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

Model Number 22115

Device Problem Material Deformation (2976)

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

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital consistently uses the same model graft, and unlike usual use, it is said that the upper part was thin and the lower part was thick based on the blue line of the graft.He wants to ask the manufacturer if there is any problem with using the needle when the thin part is dialysis.There was no problem with the operation.

Manufacturer Narrative

Investigation: the details of the complaint were the following "the hospital is a hospital that consistently uses the same model, and unlike usual use, it is said that the upper part was thin and the lower part was thick based on the blue line of the graft.He wants to ask the manufacturer if there are any problems with using the needle when the thin part is dialysis.There was no problem with the operation, and the remaining part can be returned." clarification on the initial complaint description was received from gfe responses.Photos were provided which clarify that the concern is with the differing wall thickness around the circumference of the graft.On the side of the graft where the blue line is printed, the wall thickness is thinner than on the opposite side of the graft.The device was implanted in the patient without adverse event and the remaining portion of the device was returned for evaluation.The returned device was evaluated.The complaint is confirmed as the differing wall thicknesses have been observed on the sample that was returned.A review of the finished good lot device history records as well as all sub assembly lots show that the grafts passed all quality and performance requirements during the manufacture of the product.There were no nonconformities identified that could be related to the complaint and there is no evidence that procedural or specification changes that occurred surrounding the time of the build could be related to the complaint.There is no indication of a nonconformity with this lot of grafts.A complaint history, complaint trend, and capa review did identify one related complaint for the same product code.That complaint was not confirmed and the device was also found to be conforming.The root cause was listed as user preference.There were no capas or complaint trends identified to specifically aid in the investigation.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 labeling review determined that the instructions for use are appropriate as there are clear warnings and usability instructions related to use of a device that appears damaged.The investigation identifies that the manufacturing process allows variation in the wall thickness, however, the wall thickness of the device related to this complaint has been confirmed to be within specification.Therefore, the cause for the complaint is user preference.

• 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: 16410291
• MDR Text Key: 310091406
• Report Number: 3011175548-2023-00065
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862221152
• UDI-Public: 00650862221152
• 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
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 22115
• Device Catalogue Number: 22115
• Device Lot Number: 486233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1