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

Model Number 1000606-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/19/2010

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

A patient reported having a lower left abdominal hernia repair.A couple of weeks after the surgery he had problems with stomach bloating and pain.

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: an inguinal hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the lower abdominal muscles.The resulting bulge can be painful, especially when you cough, bend over or lift a heavy object.An inguinal hernia doesn't improve on its own, however, and can lead to life-threatening complications.Surgery is recommended to repair an inguinal hernia that's painful or enlarging.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.Gastrointestinal bloating and pain can occur after any type of surgery, but is most common after abdominal and pelvic surgery.Both open surgery and laparoscopic surgery in the abdominal cavity can leave the bowels (intestines) stunned'.Anesthesia can slow down the bowels, preventing the passage of gas and stool.Intraperitoneal bloating is caused by gas trapped outside of the intestines, but inside the abdominal cavity.The gas that becomes trapped in abdominal cavity or against the diaphragm muscle itself usually follows laparoscopic surgery.Prolonged pain can be defined as pain persisting for more than three months after surgery and it is a complication of many common procedures including hernia repair.Surgical technique can influence the development of chronic post-surgical pain and techniques to minimize nerve injury should be used whenever possible.The instructions for use 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.

Manufacturer Narrative

Additional information: attached mw(b)(4) which is for a home patient that previously reported this event.

• Brand Name: PROLITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6633315
• MDR Text Key: 77308584
• Report Number: 1219977-2017-00091
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300079
• UDI-Public: 00650862300079
• Combination Product (y/n): N
• PMA/PMN Number: K0930669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2017

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Model Number: 1000606-00
• Device Catalogue Number: 1000606-00
• Device Lot Number: 10624883
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 06/08/2017; 10/29/2018
• Supplement Dates FDA Received: 06/30/2017; 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 91