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

Model Number 22064

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/03/2016

Event Type  malfunction  

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: 3011175548-00010.

Event Description

Report received stated that the second layer of the graft was lifting during the removal of the helix.

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
• Type of Device: ADVANTA VXT, 8X50, 1GDS, FH, STR-SW
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6119502
• MDR Text Key: 60862959
• Report Number: 3011175548-2016-00011
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862220643
• UDI-Public: 00650862220643
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/18/2019
• Device Model Number: 22064
• Device Catalogue Number: 22064
• Device Lot Number: 405247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1