MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM C-QUR MESH; MESH, SURGICAL, POLYMERIC

Model Number	31544
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Associated file: 1219977-2016-00131.On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received from patient that she required an explant of a mesh that was implanted several years earlier.She reported a bulge at the umbilicus and stated that a type of 'bolt' was used to secure the mesh and there were four of them.
Additional Manufacturer Narrative
A review of all manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging.Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.Clinical evaluation: recurrent hernia is a common adverse event that occurs due to, but not limited to, non-compliance with activity restrictions post-operatively and inadequate suture fixation or overlap.This event would require the patient to undergo a second surgery to correct the defect in order to prevent incarceration of the hernia and small bowel obstruction.Adequate mesh size, customizing the mesh, correct and generous dissection of pre-peritoneal space and wrinkle-free placement of the mesh are important factors in avoiding recurrence and complications.The instructions for use states complications may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption.The fixation technique, method and products used are left solely to the discretion of the surgeon to optimize clinical outcomes.Important aspects of user experience include the necessity of having operative planning with full identification of the extent of the hernia, adept skills in the application of sutures/tacks, and reconstruction skills assuring closure of the wound in layers and coverage of the implanted mesh with minimal space for serous collections and no direct pathway to the mesh from the skin.

• Brand Name: ATRIUM C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• MDR Report Key: 5733270
• Report Number: 1219977-2016-00132
• Device Sequence Number: 219218
• Product Code: FTL
• UDI-Device Identifier: 00650862315448
• UDI-Public: 00650862315448
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: 31544
• Device Catalogue Number: 31544
• Device Lot Number: 10824804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 07/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR