of japanese society for dialysis therapy 2022: 55(suppl.1) p.457 case report of gore® acuseal vascular graft implanted for arteriovenous access, and delamination occurred.For this case, a delamination in the posterior puncture site was suspected on the ultrasound imaging.There was no blood flow obstruction.It is unknown if a reintervention was performed.Reportedly, the delamination might have been caused by needle punctures into the vascular graft.Further information was requested but not made available.

Manufacturer Narrative

B1: updated to serious injury and malfunction.H6 - code e2402: graft delamination due to needle punctures not adequately separated.Image evaluation was conducted based on images from article: the device was not returned to w.L.Gore & associates.Submitted in this case was a journal article, ultrasound and intraoperative images of the reported device for case 2.In photos (e) and (f) in figure 1 below, there appears to be a gore® acuseal vascular graft with delamination of the innermost and silicone layers; however, the images are not sufficient to accurately determine the cause of delamination.The identity of the device was not provided; therefore, the device history record (dhr) could not be examined to identify any potential root causes attributable to the manufacture of the device.The condition of the device in the images is consistent with the case description.The reported failure mode is consistent with the condition of the device in the images provided.The evaluation found no anomalies attributable to the manufacture of the device.Instructions for use for gore® acuseal vascular graft: vascular access procedures: 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.Potential device or 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: infection; mechanical damage or tearing of the suture line, graft, and/or host vessel.A1, a2, a3: updated patient information obtained from the full article.B5: event description was revised, based on information from full article.B7: patient history was added based on information from full article.

Event Description

Article reviewed: delamination of acuseal arteriovenous graft: two case reports.Authors masashi munemoto, sukemasa mukai, shigeichi shoji and tomoyuki yamakawa.The journal of vascular access, date accepted (b)(6) 2023.Case 2 is a 49-year-old female with esrd had an arteriovenous graft in her left forearm for hemodialysis.After four years, the patient underwent partial replacement with a 6mm gore® acuseal vascular graft (avg) due to a graft infection of the previously implanted graft (unknown manufacturer).Ultrasound examinations were done every few months post-operatively with no abnormal findings.However, 21 months after the avg implantation, delamination was detected in the avg segment.The delamination was located at the posterior wall of the cannulation needling site.The luminal eptfe layer appeared to be separated from the elastomeric middle layer.Vascular access (va) was maintained, so use of the avg was continued for hemodialysis.Half a year later, the dissected avg component was excised owing to graft infection.A piercing hole at the posterior wall of the outer eptfe layer was confirmed, and the luminal eptfe had a hole at the point corresponding to this outer eptfe damage.This finding suggested that luminal eptfe damage resulting from mis-needling the posterior wall caused graft delamination.In case 2, we inferred that cannulation needling was a trigger.Intraoperative findings showed delamination and a piercing hole in the posterior wall of the outer eptfe layer at a place corresponding to the cannulation needling site.

Manufacturer Narrative

Article citation: delamination of acuseal arteriovenous graft: two case reports.Authors masashi munemoto, sukemasa mukai, shigeichi shoji and tomoyuki yamakawa.The journal of vascular access, date accepted (b)(6) 2023.B3: date of event was updated with 'article date accepted'.

Manufacturer Narrative

B1 and h1: correction made (product malfunction only) h6 - code e2402 and f28: primary reason for intervention (graft explant) was due to graft infection.The explant was not due to the suspected delamination.This type of complaint is not considered reportable as the vascular graft was utilized for dialysis and cannulated over several months after the implant procedure.Therefore, this report is changed to product malfunction.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15928326
• MDR Text Key: 306913534
• Report Number: 2017233-2022-03549
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: 10/25/2023
• 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: 49 YR
• Patient Sex: Female