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

Model Number	22209
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After removing helix rings from advanta vxt eptfe vascular graft, the graft had started to fray (only about 3-4 cm both proximally and distally).Graft is performing well.Ct-scan afterwards was perfect, patient is doing well.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information: section d8, h6 & h10.Corrected information: section d1 & d4 - udi #.Investigation summary: this complaint reports that an advanta vxt graft (p/n 22209, l/n 499165) appeared frayed after removing the helix rings were removed.The graft was successfully implanted with no other issues and no harm to the patient.Pictures were provided by the user which show the removed helix monofilament with strands of the eptfe graft attached to it.The user was asked how much of the helix was removed, what tools were used to remove it, and at what angle it was removed.The user stated that 3-4cm of the helix was removed from either end of the graft, that mosquito forceps were used to grasp the helix and the graft body was held by hand, and that the helix was peeled off at an angle less than 45°.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 remove the helix.The ifu states that in the case that the outer layer frays, the procedure can still be completed as long as the base layer is intact.Most details regarding technique provided by the user adhered to the instructions in the ifu except that they reported removing the helix at an angle less than 45°.The user did not specify what the angle was, but the ifu instructs the user to remove the monofilament at a 45° angle, so this action may have contributed to the complaint.The most likely root cause of this complaint is user error due to the technique used to remove the helix.The dhr for lot 499165 and relevant subassemblies were reviewed and no anomalies in manufacturing were found.All samples tested from this lot passed helix peel strength testing during manufacturing.No ncrs were identified for any of the manufacturing lots associated with the device.A recurring lot number report was completed which identified no other complaints involving lot 4499165.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.

• 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: 19834375
• Report Number: 3011175548-2024-00197
• Device Sequence Number: 18080556
• Product Code: DSY
• UDI-Device Identifier: 00650862222098
• UDI-Public: (01)00650862222098(17)260803(21)499165000
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 08/03/2026
• Device Model Number: 22209
• Device Catalogue Number: 22209
• Device Lot Number: 499165
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 85 KG