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

Model Number 22012

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2024

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

During a tunneling procedure, the gds separated after tunneling and combining, it just falls out when pulled out.It was removed and replaced with new product.No patient harm, only five minute delay to replace graft.

Manufacturer Narrative

Additional information: section d9 & h6 investigation summary: the details provided indicate that during the procedure ¿lt, axilla avg just fell out when i took it out after combining it with the tunnel.¿ there was no report of excessive force or manipulation to pull the graft through the tunnel.The event was clarified to mean that the gds disconnected from the graft when an attempt was made to pull the graft through the tunnel under the patient¿s skin while it was connected to the tunneler rod.The graft was not used and a new graft was obtained and implanted instead.The device in question was returned and evaluated.The gds of the graft had been separated as anticipated based on the details provided confirming the complaint.The graft in this case was not used and the entire graft was returned.There was no other damage noted of the graft.A review of the crimp witness marks from when the swivel rod is crimped to the swivel rod were very faint.Based on the details provided and review of the returned product the separation of the gds is highly likely of the same issue as documented within ncr005601, cr 987940, capa 1009364 and (b)(4) 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 complaint history review identified 7 other complaints where the swivel rod separated from the swivel core.All related complaints found the root cause to be related to the manufacturing assembly process.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 and one capa identified in regard to the functionality of the gds crimper.This is ncr005601 and cr 987940 and capa 1009354.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.(b)(4) has been completed and covers this complaint.This complaint is being addressed by the actions in capa 1009364.Field action ref: 3011175548-05/08/2024-001-r.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Type of Device: 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: 19172910
• MDR Text Key: 341014440
• Report Number: 3011175548-2024-00107
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862220124
• UDI-Public: 00650862220124
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: 22012
• Device Catalogue Number: 22012
• Device Lot Number: 502121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: SEE NARRATIVE
• Patient Sequence Number: 1
• Treatment: TUNNELING 6MM TIP
• Patient Sex: Prefer Not To Disclose