MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. PROLOOP; MESH, SURGICAL, POLYMERIC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

We are attempting to obtain further details on this event.A follow up report will be submitted upon the completion of the investigation.

Event Description

Received a report of recurrence of inguinal hernia medically to the pubic cubical stemming from a slight contraction of the mesh.Patient was supposedly lifting and went back to work early against the doctors advice.Doctor put another plug in from bard to fix it.Mesh was not explanted and was integrating very well.

Manufacturer Narrative

Investigation - no product was returned.A thorough review of the device history records as well as the sterilization records could not be performed as the product catalog number and lot number were not provided.From the complaint description "recurrence of inguinal hernia medically to the pubic cubical stemming from a slight contraction of the mesh.Dr.Is not saying it is mesh fault as there are multiple factors that could contribute to this, including patient activity when told not to." patient was supposedly lifting and went back to work too early.He works at a job that requires lifting.Doctor put another plug in from bard to fix it.Mesh was not explanted and was integrating very well the adverse reactions section of the ifu states the following: "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".Summary/conclusion - based on the review of the complaint details atrium can find no fault with the product.There was not enough information provided to determine the root cause of the complaint.Clinical evaluation: a hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles.The resulting bulge can be painful, especially when you cough, bend over or lift a heavy object.An inguinal hernia is when tissue or intestines protrude through a weakened area of tissue in the area on either side of the pubic bone.A hernia doesn't improve on its own, however, and can lead to serious complications.Surgery is recommended to repair a hernia that is painful or enlarging.Atrium proloop mesh is indicated for use in hernia repair, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.A recurrent hernia is a common adverse event and is usually related to using a mesh product that is too small or to the fixation method and technique.It may also be related to non-compliance with activity limitations post operatively.The treatment for a recurrent hernia is surgical correction.Other factors that contribute to the outcome of recurrent hernia are the patient's weight and medical comorbidities such as diabetes and a history of smoking.Problems after hernia repair are usually related to using a mesh product that is too small or to the fixation method and technique.It may also be related to non-compliance with activity limitations post operatively.Other factors that contribute to the outcome of hernia repairs are the patient's weight and medical comorbidities such as morbid obesity, diabetes and a history of smoking.The instructions for use (ifu) states complications that may occur with 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).

• Brand Name: PROLOOP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 6940751
• MDR Text Key: 89243687
• Report Number: 3011175548-2017-00164
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention