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

Model Number	25058
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The gds metal tip on a flixene graft fell apart while tunneling the graft.The customer had to xray the body to make sure no metal pieces were left in the body from the graft.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: d9.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details of the complaint the gds of the graft separated while tunneling through the vasculature.It remains unknown what force or if excessive force was used during the tunneling procedures.The details state normal force.Upon receipt of the returned gds section of the graft the two pieces of the gds were separated confirming the complaint.The sample had to be disinfected as the graft had been tunneled through the vasculature.Upon inspection of the tip of the gds there were 4 distinct marks at the top of that are indicative of a properly crimped device.Measurements of the swivel rod part number: 000332-001 were completed to the print and all critical dimensions were met.The swivel core, slider part number: 000331 was also measured and met all critical dimensions as well.Based on the details of the complaint and evaluation of the physical product, the complaint can be confirmed as the core pin had separated from the swivel rod however based on the details of the complaint and review of the physical device we cannot confirm that the device was at fault as it is unknown how much force was applied to the device when it separated.The root cause is impossible to determine.The trend review was completed which did not identify any trending excursions for the reported defect within the two time periods reviewed.A capa request was previously initiated in jan 2021 for a complaint trend excursion for two complaints with the same hazardous situation, but different level of harm.This was for two reports from the same facility that the adapter disconnected from the prosthesis when tunneling under the prosthesis.This did not escalate to a capa.The root cause was undetermined in regards to the gds separation and not unlike this complaint cannot determine the amount of force that was applied to the graft during the clinical procedure.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.

• Brand Name: GRAFTS FLIXENE GRAFTS W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12843490
• Report Number: 3011175548-2021-01167
• Device Sequence Number: 4265747
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: 00650862250589
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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 Expiration Date: 11/05/2023
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 463102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 09/16/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/01/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown