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

Model Number	22176
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation a follow-up report will be submitted.
Event or Problem Description
Once in place, the prosthesis began to bead and show signs of leakage.There were ring impressions, but it was an unringed prosthesis.
Additional Manufacturer Narrative
Correction section: h6-health impact getinge was made aware of an ansm report which stated that an advanta vxt graft (p/n 22176, l/n 506832) was placed in a patient and then showed showed signs of leaking and beading.It was mentioned that the user saw "ring impressions" on the graft although it was a non-ringed prosthesis.The user sealed the leak with tachosil, a surgical patch that stops bleeding and leaking.The surgery was completed and the graft remains implanted, with no further harm to the patient reported.Details such as the location of the leak are unavailable.Common ways for this to occur are the use of inappropriate suturing needles or inappropriate clamping tools which can tear or delaminate the graft.Leaks caused in this way would typically be seen near one end of the graft where it is sutured to the native vessel.The graft remains implanted and cannot be returned for evaluation.No pictures were provided.The complaint was receive through ansm and the user facility has not responded to requests for additional information, so limited information about the event is available.The graft used is not manufactured with a supporting helix so it should not have had signs of one.Without the device or pictures to evaluate, it cannot be determined from the provided information what may have caused this complaint.The dhr for lot 506832 and relevant subassemblies and inspection documents were reviewed and no anomalies in manufacturing were found.No ncrs were identified for any of these lots.A recurring lot number report was completed which identified no other complaints involving lot 506832.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.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 warns the user not to pre-wet the graft, as this may cause damage to the device or patient.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found one similar complaint, in which the graft was returned and no leak could be identified during evaluation.A review of crs/capas identified no related crs or capas.No related scars were identified.No related ncrs were identified.There is no indication that the product was nonconforming when it left the manufacturing facility or that the instructions for use were inadequate.The complaint could not be confirmed.The device was successfully implanted and was not returned for evaluation.No pictures of the event were provided.The root cause of this complaint is impossible to define.
Event or Problem Description
N/a.

• 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: 21074723
• Report Number: 3011175548-2025-000000
• Device Sequence Number: 20939436
• Product Code: DSY
• UDI-Device Identifier: 00650862221763
• UDI-Public: (01)00650862221763(17)270318
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 03/03/2025

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 Model Number: 22176
• Device Catalogue Number: 22176
• Device Lot Number: 506832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown