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

Model Number	22114
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
During the avg procedure, while connecting the graft gds to the tunneler for the graft deployment process, severe twisting of the graft body occurred.The graft was removed, and the surgery was completed using a consigned product of the same model (sn (b)(6)).It appears that during the process of connecting the gds to the tunneler, not only the gds but also the graft rotated together.
Additional Manufacturer Narrative
Additional information section: a3, d10, e1, g2.Corrected section: e3.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
This complaint reports that an advanta vxt graft (p/n 22114, l/n 509408) was being prepared and when the gds was being attached the graft severely twisted.The graft was removed and another of the same model was used to complete the procedure.The device was returned for evaluation.Half the graft is coated in blood and the rest has fingermarks.The graft appears squeezed and bent in places, but none more severe than the graft would experience being implanted.There does not appear to be any significant damage to the graft caused by twisting.The gds is clear of tissue or other debris other than some smudges of blood from the surgeon handling the graft.The tip of the gds is able to spin freely without twisting the graft.In the state it was received, using proper technique it should have been possible to connect the gds from the tunneling rod without twisting the graft.The dhr for lot 509408 was reviewed and no anomalies were identified.Nothing in the manufacturing or design of this device was identified as potentially related to this complaint.The ifu provides adequate instructions for the use of this device and does not include any instructions that would lead to the twisting of the device.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 2.This was determined to be appropriate based on the harm that was reported in the complaint.A complaint history review was completed which found no similar complaints.A recurring lot number report was completed which identified no other valid complaints involving lot 509408.A review of crs/capas identified none related to this complaint.This complaint is confirmed, however a device nonconformance is not.While it is likely that this complaint was caused by user technique, not enough information about the handling of the device is available to say that for certain.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: 21024205
• Report Number: 3011175548-2024-000025
• Device Sequence Number: 8367766
• Product Code: DSY
• UDI-Device Identifier: 00650862221145
• UDI-Public: (01)00650862221145(17)270617
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 509408
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/09/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: ADVANTA VXT SN (B)(6).; TUNNLER 6MM.
• Patient Sex: Female