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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/27/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2014, a patient was implanted with a gore acuseal vascular graft in the left arm for arteriovenous access.The graft was cannulated on (b)(6) 2014.On (b)(6) 2014, the patient developed a superficial wound infection after the surgical revision procedure which was managed conservatively.A local sepsis was proven and a temporary access for the dialysis treatment was created based on graft infection.An infected haematoma was treated with a 7 days antibiotics cure.It was reported to gore that on (b)(6) 2014, the graft lost primary patency and a surgical declot procedure and an angioplasty of outflow stenosis were performed.Altogether there were four surgical declots performed on the graft until the graft lost functional patency on (b)(6) 2014.During on procedure a gore viabahn endoprosthesis was implanted additionally.Finally, a kidney transplant was performed on (b)(6) 2015.This is part of a data collection study from dr.(b)(6) using the gore acuseal vascular graft for arteriovenous access.

• 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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5239563
• MDR Text Key: 31739828
• Report Number: 2017233-2015-00823
• 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
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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: 51 YR
• Patient Weight: 82