MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  Injury  

Event Description

The following was reported to gore: on unknown date, a gore® acuseal vascular graft was implanted as an arteriovenous shunt.On unknown date, a delamination was suspected at the venous anastomosis of the graft.Attempts to repair by ballooning were unsuccessful, and an additional stent graft, viabahn, was successfully implanted.The patient tolerated the procedure.The physician stated that the cause of the delamination was probably not due to puncture because of the delamination was at the anastomosis and anterior wall of the graft.In most cases of delamination, it can be repaired with pta balloon, and he was surprised that he had never experienced a case like this that was as difficult to repair with balloon.Reportedly, the catalog number might be ech060040j but it was not sure.It seems that the delamination was not actually confirmed by open surgery, but rather by echo-imaging or something else that made them suspect delamination.Medical history: renal failure.

Manufacturer Narrative

Unknown information was asked for but remains unknown.(b)(4).

Manufacturer Narrative

Cbas® heparin surface essentially incorporates non-eluting.Cbas-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.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14189927
• MDR Text Key: 290539679
• Report Number: 2017233-2022-02876
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 08/19/2022
• 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): Required Intervention