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

Model Number	31506
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted following the completion of the investigation into this event.
Event or Problem Description
Recently the patient complained of pain and bulging in area of the laparoscopic ventral repair of more than two years ago.Surgeon found bowel to be severely adhered to the mesh requiring surgical intervention.
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 (course and wale) and ball burst conducted on the mesh at incoming.Fourier-transform infrared spectroscopy testing, in-process visual inspection of the cured coated mesh/panels, coating density of the cured coated 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: recurrent hernia is a common adverse event that occurs due to, but not limited to, non-compliance with activity restrictions post-operatively, 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, porosity of mesh material, slitting of the mesh, correct and generous dissection of preperitoneal space and wrinkle-free placement of the mesh are important factors in avoiding recurrence.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.Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue.Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6282958
• Report Number: 1219977-2017-00010
• Device Sequence Number: 19235048
• Product Code: FTL
• UDI-Device Identifier: 00650862315066
• UDI-Public: 00650862315066
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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: 01/31/2017
• Device Model Number: 31506
• Device Catalogue Number: 31506
• Device Lot Number: 200939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABSORBABLE TACKS
• Outcome Attributed to Adverse Event: Required Intervention