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

Device Problem Material Deformation (2976)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.Related report: submitted 1219977-2015-00311 on (b)(6) 2015 and could not obtain fda acknowledgements.Only the first acknowledgement was received.Sent message to esg help desk and received confirmation of help requested but no follow up.It has been two weeks.Filing a new report to assure fda timeframe for reporting is met.

Event Description

Patient had laparoscopic hernia repair approximately one year ago.Three months ago there was a query of immunodeficiency and lupus so the patient was put on steroids.Patient developed wound complications, cellulitis, abdominal pain and discharge.Surgeon took patient back into the operating room and mesh was completely intact with no incorporation into surrounding tissue.Described mesh as being like it was tofu/green in color and lumpy.Mesh was removed.Pathology on mesh and tofu-like substance came back as sterile.

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number or sample was provided.Atrium's mesh with omega three fatty acids (o3fa) will typically absorb over 19-24 months under normal healing conditions.It may take longer on an immunocompromised patient, who is susceptible to bacterial, fungal, and viral infections that healthy immune systems usually conquer.The mesh may be 'free floating' on the abdominal wall due to an error in clinical technique, inadequate suture fixation and/or inadequate placement which will cause separation of the mesh from the abdominal wall.Adequate fixation and proper placement is necessary for mesh incorporation.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.Furthermore, the anti-inflammatory properties of omega-3 fatty acids may contribute to a low-grade inflammatory response of the c-qur o3fa coated mesh as compared with bare polymer mesh.The instructions for use state in adverse reactions, "complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection, seroma, hematoma, fistula formation, mechanical disruption of the tissue and/or mesh material and possible adhesions when placed in direct contact with the viscera (intestines) and organs.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5201119
• MDR Text Key: 30386063
• Report Number: 1219977-2015-00322
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050311
• 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
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention