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

Catalog Number ECH060040W

Device Problem Peeled/Delaminated (1454)

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lots met all pre-release specifications.The image(s) received cannot be used to perform an imaging evaluation due to acuseal graft not being a device that gis evaluates.The identity of the device was provided; no abnormalities were found in the associated dhr.The case description could not be confirmed from the images provided for evaluation.The reported failure modes reflect the case description, but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.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 was reported to gore: on (b)(6) 2021, a patient was implanted with a gore® acuseal vascular graft to treat arteriovenous graft (avg).The graft anastomosis was brachial artery and median cubital vein.On (b)(6) 2021, the patient was examined with b-ultrasound.It was found there were delamination and dissections at vascular graft in the area of arteriovenous puncture and vein segment passing through the elbow joint, which resulted in thrombosis.It was also found vcuseal vascular graft silica gel layer delamination.Therefore, the vascular graft was removed and another vascular graft (maquet) was used to complete the procedure on (b)(6) 2021.The patient tolerated the procedure.Physician suspected that the dissection/thrombosis/device delamination might be caused by two issues, one was that the tunneler (u type) used during initial procedure was not appropriate, the other was that the limitation of puncture operation during hemodialysis as the patient had kidney disease.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12766843
• MDR Text Key: 280450014
• Report Number: 2017233-2021-02520
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: ECH060040W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/08/2021
• Date Device Manufactured: 04/13/2020
• 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): Required Intervention
• Patient Age: 58
• Patient Sex: Female