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

Model Number	25128
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
After the implantation of a flixene, massive local signs of inflammation appeared within a short time.No evidence of bacterial infection.Prosthesis had to be explanted and discarded, products from other companies were implanted without problems.
Additional Manufacturer Narrative
Additional information: section a1, b5, b6, b7, d9, h6.
Event or Problem Description
Initial report: after the implantation of a flixene, massive local signs of inflammation appeared within a short time.No evidence of bacterial infection.Prosthesis had to be explanted and discarded, products from other companies were implanted without problems.Additional information received from physician: patient suffers from acute leukemia that can no longer be treated.The inflammatory status of the tissue can most likely be attributed to this diagnosis.Subsequent implant also became inflamed/infected.Even after the prosthesis was explanted, the wound did not heal, pus-filled blisters formed all over the body and all plastic dialysis accesses had to be removed within a short time due to massive infections.The family and the patient decided on palliative care at home and dialysis was discontinued.
Additional Manufacturer Narrative
Investigation results: it was reported that the patient was previously on dialysis with a shunt.During the course of treatment following graft implantation, the patient had an incidental finding of severe acute leukemia (95% of blood smear is blast) and could no longer be treated.The subsequent implant also became inflamed/infected.Even after the prosthesis was explanted, the wound did not heal, pus-filled blisters formed all over the body and all plastic dialysis accesses had to be removed within a short time due to massive infections.The family and the patient decided on palliative care at home and dialysis was discontinued.An implant/explant date was not provided.Images were provided of the patient¿s arm post-surgery, which confirm the complaint.The physician noted ¿there was immediate swelling with tension patches in the entire arm post-operatively, with stenosis ruled out by phlebography and no evidence of germs in the prosthetic canal.¿ the device history records review did not identify any non-conformances.All incoming inspections of materials were found to be within specification prior to release.The complaint history shows that there have been no other recent complaints related to redness and swelling associated with the graft¿s products other than the other related complaint from the same hospital and physician, complaint (b)(4).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.The instructions for use provide adequate instruction in regards to the use of the device and adverse events associated with the use of the graft¿s.Based on the details of the complaint available to us and review of the device history records including sterilization records, there is no indication that any deficiency in the flixene graft was the cause of the inflammation.It is very likely that the root cause of this patient¿s adverse event is related to the patient conditions and ¿severe acute leukemia¿ diagnosis.The physician has specifically stated that this particular case has been clarified for her in this regard, and thus no further information on the patient/case was provided to us for review.H3 other text : device not returned.

• 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: 17620776
• Report Number: 3011175548-2023-00166
• Device Sequence Number: 12282999
• Product Code: DSY
• UDI-Device Identifier: 00650862251289
• UDI-Public: 00650862251289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 06/12/2026
• Device Model Number: 25128
• Device Catalogue Number: 25128
• Device Lot Number: 497788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 10/12/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/11/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown