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

Catalog Number ECH060040

Device Problems Partial Blockage (1065); Peeled/Delaminated (1454)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

All device lot numbers were investigated and the lots met pre-release specifications.The remaining for devices are as follows: ech060040 5662203pp022 udi: (b)(4), ech060040 5675645pp004 udi: (b)(4), ech060040 5675645pp017 udi: (b)(4), ech060040 5633976pp018 udi: (b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was underwent a procedure for arterio-venous access in the forearm with a gore® acuseal vascular graft.The procedure was completed successfully.On (b)(6) 2019 following a dialysis session the graft was found to be stenosed for several cm at the inflow site.Because of the risk for total occlusion, a graft bypass was planned.On (b)(6) 2019 the patient underwent open bypass surgery using a gore® propaten® vascular graft.The gore® acuseal vascular graft remains implanted.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was underwent a procedure for arterio-venous access in the forearm with a gore® acuseal vascular graft.The procedure was completed successfully.On (b)(6) 2019 following a dialysis session the graft was found to be stenosed for several cm at the inflow site.Because of the risk for total occlusion, a graft bypass was planned.On (b)(6) 2019 the patient underwent open bypass surgery using a gore® propaten® vascular graft.During the procedure, some disruption of the graft layers of the gore® acuseal vascular graft were observed.The gore® acuseal vascular graft remains implanted.No adverse events have been reported following this procedure.

Manufacturer Narrative

Additional information was received making this event reportable.The report fields have been repopulated in this follow-up.H.6.Results code 1: 213: the exact lot number could not be determined, however 5 devices were available for use at the time of the implantation.All device lot numbers were investigated and the lots met pre-release specifications.The remaining for devices are as follows: ech060040 5662203pp022 udi: (b)(4); ech060040 5675645pp004 udi: (b)(4); ech060040 5675645pp017 udi: (b)(4); ech060040 5633976pp018 udi: (b)(4), 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 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 an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.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

H.1.Medwatch # 2017233-2019-00976 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch is being retracted.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9148018
• MDR Text Key: 162315780
• Report Number: 2017233-2019-00976
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

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
• Device Expiration Date: 07/06/2020
• Device Catalogue Number: ECH060040
• Device Lot Number: 5633976PP021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention