MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE SLIDER GDS; 6MM X 50 CM FLIXENE GRAFT W/GDS

Model Number	25052
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Physician reported that a patient was implanted with a flixene graft that seemed to bleed more at the suture hole site and puncture site.Patient went to dialysis unit to be cannulated and they could not stop the bleeding from one of the sites.Physician had to bring patient back to surgery to repair the dialysis needle hole.
Additional Manufacturer Narrative
The graft was not returned for evaluation.A thorough review of the device history records for this graft lot was performed, all of the dhr's were found to be complete and accurate all of the performance testing met the acceptance criteria.The performance test for this failure mode is the water entry pressure test (wep).This test measures the minimum pressure necessary to push water through the wall of the graft.The minimum specification for wep is 155mmhg.The wep test was performed on samples from this lot, the minimum result obtained during the wep test was 358mmhg which is greater than the minimum specification of 155mmhg.Clinical evaluation: bleeding may occur if the graft is sized incorrectly and tension exists at the anastomosis.Other causes of bleeding at the suture sites would occur if during creation of the anastomosis a 'cutting' needle was used instead of the recommended taper point suture needles as cutting needles can damage the graft material and/or host vessel.It is important when creating the anastomosis to avoid the formation of elongated needle holes as they may result in bleeding.The instructions for use (ifu) state, "do not apply excessive tension to the anastomosis as elongated needle hole formation and /or material disruption may result, causing bleeding, weeping, and /or localized host vessel damage.Failure to follow all handling and operative technique warnings and precautions may result in blood loss and other adverse events.".

• Brand Name: FLIXENE SLIDER GDS
• Common Device Name: 6MM X 50 CM FLIXENE GRAFT W/GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6514318
• Report Number: 3011175548-2017-00014
• Device Sequence Number: 884729
• Product Code: DSY
• UDI-Device Identifier: 00650862250527
• UDI-Public: 00650862250527
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K060124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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
• Operator of Device: Physician
• Device Expiration Date: 08/22/2019
• Device Model Number: 25052
• Device Catalogue Number: 25052
• Device Lot Number: 407713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention