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

Model Number	22212
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was a peripheral vascular bypass surgery.On trimming the anastomotic site with the patient's blood vessel, the coating on the tip was peeled off.(like a frayed thread).
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details provided, when trimming the anastomotic site with the patient's blood vessel, the coating on the tip was peeled off.(like a frayed thread).A small piece of the graft was returned for evaluation.Upon receipt the piece that was returned was the small section removed from the graft when creating the angled cut for the alignment with the anastomosis site of the vessel.There was a very small area at the very tip with a thread of the ptfe material.Appears to be an artifact of cutting the graft with a dull instrument or not connecting the cut point intersection.The remainder of the graft was not returned for evaluation.There were also no images provided by the institution to aid in the investigation and no answers received back from the complainant.The complaint has confirmed that a small thread of ptfe material was present but cannot confirm that this was associated with the manufacture of the graft.Within the instructions for aw011456 the following is provided in regards to the removal of the external rings from the graft."instructions on removal of external ¿rings¿ or ¿helix¿ from the advanta vxt vascular graft while the rings are added to the advanta vxt to improve kink, compression and torque resistance, a physician may choose to remove portions of it for surgical/technical reasons.The steps to do so are as follows: 1.Hold the graft flat (horizontal).2.Take the very distal portion of the ptfe ring with a pair of forceps and slowly pull off the ring at a 45 degree angle, being mindful not to catch the outer soft wrap.3.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.A trend review covering november 2020 - july 2022 was performed.This complaint occurred in january 2022 and was the only one identified in this time period for this reported defect.Three similar complaints with different descriptions were identified since jan 2020.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.The device is operating within its approved risk profile.There have been no related capas or ncrs.The device history review did not identify any nonconformances and anomalies.Based on the details of the complaint and investigation of the small piece of the graft returned combined with the detailed review of the device history records there is no indication that the device was faulty.The piece returned appears as if the medical scissors may have not been sharp or completed to intersect the corresponding cut creating a tip of frayed material.In this regard the root cause is likely operational context.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM 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: 13358452
• Report Number: 3011175548-2022-00035
• Device Sequence Number: 4104483
• Product Code: DYF
• UDI-Device Identifier: 00650862222128
• UDI-Public: 00650862222128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 11/20/2023
• Device Model Number: 22212
• Device Catalogue Number: 22212
• Device Lot Number: 465620
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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