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

Model Number 25129

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/20/2023

Event Type  Injury  

Event Description

Flixene vascular graft clotted when in the recovery room shortly after placement, the patient had to be taken back to surgery.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: sections a1, a3 & e1.

Event Description

N/a.

Manufacturer Narrative

Investigation: this complaint claims that a blood clot formed in a flixene graft (p/n 25129) shortly after surgery, while the patient was in the recovery room.The patient was taken back to surgery to treat it.The device has not been returned and no pictures were provided.The outcome of the additional surgery was not reported.It was not reported whether patency was restored to the graft or whether it was removed.No adverse effects to the patient were reported.Several requests were sent to the reporter for additional information and no response was received.A medical assessment was completed for this complaint which stated that thrombosis is the cause of 80% of vascular graft failures and that it is an anticipated and well known risk with implants for hemodialysis access.The assessment concludes that this failure was likely multifactorial and not solely caused by the graft.There are a myriad of factors involving surgical technique and patient conditions which could have contributed to this failure.The dhr for lot 488427 was reviewed and no anomalies in manufacturing were found.It was noted in the review that there is no inspection in place to look for defects in the graft body in the finished good procedures.However, a design control quality plan is in place under (b)(4) to add a tactile and visual inspection to (b)(4) (graft finished assy, cutting and length verification), which will add an inspection step to the graft body of the finished good before the gds tip is added and the graft is packaged.The ifu provides adequate instructions for the use of this device and cautions against its use in areas with a wide range of motion.The instructions are adequate to avoid damaging or delaminating the graft and contributing to a thrombus.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.One excursion was identified in april 2023 for the rate of occurrence exceeding 3 standard deviations.(b)(4) was opened for this excursion and is currently under review.A complaint history review was completed which found 1 similar complaint, which was determined to be due to the users handling and treatment of the graft.A recurring lot number review was completed which identified no other complaints involving lot 488427.A review of crs/capas found no crs in addition to the one opened for complaint trending and no capas were identified.The user did not provide any evidence, pictures, or return the device for evaluation, so the complaint cannot be confirmed.No evidence was found in the investigation to support there being a device nonconformance.The root-cause of this complaint is user - operational context.H3 other text : device not available for return.

Event Description

N/a.

• 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: 16841482
• MDR Text Key: 314261090
• Report Number: 3011175548-2023-00103
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251296
• UDI-Public: 00650862251296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25129
• Device Catalogue Number: 25129
• Device Lot Number: 488427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male