MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SLIDER GDS; 6MMX80CM, TW, H, ADVANTA VXT, GDS

Model Number	22225
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/26/2017
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 when the physician attempted to remove the helix of the graft the second layer of the graft also peeled off.
Additional Manufacturer Narrative
The graft sample was not returned; therefore an evaluation of the actual product could not be performed.The pictures provided exhibit shredding of the surface of the graft when attempting to remove the helix wrap.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.All dhr's associated with the graft lot were reviewed and found to be complete and accurate.All of the test results met the acceptance criteria.

• Brand Name: ADVANTA SLIDER GDS
• Common Device Name: 6MMX80CM, TW, H, ADVANTA VXT, GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6294386
• Report Number: 3011175548-2017-00005
• Device Sequence Number: 759337
• Product Code: DSY
• UDI-Device Identifier: 00650862222258
• UDI-Public: 00650862222258
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/26/2017

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: 08/08/2019
• Device Model Number: 22225
• Device Catalogue Number: 22225
• Device Lot Number: 407271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR