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

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the surgeon reflects that the clear plastic sleeve is not easy to remove.He asked would it be possible to make a small hole at the clear plastic sleeve in the future so it could be removed by tearing.

Manufacturer Narrative

Analysis: the complaint is in regards to the clear plastic sheath that fits over the graft.The physician had commented that the clear sheath was not easily removed and if there was a way to make a small hole at the clear plastic sleeve in the future so it could be removed by tearing.The clear outer sheath was designed to withstand the graft being pulled through the vasculature.A review of the complaint system going back the last 3 years shows that there has only been one other incident where a physician complained about having a difficult time removing the clear plastic sheath.In the past 3 years there have been over 22,000 flixene grafts sold.The instructions for use in the ¿standard bypass surgical technique and tunneling procedure¿ section state the following: "cut the graft and clear sheath closest to the gds.Remove and discard the gds.The graft may be cut using sharp surgical scissors or a scalpel.It is strongly recommended that the graft be cut with scissors to provide an even cut.Unless absolutely necessary, it is recommended not to cut the graft until it has been tunneled and is in place, ensuring that the graft will be long enough.¿ ¿secure the graft at the proximal incisional end using a pair of shod forceps.Make sure that when securing the graft with the forceps, the clear sheath is not secured as well.Using gentle steady pressure, pull the clear sheath from the distal incisional site and withdraw it from the graft/patient entirely.¿ additional instructions are also provided in the instructions for use (ifu) in the ¿av access arm loop graft placement¿ state the following: ¿using sharp surgical scissors carefully cut the clear sheath in the mid portion of the loop so that each end of the sheath can be removed separately from the proximal incision site.Do not cut any portion of the graft wall when cutting or separating the sheath in the mid portion of the loop graft.¿ ¿next, cut the graft and clear sheath closest to the gds.Remove and discard the gds.The graft may be cut using sharp surgical scissors or a scalpel.It is strongly recommended that the graft be cut with scissors to provide an even cut.If a double ended gds has been used, remove the other gds unit at this time.¿ ¿gently secure the graft at the middle of the loop using a pair of shod forceps.Make sure that when securing the graft with the forceps, the clear sheath is not secured as well.Using a clamp to secure either proximal end of the clear sheath, pull on the sheath to remove it from the graft/patient.Repeat this procedure and remove the other half of the clear plastic sheath.¿ the details surrounding the difficulties experienced by this physician were not provided and there were no images of the device in question provided with the complaint.The instructionsfor use clearly instruct the physician how to remove the clear plastic sheath.There was also no product lot number provided.As such a review of the device history records could not be performed.Conclusion: based on the complaint details atrium medical corporation cannot conclude that the manufacture or design of the product is at fault.There are very clear instructions on the removal of the clear sheath provided within the instructions for use that are supplied with every graft.H3 other text : not available for return.

Event Description

N/a.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10170222
• MDR Text Key: 196229748
• Report Number: 3011175548-2020-00831
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1