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

Model Number BXA093902A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: on an unknown date, the patient was implanted with a gore® acuseal vascular graft as a shunt for dialysis.On an unknown date, it was noted that the graft appeared to be delaminated.On an unknown date, a reintervention explanting the graft was performed.The patient tolerated the procedure.It was reported that it seems that the delamination has started from where the bare metal stent is implanted.(the reason why the bare metal stent was implanted is unknown, the information was not provided.) it was also reported that the puncture might have caused the delamination because a lot of punctures have been performed since the graft was implanted.The device will be returned to us for analysis.A customer response is required.The physician requested detailed analysis such as he staining, and requested to provide an observation picture/image of the delaminated portion.

Manufacturer Narrative

C1 - name (give labeled strength and mfr/labeler), cbas® heparin surface.C1 - manufacturer/compounder, w.L.Gore & associates, inc.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.D1 - product name, gore® acuseal vascular graft.

Event Description

The device is not available for return to the u.S.For an evaluation.

Manufacturer Narrative

Corrected section b5, to update no device return.Updated investigation conclusions code to 4315.

• 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
• MDR Report Key: 10309017
• MDR Text Key: 199898300
• Report Number: 2017233-2020-01041
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132637355
• UDI-Public: 00733132637355
• Combination Product (y/n): Y
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BXA093902A
• Device Catalogue Number: BXA093902A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention