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

Model Number 25141

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Doctor implanted flixene graft and graft occluded 4 weeks after implantation sooner than he expected versus his standard artegraft.

Manufacturer Narrative

Investigation: this complaint reports that a flixene graft (p/n 25141, l/n 484162) was implanted in a patient with sickle cell anemia and small blood vessels.After four weeks a thrombus formed in the graft and the patient underwent a thrombectomy to treat it.The surgeon reported that the graft occluded sooner than he expected.There were no details provided about the thrombectomy procedure or patient or graft status after the thrombectomy.The device has not been returned and no images have been provided.A medical assessment was completed which concluded that multiple factors likely contributed to this event, in particular noting the sickle cell anemia of the patient which predisposes the patient to thrombus formation.The dhr were reviewed and no anomalies in manufacturing were found.No ncrs were identified for any of these lots.There is no evidence to suggest that manufacturing, equipment, materials, or design are related to the complaint root cause.The ifu provides adequate instructions for the use of this device and no evidence was identified to suggest the ifu is related to this complaint.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 information provided by the customer indicates that the patient has sickle cell anemia, a condition that predisposes them to the assigned reported defect.The root-cause is user - operational context.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 3.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.Neither the complaint nor a device nonconformance can be confirmed.Two similar complaints were identified, which were both assigned the root-cause of operational context.One crs was identified for an excursion of the assigned reported defect, which was not escalated because it was determined not to be a systemic issue.No capas, scars, or ncrs were identified.This complaint did not identify any adverse trends or systemic issues.

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: 17695790
• MDR Text Key: 322798444
• Report Number: 3011175548-2023-00175
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25141
• Device Catalogue Number: 25141
• Device Lot Number: 484162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American