MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE GRAFTS W/GDS; PROSTHESIS, VASCULAR GRAFT >OR= 6MM

Model Number 25058

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Delamination (2904)

Patient Problem Failure to Anastomose (1028)

Event Date 06/30/2014

Event Type  Injury  

Event Description

Report received that a surgeon was performing an arteriovenous loop graft of the thigh.He completed the arterial anastomosis and tunneled the graft.He then cut the graft to prepare for the venous anastomosis and found that the graft had de-laminated.Specifically, the outer-layer had separated away from middle layer over the thickest portion of the graft.Once completed the surgeon closed the opening and was happy that the graft was satisfactorily placed.Later the surgeon returned to see the pt and it was noted that the drain had filled with a certain amount of fluid.During inspection the surgeon found the graft to be weeping.He drained the cavity and applied some packing and closed.Some 12 hrs later the fluid draining into the drain had settled.

Manufacturer Narrative

The lot history of the graft was reviewed and the product was found to have met all specifications.The investigation is underway and a follow up report will be submitted upon conclusion of the investigation.

• Brand Name: FLIXENE GRAFTS W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT >OR= 6MM
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4004722
• MDR Text Key: 4776005
• Report Number: 1219977-2014-00232
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K060124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 203019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 66 YR