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

Model Number ECH470045A

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

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 Description

The following was reported to gore: on an unknown date, a patient underwent revision of an av fistula involving a gore® acuseal vascular graft that had been implanted in (b)(6) 2019.It was reported that there was possible delamination.More information has been requested, but has not been made available.

Event Description

The following was reported to gore: on an unknown date, a patient underwent revision of an av fistula involving a gore® acuseal vascular graft that had been implanted in (b)(6) 2019.It was reported that there was delamination.It was reported that the physician and nurses suspected repeated cannulation of the same spot of the graft in a busy dialysis facility led to the delamination.Further information was requested by gore, but no further information was reported.As event date is unknown, date gore aware is being used instead.

Manufacturer Narrative

Multiple attempts were made to obtain additional information regarding this event, including patient details, procedural details, and patient outcomes.No additional information has been received by gore, therefore this investigation is considered complete.

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13479724
• MDR Text Key: 289288812
• Report Number: 2017233-2022-02720
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132626984
• UDI-Public: 00733132626984
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: ECH470045A
• Device Catalogue Number: ECH470045A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization