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

Model Number 25058

Device Problem Material Puncture/Hole (1504)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

Got a call today from customer at (b)(6) stating a flixene graft had holes in it and leaked.

Manufacturer Narrative

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

Event Description

Additional information received stated the implanted graft had a revision on (b)(6) 2023 using a gore graft, during the revision it was noted that graft had a degenerated segment in two places and the holes in the graft were also identified during the revision.

Manufacturer Narrative

Additional information: sections b3, b5, b7, d1, d4, d6a, d9, h4 & h6.

Event Description

N/a.

Manufacturer Narrative

This complaint reports that a flixene graft (p/n 25058, l/n 488956) degenerated in two spots, causing holes that leaked.The graft was implanted in the patient's forearm on (b)(6) 2022 and explanted on (b)(6) 2023.The customer confirmed that the graft was used for dialysis, but could not say how frequently.They confirmed that the degradation corresponded with areas of repeated punctures.And they stated that there was no occlusion in the graft.The graft was replaced due to a pseudoaneurysm.The graft is not being returned for evaluation.No adverse events related to this device were reported and details about the patient's condition were not shared.A medical assessment was completed for this complaint and states that pseudoaneurysm is a rare complication that can arise from repeated punctures of the graft.The repeated punctures can lead to the degradation of the graft and allow leaking.It concludes that the incident is likely multifactorial, but is probably related to the repeated puncture of the graft for dialysis.The dhr for lot 488956 and relevant subassemblies 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, or design are related to the complaint root cause.The ifu provides adequate instructions for the use of this device and cautions the user to adequately space out puncture sites to avoid material disruption of the graft.The information provided by the customer indicates that the instructions to adequately separate puncture sites to avoid multiple punctures in the same area where not followed.A complaint history review was completed which found no similar complaints.A recurring lot number report was completed which identified no other complaints involving lot 488956.The graft was not returned for evaluation and no pictures have been provided, therefore a device nonconformity cannot be confirmed.The information provided by the customer indicates that the instructions for use were not followed, which is the most likely cause of this complaint.Although the customer did not return the device or provide pictures to show the nonconformity, the complaint is considered confirmed, as the complaint reported involves a known use error in that the device was not used in accordance with the instructions provided to the user.The root-cause of this complaint is assigned as user error.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.No related complaints, crs, capas, scars, or ncrs were identified.H3 other text : device not available for return.

• Brand Name: 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: 17647558
• MDR Text Key: 322267276
• Report Number: 3011175548-2023-00171
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: 00650862250589
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 488956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/01/2023; 10/06/2023
• Supplement Dates FDA Received: 09/05/2023; 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1