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

Model Number	31535
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including testing for suture retention and ball burst conducted on the mesh at incoming.Fournier transform infrared spectroscopy testing and coating density of the cured omega-3 fatty acids coated c-qur panels and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met.Clinical evaluation: c-qur products are provided sterile.The instructions for use advise to use sterile technique when using the mesh.It was reported that the patient experienced complications following the implant of surgical mesh.Fistulas are a known complication of incisional hernia repairs using prostheses.Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, diabetes mellitus, elder age and poor nutritional status.Fistulas are a late complication of repairs with mesh particularly if the mesh is in direct contact with the intestine and may be caused by chronic infection.Atrium's mesh with omega three fatty acids (o3fa) will typically absorb over 19-24 months under normal healing conditions.The o3fa gel coating on the c-qur mesh breaks down via hydrolysis by body fluids into naturally occurring fatty acids and glycerides, which are readily absorbed by normal lipid metabolism.Any surgery that causes a break in the skin can lead to a postoperative infection.Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.Other risks for ssis include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to fistula formation and infection.Adequate mesh fixation is required to minimize post operative complications and recurrence." related file 1219977-2016-00224.
Event or Problem Description
Approximately four weeks after mesh was implanted it was explanted due to infection and fistula.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6149107
• Report Number: 1219977-2016-00243
• Device Sequence Number: 13547204
• Product Code: FTL
• UDI-Device Identifier: 00650862315356
• UDI-Public: 00650862315356
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2016

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: 08/31/2017
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 214181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2016
• Initial Report FDA Received Date: 12/06/2016
• 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: 35 YR