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

Model Number 25061

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022, use flixene 6mm40cm and embed about 20cm like the attached file schema.On (b)(6) occlusion and organic thrombus were observed in the elbow joint, and blood flow resumed with shunt massage.On (b)(6), an attempt was made to remove the remaining thrombus by direct surgery, and when a lateral incision was made after exposing about 2 cm of the artificial blood vessel at the elbow, the three-layer structure was dissociated.Since this part has never been punctured in the past, it is unlikely that the three-layer structure will dissociate.The part that caused the dissection is the elbow joint, which is normal and can be flexed and stretched.

Event Description

On (b)(6) 2022, 20cm of a flixene 6mmx40cm graft was implanted.On september 5, occlusion and organic thrombus were observed in the elbow joint, and blood flow resumed with shunt massage.On (b)(6) 2022, an attempt was made to remove the remaining thrombus by direct surgery, and when a lateral incision was made after exposing about 2 cm of the artificial blood vessel at the elbow, the delamination was observed between the outer layer and middle layer of the graft near the elbow joint.Reanastamosis was performed in this surgery and the graft remains implanted.

Event Description

N/a.

Manufacturer Narrative

The customer reported that they placed 20cm of a flixene graft (p/n 25061) in a patient's arm on (b)(6) 2022 to form an arteriovenous graft.On (b)(6) 2022, they observed an occlusion and an organic thrombus in the graft at the elbow joint.This was treated with a "shunt massage," which allowed blood flow to resume but did not fully remove the thrombus.On (b)(6) 2022, the remaining thrombus was removed surgically; however, the surgeon noted that the outer and middle layers of the graft had peeled back at the incision point.The surgery was successful and the patency of the graft was reestablished.The graft was not returned because it is still implanted in the patient.The customer sent pictures of x-rays taken of the graft, which show the thrombus and indicate where the delamination occurred.Although the pictures do not clearly show delamination, the graft does appear narrower at the point indicated which could be due to the loss of the middle and outer layers in that spot.This complaint is confirmed.The exact condition of the device cannot be known because it has not been returned and the pictures do not clearly show the delamination.Based on the information reviewed in this investigation, it cannot be confirmed that the device was nonconforming when it left the manufacturer.A medical assessment was completed for this complaint, which reviewed both this event as well as literature about similar events.It was concluded that there are most likely multiple factors involved in the delamination including surgical technique, excessive manipulation of the graft, mechanical disruption, and possible damage done during the shunt massage.The device history record 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 dd022187 to add a tactile and visual inspection to mp000502 (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.It also includes specific instructions for performing thrombectomy.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found 3 complaints related to graft delamination, all of which were determined to be caused by the user not following the provided instructions.Each of those complaints occurred during the preparation of the graft.This complaint is considered unrelated to those because multiple factors are believed to have led to this complaint, both in the preparation of the device and after its placement.No other complaints have been identified which match this reported event, which further suggests that the root cause of this complaint is in the specific context of this patient's procedure and use of the device and not in the device's manufacturing.A recurring lot number review was completed which identified one other complaint for the reported device lot.A review of cars/capas found two related cars, which were initiated due to trending.Neither were escalated to capa because they were found to be adequately documented in the risk management file.The root-cause of this complaint was determined to be user - operational context.H3 other text : device not available for return.

• 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: 15798596
• MDR Text Key: 303655970
• Report Number: 3011175548-2022-00363
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862250619
• UDI-Public: 00650862250619
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 25061
• Device Catalogue Number: 25061
• Device Lot Number: 472379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 01/09/2023
• Supplement Dates FDA Received: 11/28/2022; 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female