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

Model Number 1000212-00

Device Problem Material Erosion (1214)

Patient Problems Death (1802); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Type  Death  

Manufacturer Narrative

Investigation - a full review of all manufacturing lot history records was performed and no deficiencies were noted during the review.All the records indicate that the product in question met the product requirements.

Event Description

Vaginal mesh erosion detected 2 years after laparoscopic sacrocolpopexy.Details of injury - dyspareunia, pelvic pain and discharge.Mesh was explanted.Patient death.

Manufacturer Narrative

A full investigation was not able to be performed because the complainant did not answer any questions and without the operative notes, progress notes, death certificate and other objective evidence we are not able to do a full investigation.The product is not likely to be related to the outcome of the adverse event.Clinical evaluation: no surgery is taken lightly and is considered only after weighing the benefits, risks and treatment alternatives with a physician.Postoperative complications may either be general or specific to the type of surgery undertaken and should be managed with the patient's history and comorbidities in mind.Common post-operative complications include postoperative fever, atelectasis, wound infection, embolism and deep vein thrombosis, all of which have the potential to progress to a life threatening event or death.The highest incidence of postoperative complications is between one and three days after the operation.However, specific complications may occur early postoperative, several days after the operation, throughout the postoperative period and in the late postoperative period.The incidence of surgical complications and death is low in the general population, but high-risk patients have outcomes in which complication and death occur more frequently.Advanced age, comorbid disease and major/urgent surgery are the key factors associated with the increased risk of these events.Pelvic organ prolapse (pop) 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.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.Mesh is sometimes used to reinforce the abdominal wall and support abdominal organs in various procedures.The concern regarding risks of complication and morbidity would be that reoperation may be required and surgical revision would be significantly more difficult than if the mesh had not been placed in a previous procedure.Remote morbidity post-operative mesh implant is likely the result of comorbidities or acute processes.The instructions for use (ifu) states ¿do not use prolite and prolite ultra mesh for pelvic floor repair, pelvic organ prolapse (pop) repair or surgical treatment of stress urinary incontinence (sui).¿ the ifu also 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.

• 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: 7321216
• MDR Text Key: 101775701
• Report Number: 3011175548-2018-00230
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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: 05/31/2015
• Device Model Number: 1000212-00
• Device Catalogue Number: 1000212-00
• Device Lot Number: 10631366
• Other Device ID Number: 00650862300031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/16/2018
• Date Device Manufactured: 05/06/2010
• 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
• Patient Outcome(s): Death