MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION 8MMX50CM, SW, H, ADVANTA VXT, GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	22064
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received stated that during anastomosis, while attempting to remove the helix from the graft the second layer was lifting.
Additional Manufacturer Narrative
Correction: this mdr was originally submitted on may 02, 2017 the mdr submission had an error in the mdr number 3011175548-2107-00011 the mdr number should have been 3011175548-2017-00011.This mdr is being submitted to correct the mdr number and provide the follow-up additional information.The returned graft segment was received and visually inspected, one end of the graft had the helix removed, there were portions of the wrap layer that had separated from the base graft and remained adhered to the helix.A clean cut was made on the opposite end of the graft segment and the helix was removed.It was observed that portions of the wrap layer separated from the base graft and remained adhered to the helix, however a root cause has not been determined.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 instructions for use (ifu) clearly define the appropriate steps of removing the helix.Hold the graft flat (horizontal).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.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 device history record review was performed and the graft lot was found to have met all specifications.Clinical evaluation: the graft needs to be sized correctly prior to implant to ensure the integrity of the anastomosis sites.If a graft is too short there would be excessive tension at the suture sites and could potentially result in tearing or shredding.The instructions for use state complications may occur during the use of any vascular graft include mechanical disruption or tearing of the graft material which may result in adverse events.

• Brand Name: 8MMX50CM, SW, H, ADVANTA VXT, GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6436867
• Report Number: 3011175548-2017-00011
• Device Sequence Number: 19003282
• Product Code: DSY
• UDI-Device Identifier: 00650862220643
• UDI-Public: 00650862220643
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: 22064
• Device Catalogue Number: 22064
• Device Lot Number: 405930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1