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

Model Number	BXA093902A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem Description
The device is not available for return to the u.S.For an evaluation.
Additional Manufacturer Narrative
Corrected section b5, to update no device return.Updated investigation conclusions code to 4315.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Common Device Name: 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
• Report Number: 2017233-2020-01041
• Device Sequence Number: 2261175
• Product Code: DSY
• UDI-Device Identifier: 00733132637355
• UDI-Public: 00733132637355
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K130215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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
• Operator of Device: Health Professional
• Device Model Number: BXA093902A
• Device Catalogue Number: BXA093902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 03/31/2021
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 02/05/2021; 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention