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

Model Number	ECH060040A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that the gore® acuseal vascular graft delaminated post procedure.Reportedly, dr.(b)(6) stated that the acuseal delaminated and her could visualize it on ultrasound.It was reported that the physician determined the graft and access were compromised, so the patient was taken to surgery and revised the graft with another piece of acuseal.Reportedly the patient is ok.
Additional Manufacturer Narrative
Pending imaging evaluation-results will be provided in follow-up report.A review of the manufacturing records revealed that the lot met all pre-release specifications.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Additional Manufacturer Narrative
Analysis of the production records showed that the lot met all pre-release specifications.Due to no device return, an engineering investigation could not be performed.Imaging evaluation could not be performed.
Event or Problem Description
On (b)(6) 2020, the patient received treatment in the upper arm for dialysis access with the gore® acuseal vascular graft.On (b)(6) 2022, it was observed by the physician, through ultrasound imaging that the gore® acuseal vascular graft had delamination.The physician states that the graft and access were compromised.The patient received a reintervention to revise the graft with another gore® acuseal vascular graft.The patient tolerated the procedure.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14087366
• Report Number: 2017233-2022-02860
• Device Sequence Number: 17461876
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 02/09/2023
• Device Model Number: ECH060040A
• Device Catalogue Number: ECH060040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 03/23/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/06/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female