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

Model Number 25135 - FLIXENE 4-7MMX45CM GWT W/DBL GDS

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated the surgeon tried to remove clear plastic sleeve and it kept ripping.Plastic sleeve frayed when being pulled out of body.

Manufacturer Narrative

Upon receipt of the returned device the device had clearly been in place as the graft was very badly blood stained and had not been disinfected.The two ends of the graft had been cut clean to remove the gds connectors.The ptfe and clear outer sheath had clean cuts from the process of removal of the gds connectors.It is important to note that when both gds connectors are removed the clear outer sheath is no longer anchored as the gds connections hold the clear outer sheath firmly as it is crimped under the gds connector.There is nothing holding the clear sheath once the gds connectors are removed.Also returned was the remaining clear outer sheath material.It was clear that there was a section approximately 5 inches in length missing.Neither of the remaining two section of materials had clean cut ends.Since the gds connections and sheath were cut cleanly it is not understood why the remaining sections of clear sheath material did not have clean cut ends.The actual ptfe graft on one end had been clamped using serrated forceps.If the forceps were also holding the clear outer sheath it would explain why the clear sheath would not come off the flixene graft.There was no other mechanical fixation of the clear sheath material once the gds connectors were cut off.A thorough review of the device history records for this graft lot was conducted.The device lot in question met all quality and performance testing requirements and no non-conformance were noted during the build of the product related to the complaint.Based on the review of the device history records and product complaint details atrium medical corporation cannot conclude that the inability of the physician to remove the clear outer sheath was directly related to the flixene graft.It is possible that the outer sheath had been clamped with the forceps preventing easy removal of the clear outer sheath.A graft may be torn if excessive manipulation is used in the preparation or implantation of the device.The flixene graft products are packaged with a blue transfer sleeve and they feature a protective handling cover, which is to be removed prior to graft implantation.

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 03054
• MDR Report Key: 8755590
• MDR Text Key: 149933409
• Report Number: 3011175548-2019-00735
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251357
• UDI-Public: 00650862251357
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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 Expiration Date: 12/10/2021
• Device Model Number: 25135 - FLIXENE 4-7MMX45CM GWT W/DBL GDS
• Device Catalogue Number: 25135
• Device Lot Number: 440183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77