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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31533
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Fistula (1862)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
After mesh was implanted patient ended up with fistula.
 
Manufacturer Narrative
We are unable to fully investigate this report as no product number, lot number or sample was provided. There is no indication this event is due to a device failure. Clinical evaluation: 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. The instructions for use state complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and fistula formation, mechanical disruption of the tissue and/or mesh material when placed in direct contact with the viscera and organs.
 
Manufacturer Narrative
Additional information added to age/date of birth, sex, describe event or problem, model #/lot #, implant date, concomitant medical products, and device manufacture date. 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 mosaic 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: abdominal adhesions are bands of fibrous tissue that can form between abdominal tissues and organs after abdominal surgery. Surgery in the lower abdomen and pelvis carries an even greater chance of abdominal adhesions which can become larger and tighter as time passes, sometimes causing problems years after surgery. 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. 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 pain and mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.
 
Event Description
Approximately 4 weeks after mesh was implanted it was explanted due to infection and small bowel resection.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
5 wentworth drive
merrimack NH 03051
Manufacturer Contact
lori gosselin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key6043245
MDR Text Key57931442
Report Number1219977-2016-00224
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model Number31533
Device Catalogue Number31533
Device Lot Number218974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2016 Patient Sequence Number: 1
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