MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problems Material Puncture/Hole (1504); Unexpected Therapeutic Results (1631)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  Injury  

Event Description

The following information was reported to gore: on an unknown date, in (b)(6) 2022, a gore® acuseal vascular graft was implanted for arteriovenous access.It was reported the patient initiated dialysis a day after the device was implanted.On (b)(6) 2022, the patient presented with outflow stenosis and thrombus accumulation at both venous and arterial ends of the graft.It was reported during angiographic evaluation, contrast was observed exiting through multiple cannulation needle holes in the center of the graft.The physician decided to abandon the graft and implant another vascular graft.The gore® acuseal vascular graft remains implanted.The patient tolerated the procedure.

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

Added g3/g4: pma/510(k)number.Added h1/h2 and h6.Additional 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.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14356782
• MDR Text Key: 291405068
• Report Number: 2017233-2022-02916
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• 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