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

Model Number	ECH060040A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Appropriate clinical signs, symptoms, conditions term/code not available: patient underwent reintervention.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
The following was reported to gore: on an unknown date in (b)(6) 2020, an interposition basilic vein gore® acuseal vascular graft was implanted for dialysis.The patient tolerated the procedure.On (b)(6) 2020, the surgeon performed a venogram and observed an irregularity in the graft.On (b)(6) 2021, the physician advanced a bard covera 7mm x 40mm to try to overcome the irregularity but during the procedure, the irregularity moved further down to make another irregularity in the gore® acuseal vascular graft.The physician then operated to elevate the gore® acuseal vascular graft and noted that the inner layer had separated from the outer layer for approximately two inches in length.The physician proceeded to excise the delaminated portion and implant a new gore® acuseal vascular graft to replace the excised section.The patient tolerated the procedure.
Additional Manufacturer Narrative
No device was returned, but device images were evaluated as part of the investigation: the identity of the device was provided; the dhr associated with the serial number provided was reviewed, and all process steps associated with device delamination had the appropriate signatures and evidence of conformation.The device images are consistent with the case description but could not be confirmed.The reported failure mode reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.

• 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: 11275062
• Report Number: 2017233-2021-01646
• Device Sequence Number: 11658290
• Product Code: DSY
• UDI-Device Identifier: 00733132605354
• UDI-Public: 00733132605354
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: ECH060040A
• Device Catalogue Number: ECH060040A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD COVERA 7MM X 40MM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86