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

Model Number	25137
Medical Device Problem Codes	Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
After declamping, the 45 cm long 4-6 mm conical flixene prosthesis was filled with blood and immediately stiffened, making it impossible to create the loop (folding it formed an angle, "kinking" effect).The prosthesis was explanted, a patch inserted in the vein and another flixene graft (straight) implanted without issue.
Additional Manufacturer Narrative
Additional information: d10.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details of the complaint the flixene graft was filled with blood and immediately stiffened, making it impossible to create the loop (folding it formed an angle, "kinking" effect.Upon receipt of the returned complaint the graft was disinfected as the graft had been used.As the material is porous the graft still remained stained.The graft itself was inspected and was found to be pliable to the touch and is within normal variation as compared to other grafts.It is normal to have a certain amount of stiffness when the graft is filled with blood.It will not be as pliable as when removed from the packaging.Due to the condition of the graft after being implanted it is extremely difficult to assess the condition of the graft.Based on the tactile inspection of the graft the material is not non-conforming.There was a great amount of detail provided by the physician however we are unable to duplicate the conditions experienced by the physician.Each lot of grafts are 100% inspected to ensure there are no anomalies or defects within the ptfe material including hard spots.Based on the details of the complaint and the returned product the complaint cannot be confirmed.Based on the dhr review there is no indication that a design, test methods, manufacturing processes, equipment, or raw materials was the cause of the complaint.The product met all quality and performance requirements.The review of the associated device history records did not identify any non-conformities during the review and all quality and performance requirements were met during the manufacture of this product.Two 15-month periods (february 2020 - april 2021 and may 2021 - july 2022) of complaint trending were reviewed to identify other complaints with the reported defect, "difficulty in graft placement or minimal damage of graft/prolonged procedure." two complaints were identified in the 30 months, including this one.The actual occurrence level did not exceed the anticipated occurrence level per the product's risk management file.There have been no capas or ncrs associated with this issue.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: 11768758
• Report Number: 3011175548-2021-00487
• Device Sequence Number: 3778025
• Product Code: DSY
• UDI-Device Identifier: 00650862251371
• UDI-Public: 00650862251371
• Combination Product (Y/N): N
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 465824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 05/26/2021; 11/05/2021; 09/19/2022
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/06/2021; 11/09/2021; 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic