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

Model Number	1000212-00
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446)
Date of Event	07/01/2005
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Patient experienced infection, vaginal bleeding, pain, mesh ulcerations and inflammation after being implanted with mesh for pelvic organ prolapse.
Additional Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of v-patch mesh passed all quality and performance requirement.The sterility records indicate that the lot in question was properly sterilized.Clinical evaluation: when the muscles and ligaments supporting a woman's pelvic organs weaken, the pelvic organs can slip out of place and create a bulge in the vagina (prolapse).Women most commonly develop pelvic organ prolapse years after childbirth, after a hysterectomy or after menopause.This bulge can worsen over time and may require surgical intervention.Recurrent prolapse is common, as surgery does not repair the underlying weakened tissues.Prolite mesh is provided sterile.The packaging should be inspected prior to use to ensure it is intact and not damaged or opened.Prolite 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.Adequate mesh fixation is required to minimize postoperative complications and recurrence.The fixation technique, method, and products used, is left to the discretion of the surgeon to optimize clinical outcomes.Symptoms of transvaginal mesh erosion are a known adverse event associated with pelvic organ prolapse repair.Symptoms may include vaginal bleeding, pain, inflammation and sexual dysfunction.Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.The instructions for use (ifu) state, "complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs." the fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes.Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue.Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions and pain.The ifu also states that it is important to orient the mesh correctly for proper function.The smooth side of the mesh should be positioned facing the bowel or other visceral surfaces where minimal tissue attachment is desired.The anterior side to which the positioning straps are attached should be placed uniformly against the parietal tissue where tissue in-growth and incorporation is desired.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6615436
• Report Number: 1219977-2017-00081
• Device Sequence Number: 507601
• Product Code: FTL
• UDI-Device Identifier: 00650862300031
• UDI-Public: 00650862300031
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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: Physician
• Device Expiration Date: 07/31/2006
• Device Model Number: 1000212-00
• Device Catalogue Number: 1000212-00
• Device Lot Number: 11762317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/28/2017
• 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