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

Catalog Number ECH470045A

Device Problems Material Separation (1562); Device Handling Problem (3265)

Patient Problem Thrombosis (2100)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number information was supplied; therefore, no review of the manufacturing record history could be performed.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

On an unknown date, a patient was implanted with a gore® acuseal vascular graft in an arteriovenous access application.It was reported the acuseal graft was being used with a hero catheter.It was also reported to gore that the patient had previous interventions on unknown dates at other user facilities.On (b)(6) 2018, the patient presented for another intervention.During the procedure, graft delamination was observed.It was reported that the graft delamination was likely due to repeated cannulations in same location during dialysis sessions.During the intervention, ballooning was performed, and a stent (unknown manufacturer) was placed in the mid-segment of the acuseal graft.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7268149
• MDR Text Key: 99962508
• Report Number: 2017233-2018-00099
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH470045A
• 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
• Treatment: HERO CATHETER
• Patient Outcome(s): Required Intervention