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

Model Number ECH470045A

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Event Description

The surgeon, during the placement of a left upper extremity brachial artery to axillary vein av graft placed in the arm using a tunneler, attempts to reposition with a kelly for right arm placement.The graft tore in the middle.Graft was taken out of the arm removed from the field - no harm to the patient another graft successfully placed.

• 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 north fourth street; flagstaff, AZ 86004
• MDR Report Key: 5871242
• MDR Text Key: 51975849
• Report Number: 5871242
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ECH470045A
• Device Catalogue Number: ECH470045A
• Device Lot Number: 4996450PP006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2016
• Event Location: Other
• Date Report to Manufacturer: 08/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR