MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 09/06/2020

Event Type  Injury  

Manufacturer Narrative

Cbas(r) heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.No lot number information was supplied; therefore, no review of the manufacturing records could be reviewed.The device remains implanted.Therefore, direct product analysis was not possible.Medwatch report #2017233-2020-01316 was previously submitted, related to same patient for ongoing vascular access events.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient with diabetic nephropathy and history of occlusive vascular access presented again with occlusion of the vascular access.Restenosis of the arterial anastomosis and stenosis at the proximal end of a previously implanted gore(r) viabahn(r) endoprosthesis with heparin bioactive surface (viabahn device was confirmed.Surgical thrombectomy and ballooning were performed.Significant recoil was observed at the proximal end of the endoprosthesis, requiring an additional viabahn device to be implanted.The occlusion was resolved, and the patient tolerated the procedure.On (b)(6) 2020, the patient presented again with vascular access occlusion and the patient was hospitalized.Occlusion and restenosis at the proximal end of the viabahn devices were confirmed.Surgical thrombectomy was performed, and a jump graft was placed to proximal artery over the arterial anastomosis.Percutaneous transluminal angioplasty (pta) was also done at the proximal end of the viabahn device.The occlusion was resolved, and the patient tolerated the procedure.On (b)(6) 2020, the vascular access was occluded again.The patient refused to have the vascular access recanalized.Consequently, dialysis was performed via a catheter.The cause of the occlusion and relationship of the event to the device/procedure was reportedly unknown as the access was not recanalized.It is unknown if the viabahn devices were also occluded.On (b)(6) 2020, a permanent dialysis catheter was implanted from the right side of neck.It was also noted that on (b)(6) 2020, the patient was transferred to this hospital and was hospitalized because of infection of the residual graft.Information was requested but not made available at this time.

Manufacturer Narrative

Revised : g3/g4- pma/510(k)number.Added: h6 health effect - impact code and component code.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11057099
• MDR Text Key: 223191277
• Report Number: 2017233-2020-01555
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• 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
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 61 KG