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 Thrombosis/Thrombus (4440)

Event Date 07/20/2020

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 article was reviewed: hans ss, lee mm, jain n.Ureteral stenosis following iliac artery stenting.J vasc surg cases innov tech.2020 jul 20;6(3):469-472.Doi: 10.1016/j.Jvscit.2020.07.012.Pmid: 32923750; pmcid: pmc7475513.In (b)(6) of 2012, a patient presented with complete occlusion of the left common iliac artery and underwent treatment utilizing a gore® viabahn® endoprosthesis.The viabahn device was successfully implanted in the common iliac artery, but arteriography showed a filling defect noted to be probable thrombus or atheromatous plaque within the stent graft.The physicians attempted to resolve the thrombus with an infusion catheter, but ultimately a left iliac thrombectomy via left femoral artery cutdown had to be performed.An organized plaque with thrombus was retrieved and the patient tolerated the procedure.In (b)(6) of 2013, the patient returned with intermittent claudication and a decrease in abi.Angiography revealed an in-stent stenosis in the left external iliac artery.An absolute pro stent was placed within the previously implanted viabahn stent as treatment.In (b)(6) of 2017, the patient underwent successful balloon angioplasty for left iliac in-stent stenosis.In (b)(6) of 2019, a ct urogram showed moderate left ureterohydronephrosis in close proximity to the left common iliac artery stent.Operative findings included dense scar tissue forming an inflammatory rind around the ureter which was adherent to the left common iliac artery.The patient underwent treatment and tolerated the procedure.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12384024
• MDR Text Key: 268675332
• Report Number: 2017233-2021-02316
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR