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

Catalog Number ECH060040J

Device Problem Mechanical Problem (1384)

Patient Problems Stenosis (2263); No Code Available (3191)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

As it is unknown which device(s) may have contributed to the delamination and removal of the device, three additional gore® acuseal vascular graft devices have been included in this report: 5291291pp016/ech060040j, udi: (b)(4), 5240434pp008/ech060040j, udi: (b)(4), 5236209pp012/ech060040j, udi: (b)(4).(b)(4).

Event Description

On an unknown date, in (b)(6) 2017, approximately 2 years ago, the patient was implanted with a gore® acuseal vascular graft as an av shunt for hemodialysis.The device implanted was a ech060040j.However, the serial / lot could not be determined and maybe one of the following lot numbers: 5260604pp009 or 5291291pp016 or 5240434pp008 or 5236209pp012.Stenosis was repeatedly observed one year after the index procedure.Pta was performed several times for the treatment.Occlusion was observed about 2 years after the index procedure.Then echo examination was performed and graft delamination was confirmed.On an unknown date, during follow-up echo examination, graft delamination was suspected.On (b)(6) 2019, a re-intervention was performed, whereby, the gore® acuseal vascular graft was removed and replaced with a new vascular graft.The physician commented that the delamination was due to a puncture.At the time of puncture, there was a possibility that the event was occurred because the needle was advanced without completely passing the needle through the entire graft wall.

Manufacturer Narrative

Code 213: a review of the manufacturing records indicated these lots met pre-release specifications.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) (b)(6); manufacturer/compounder: w.L.Gore & associates, inc.Lot #5260604pp009.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Corrected data: h6.Patient code 1.H6.Method code 2.H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned specimen found no anomalies attributable to the manufacture of the device.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9385537
• MDR Text Key: 168433547
• Report Number: 2017233-2019-01193
• 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,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Catalogue Number: ECH060040J
• Device Lot Number: 5260604PP009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention