MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Partial Blockage (1065)

Patient Problems Occlusion (1984); 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 in the initial case, 2 gore hybrid grafts were used.Stent graft diameter ranged from 9mm to 13mm.Mean follow-up was 852 ± 339 days(range, 488-1483 days).At 12 months and 24 months, primary patency was 67% and 67%, and secondary patency was 89% and 78%, respectively.The initial costoclavicular bypass was performed in a patient unable to undergo general anesthesia.The costoclavicular bypass was created with two 9-mm gore hybrid vascular grafts.Through a percutaneous access in the external jugular vein, the first hybrid graft was placed on a balloon catheter through a peel-away sheath into the external jugular vein and ballooned in place.The stent end of the second hybrid graft was similarly placed into the outflow vein of the fistula.The central graft was tunneled subcutaneously to the outflow graft, and the grafts were sutured together with 5-0 ptfe suture (w.L.Gore & associates).This bypass was prone to kinking and narrowing of the unsupported portions of the grafts, as the patient had significant weight loss and resolution of swelling, which resulted in stenosis and thrombosis requiring over-stenting of these segments to maintain patency.Recognizing this problem, the hybrid graft was abandoned in favor of the viabahn graft.Fistula type brachiobasilic lesion location = thoracic outlet; outflow axillary; central access = external jugular.The gore hybrid graft had issues with kinking and edge stenosis that required over-stenting with bare metal and covered stents that led to graft thrombosis and edge stenosis.The fistula created by gore hybrid vascular graft thrombosed and was abandoned after three years.

• Brand Name: GORE HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick la fave ; 9285263030
• MDR Report Key: 9844809
• MDR Text Key: 196406861
• Report Number: 2017233-2020-00193
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093934
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2020
• 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