MAUDE Adverse Event Report: ATRIUM MEDICAL; MESH, SURGICAL, POLYMERIC

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Surgeon report that the coating peeled off during handling.Additionally, c-qur was difficult to fix to abdominal wall by absorbatack.

Manufacturer Narrative

Analysis - as the lot number of the mesh was not provided a full review of all manufacturing lot history records could not be performed.If the lot number had been provided the records would have been reviewed to ensure that the product in question met the product requirements and that there were no non-conformances during the manufacture of the device.In regard to the coating being easily peeled off during handling.Without images or the returned product an investigation into this claim cannot be confirmed.Atrium medical has conducted 3 year real time aging studies where the coating of the mesh was evaluated.There were no instances where the coated had peeled off reported.Summary/conclusion - based on the information provided, atrium medical cannot conclude that there was a deficiency with the product.Clinical evaluation: - a hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles.The resulting bulge can be painful, especially when you cough, bend over or lift a heavy object.A hernia doesn't improve on its own, however, and can lead to serious complications.Surgery is recommended to repair a hernia that is painful or enlarging.C-qur mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.C-qur mesh has a coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bio-absorbable oil coating).It has a coating that is absorbable by the body and if in the event it does flake or come off during a procedure it would cause no harm to the patient, the mesh would then become the equivalent of bare mesh.A physician may determine a product is not suitable for an intended procedure at any time and for any reason he deems significant enough to compromise patient outcomes.In the event the physician has a change of plan during a procedure it would result in a delay in treatment.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.The ifu also states adequate mesh fixation is required to minimize post-operative complications and recurrence.The fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes.It is important to orient c-qur mesh correctly to prevent recurrence.The absorbable coating is located on the polypropylene monofilaments of the mesh and is not a tissue separating layer.Avoid direct contact with the viscera (intestines) to minimize the possibility of adhesions.Do not use a c-qur mesh in patients where tissue separation is of particular concern.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7586467
• MDR Text Key: 111079810
• Report Number: 3011175548-2018-00575
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention