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

Catalog Number 0650HYB0805A

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/15/2019

Event Type  Injury  

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.Abstract reviewed: american society for diagnostic and interventional nephrology (asdin) 15th annual scientific meeting (atlanta, georgia) abstracts.Cobb j, rawls f, palacherla j, tuanhang m, niyyar vd.The journal of vascular access 2020, vol.21(2) np1¿np13.A second mdr was submitted for case one (83 yo female patient), based on same poster 23.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.

Event Description

Abstract reviewed: exposed arteriovenous grafts in hemodialysis patients¿ not so uncommon? there have been reported cases of exposed dialysis arteriovenous graft (avg) but they have been usually associated with severe infections.We present two (2) unusual cases of hemodialysis patients that developed exposed avgs without obvious signs of infection that required excision.One was an avg currently in use and the other was a retained non-functioning avg.These cases highlight the need for dialysis staff diligence in monitoring dialysis av access.For case one, a 29 year old patient with esrd for two (2) years secondary to lupus nephritis, was receiving hemodialysis through a left upper extremity bbt avf which underwent severe aneurysmal degeneration, requiring an inter-position left arm 8 mm gore® hybrid vascular graft (avg).The new avg required multiple interventions including angioplasties, stent placement and thrombectomies prior to abandonment and placement of a cvc.Two weeks after her last thrombectomy, the patient noticed her avg was exposed with overlying skin dehiscence.She denied fever, chills, or drainage from the affected area, and was admitted.She was started on empiric antibiotics for mild leukocytosis despite being on steroids for lupus related hemolytic anemia.The avg was excised and a new 6 mm bovine graft was placed in the same extremity (no purulent drainage observed).Patient was discharged on antibiotics and continued use of cvc.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14894877
• MDR Text Key: 295228263
• Report Number: 2017233-2022-03093
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K093934
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0650HYB0805A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Race: Black Or African American