MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS FLIXENE GRAFTS W/GDS; PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Model Number	25137
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Not available for return.
Event or Problem Description
It was reported that two days after implant the graft became occluded.The graft had to be explanted 3 weeks after implant.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details provided a determination as to the reasons why the graft thrombosed is unknown.Being that the physical graft could be seen at the distal incision after 3 weeks may have contributed to the thrombosis formation seen.As mentioned in the adverse reaction section of the instructions for use, thrombus formation is listed.The graft product is provided sterile to the user.The product is sterilized using a traditional 3-step ethylene oxide (eo) cycle that delivers a 10-6 sterility assurance level (sal).This cycle is validated using biological indicators (bis) per the ¿overkill method¿ outlined in ansi/aami/iso 11135-1:2007, sterilization of health care products¿ethylene oxide ¿ part 1: requirements for development, validation and routine control of a sterilization process for medical devices.As the lot number was not provided a review of the device history records could not be performed.Conclusion: atrium medical corporation cannot conclude that the thrombosis and collapse of the graft was due to the manufacture or design of the product.

• Brand Name: GRAFTS FLIXENE GRAFTS W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9219651
• Report Number: 3011175548-2019-01121
• Device Sequence Number: 13926181
• Product Code: DYF
• UDI-Device Identifier: 00650862251371
• UDI-Public: 00650862251371
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: Health Professional
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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