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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Hernia (2240)
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| Event Date 09/07/2021 |
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Event Type
Injury
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Manufacturer Narrative
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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.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2012 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2021 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions, abscess, hernia recurrence, mesh removal, chronic pain.Additional event specific information was not provided.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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 preoperative complaints: no information implant procedure: no information implant date: no information wound classification: findings: description of hernia being treated: ¿¿¿.¿ implant size and fixation: relevant medical information: explant preoperative complaints: (b)(6) 2021: (b)(6) center.(b)(6) do.Indications: ¿patient is (b)(6) female has had multiple intra-abdominal surgeries.She has had a prior ventral hernia repair with mesh that has recurred.She has increased size of her bulge in both lower c -section scar as well as midline laparotomy scar.Complains of pain secondary to the hernias.¿ explant procedure: robotic assisted repair of recurrent ventral incisional hernias with mesh.Removal of mesh from prior hernia repair.[implant ovitex 2s permanent] explant date: (b)(6), 2021 [same day admission] (b)(6) 2021: (b)(6) center.(b)(6) do.Operative report.First assistant: (b)(6), do.Second assistant: (b)(6), do.Preoperative diagnosis: recurrent ventral incisional hernias.Postoperative diagnosis: same.Anesthesia: general.Wound classification: not provided.Findings: ¿patient had 2 large mouth ventral hernias.There was an additional smaller hernia that was in between the 2 larger openings.The superior largest opening was in the midline and was 7cm at its widest diameter.The most inferior hernia was approximately 5 cm in its largest diameter and was within the pfannenstiel incision.In the midline between these 2 hernias was a smaller 3cm defect as well.There was bowel adhesed within the superior hernia as well as bowel and omentum within the hernia in the pfannenstiel incision.There was hard fibrotic mesh within the lower incision that was within the hernia sac.To assist in removal of the previous mesh and redundant hernia sac, a pfannenstiel incision was made as well as to excise excess of skin.This allowed for much better cosmetic closure of the skin and hernia sac.Abdominal wall was able to be brought together at the fascial level with minimal tension.A 20 x 20 piece of mesh was cut to 20 x 14 cm to allow for good overlap of the mesh of the hernia sac.A larger piece of mesh was used to completely cover the swiss cheeselike defects.¿ procedure: ¿the patient was seen and examined the preoperative holding area.The procedure, benefits, risks, and alternatives were explained to them in detail.All questions were answered and they agreed to proceed with the above listed procedures.Consent is signed on chart.Patient was then taken back to the operative room.Placed in the operative table in the supine position.General endotracheal anesthesia was performed without complication.A timeout was called for correct patient and procedure identification.This was confirmed the patient did receive preoperative antibiotics as well as heparin prior to procedure initiation.The area along the patient's abdomen was prepped and draped in the standard sterile fashion.And (sic) palmer's point in the left upper quadrant, incision was made abdominal wall was elevated towel clamps and a veress needle was inserted into the abdomen through this incision.After low opening pressures and a negative water drop test, the abdomen was insufflated to 15 mmhg.An optically guided 8 mm port was then placed in the abdomen through this incision.Laparoscope was inserted and showed no injury to any peritoneal contents.Hernia sac was identified and due to the positioning, ports were placed along the upper abdomen spaced 8 cm apart.3 additional working ports were placed under direct visual guidance.The da vinci xi robot was brought to the sterile field and docked.Correct anatomy was targeted.Remaining ports were docked and instruments were placed under direct visual guidance.Care was then taken to dissect the small bowel adhesions from superior hernia sac.Once able to completely reduce attention was turned to the lower pfannenstiel hernia.With the aid of external pressure small bowel contents were reduced from the hernia and adhesions were taken down untill it was completely reduced.Within this hernia sac was a large amount of small bowel as well as prior mesh from previous hernia repair.Mesh was densely adhered and fibrotic.Patient had significant amount of redundant skin in this lower abdominal area.A decision was made to recreate the pfannenstiel incision, to excise extra skin as well as aid in excision of prior mesh.The robot was undocked and removed from the sterile field initially.An elliptical incision was made at pfannenstiel fashion down to the hernia sac.Hernia sac was circumferentially dissected down to the level of the fascia.Hernia sac and contents to include the prior mesh were excised completely.Fascia was identified and reapproximated with 0 pds suture, horizontal in a pfannenstiel fashion just prior to closure of the fascia, the mesh was placed in the abdominal cavity for later use.Prior to creating the pfannenstiel incision, the defects were measured with the largest diameter of the swiss cheese defect being 7 cm.In length, the hernia measured approximately 15 cm.A 20 x 20 piece of 2s mesh was cut to 20 x 14 cm.With the pfannenstiel incision closed, the robot was replaced, docked, and instruments replaced under direct visualization.The midline fascia was reapproximated with 0 strata fix suture in a running fashion.Pressure was dropped on the abdominal cavity to 8 mmhg during closure.Abdomen closed with minimal tension.The mesh was placed overlying the hernia defects and secured in place circumferentially with a running 3-0 vicryl suture.Through the central portion of the mesh a single strand of 0 pds suture was placed to aid in good approximation.Hemostasis was visualized.There is good approximation of the mesh.Instruments removed and remaining ports were undocked from the robot.Pneumoperitoneum was released and the ports were removed showing good hemostasis.Port site incisions were reapproximated with 4 monocryl in a subcuticular fashion.The pfannenstiel incision was approximated with 3-0 monocryl through the dermal and subcutaneous layers and running 4 monocryl subcuticular fashion.Dermabond was applied.This completed the patient's procedure.Patient tolerated well be taken recovery in stable condition.All sponge, needle, and instrument counts were correct prior to closure.Condition: transferred to recovery in stable condition.¿ (b)(6) 2021: (b)(6) center.(b)(6), do.Surgical pathology: ¿diagnosis: hernia sac: mesothelial lined fibroadipose tissue, consistent with hernia sac.Mesh material (gross examination only).¿ ¿microscopic description: microscopic examination was performed.Gross description: hernia sac with mesh.This specimen is received in formalin in a container labeled as follows: patient name: (b)(6).Second identified: dob.Specimen source: hernia sac.Gross description.Number of fragments: 2.Description: pink-tan fibromembranous and soft tissue with a moderate amount of yellow lobulated tissue and a portion of thin, white-gray firm rubbery material that measures 8.8 x 0.6 cm.Size: 14.2 x 8.9 x 1.7 in aggregate.Sectioning reveals a grossly unremarkable cut surface.Representative sections to include thin, firm, rubbery area are submitted in one block.¿ (b)(6) 2021: (b)(6) center.Operative report.¿implants: ovitex 2s permanent, 20 x 14 cm, model number f10248-2020p¿ relevant medical information: 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.
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Manufacturer Narrative
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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® 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: 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.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.
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