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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, no investigation on the device can be performed.Further information like the lot-/serial no.And patient details were requested, but not provided yet.As event date (b)(6) 2020 was chosen, as only the month, since when it occurred, was provided.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

It was reported to gore that patient underwent treatment for dialysis access in (b)(6)2020 by implanting a gore® acuseal vascular graft.It was stated that the patient had been dialysing through the graft for approximately 8 months without problems, but from last december he developed an unusual rash over the graft area.It was reported that they stopped using the graft and inserted a tunnelled line.Patient was referred to the dermatologist who diagnosed contact dermatitis and prescribed medication.The patient has been dialysing through the line since (b)(6) 2021, but there has been only little improvement.The hospital is wondering whether the patient might be reacting to the graft material itself.

Manufacturer Narrative

After consultation with gore office of medical affairs, as reported the gore graft was implanted and used for 8 months with no issue, and no information was provided to gore that reasonably suggests the gore device caused or contributed to a reportable serious incident/adverse event, therefore this report is being retracted.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12445481
• MDR Text Key: 270529625
• Report Number: 2017233-2021-02344
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention