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

Catalog Number ECH050050J

Device Problem Peeled/Delaminated (1454)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/16/2021

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: on (b)(6) 2021, the patient was implanted with a gore® acuseal vascular graft as an av shunt for hemodialysis.Acuseal was implanted in the radial artery-ulnar brachial vein as a straight shape.On (b)(6) 2021, an increase in venous pressure was observed.As a treatment, pta (percutaneous transluminal angioplasty) was performed.Angiography showed a stenosis at the graft outflow tract.During the intervention, a contrast defect (suspected graft delamination) was observed in the graft.The suspected delamination site was located at the puncture site of the dialysis and the potential delamination was about 2-3 cm in length.Ballooning was performed and the reintervention was completed.On (b)(6) 2021, the patient's venous pressure was still high and shunt sound could not be confirmed.Reintervention was performed and the graft intima was removed with a fogarty catheter to treat the suspected delamination.Aside from removal of the intima, the entire original graft remains in the patient.It was confirmed that the shunt sound was improved.The patient tolerated the procedure.

• 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: 12561602
• MDR Text Key: 278323927
• Report Number: 2017233-2021-02426
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: ECH050050J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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): Hospitalization; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 52 KG