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

Catalog Number 10MM X 15CM

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Skin Erosion (2075); Skin Infection (4544)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Publication reviewed: percutaneous extra-anatomic costoclavicular venous bypass with delayed stent graft erosions.Percutaneous extra-anatomic costoclavicular bypass was performed for hemodialysis patients with symptomatic thoracic inlet venous occlusions who had failed recanalization techniques.The intervention involves connecting the dialysis access outflow to a central thoracic vein using gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn stent grafts) via a subcutaneous tunnel.The technical success and short-term clinical success was 100%.This report describes two patients with external stent graft erosion through the tissue and skin after undergoing percutaneous extra-anatomic costoclavicular bypass.Patient one (1) is a 45-year-old female (body mass index 20.5 kg/m2), who underwent bilateral mastectomy and chemoradiation for left breast carcinoma three years ago.She presented with a left axillary recurrence complicated by left upper-extremity swelling.Computed tomographic venography showed an axillo-subclavian vein occlusion peripheral to the thoracic inlet.Upper-extremity vein involvement and a potential compression of stent reconstruction at the thoracic outlet necessitated costoclavicular bypass.There were no prior recanalization attempts.The patient underwent bypass creation, joining the left brachial and internal jugular veins using overlapping 10 mm × 15cm, 10mm × 10cm, and 10 mm × 10 cm viabahn stent grafts, with no immediate adverse events.Access sites were closed using resorbable 2-0 sutures and skin glue.The patient was started on 81 mg of aspirin daily and 1 mg/kg of enoxaparin twice daily.The left upper-extremity swelling improved within 48 hours.On day 40 post implant, the patient presented with erythema, pain, and purulence on the left lower portion of the neck.Chest ct revealed a 2-cm dehiscence of the dermatotomy on the left side of the neck with an exposed stent graft.Staphylococcus aureus cellulitis was treated with vancomycin and piperacillin-tazobactam and later cefazolin for two weeks.This was then transitioned to 100 mg of doxycycline twice daily.On day 78 after the procedure, fasciocutaneous flap closure was performed from the supraclavicular, platysma, and pectoralis minor donor site to the area of the exposed stent graft.Follow-up evaluation on day 101 after the procedure showed complete healing of the flap.Follow-up duplex ultrasound on day 232 after the procedure showed patency of the bypass graft.The pathophysiology of graft-related skin erosion remains uncertain.However, patient activity and resultant kinetic forces, the anatomic course of the bypass tunnel, graft length and diameter, or closure site stresses may be contributors.A deeper subcutaneous tunnel, >2 cm below the skin surface, may induce less stress on the bypass construct, decreasing susceptibility to kinetic forces due to shoulder movement.Shorter-length and smaller-diameter stent grafts may reduce stretching and skin erosion.Adverse events may be mitigated by patient selection, deeper subcutaneous placement, smaller stent grafts, reinforced dermatotomy closure, and close surveillance.

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Patient dob and weight; relevant medical information was requested from author.No information, including device lot/serial numbers, were made available.Per article, device(s) remains implanted; therefore, direct product analysis was not possible.(b)(4).Article: percutaneous extra-anatomic costoclavicular venous bypass with delayed stent graft erosions.Authors: f bertino md, ds shin md, cr ingraham md, ss vaidya md, mh meissner md, jfb chick md.Journal of vascular and interventional radiology, vol 32 issue 7, july 2021.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 15236863
• MDR Text Key: 298025805
• Report Number: 2017233-2022-03217
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130006
• 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
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10MM X 15CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female