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

Model Number	22072
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
During surgery for a fem-pop bypass case.Incisions were made both pop and fem, then gds insertion from fem to pop through tunneler.Proximal anastomosis done and cut off gds.Adjusting distal graft for positioning by mild manipulation, then the graft close to proximal anastomosis area broke off (not cut by surgeon but torn / broke off) the same sized graft not available and proximal anastomosis already done, they brought a 7x70 size as emergency for stitching to the broken part of 8x70 to reserve already implanted proximal area.And then, reinserted 7x70 to the distal area via tunneler for distal finish.The surgeon had concerns that because the broken part was close to the proximal anastomosis and if it were to occur after implantation it may cause a death or serious injury.
Additional Manufacturer Narrative
Additional information section: e1.D9, h6 corrected information section: e1 initial reporter.Due to character restrictions in block e1 event site address: (b)(6).This complaint reports that a vxt graft (p/n 22072, l/n 508590) tore during implantation.The user describes that they had removed the gds and completed the proximal anastomosis.When they were positioning the distal end, the graft tore near the proximal end.The user stated that a short piece of the graft remains implanted in the patient and that another graft was used to finish the procedure.The removed portion of the graft was returned for evaluation.The device was received in 3 pieces.The first piece is the end with the gds and clear sheath attached.The second is a long segment of graft, each end of which appears to match up with one of the other two pieces.The third piece is a very short segment.The piece with the gds was removed in order to make the proximal anastomosis.It appears that the tear occurred between the second and third piece and the third piece was cut from the implant afterward.On the two pieces where the tear occurred, much of the edges is rough, appearing as though the graft did tear apart.But there is also a flat section which appears more cleanly split.The helix also appears relatively cleanly split.This indicates that the graft may have been nicked with a sharp instrument.This may have happened while cutting away the clear sheath, while peeling back or trimming the helix, or while cutting the suturing material.A small cut could have gone unnoticed, especially with the graft covered in blood, as it was when it was returned.While preparing to make the distal anastomosis, tension placed on the graft could have caused the cut at the proximal end to further split apart, causing the rougher looking edges.The user did not mention having to cut the helix after the graft tore, so it is presumed that both the graft and the helix tore apart during this event.These are two separate pieces of eptfe that are sintered together during manufacturing, so it is unlikely that a defect in the ptfe occurred on both pieces and happened to align in the exact same spot.The most likely possibility of a manufacturing issue would be a problem during sintering, however there is no indication of that occurring in the dhr review and no history of it identified in any of the historical reviews completed in this investigation.A dhr review was completed and did not identify any anomalies in manufacturing.All sampled grafts from this lot passed tensile strength tests.There is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.A recurring lot number query was conducted for l/n 508590 and there have been no other complaints associated with the production lot of finished goods.The ifu provides adequate instructions for the use of this device and cautions a user not to use a damaged a device and how to avoid causing damage to the device.It also provides specific instructions about how to handle the graft and what tools to use/not use.There is no indication that inadequate instructions are related to this complaint.A historical review of capa, ncrs and complaints was completed, which did not identify any issues directly related to this complaint.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.There is no indication that the product was nonconforming when it left the manufacturing facility or that the instructions for use were inadequate.There were some signs on the returned device that it may have been accidentally nicked with a sharp instrument.However, based on the state of the returned graft and the information available, it is not possible to determine with certainty the cause of this complaint.The root cause of this complaint is impossible to define.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: after receiving a response letter, the user reached out with additional information.It was originally believed that both the graft material and the helix tore in the same spot.The user clarified that only the graft material tore, and the helix was cut in order to remove the disconnected piece of graft.This clarification explains why the helix appeared cleanly cut.It does not explain why the graft may have torn and it remains true that no evidence was identified in the trending or manufacturing review to indicate the cause.While the edge of the graft appears to have been cut slightly, the cause still cannot be known for certain.The root cause remains impossible to define.

• Brand Name: ADVANTA SLIDER 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: 22294522
• Report Number: 3011175548-2025-000006
• Device Sequence Number: 8374027
• Product Code: DSY
• UDI-Device Identifier: 00650862220728
• UDI-Public: (01)00650862220728(17)270425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K231972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22072
• Device Catalogue Number: 22072
• Device Lot Number: 508590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 09/09/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/03/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female