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

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 06/30/2014

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; 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 superficial femoral artery to the femoral vein for arteriovenous access.It was stated that during the implant procedure the patient experienced a myocardial infarction.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the graft lost primary and functional patency and the patient expired due to a myocardial infarction.This is part of a data collection study from dr.(b)(6) using the gore® acuseal vascular graft for arteriovenous access.

Manufacturer Narrative

Physician stated the event was not related to the graft itself, but was related to the patient's condition.The instructions for use for gore® acuseal vascular graft state that complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.

• 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: 5217915
• MDR Text Key: 30995277
• Report Number: 2017233-2015-00775
• 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: 71 YR
• Patient Weight: 78