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

Model Number 25128

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/22/2023

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event 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.

Manufacturer Narrative

Complete relevant history: shunt dysfunction, dm ii, art.Hypertension, ask, immunosuppression in z.N.Kidney tx, z.N.Prostate ca.

Event 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 from physician: patient had been undergoing dialysis with shunt.Shunt flow was low and sufficient dialysis was difficult.Flixene graft was placed on (b)(6) 2023 as a forearm loop to maintain puncture distance.It was tunneled directly subcutaneously as usual with the associated tunneling system and anastomosed end-to-side to the proximal radial artery and the antebrachial cephalic vein end-to-end.Swelling and redness appeared on the first postoperative day, with pain and warmth.The entire arm was swollen even though only the forearm had been operated on.After about a week a classic hyperemia developed, which could be pushed away and recurred, compresses with octenisept had no effect.Central stenosis was ruled out.When the arm was elastically wrapped and elevated, the swelling only decreased very slowly over a long period of time, even after the prosthesis had already been explanted.The pain during the course of the prosthesis stopped after explantation.Sonographically, some hyperechoic material was found in some places next to the prosthesis, initially interpreted as a hematoma, but increasing over time and finally acoustic shadows interpreted as small air pockets.No adequate increase in laboratory infection values, no fever or impairment of the az was found.The intraoperative findings were not typical of an infection.No germ was detectable in the intraoperative swabs.Graft was explanted on (b)(6) 2023.

Manufacturer Narrative

Investigation results: patient had been undergoing dialysis with shunt.Shunt flow was low and sufficient dialysis was difficult.Flixene graft was placed on (b)(6) 2023 as a forearm loop to maintain puncture distance.It was tunneled directly subcutaneously as usual with the associated tunneling system and anastomosed end-to-side to the proximal radial artery and the antebrachial cephalic vein end-to-end.Swelling and redness appeared on the first postoperative day, with pain and warmth.The entire arm was swollen even though only the forearm had been operated on.After about a week a classic hyperemia developed, which could be pushed away and recurred, compresses with octenisept had no effect.Central stenosis was ruled out.When the arm was elastically wrapped and elevated, the swelling only decreased very slowly over a long period of time, even after the prosthesis had already been explanted.The pain during the course of the prosthesis stopped after explantation.Sonographically, some hyperechoic material was found in some places next to the prosthesis, initially interpreted as a hematoma, but increasing over time and finally acoustic shadows interpreted as small air pockets.No adequate increase in laboratory infection values, no fever or impairment of the az was found.The intraoperative findings were not typical of an infection.No germ was detectable in the intraoperative swabs.Images were provided of the patient¿s arm post-surgery, which confirm the complaint, as swelling and redness was viewed in the image.Additionally, an image of the patient¿s post-operative bloodwork were provided, showing in increase in c-reactive protein (crp) values following implantation of the graft on (b)(6) 2023, which is an indicator of inflammation.The graft was ultimately explanted on (b)(6) 2023.The patient diagnosis was the following as provided by the institution: shunt dysfunction, dm ii, art.Hypertension, ask, immunosuppression in z.N.Kidneytx, z.N.Prostate ca.Further information was requested, including microbiology results from the tissue samples, make/model of the subsequent implant, details of the patient¿s cancer treatment, surgical notes, etc., however, additional requested information was not provided.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.The cause of the patient¿s inflammatory response to the flixene graft implant is likely multifactorial due to the patient¿s multiple comorbidities including kidney disease, type ii diabetes, and prostate cancer.The patient was additionally being immunosuppressed for a kidney transplant.It is also possible that the patient presented with an allergic reaction or hypersensitivity to ptfe.While a very rare complication, this type of reaction has been observed in case studies and is acknowledged in the product¿s risk management file.This cannot be ruled out as a possibility, as the patient was not tested for this type of allergy.It is also not known what type of graft was implanted subsequent to the flixene.For example, if a non-ptfe graft was subsequently used without incident (as it was noted ¿products from other companies are implanted without any problems¿ in the initial report), a ptfe allergy could be relevant in this case.H3 other text : device not returned.

• Brand Name: GRAFTS FLIXENE GRAFTS W/GDS
• Type of Device: 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: 17620772
• MDR Text Key: 321923200
• Report Number: 3011175548-2023-00165
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251289
• UDI-Public: 00650862251289
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25128
• Device Catalogue Number: 25128
• Device Lot Number: 494821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAQUET TUNNELER
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG