MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number JHJR071002J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 06/01/2019

Event Type  Injury  

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.

Event Description

The following information was reported: this patient is a man in his (b)(6).On an unknown date, the patient fell during snowboarding.Three days later, swelling and pain in the right shoulder got worse, and the patient was referred to the hospital.Computed tomography angiography (cta) was performed, and pseudoaneurysm and arteriovenous fistula in the distal portion of the right axillary artery was suspected.The patient was in poor general condition due to bleeding, and had disseminated intravascular coagulation (dic), so it was elected to utilize gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).A micro guidewire was inserted from the right upper arm and a snare system was inserted from the right common iliac artery to apply pull-through technique.The viabahn device was implanted in the target lesion with no reported issue.Three days after the procedure, cta confirmed that the pseudoaneurysm and the arteriovenous fistula were disappeared.The patient discharged from the hospital seven days after the procedure.After the procedure, the patient was monitored with dual antiplatelet therapy (dapt).Four months after the procedure, computed tomography showed a middle stenosis around proximal portion of the viabahn device and mild stenosis located distal to the first stenosis region.However, at that time, contrast effect remained in its distal area.(reported previously under mfr report # 2017233-2019-01082) two years after the procedure, the patient underwent a re-intervention using a cutting balloon (6 mm/2 cm) and a non-compliant high pressure balloon (7 mm/4 cm) for the stenosis.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12177671
• MDR Text Key: 263374037
• Report Number: 2017233-2021-02175
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2021

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 Catalogue Number: JHJR071002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention