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

Model Number 25058

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Approximately 45 days after flixene was inserted, blood clots were formed in the veins of autogenous vascular which caused blockage.The patient returned to the emergency room of the hospital for revascularization.The blockage occurred again shortly after the revascularization.Thus, the patient returned to the hospital again.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint the patient formed a blood clot about 45 days after flixene graft was inserted, blood clots were formed in the veins of autogenous vascular graft which caused blockage.The patient returned to emergency room (er) of the hospital for revascularization.The blockage occurred again shortly after the revascularization.To obtain as much information as possible regarding this case multiple questions were asked to understand patient conditions.The information provided indicates the patient was not on any anti-coagulation medication and was being cannulated three times a week.The image that was provided shows that the blockage is occurring in the native vessel and not within the flixene graft.It is unknown why the patient has experienced blood clot formations within their native vasculature however; adverse reactions or complications that can occur with the use of any vascular graft include but are not limited to thrombus formation and stenosis.This is captured in the instructions for use (ifu) provided with the flixene graft in the adverse reactions section.Blood clots or thrombus formation can occur and there is a section in the ifu called "thrombectomy" which states that in the event that an incision needs to be made to the advanta or flixene graft (e.G.For the purpose of providing an access site for declotting the distal anastomosis) post implantation, the following is recommended: ¿ if and when a longitudinal incision is made for a thrombectomy, it is recommended to place a stay stitch at each end of the longitudinal incision prior to balloon catheter use.¿ a horizontal mattress suture technique should be used for closure of the incision site of the graft.¿ do not apply excessive tension on the implanted advanta or flixene eptfe graft during inflated balloon catheter withdrawal.Over inflation of an embolectomy, balloon or use of an inappropriate sized catheter may cause damage to the graft and anastomosis.¿ extreme care must be exercised with the use of all mechanical water jet thrombectomy and mechanical rotary brush devices to not disrupt or damage the advanta or flixene eptfe graft material, prior vascular access holes and/or suture line.There was no product returned therefore an evaluation of the reported device could not be conducted.The review of the dhr did not identify any issues in regards to the performance of the graft.The details provided indicate that the patient conditions and operative technique played a role in the formation of the blood clots.The image provided also indicated that the clots were not within the flixene graft but proximal and distal of the implant.Based on the provided complaint details, the device history record review and response from the physician, the investigation could not conclude or confirm that the flixene graft was the cause of the blood clot formation.

Event Description

N/a.

• 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
• MDR Report Key: 11256702
• MDR Text Key: 229570962
• Report Number: 3011175548-2021-00111
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: 00650862250589
• Combination Product (y/n): N
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 437736
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR