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

Model Number 1DLMC06

Device Problem Insufficient Information (3190)

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

Event Date 05/25/2010

Event Type  Injury  

Manufacturer Narrative

It should be noted that the gore® dualmesh® 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® 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 incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of infected mesh, debridement of wound area, drainage of purulent abscess and seroma, and pain and suffering.Additional event specific information was not provided.

Manufacturer Narrative

H6: updated results code.Conclusion code remains unchanged it should be noted that the gore® dualmesh® 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® 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

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair of incisional hernia.Implant: gore® dualmesh® biomaterial [1dlmcp06/(b)(6), 18 x 24cm x 1mm] implant date: (b)(6) 2010 (same day surgery) (b)(6) 2010: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: 100ml.Fluids: crystalloid.Condition: stable.Indication for procedure: the patient is a 72-year-old female who presented with incisional hernia following open colon resection.Procedure in details: ¿the patient was brought into the operating room and placed on the operating table in supine position.Following induction of general anesthesia, the abdomen was prepped and draped in the usual sterile fashion.The existing lower midline incision was opened with a #10 scalpel blade and deepened through subcutaneous tissues using electrocautery.Following this, the hernia sac was identified.Fascial edges were delineated.The patient was noted to have multiple large and small hernia defects in the incision.These were fully mobilized and connected.Fascial edges were delineated such that there was actually one edge on either side.Next, it was elected to perform mesh repair.Suitable size portion gore-tex dualmesh was brought into the operative field, was sutured to the surrounding fascial edges with multiple interrupted u-sutures of #1 prolene.Subcutaneous tissue was reapproximated with vicryl.Two 19-french blake drains were placed in the subcutaneous tissue, brought through a separate stab wound incision, secured to the skin with 3-0 nylon suture.The skin was closed with staples.Sterile dressings were applied.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.¿ (b)(6) 2010: (b)(6) medical center.Implant log.Implant: graft, dual mesh 18 x 24cm x 1mm.Qty: 1.Model manufacturer: sb0000219.Exp date: 11/15/14.(b)(6) 2010: (b)(6) health care system.Implant sticker.Implant: gore dualmesh® biomaterial.Ref catalogue number: 1dlmc06.Lot batch code: (b)(6).W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc06/(b)(6)) was implanted during the procedure.Explant procedure: removal of infected mesh, repair of incisional hernia with biologic mesh.Explant date: (b)(6) 2010 (hospitalization unknown).(b)(6) 2010: [facility not indicated].(b)(6) md.Operative report.Preoperative diagnosis: infected mesh status post incisional hernia repair.Postoperative diagnosis: infected mesh status post incisional hernia repair.Anesthesia: spinal.Estimated blood loss: 50 ml.Fluids: crystalloid.Condition: stable.Indication: the patient is a 72-year-old female several weeks¿ status post repair of an incisional hernia with gore-tex mesh.The patient now presents with infections of the mesh.Procedure in detail: ¿the patient was brought into the operating room and placed on the operating table in supine position.Following the induction on general anesthesia, the abdomen was prepped and draped in usual sterile fashion.The existing midline incision was opened with #10 scalpel blade, deepened through subcutaneous tissues and electrocautery.Following this, the mesh was identified, large areas of purulent material were debrided and irrigated from around the mesh.The mesh was then removed by excising the tethering sutures.Following this, the fascial edges were delineated further with cautery dissection and it was felt it was impossible to perform primary repair.Thus a suitable size, flex hd mesh was brought into the operative field, tapered to the appropriate dimension.The mesh was then sutured to the surrounding fascial edges with multiple interrupted u sutures of #1 prolene.Two 19-french blake drains were placed in the operative field, brought out through separate stab wound incisions, secured to the skin with 3-0 nylon suture.Subcutaneous tissue was reapproximated with vicryl.The skin was loosely approximated with staples and the open thin edges was packed with iodoform gauze.Sterile dressings were applied.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.¿ it should be noted that the gore® dualmesh® 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® 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.".

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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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® 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 material.¿ 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.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® 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: heidi womble ; 1505 n. fourth street; flagstaff, AZ ; 9285263030
• MDR Report Key: 11590955
• MDR Text Key: 243040651
• Report Number: 3003910212-2021-01192
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600991
• UDI-Public: 00733132600991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992189
• 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: 06/20/2023

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: 11/15/2014
• Device Model Number: 1DLMC06
• Device Catalogue Number: 1DLMC06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 03/30/2021; 05/26/2021; 05/26/2021
• Supplement Dates FDA Received: 04/27/2021; 06/02/2021; 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female