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

Model Number	22209
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report received stated that when preparing for fem - fem bypass surgery the soft-wrap, not the ring came off more than usual, so the user judged it to be defective and did not use it.The surgery was completed using another product.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation: the device in question was returned and evaluated.Upon initial review the eptfe material was pulling off as it was sticking to the monofilament as described by the complainant.The graft itself was stained from handling in the surgical suite.The opposite end was in good condition and appeared to have been untouched.To determine if this fraying was related to the method of pulling the monofilament off the base graft, the monofilament on the untouched end was removed per the instructions for use aw011456 rev aa.The instructions for use say to remove the helix at a 45°angle.When this was conducted no attachment of the eptfe to the monofilament was observed.When the monofilament was pulled straight up off the graft the fraying was observed.In an attempt to determine if the fraying was only specific to one end, the fraying ptfe strands that were adhered to the monofilament were cut away using a razor blade.The monofilament was then pulled off the graft again following the ifu.No strands of eptfe were attached to the monofilament.Based on the condition of the returned device the complaint can be confirmed to have fraying or strands of eptfe attached to the monofilament.The device history records review did not identify any related non-conformances.All product quality and performance requirements were met.There was no on demand maintenance of associated manufacturing equipment identified around the time of manufacture and all equipment was in calibration.No significant design, material, procedural or process changes around the time of device manufacture were identified.The ifu provides adequate instructions and warnings for proper use of the device and no evidence was identified to suggest it is related to this complaint.It is also important to note that the ifu states ¿ if the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure¿ complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found two other similar complaints where the customer noted the ptfe outer cover of the graft began peeling or fraying when removing the helix rings from the graft.One complaint and was closed with a root cause of user error since the user described using a peeling technique which was not in alignment with the ifu.The second complaint had identified that the scissors or scalpel used in the procedure may have been dull and not sharp describing the root cause as operational context.A recurring lot number report was completed which did not find any other complaints involving lot: 492703.A review of crs/capas found no related crs and no related capas during the time period reviewed.A review of ncrs found no related ncr s associated with the fraying of the graft during the time period reviewed.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.Based on the investigation, the root cause is impossible to define.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.No evidence was identified to suggest that this complaint is related to design, materials, equipment or process or instructions for use.

• 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: 17857993
• Report Number: 3011175548-2023-00187
• Device Sequence Number: 14885480
• Product Code: DSY
• UDI-Device Identifier: 00650862222098
• UDI-Public: 00650862222098
• 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
• Report Date (Section B): 11/16/2023

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: 01/06/2026
• Device Model Number: 22209
• Device Catalogue Number: 22209
• Device Lot Number: 492703
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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: UNKNOWN.
• Patient Sex: Unknown