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

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Skin Erosion (2075)

Event Date 03/13/2015

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2014, a patient was implanted with a gore® acuseal vascular graft in the left brachial artery to the axillary vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2015, the patient presented with the skin erosion with the graft externally exposed.There was no evidence of infection.The graft was explanted.An arteriovenous fistula was created for dialysis access.This is part of a data collection study from dr.(b)(6) using the gore® acuseal vascular graft for arteriovenous access.Skin erosion with the graft externally exposed.

Manufacturer Narrative

Physician stated the event was not related to the graft itself, but was related to the patient's condition.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5218098
• MDR Text Key: 30994633
• Report Number: 2017233-2015-00779
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• 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
• 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
• Patient Age: 28 YR
• Patient Weight: 67