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Additionally, event information such as item/lot number, implant date, date of explant, patient medical history were requested, however no information has been received.According to the instructions for use (ifu) for gore® dualmesh® biomaterial complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation,perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.
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Previous patient code (1930) was reported based on the original complaint and is no longer applicable per gore¿s investigation.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.No further investigation is required at this time.The following publication was reviewed: the use of three different mesh materials in the treatment of abdominal wall defects.The publication reports between 1996 and 2000, 56 patients underwent surgery for the treatment of large abdominal wall defects with the use of synthetic prosthetic materials.The article reports in twenty-three patients the surgeon used gore® dualmesh® biomaterial.The article reported the radius of the mesh was about 4-5 cm larger than the defects.The articles reports in the e-ptfe group one obese patient (4.34%) developed a persistent seroma that was infected after repeated aspirations.The article reported the infection led to mesh removal and recurrence of the hernia 3 months later.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial is provided sterile.Procedure and specific patient factors may contribute to or cause infection, leading to contamination or infection of the mesh material.The instructions for use further state: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to,adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315 (-z): cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through review of the article.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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