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

Model Number	22012
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
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
While performing an upper arm avbg (arterio-venous bridge graft), trying to connect the graft after drilling it with a tunneler, hospital said they couldn't connect it because the gds part was separated.The surgery was completed by replacing it with another consignment product of the same size.The surgery went off without any problems.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation summary: during an upper arm arterio-venous bridge graft procedure, the user attempted to attach the gds component of a 6x40 sw advanta vxt graft (part number 22012) to the tunneler rod but couldn¿t because the gds components were separated.There was no patient injury reported and the procedure was completed using a different graft.The device in question was received and evaluated.The device was clean (free from blood) and did not appear to be tunneled, aligning with the report that it broke while trying to attach to the tunneler rod.Upon reviewing the returned device, it was clear that the swivel rod had separated from the swivel core confirming both the complaint and a device nonconformity.The crimping on the end of the swivel rod was very light/shallow.The crimps are what hold the swivel rod onto the swivel core and a shallow crimp will not be as strong as a deeper crimp.The swivel rod was placed back over the swivel core and a 2mm gap between the end of the gds swivel rod and the gds anchor was seen.The review of the device history record shows that there were no non-conformances during the manufacturing process build.All product when inspected was within specification.The complaint history review identified 4 other complaints where the swivel rod separated from the swivel core.There were also three complaints identified where the gds was reported to have a large gap between the components but was not separated.The investigation for these complaints found the root cause to be related to the manufacturing assembly process with 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.There was one ncr and one capa request identified in regard to the functionality of the gds crimper.This is ncr005601 and (b)(4).The capa request is still under investigation.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.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.Escalation is required for this complaint.It has been added to (b)(4).The investigation has concluded that the product in question was possibly not assembled properly based on the separation of the swivel rod from the swivel core and is related to the gds crimping equipment discrepancies found in previous investigations.Hhe 2024002 has been initiated and covers this complaint as well.

• 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: 18595549
• Report Number: 3011175548-2024-00014
• Device Sequence Number: 6811058
• Product Code: DSY
• UDI-Device Identifier: 00650862220124
• UDI-Public: 00650862220124
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2024

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: 08/28/2026
• Device Model Number: 22012
• Device Catalogue Number: 22012
• Device Lot Number: 500356
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 04/12/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/21/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown