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

Model Number	1010202-01
Health Effect - Clinical Code	Impotence (1925)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.Device not returned.
Event or Problem Description
Received report that states there is blockage/destruction of the vas deferens due to scar tissue from the prolite mesh.Following a sperm aspiration procedure, it was determined that the patient does have viable sperm in the testicles, however, the blockage/destruction is resulting in a zero sperm count.
Additional Manufacturer Narrative
A review of the device history records was performed and there were no non-conformance's noted during the manufacture of the mesh lot in question.Based on the details of the complaint atrium medical corporation cannot conclude that the mesh in question was the direct cause of the symptoms that the patient has experienced since the mesh was implanted in 2005.Adhesions are a common complication after any surgery and may be the result of, but not limited to, infection, inflammation, surgical technique or fixation methods.Clinical evaluation - a lipoma is a lump under the skin that occurs due to an overgrowth of fat cells.Doctors consider lipomas to be benign tumors.Lipomas can occur anywhere on the body where fat cells are present, but they tend to appear on the shoulders, chest, trunk, neck, thighs, and armpits.In less common cases, they may also form in internal organs, bones, or muscles.They usually grow slowly over a period of months or years and typically reach a size of around 2¿3 centimeters (cm).Iatrogenic vas deferens injuries as medical conditions are critical complications of surgical operations in the inguinal region of children and adults.Inguinal herniorrhaphy, one of the most common therapies carried out worldwide by surgeons, is executed through using a variety of approaches and transection or ligation induced injuries account for about many of iatrogenic vas deferens damages.It is well documented that any scant disturbance in vas deferens mucosa will endanger fertility and manipulations during inguinal hernia repair can cause perforation and/or obstruction of damaged vas deferens resulting in male fertility reduction.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 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) are left to the discretion of the surgeon to optimize clinical outcomes.".

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9340258
• Report Number: 3011175548-2019-01173
• Device Sequence Number: 2225272
• Product Code: FTL
• UDI-Device Identifier: 00650862301021
• UDI-Public: 00650862301021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: Health Professional
• Device Expiration Date: 09/30/2009
• Device Model Number: 1010202-01
• Device Catalogue Number: 1010202-01
• Device Lot Number: 10010239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: 40 YR