MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number ECH060040J

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

Patient Problem Stenosis (2263)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following information was reported to gore: around 2016, this patient underwent an implantation of a gore® acuseal vascular graft in the upper arm-forearm as arteriovenous graft shunt for hemodialysis due to renal failure.On an unknown date, puncture sites of the acuseal graft were found to be delaminated and graft stenosis was also noted.Although pta ballooning was performed to resolve the graft stenosis, blood flow entered the space between the delaminated layer and the graft wall.Therefore, it could not be resolved.On (b)(6) 2021, a partial replacement of the graft was performed at the reporting clinic.The delaminated part was removed and 6 mm of acuseal graft was newly placed.The patient tolerated the procedure.The reporting physician commented as follows: the graft delamination occurred in the puncture sites; therefore, it was probably due to aging deterioration of the graft.There is no unfavorable impression of acuseal graft.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12266267
• MDR Text Key: 264707390
• Report Number: 2017233-2021-02213
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other