MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Migration (4003)

Patient Problems Edema (1820); No Code Available (3191)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).All patients had esrd, arteriovenous fistula and symptomatic occlusion of the cephalic arch or subclavian vein.Hypertension = 100% of patients.5/9 had diabetes mellitus.Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.

Event Description

The following article was reviewed: ¿percutaneous costoclavicular bypass for thoracic outlet syndrome and cephalic arch occlusion in hemodialysis patients¿; jeffery hull, m.D.And james snyder, m.D.A retrospective review of percutaneous costoclavicular bypass patients between november 2014 ¿ december 2017 was performed.Stent grafts were placed subcutaneously over the clavicle from the fistula outflow (axillary or cephalic vein) into a jugular vein or collateral.The fistula outflow was cephalic in 67% (6/9) and axillary in 33% (3/9).The return vessel was external jugular in 78% (7/9) and internal jugular in 22% (2/9).Two overlapping viabahn stent grafts were used in 88% of cases (7/8) and 3 stent grafts in 1 case.At 12 months and 24 months, primary patency was 67% and 67%, and secondary patency was 89% and 78%, respectively.Complications included late thrombosis, secondary infection and stent migration.There were no anastomotic leaks or seromas associated with extravascular stent grafts.One patient demonstrated stent migration at the fistula after resolution of severe arm swelling.The migrating was treated with overlapping stent graft extension.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick la fave ; 9285263030
• MDR Report Key: 9844997
• MDR Text Key: 193940189
• Report Number: 2017233-2020-00195
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR