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

Model Number 1000212-00

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Date 03/15/2011

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow-up report will be submitted.

Event Description

Report received stated that a prolite mesh was implanted for a vaginal vault prolapse (sacrocolpopexy).The patient experienced mesh exposure 3mm into her vagina, painful intercourse and vaginal pain requiring partial explant of the mesh.

Manufacturer Narrative

There was no device available for return, therefore an evaluation of the device could not be performed and the reported complaint could not be confirmed.The prolite mesh is not indicated for vaginal vault prolapse.The prolite mesh was never tested or evaluated for use in regards to vaginal vault prolapse.The instructions for use (ifu) states the following in regards to indications for use: ¿polypropylene mesh is intended for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material." the warnings also specify: "avoid direct contact with the viscera (intestines) to minimize the possibility of adhesions.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".The precaution section also states the following: "careful attention to surgical mesh handling, suture, staple, or tacker fixation is required in the presence of nerves and vessels in the surgical field." the adverse reactions also mention the following: ¿complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines)." there is also guidance in the ifu for proper handling and operative techniques it states the following: "atrium mesh should be shaped, cut to size, and affixed, taking into consideration the patient¿s posture, weight and anatomical location.Careful attention to suture/staple/tacker placement and spacing will help prevent excessive tension or disruption between the mesh material and connective tissue.It is recommended that suture/staples/tackers be placed 1/4 in.Or 6.5 mm from the edge of the mesh material for best results." the prolite mesh device history records for the finished good lot and the sub-assembly lot were reviewed and found to have met the manufacturing, quality and product performance specifications.A review of the incoming inspection records of the mesh raw materials was also conducted.The records show that the raw mesh material at incoming met all quality and performance requirements.Based on the provided details it is not known why the prolite hernia mesh was chosen.It is recommended that suture/staples/tackers be placed 1/4 in.Or 6.5 mm from the edge of the mesh material.It is not known how the prolite mesh was placed or tacked/sutured into place.All the surgical techniques are left to the discretion of the physician.The instructions provided guidance in this regard but again, the complaint is for a vaginal prolapse (sacrocolpopexy) that is not indicated in the instructions for use.H3 other text : not available for return.

• Brand Name: MESH PROLITE SHEETS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10518204
• MDR Text Key: 206479896
• Report Number: 3011175548-2020-01132
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300031
• UDI-Public: 00650862300031
• Combination Product (y/n): N
• PMA/PMN Number: K930669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: 1000212-00
• Device Catalogue Number: 1000212-00
• Device Lot Number: 10631366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR