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

Model Number	25129
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon cut flixene graft with a scalpel to prepare for suturing.After cutting the graft it delaminated approximately 1cm, the outer layer of graft peeled back on itself.Physician then cut graft again with no issue and case was completed.There was no injury to patient.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The details of the complaint state that "after cutting the graft delaminated approximately 1cm, outer layer of graft peeled back on itself." the product in question was returned and evaluated.There were two pieces returned for the evaluation.One sample was in fine condition and had no noticeable damage and was approximately 4.5 cm long and was a piece from the tapered section of the graft.The second piece was of the larger end of the graft ad had the outer ptfe layer of the graft peeled back upon itself.For the material to invert back on itself outside influence would be required as there is no tension on the material.Upon closer inspection there were very defined outlines of serrated forceps used to clamp the graft.There is no evidence on the far end of the graft of any delamination of the outer layer and no signs of serrated forceps being used.There is no indication based on the physical inspection of the returned graft that the device was non-conforming.Based on the results of the investigation it would appear that the outer layer was peeled back by an outside influence likely caused by the outer layer of the graft sticking to the serrated forceps used in the case or by other means.The instructions for use aw011456 in the warnings section of the ifu the following: "5.Clamping of the graft should be avoided whenever possible and limited to clamps shod with soft material." based on the details of the complaint and the results of the investigation the complaint can be confirmed as the returned segment did have the outer layer peeled back but based on the results of the investigation cannot be associated with the manufacture of the product.The root cause is determined to be use error.Based on the dhr review there is no indication that a design, test methods, manufacturing processes, equipment (e.G.Unscheduled maintenance), or raw material was the cause of the complaint.The product met all quality and performance requirements.The review of the associated device history records did not identify any non conformities during the review and all quality and performance requirements were met during the manufacture of this product.No related capas or ncrs were identified.The trend review identified a standard deviation excursion for the reported defect "defective or damaged device is identified during use and before completion of procedure/prolonged procedure" for the month of (b)(6) 2022.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.
Event or Problem Description
N/a.

• Brand Name: GRAFTS FLIXENE GRAFTS W/GDS
• Common Device Name: 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: 13285973
• Report Number: 3011175548-2022-00030
• Device Sequence Number: 20048977
• Product Code: DSY
• UDI-Device Identifier: 00650862251296
• UDI-Public: 00650862251296
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: 25129
• Device Catalogue Number: 25129
• Device Lot Number: 471878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/03/2022; 09/21/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/08/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male