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

Model Number	1DLMC04
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2003
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's complete address (b)(6).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 #1 and #2 preoperative complaints: (b)(6) 2003 (b)(6) : the patient is a morbidly obese middle-aged woman with multiple comorbidities who presents with a large ventral hernia in the upper midline incision following previous fairly unsuccessful gastric restrictive procedure.A preoperative workup including a colonoscopy and ultrasound were unremarkable.Implant #1 and #2 procedure: laparoscopic enterolysis with open ventral hernia repair with mesh.Implant: gore¿ dualmesh¿ biomaterial x2, [#1.1dlmc04/01692603.#2.1dlmc04/01668657].Implant #1 and #2 date: (b)(6) , 2003 (hospitalization (b)(6), 2003) (b)(6), md.Operative report.Preoperative and postoperative diagnosis: ventral hernia.Anesthesia: general.Findings: there were mild-to-moderate adhesions to the anterior abdominal wall defect, however the defect measured at least 20 x 15 cm and we were unable to use a large enough piece of mesh within the peritoneum to close it.We therefore performed an open repair after an extensive laparoscopic enterolysis.Findings: hand-written note: adhesions to anterior abdominal wall.Massive fascial defect ~ 20 x 30 cm.Covered with (2) large dualmesh.Procedure: with the patient under general anesthetic, the abdomen was prepped and draped.A small incision was made in the left lateral abdomen and a hasson cannula was inserted under direct vision.The abdomen was insufflated and two 5 mm trocars were placed in the left upper and lower quadrants.Extensive omental and colon adhesions were taken down using the harmonic scalp.The fascial defect encompassed almost the entire upper abdomen which was quite large from the umbilicus to the pubis extending a distance of approximately 20-30 cm in length and 15-20 cm in width.I contemplated sewing two or three or four large dual mesh gore-tex pieces together but overall felt that this would not be an acceptable type of repair for her.The trocars were removed and the abdomen was incised in the midline.The fascia was exposed and the hernia sac was excised.The fascia was undermined superiorly circumferentially.Two large pieces of gore dual mesh were sutured in an overlapping fashion with 3-0 gore-tex suture.A wet lap pad was applied over the viscera covered with a fish retractor.The large combined pieces of dual mesh were inserted into the abdomen with the smooth side down.It was then sutured circumferentially with significant overlap all around utilizing a running 3-0 gore-tex suture.The upper portion of the incision was reinforced with #1 vicryl.The fish and lap pad were removed prior to closure.The subcutaneous tissue was closed over a flap suction catheter utilizing #1 vicryl.The skin was closed with staples.The suction catheter was let out through one of the stab wounds for the trocar site.Dry sterile gauze was applied and the patient was awakened, extubated and returned to pacu where she was to undergo placement of an epidural catheter by dr.Solley.Estimated blood loss, less than 200 cc.Specimens, none.Complications, none.(b)(6) medical center.Implant stickers: o #1: gore-tex dualmesh biomaterial.Item#: 1dlmc04.Lot#: 01692603.O #2.Gore-tex dualmesh biomaterial.Item#: 1dlmc04.Lot#: 01668657.Implant #3 preoperative complaints: (b)(6) medical center.(b)(6) md.Operative indications: the patient is a morbidly obese, middle-aged woman who recently underwent repair of a large ventral hernia.She developed a recurrence with incarceration of small bowel.Implant #3 procedure: repair of recurrent incarcerated ventral hernia.Implant: gore¿ dualmesh¿ biomaterial [1dlmc04/01692595].Implant #3 date: (b)(6) 2003 (hospitalization dates unknown).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 or Problem Description
It was reported to gore that the patient underwent ventral hernia repair on (b)(6) 2003 whereby a gore dualmesh¿ plus biomaterial was implanted.The complaint alleges that on (b)(6) 2003, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh infection & removal.Additional event specific information was not provided.
Additional Manufacturer Narrative
H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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 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.
Additional Manufacturer Narrative
H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi womble ; 9285263030
• MDR Report Key: 11638600
• Report Number: 2017233-2021-00002
• Device Sequence Number: 14376952
• Product Code: FTL
• UDI-Device Identifier: 00733132600977
• UDI-Public: 00733132600977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2003
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2007
• Device Model Number: 1DLMC04
• Device Catalogue Number: 1DLMC04
• Device Lot Number: 01668657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/30/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female