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 Problem Vascular Dissection (3160)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Patient weight information was not made available.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 during a arteriovenous graft (avg) procedure.The graft anastomosis was brachial artery and median cubital vein.During the postoperative follow-up on (b)(6) 2021, it was found there was dissection at anastomotic site of graft in the area of arteriovenous puncture and vein segment passing through the elbow joint, which led to thrombosis.It was also found vcuseal vascular graft silica gel layer delamination at same area.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 puncture operation may hurt vascular graft during hemodialysis as the patient had kidney disease.The vcuseal vascular graft was removed and another non-gore vascular graft (maquet) was used to complete the procedure on (b)(6) 2021.The patient tolerated procedure.

Manufacturer Narrative

A review of the manufacturing records, indicated the lots met all pre-release specifications.Due to no device and no imaging return, an evaluation could not be performed.

Manufacturer Narrative

H6: add component code.B5: describe event or problem - correction of the wording from "vcuseal" to "acuseal".

Event Description

The following was reported to gore: on (b)(6) 2021, a patient was implanted with a gore® acuseal vascular graft during a arteriovenous graft (avg) procedure.The graft anastomosis was brachial artery and median cubital vein.During the postoperative follow-up on (b)(6) 2021, it was found there was dissection at anastomotic site of graft in the area of arteriovenous puncture and vein segment passing through the elbow joint, which led to thrombosis.It was also found acuseal vascular graft silica gel layer delamination at same area.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 puncture operation may hurt vascular graft during hemodialysis as the patient had kidney disease.The acuseal vascular graft was removed and another non-gore vascular graft (maquet) was used to complete the procedure on (b)(6) 2021.The patient tolerated 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12695048
• MDR Text Key: 278824439
• Report Number: 2017233-2021-02489
• 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,Followup,Followup
• Report Date: 12/13/2021

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: 03/30/2023
• 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: 10/26/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 10/14/2021
• Supplement Dates FDA Received: 11/24/2021; 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male