MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Model Number 1DLMCP03

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Seroma (2069)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.

Event Description

It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2012 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infected mesh, removal of mesh, recurrence, drainage, scar tissue, abscess, seroma, pain and suffering.Additional event specific information was not provided.

Manufacturer Narrative

H6: conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair of ventral incarcerated hernia utilizing dualmesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp03/9115360) implant date: (b)(6) 2012 (hospitalization (b)(6) 2012) (b)(6) 2012: [facility ni].(b)(6).Operative report.Preoperative diagnoses: morbid obesity.Recurrent ventral hernia, incarcerated.Postoperative diagnoses: morbid obesity.Recurrent ventral hernia, incarcerated.Procedure: repair of ventral incarcerated hernia utilizing dualmesh.Assistant: dr.(b)(6).Anesthesia: dr.(b)(6), general endotracheal.Description of procedure: ¿this 41-year-old male was brought to the operating room and placed on the operating table in the supine position.The patient was maintained under satisfactory general endotracheal anesthesia.The patient's abdomen was prepped and draped in a sterile fashion.The patient had attenuated skin at the base of his umbilicus.It was overlying incarcerated omentum.An incision was started above the umbilicus and extended to below the umbilicus.The attenuated skin was excised and left attached to the hernia sac.A significant portion of omentum was adherent within the hernia sac.This was ligated in pedicles using 2-0 silk ties and then transecting them.The hernia sac was excised at the level of the fascia.The fascial defect measured approximately 4 cm in diameter.A portion of the previously placed mesh was identified where it had pulled free from the left side of the abdominal wall.Some of the mesh was grasped and extracted and then amputated.An area underneath the fascia on all sides was identified at this point.A piece of dualmesh that initially was 10 x 15 cm was ceased onto the field.The mesh was fashioned to create a 10 cm circular repair.Placing sutures approximately 4 cm back from the edge of the fascia, approximately 10 different circumferential mattress sutures were placed full thickness through the abdominal wall, then through the mesh, and then back out through the abdominal wall.None of the sutures were tied until all were placed.Traction was placed on all the sutures, and the mesh was thus positioned as an underlay underneath the defect.The sutures were tied down.This created a patch for the fascial defect.The fascial edges themselves were then reapproximated in a transverse direction with running #1 pds suture.The subcutaneous of the base of the umbilicus skin was sutured to the fascia.The skin was then closed with a running 4-0 undyed vicryl subcuticular suture.The wound was cleansed and dried, and octylseal sterile glue was applied.After this was allowed to dry, a sterile dressing was placed over this.The needle, sponge, and instrument counts were noted to be correct at the end of the procedure.The patient was awakened and extubated and taken to the recovery room in stable condition.The patient tolerated the procedure well.¿ (b)(6) 2012: [facility ni].Implant record.Description: mesh biomtl set hrn.Eptfe 15, dualmesh plus, sl gore- medical products, 1dlmcp03.Lot number: 9115360.Expiration date: 03/2014.Catalog no: 1dlmcp03.Implant site: abdomen.Manufacturer: wl gore.Size: 10 cm x [blank].Quantity: 1.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/9115360) was implanted during the procedure.Explant procedure: removal of infected prosthetic mesh material, primary repair of recurrent ventral hernia.Explant date: (b)(6) 2014 (hospitalization (b)(6) 2014) (b)(6) 2014: [facility ni].(b)(6), md.Operative report.Preoperative diagnosis: profound morbid obesity, infected mesh from a prior ventral hernia repair, with recurrent ventral hernia.Postoperative diagnosis: profound morbid obesity, infected mesh from a prior ventral hernia repair, with recurrent ventral hernia.Procedure: removal of infected prosthetic mesh material, primary repair of recurrent ventral hernia.Assistant: dr.(b)(6).Anesthesia: dr.(b)(6) , general endotracheal.Description of procedure: ¿this 43-year-old, morbidly obese male was brought to the operating room and placed on the operating table in the supine position.The patient was maintained under satisfactory general endotracheal anesthesia.The patient's abdomen was prepped and draped in a sterile fashion.The previous incision that had started below the umbilicus and extended to above the umbilicus was reopened.There was a sinus tract with draining pus from the depths of the skin at the base of the umbilicus.Dissection was carried through the scar tissue down to the fascia.The fascia was opened and a pocket or pus was encountered along with the mesh material.Prolene sutures that were still in place holding the mesh to the fascia were transected, and the mesh and prolene sutures were extracted from the wound.Culture was obtained front the infected material.The area was aspirated.By palpating from within the peritoneal cavity, the fascial defect slightly more cephalad was identified, and the fascia was opened to include this fascial defect.The remaining fascia was then reapproximated with interrupted figure-of-eight #1 pds sutures.The skin at the base of the umbilicus was sutured down to the fascia.The skin was then approximated with interrupted subcuticular.4-0 vicryl sutures.A sterile dressing was applied.The needle, sponge, and instrument counts were noted to be correct at the end of the procedure.The patient was awakened, extubated, and taken to the recovery room in stable condition.The patient tolerated the procedure well.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.  it should be noted that the gore® dualmesh® plus biomaterial instructions for use 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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.

Manufacturer Narrative

H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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.

Manufacturer Narrative

H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus 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 instructions for use further warn: ¿¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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.

• Brand Name: GORE® DUALMESH® PLUS BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12343522
• MDR Text Key: 267306372
• Report Number: 3003910212-2021-01275
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132601103
• UDI-Public: 00733132601103
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2023

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: 03/31/2014
• Device Model Number: 1DLMCP03
• Device Catalogue Number: 1DLMCP03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 04/01/2022; 04/01/2022
• Supplement Dates FDA Received: 08/25/2021; 04/07/2022; 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2011
• 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
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 181 KG