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

Model Number	22114
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Report received stated that during the arteriovenous graft (avg) operation, eptfe stands adhered to the helix upon removal.The operation was performed with the same model graft and there was no problem or delay in the operation.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that during the arteriovenous graft (avg) operation, eptfe stands adhered to the helix upon removal.The operation was performed with the same model graft and there was no problem or delay in the operation.
Additional Manufacturer Narrative
Additional information: d9.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The complaint description states that a "hair" was loosened from the front of the graft during the operation so the graft was replaced.Upon evaluation of the returned graft, what appears to have occurred is a fiber became frayed when the tip of the graft was trimmed and in an attempt to remove it, the fiber was pulled on rather than trimmed.This caused the fiber to continue unraveling from the graft, at which point the graft was replaced.Upon investigation of the returned device, it is confirmed that delamination occurred and the outermost layer of the device was unraveled.This is an anticipated failure mode for which there are instructions in the ifu to specifically prevent.The ifu for this device instructs the user to cut the graft using sharp surgical instruments (preferably scissors) in order to prevent damaging the layers of the device.It also warns the user not to pull on any layer of the device that becomes separated.The complaint can be confirmed however there is no indication that the product was faulty as the device history records show that the product met all quality and performance requirements and there were no non-conformances during the manufacturing process.Based on the details of the complaint and investigation the thread of material appears to be from handling.The small piece of the graft rather than being trimmed was pulled unraveling the graft further.In this regard the root cause is most likely user error.The graft was likely not cut with a sharp instrument, as instructed in the ifu.The complaint trend review was completed for the 15-month periods ((b)(6) 2020 - (b)(6) 2022) to identify other complaints with the reported defect.In the 20 total months reviewed, this complaint was the only one identified with the stated reported defect.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.
Event or Problem Description
N/a.

• 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: 13581735
• Report Number: 3011175548-2022-00088
• Device Sequence Number: 4410429
• Product Code: DYF
• UDI-Device Identifier: 00650862221145
• UDI-Public: 00650862221145
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 10/06/2024
• Device Model Number: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 475583
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/28/2022; 09/21/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/31/2022; 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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