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

Model Number 1000212-00

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

A full review of all manufacturing lot history records was performed and no deficiencies were noted during the review.All product manufactured met the product requirements.Based on the product meeting all product quality and performance requirements atrium cannot conclude that the prolite mesh was defective.Clinical evaluation: pelvic organ prolapse occurs when organs sag or fall into the vaginal canal because of weak pelvic muscles.Transvaginal mesh serves as a hammock beneath the organs to hold them up.Usually, the bladder, uterus, rectum or bowel is involved in the prolapse.The bladder is the most common organ affected.Depending on the organs involved, surgeons may place the piece of mesh on the front, back or top wall of the vagina.If advanced prolapse is left untreated, organs can eventually bulge into the vagina or hang out of the body when standing or walking.Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women.Transvaginal mesh can cause numerous complications, including severe pain, nerve damage, vaginal scarring, infections, tissue erosion or organ perforation.Sacrocolpopexy (sacral colpopexy) is a surgical technique for repairing pelvic organ prolapse.Reconstruction is achieved with an open abdominal technique or with the use of minimally invasive techniques.The specific treatment approach is chosen in accordance with the type and degree of pelvic organ prolapse, as well as the severity of symptoms.A graft or mesh is used to support the vaginal wall and suspend the apical vault to the sacral promontory.Prolite ultra 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.Mesh erosion and exposure is a serious and not uncommon complication in women undergoing vaginal mesh repair.It is likely associated with the patient¿s comorbidities, surgical procedures, and mesh material.Concomitant hysterectomy and hypertension were associated with this.In the management of mesh erosion and exposure, conservative treatment can be tried as the first-line treatment for smaller issues, while surgical repair for larger ones.Urinary tract infections typically occur when bacteria enter the urinary tract through the urethra and begin to multiply in the bladder.Although the urinary system is designed to keep out such microscopic invaders, these defenses sometimes fail.When that happens, bacteria may take hold and grow into a full-blown infection in the urinary tract.Risk factors include but are not limited to female anatomy, urinary tract abnormalities, suppressed immune systems, diabetes and indwelling catheter use.There are several types of drainage and are indicative of different occurrences.Serous is plasma drainage which indicates an increase in bacteria living on the surface, while sanguineous is bloody drainage.These and a combination, called serosanguinous, may indicate trauma, which hinders healing.The other type of drainage is purulent and indicates infection.Dyspareunia (painful intercourse) can occur for reasons that range from structural problems to psychological concerns.Many women have painful intercourse at some point in their lives.Dyspareunia is defined as persistent or recurrent genital pain that occurs just before, during or after intercourse.Some of the causes are dryness, injury, trauma, surgery, infection and congenital abnormalities.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.

Event Description

A 2 cm vaginal mesh exposure on posterior vaginal wall.Had laparoscopic sacrocolpopexy (b)(6) 2012.Recurrent uti, vaginal discharge and dyspareunia.

• Brand Name: PROLITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7583817
• MDR Text Key: 110532757
• Report Number: 3011175548-2018-00581
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K930669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2015
• Device Model Number: 1000212-00
• Device Catalogue Number: 1000212-00
• Device Lot Number: 10698443
• Other Device ID Number: 00650862300031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Date Device Manufactured: 10/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1