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

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

American society for diagnostic and interventional nephrology (asdin) 17th annual scientific meeting (virtual) abstracts.The journal of vascular access."a foreign body in early cannulation dialysis graft" muhammad shakoor, et al.A 60-year-old female with history of eskd on hemodialysis via right forearm brachial basilic vein loop graft (gore® acuseal vascular graft ,2016) complicated by frequent basilic vein in-stent stenosis and thrombosis requiring multiple angioplasties was referred to our access center for urgent evaluation due to failure to cannulate.Graftogram revealed diffuse thrombosis of the graft.Thrombectomy, angioplasty of body of access and stent graft placement for a basilic vein stent edge stenosis were successfully performed.Flows remained poor and an additional set of ante grade and retrograde sheaths were inserted to remove residual thrombus.Two silicone appearing fragments were removed with clot, which were likely from internally degraded iaavg with exposure of the silicone layer due to frequent.

Manufacturer Narrative

American society for diagnostic and interventional nephrology (asdin) 17th annual scientific meeting (virtual) abstracts.The journal of vascular access."a foreign body in early cannulation dialysis graft" muhammad shakoor, et al.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.

Manufacturer Narrative

Product evaluation: the identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The case description could not be confirmed, as no identity or images of the device were provided for evaluation.

• Brand Name: GORE® ACUSEAL 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16469075
• MDR Text Key: 310598322
• Report Number: 2017233-2023-03771
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female