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

Model Number	22059
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
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 an avf (left upper arm) procedure the gds was separated during the process of graft removal by connecting the avf (left upper arm) tunneler.Return of problematic products is not possible as they are inserted into the patient's body.Current patient status - nothing special.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation summary: the details provided indicate that during an avf of the left upper arm, the gds components of a 6x40 sw advanta vxt graft separated while pulling the graft through the tunnel made in the arm of the patient.There was no report of excessive force or manipulation to pull the graft through the tunnel.The graft separated from the tunneler rod and thus had to be retrieved using a kelly clamp (surgical instrument).There was little delay noted due to the intervention.The graft in question was implanted in the patient without incident.The gds portion of the graft was discarded and not available for return.The device in question was not returned and no images of the separated gds were provided, however based on the details provided the separation of the gds is highly likely of the same issue as documented within ncr005601, capa request, cr 987940, capa 1009364 and health hazard evaluation, hhe 2024002 as these were all opened to address the insufficient crimping of the gds that has led to separations of the gds in the field.In this regard the complaint and a device nonconformance can been confirmed.The ncr investigations concluded that machine is found to be the most probable root cause for this non-conformance.Investigations performed proved that loose faceplate leads to poor crimping.The reason for having a loose faceplate could be due to stud slippage over time due to machine vibrations and wear.It was also found one of the original studs of the equipment to be sheared to a shorter length.Additionally, method is a contributor for this ncr as the inspections in place are not adequate to catch a nonconformance under typical use in the field.The complaint history review identified 7 other complaints where the swivel rod separated from the swivel core and 3 other complaints where there was a larger than expected gap between the components of the gds.Of the 10 complaints, 8 of the investigations are complete and all 8 found the root cause to be related to the manufacturing assembly process.For the three complaints related to the gap, the root cause also noted a contributing factor of design.The equipment used to crimp the swivel rod onto the swivel core was found to be out of specification, resulting in the inadequate crimp.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.Actions to address this issue are ongoing as per the outcome of hhe2024002.
Event or Problem Description
N/a.

• Brand Name: GRAFTS ADVANTA VXT W/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: 18883009
• Report Number: 3011175548-2024-00077
• Device Sequence Number: 20730543
• Product Code: DSY
• UDI-Device Identifier: 00650862220599
• UDI-Public: 00650862220599
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2024

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 Model Number: 22059
• Device Catalogue Number: 22059
• Device Lot Number: 501930
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 04/26/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/12/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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: TUNNELER 6MM, KELLY (SURGICAL INSTRUMENT).; UNKNOWN.
• Patient Sex: Prefer Not To Disclose