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

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2023

Event Type  Injury  

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.(b)(4).The vascular graft likely remain implanted as article did not mention explant.Further details were requested from author, but none was made available.Therefore, further investigation was not possible.Publication reviewed: delamination in acuseal.Journal of japanese society for dialysis therapy 2022: 55(suppl.1) p.457.See mfr report # 2017233-2022-03549 for case 1 patient mentioned in same article.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: title: delamination in acuseal.Journal of japanese society for dialysis therapy 2022: 55(suppl.1) p.457.Abstract reported two case of acuseal in which delamination occurred.The vascular grafts were implanted for arteriovenous access.For case 1, a delamination at the site of anastomosis with a pre-existing graft (unknown manufacturer) was suspected on the ultrasound imaging.There was no blood flow obstruction, but a false lumen was formed.A percutaneous transluminal angioplasty (pta) was performed, and improvement was observed in the true lumen.Further information was requested but not provided.

Manufacturer Narrative

H6 - code f1205: a percutaneous transluminal angioplasty (pta) was performed, and improvement was observed in the true lumen.H6 - code e0519 was added.

Manufacturer Narrative

An engineering evaluation was performed: the identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The case description could not be confirmed, as no identity or images of the device were provided for evaluation.The reported failure mode reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.B1: both fields were checked.

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 7 january 2023.Case 1: a patient with esrd on hemodialysis had multiple graft infections and graft replacements.The patient presented with thrombosis a year after implant of a 6mm gore® acuseal vascular graft (avg) in the left upper arm.Percutaneous thrombectomy and balloon angioplasty were performed, and the blood flow was restored.One month later, an ultrasound examination detected delamination in the avg segment.The delamination was located at both the anterior and posterior walls of the non-cannulation needling site.The elastomeric middle layer appeared to be separated from the outer expanded polytetrafluoroethylene (eptfe) layer.Vascular access (va) function was maintained and the avg continued to be used for hemodialysis.Follow-up ultrasound examination one month later demonstrated va flow reduction with venous stenosis of the axilla and venous anastomosis.Findings of the avg delamination segment were identical to the first detected delamination.Percutaneous transluminal angioplasty (pta) was performed, and va function was restored.The delaminated avg was dilated by balloon angioplasty at the same time, without improvement after the pta.Surprisingly, a follow-up ultrasound examination one month after the pta showed natural improvement of the true lumen of the avg.This state was maintained for five months without any need for therapeutic intervention.The patient was admitted to an outside facility and died due to another disease; therefore, the follow-up surveillance was terminated.For case 1, it is believed the pta was strongly linked to the avg delamination because pta was performed against graft occlusion 1 month before delamination was detected.Balloon angioplasty might separate each layer, resulting in delamination.Also, it is suspected luminal eptfe damage resulting from mis-needling the posterior wall may lead to graft delamination; therefore, careful needling techniques may aid in preventing avg delamination.

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 7 january 2023.H6 - code b15: engineering evaluation of images provided within article: the identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The provided images of the device were not sufficient for evaluation.The evaluation found no anomalies attributable to the manufacture of the device.H6 - code d12: ifu 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.A1, a2, a3: updated with patient information obtained from article.B3: date of event was updated based on article (date accepted) b5: event description was updated based on article information.B7: updated with patient medical history obtained from article.

• 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: 15927582
• MDR Text Key: 304952025
• Report Number: 2017233-2022-03550
• 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: 01/04/2023
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Female