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

Device Problem Material Deformation (2976)

Patient Problem Occlusion (1984)

Event Date 01/02/2021

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: in an article titled "endovascular treatment of arteriovenous graft dysfunction as a result of graft delamination and fracture" it states the following: background: graft thrombosis due to fabric delamination is a rare cause of delayed failure of arteriovenous grafts.Graft delamination is primarily an imaging diagnosis and is confirmed with the help of ultrasound which shows the separation of graft fabric layers.Only two such cases have been described in the literature so far.Case presentation: we present a case of upper extremity arteriovenous graft thrombosis in a (b)(6) year old covid-19 positive patient with end-stage renal disease.The diagnosis was established on ultrasonography which revealed separation of the graft fabric layers with thrombosis within the "false" and "true" lumen of the graft.The patient was managed with angioplasty and embolectomy of the clot material followed by stent-graft placement across the delaminated portion of the graft.Post-procedural angiography confirmed brisk flow across the graft and patient could successfully have subsequent hemodialysis sessions.Conclusions: identification of graft delamination as a cause of graft failure is important as its management differs from other conventional causes since it requires stent-grafts to cover the area of delamination to re-establish flow and salvage the av graft.The recognition of this phenomenon is essential to provide quality care and successful reuse of the av graft.

Manufacturer Narrative

Literature citation: chaurasia, a., et al.2021.Endovascular treatment of arteriovenous graft dysfunction as a result of graft delamination and fracture.Cvir endovascular 4:1-4.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11155992
• MDR Text Key: 226316914
• Report Number: 2017233-2021-01594
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female