MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SLIDER GDS; ADVANTA VXT, 8X50, 1GDS, FH, STR-SW

Model Number	22064
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/03/2016
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.Related mdr: 3011175548-00011.
Event or Problem Description
Report received stated that the second layer of the graft was lifting during the removal of the helix.
Additional Manufacturer Narrative
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.

• Brand Name: ADVANTA SLIDER GDS
• Common Device Name: ADVANTA VXT, 8X50, 1GDS, FH, STR-SW
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6119496
• Report Number: 3011175548-2016-00010
• Device Sequence Number: 551553
• 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,Followup
• Report Date (Section B): 11/07/2016

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: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 01/10/2017; 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1