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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
Unspecified Infection (1930); Seroma (2069)
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| Event Date 03/18/2019 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2005 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, pain & suffering, infection, mesh removal, seroma, infected mesh.Additional event specific information was not provided.
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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.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2005: ms.(b)(6) has had two very small incisional ventral hernias, one near the umbilicus and one in the high epigastrium that have been repaired.She now has recurrence of more hernias between these two.The patient is scheduled for laparoscopic repair.She also has a chronic ulceration near the umbilicus that has not healed.We will excise that.Implant procedure: laparoscopy with adhesiolysis and laparoscopic ventral incisional hernia repair with mesh.Scar revision.Implant: gore® dualmesh® plus biomaterial ref: 1dlmcp04; lot: 03122956.Implant date: (b)(6) 2005 [hospitalization (b)(6) 2005 ¿ discharge unknown] (b)(6) 2005: (b)(6) md.Operative report.Pre- and postoperative diagnosis: recurrent ventral incisional hernia.Chronic ulcerated wound near the umbilicus.Anesthesia: general.Estimated blood loss: about 25 cc.Specimens: the chronic wound near the umbilicus was sent.Findings: the patient had multiple small incisional ventral hernia defects in the upper midline.Procedure: "¿ after an appropriate level of anesthesia was obtained, the abdomen was then prepped and draped in the usual sterile fashion.We began by making a small transverse incision on the left side of the mid abdomen.Dissection was carried down in a muscle-splitting fashion down to the peritoneum, which was opened without incident, and a blunt-tipped 10-mm hasson trocar was placed and secured.Co2 insufflation was begun.Pneumoperitoneum was maintained at 15 mmhg, which was tolerated well.The laparoscope was inserted, and, under direct vision, a 5 mm trocar was positioned in the left upper quadrant.The endoscopic scissors and the harmonic scalpel were used to divide adhesions of the omentum, which was adhered to the anterior abdominal wall midline as well as some of the small bowel and transverse colon.These were able to be done without any injuries to the bowel.The adhesions were taken down, clearing the defect.The omental fat was pulled out of the hernia as it was reduced, and we noted the defect and spanned the hernia defects at least 5 centimeters on either side, and a 20 x 15-cm sheet of gore dual hernia was brought up onto the field.The proposed site of the hernia repair was measured, and mesh was oriented properly, and stay sutures were placed at the 12, 3, 6, and 9 o'clock positions of 0 ethibond on the mesh.The mesh was then rolled up in a cigarette fashion and placed through the left-sided hasson trocar site, and the mesh was then unrolled flat with the slick surface toward the viscera and the fascial surface toward the peritoneum.The stay sutures were individually grabbed and pulled up at their proper positioning through the fascia and secured here.Then, we used a pro tacker to secure the edges of the mesh circumferentially.A second layer of tacks was placed about 2.5 centimeters from the edge as a second row.After this was done, we used 0 ethibond sutures interspersed between the four stay sutures in a mattress fashion using the suture passer.After this was done, we assured excellent hemostasis and then released the pneumoperitoneum, removed the trocars.The left-sided fascial incision was closed with 0 ethibond interrupted sutures.After this was done, we elliptically excised the scar near the umbilicus and the chronic ulceration, which was almost epithelialized and did not appear to be grossly infected.An ioban had been placed on the skin prior to beginning the case.The scar was excised down to the level of the fascia with a 10-blade scalpel, and the edges of the skin were freed up from the fascia, and the wound was closed with a few interrupted absorbable monocryl sutures in the subdermal fascia and then 4-0 nylon interrupted vertical mattress sutures.The remainder of the skin was closed with 4-0 monocryl.(b)(6) 2005: (b)(6) medical center.Implant sticker: dualmesh plus antimicrobial item: 1dlmcp04; lot: 03122956, expiration: n/a; size n/a; quantity: (b)(4) the records confirm a gore® dualmesh® plus biomaterial (item: 1dlmcp04; lot: 03122956) was implanted during the procedure.Relevant medical information: no additional interim records.Explant procedure: exploratory laparotomy.Mesh explantation.Incision and drainage of complex abscess.Ventral incisional hernia repair.Negative pressure wound therapy.Surgery date:(b)(6) 2019 [hospitalization: (b)(6) 2019] (b)(6) 2019: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: chronic abdominal pain.Postoperative diagnosis: infected mesh.Anesthesia: general.Estimated blood loss: 25 cc.Specimens: infected mesh.Procedure: ¿mrs.(b)(6) was met in the holding area where risk, benefits and potential complications of the operation were explained.Patient voiced understanding and wished to proceed.Patient was taken to the operating room.Placed in decubitus supine position.General endotracheal anesthesia was successfully performed.Abdomen was prepped and draped in the usual sterile fashion.Time out was performed where right patient, position and procedure was confirmed.Supraumbilical midline incision was performed.Dissection carried down until the fascia was encountered.The fascia was scored.We proceeded to encounter the mesh.With metzenbaum scissors we proceeded to divide the mesh.Purulent fluid was encountered in the cavity.Culture tip x2 were obtained.In a circumferential fashion we carefully dissected the mesh from the retrorectus space.We were able to remove the mesh in its entirety.The posterior rectus sheath had a rind of tissue.This was left intact.Cavity was irrigated with 2 l of warm saline.We did not evaluate the small intestine as omentum was densely adhere to both lateral aspect of the peritoneum; so we do not contaminate the peritoneal cavity.A 19 french blake drain was placed.Midline fascia is closed with #1 pds in a continuous fashion without tension.Skin was left open, irrigated with 1 l of warm saline.Sponge was brought into the field.Placed in the wound.Transparent film was placed over.Fenestration was performed.Tubing attached to it and then suction started.Was noted to have a good seal.Patient tolerated procedure well.No acute intraoperative complications.Patient was extubated in the operating room and transferred to recovery in stable condition.¿ (b)(6) 2019: (b)(6) hospital.Pathology report not produced.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 investigation findings code.Conclusion 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.H6: corrected health effect - impact code.
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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.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.The instructions for use further state: ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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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