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

Model Number 25058

Device Problems Material Disintegration (1177); Material Integrity Problem (2978)

Patient Problem Aneurysm (1708)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Follow-up report will be submitted upon completion of the investigation.

Event Description

Report received stated that a flixene graft that was placed approximately 12 months ago in conjunction with a hero graft was explanted.The physician believes the graft has disintegrated.Additional information received stated the flixene graft was removed due to false aneurysms forming along the graft.

Manufacturer Narrative

Additional information section: a.4, d.9 & h.4.Correction section: a.4 - udi#.

Event Description

N/a.

Manufacturer Narrative

Upon opening the package there were two pieces of graft material that had a lot of tissue growth around the graft.The graft had been cut up the middle exposing the inner portion of the graft.This had already been bisected prior to the return of the device for evaluation.The inner portion of the graft was in good condition and there was nothing indicating that the graft had disintegrated as claimed in the complaint details provided.It is unclear why the physician cut open the graft after removing the two sections from the patient.There was a large hole in the graft that appeared to be at a 45 degree angle.The hole was rather large.The hole measured approximately 4.4mm in diameter.This is rather large and would appear to have been created by either cannulating repeatedly in the same location or from where the hero graft was attached as there appears to be a suture still in place around the area of the hole.Being that there was a suture at this location it is likely that the hero graft was connected to the flixene graft at this location.This may be why there was so much tissue incorporation around this area.The hero graft manufactured by merit medical is a "graft that is a long term access solution for access-challenged and catheter-dependent patients".It is not known when the hero graft was placed and if it played a role in the doctor¿s decision to explant the flixene graft.The two segments returned when measured end to end totaled 10cm.The product in question was a 6mm x 59cm length graft.It is not clear why only a 10cm segment was returned or what had happened to the other 49cm of the graft.The inner segments or lumen was very patent and not disintegrated other than the large hole created by cannulating in the same spot repeatedly or from the attachment of the hero graft.In either case the graft was in good condition and cannot confirm the complaint as the graft was not disintegrated.The other segment also had a rather large hole in it that was also at a 45 degree angle.This too could also be a connection site of a hero graft or a cannulation site.Being that the description of the event also includes that the graft was being removed due to false aneurysms there is a possibility that the graft was cannulated too many times in the same location causing the false aneurysms.According to flixene eptfe vascular graft instruction for use (ifu) complications that may occur in connection with the use of any vascular graft include, but are not limited to; thrombosis, stenosis, formation of pseudoaneurysm due to excessive needle punctures, peri-graft hematoma formation, peri-graft seroma formation, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material suture line or host vessel which may result in extreme blood lost, loss of limb function, steal syndrome, loss of limb or possible death.The patient should be advised to contact the physician should an adverse reaction occur.The review of the device history records (dhr) show that this graft passed all quality and performance requirements.There were no non-conformances noted.During the process of manufacturing a performance test is conducted to determine the suture retention force.The top assembly part specification states that the suture retention must meet or exceed.7lbf.The minimum force of the 52 samples tested was 1.59 lbf exceeding the requirement.The longitudinal tensile strength of the graft is also tested.The test results show that out of 13 samples the lowest tensile strength was 91.68lbf.The specification states the product must pass a minimum tensile force of 20lbf.This was exceeded by over 70lbf.An additional test requirement for radial tensile strength of the graft is also conducted.The data shows that the minimum radial tensile strength of the graft was 49.0lbr which meets the specification requirement of greater than 10 lbf.Based on the evaluation of the returned device the graft was not found to be disintegrated, therefore the complaint could not be confirmed.The device was found to be in good condition with no abnormalities from the process of manufacturing were noted during the investigation.

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: 12352032
• MDR Text Key: 267619158
• Report Number: 3011175548-2021-00871
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251371
• UDI-Public: 00650862251371
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 417197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: HERO GRAFT.
• Patient Outcome(s): Required Intervention