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

Model Number	22064
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/10/2025
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 implantation of advanta vxt graft it started bleeding through the graft wall and not only suture holes.This happened after part of the support helix was removed.To stop the heavy bleeding surgeon used 2 x tisseel tissue glue to get the bleeding under control.This led to a prolonged surgery.There was no reported adverse effects to the patient post surgery and the graft remains implanted in the patient.
Additional Manufacturer Narrative
Additional information section: h6.Corrected section: e1- event site address.During implantation of advanta vxt it started bleeding through the graft wall and not only suture holes.This happened after part of the support helix was removed.To stop the bleeding the surgeon used 2 x tisseel tissue glue to get the bleeding under control.Based on the details of the complaint it appears as if the outer helix was removed and part of the outer cover as well when removing.This can happen if the helix winding is not removed as per the instructions for use (ifu).The ifu specifies the following when removing the helix from the graft: ¿do not pull, peel, separate or delaminate any portion of the multi-laminate wall or reinforcement layer of the graft".Instructions on removal of external ¿rings¿ or ¿helix¿ from the advanta vxt vascular graft while the rings are added to the advanta vxt to improve kink, compression and torque resistance, a physician may choose to remove portions of it for surgical/technical reasons.The steps to do so are as follows: 1.Hold the graft flat (horizontal).2.Take the very distal portion of the ptfe ring with a pair of forceps and slowly pull off the ring at a 45 degree angle, being mindful not to catch the outer soft wrap.3.If the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.¿ if the helix is not removed properly as instructed damage can occur to the base layer of the graft.This could potentially be the cause of the complaint.There had been some answers provided by the complainant but did not provide any insight as to the reasons why there had been bleeding or weeping of blood through the cover.As the conditions experienced during the procedure are unknown duplicating the failure mode was not conducted and a contemporaneous sample was not requested from inventory.A dhr review was completed and did not identify any anomalies in manufacturing.All sampled grafts from this lot passed all quality and product performance requirements.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 514031 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 were no images of the graft provided and the graft in question was not returned as it was implanted.As the graft was not returned and no images provided the complaint cannot be confirmed.Based on the details provided and review of the details the root cause is impossible to define.It is possible the helix was removed improperly causing damage to the graft.

• 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: 22345559
• Report Number: 3011175548-2025-000006
• Device Sequence Number: 8512960
• Product Code: DSY
• UDI-Device Identifier: 00650862220643
• UDI-Public: (01)00650862220643(17)271009
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 22064
• Device Catalogue Number: 22064
• Device Lot Number: 514031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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: TISSEEL TISSUE GLUE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown