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  malfunction  

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.Patient 4: a 77-year-old male had been on regular hemodialysis for 4 months.His radio-cephalic avf on left wrist became occluded, and a graft bypass (6.0 mm acuseal; design, straight; inflow, cephalic vein on wrist; outflow, basilic vein on upper arm) was performed.Ultrasound examination was performed every 3 months.Fifteen months after the procedure, delamination of the anterior wall of the non-puncture site (the elbow) was detected by ultrasound.It was observed without intervention for 5 months until his death.

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.

• 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: 14861913
• MDR Text Key: 295350935
• Report Number: 2017233-2022-03072
• 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?: No
• 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 Age: 77 YR
• Patient Sex: Male