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

Catalog Number ECH060040J

Device Problem Mechanical Problem (1384)

Patient Problem Occlusion (1984)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

As it is unknown which device(s) were involved in the delamination event, an additional gore® acuseal vascular graft device has been included in this report: 5452050pp008/ech060040j udi - (b)(4).

Event Description

On (b)(6) 2018, a gore® acuseal vascular graft was implanted in the left forearm as a dialysis shunt.The patient tolerated the procedure.On an unknown date, in early (b)(6) 2019, it was reported that the graft was occluded.Ultrasound imaging was performed, and delamination of the graft was suspected.Reportedly, the suspected delamination occurred around a puncture site of the graft.Percutaneous transluminal angioplasty with a balloon was performed, however, the issue remained.Therefore, a stent was implanted inside of the graft.The patient tolerated the procedure.The physician reportedly considered that there is a possibility that the puncture contributed the delamination because of its location.

Manufacturer Narrative

H6: code 213 ¿ the review of the manufacturing paperwork verified that these lots met all pre-release specifications.H6.Code 4315 - as the devices were not returned, no evaluation of the devices could be performed.

Manufacturer Narrative

H6: code 4114 the engineering evaluation showed the following: two device serial numbers from the same lot were provided with this event; it is unknown which of the two devices is associated with the event.In consultation with the pfmea, the device history records were reviewed for all steps that have a potential to cause delamination of device layers.All related manufacturing steps contained the required recorded information and signatures.The event description could not be confirmed with the information provided.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9459249
• MDR Text Key: 180723666
• Report Number: 2017233-2019-01238
• 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: 02/17/2020

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: 01/12/2020
• Device Catalogue Number: ECH060040J
• Device Lot Number: 5452050PP006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2020; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention