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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCPH04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 08/07/2013 |
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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 open ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2013 and (b)(6) 2016, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal, infection, debridement, wound issues, abscess, seroma, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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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)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: on (b)(6) 2006: the uniontown hospital.(b)(6), md.¿preoperative diagnosis: incarcerated hernia.¿ implant procedure: exploratory laparotomy.Lysis of adhesions.Resection of the abdominal wall with resection of the hernial sacs and replacement of the abdominal wall with mesh.[implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph04/(b)(4), 15cm x 19cm x 1.5mm thick, oval.] implant date: (b)(6) 2006 [hospitalization dates unknown].On (b)(6) 0206: the uniontown hospital.(b)(6), md.Operative report.Preoperative diagnosis: incarcerated hernia.Postoperative diagnosis: incarcerated ventral hernia, recurrent incisional hernia.Anesthesia: general.Drains: jackson-pratt.Wound classification: not provided.Procedure: ¿this patient was put on the operating table in the supine position with general anesthesia.Prep and drape was done in the usual manner.Skin incision above the umbilicus and around towards the right side of the umbilicus was made and deepened down through the subcutaneous tissue.The abdomen was entered.The patient had a 2 hernia just to the left of the midline, one about 5 cm.Above the umbilicus which was larger and contained small bowel, which was incarcerated but not strangulated which was dissected and lead into the abdomen and also part of the omentum which was there after the lysis of the adhesions was dissected and another one, smaller which contained also small bowel, which was again dissected and let go and also part of the omentum which was down there was resected and secured with 0 silk ties.After the abdomen was tracked, there was no other acute pathology seen.Because of the fact the abdominal wall was completely involved in the 2 hernias, it was impossible to just remove the sac.The whole area from the midline to about 5 cm.To the left was resected and then the double mesh was placed and sutured around to the defect which was about 20 by 10 cm.The jackson-pratt was then placed in the subcutaneous tissue.The subcutaneous tissue was closed with chromic catgut and the skin was closed with skin clips.Dressings were applied.Sponge and instrument counts were correct.¿ on (b)(6) 2006: uh surgery.Implant record: ¿gore-tex dualmesh plus¿.15.0 x 19.0 x 1.5mm.Item #: 1dlmcph04.Lot #: 03489445.Partial explant preoperative complaints: on (b)(6) 2013: (b)(6) medicine.(b)(6), md.Indications.¿mr.(b)(6) is a pleasant morbidly obese man who is approximately (b)(6) years of age.He was operated on at an outside hospital for an incarcerated hernia, underwent surgery including bowel resection and implantation of some type of 2-sided mesh containing gore-tex on one side and polypropylene on the other side.He developed a nonhealing wound and has been treated incompletely by the attending surgeon who performed the surgery.He was in clinic seeking a 2nd opinion.When examined in the clinic it was clear that there was a significant piece of mesh that was grossly infected and unincorporated.I recommended to mr.(b)(6) that this be performed within the operating room to avoid as much as possible discomfort.We talked about possible attendant complications such as bowel injury, bleeding, infection, and clearly current wound hernia.Mr.Malone signed appropriate informed consent.¿ partial explant procedure: procedure: exploratory laparotomy.Removal of grossly infected prosthetic mesh.Debridement of skin and soft tissue and fascia from abdominal wall.Curettage of infected granulation tissue.Open wound packing.Partial explant date: august 7, 2013 [hospitalization dates unknown].On (b)(6) 2013: (b)(6) medicine.(b)(6), md.Operative report.Preoperative diagnosis: grossly infected abdominal wound.Postoperative diagnosis: grossly infected abdominal wound, infected mesh that was implanted previously at an outside hospital.Anesthesia: general.Specimen: explanted infected dual mesh; polypropylene on one side and gore-tex on the other side as well as nonviable skin, subcutaneous tissue and fascia.Estimated blood loss: 100 cubic centimeters.Drains: none.Complications: none.Wound classification: not provided.Procedure: ¿patient brought to the operating room and placed supine on the operating table.General anesthesia was induced and followed by endotracheal intubation.This procedure was staffed by dr.(b)(6) of accm.Intubation was somewhat difficult and i asked another attending from accm to assist dr.(b)(6).The abdomen was shaved, prepped with betadine, draped in a sterile fashion using standard protocol.Prior to making the skin incision a thorough briefing was held.There were no concerns raised by anesthesiology, nursing or surgery.Appropriate antibiotics and dvt prophylaxis were administered.We reopened his previous midline incision, starting to open up sinus tract that led to the infected unincorporated mesh.There was a 2nd sinus tract to the far left and the lateral abdominal wall.Once we made the midline incision it was clear that the mesh extended quite a ways to the left lateral aspect of the abdomen.We extended the incision between the opening tissue between the midline and the left lateral abdominal wall sinus tract and then explanting the infected mesh from the abdominal wall.We were able to remove the mesh completely and left no residual that i was able to visualize with the unaided eye.Infected-appearing granulation tissue was curetted and removed from the wound using a bone curette.We were able to create relatively small abdominal fascial flaps on the upper and lower edges, laterally oriented fascial opening in order to mobilize the fascia to close it partially from the lateral to medial.We were able to partially close the fascia from lateral to medial using a series of interrupted #1 maxon sutures placed in a figure-of-eight fashion.A central 8 ax 10 cm of the incision was left open for drainage and ventral vac dressing after several days of pulse lavage.A large portion of skin, subcutaneous tissue and fascia that had been devitalized during the mobilization process was then debrided sharply, removed from the operative field and submitted to pathology for review.We irrigated the wound copiously with saline.Fortunately there was no evidence of a bowel injury or any other major problem.We packed the wound with saline- impregnated fine mesh gauze.The patient was then extubated.The patient was awakened abruptly with terrible hacking and coughing despite my request that he be extubated as gently as possible given the fact that he had an open abdomen.I was very disappointed with how the patient was awakened and extubated.We elected to move him to the intensive care unit for overnight observation at that point.When he left the or he was breathing comfortably and had been extubated.His wound appeared to be intact at that point.Sponge and needle counts were correct.As mentioned previously there were no intraoperative surgical complications.¿ pathology report not provided.Relevant medical information: on (b)(6) 2013: (b)(6) medicine.(b)(6) , md.Procedure: application of 8 x 12 cm split-thickness skin graft to open abdominal wound, utilization of vac negative-pressure wound management system.Preoperative diagnosis: open abdominal wound, status post attempted mesh removal.Postoperative diagnosis: open abdominal wound, status post attempted mesh removal.Anesthesia: general.Estimated blood loss: minimal.Complications: none.Drains: one vac negative-pressure wound management drain.Specimen: none.Indications: ¿mr.(b)(6) is a morbidly obese (b)(6) year-old man whom i operated on previously and removed a significant amount of infected abdominal wall mesh.His wound has been granulating over the past several months to the point where we can now accelerate closure by transferring a split-thickness autograft from his thigh to the open abdominal wound.We had a discussion about the advisability and safety of surgery as well as the potential complications.Appropriate informed consent was obtained.¿ wound classification: not provided.Procedure: ¿the patient be brought to the operating room and placed supine on the operating table.General anesthesia was induced.He underwent oral endotracheal intubation.The abdomen and left anterolateral thigh areas were prepped with betadine and draped in a sterile fashion using standard protocol.Prior to making a skin incision, a thorough briefing was held.There were no concerns raised by anesthesiology, nursing or surgery.The dermatome was set at 0.015 and a 10 cm long x 3 cm wide piece of split-thickness autograph was harvested from the left anteromedial thigh area.The donor site was covered with epinephrine-impregnated gauze sponge to provide topical hemostasis.The autograft was meshed 1.5-1 using the standard meshing apparatus.The recipient site in the abdominal wall was then prepped using a bone curette to remove excessive granulation tissue and simulate bleeding.The autograft was then placed over the recipient site and trimmed to size using the small fine scissors.The edges of the autograft were secured to the tissue surrounding the open wound with drops of histoacryl.We then cut a template designed to be the same size as the recipient site.The template was used to cut out a piece of silver-impregnated restore and also a piece of black vac sponge to use as an onlay vac negative-pressure wound management dressing.The restore was moistened and placed over the recipient site covering the autograft.The black vac sponge was placed over the restore and this was ultimately covered with semipermeable contact material followed by application of a track pad and suction tubing was connected to a vac negative-pressure suction device set at negative 125 mmhg.The donor site from the left anterolateral thigh area was covered with a silver alginate and a tegaderm dressing.The patient tolerated the procedure well.He was awakened, extubated and moved to a gurney in preparation to be transferred to the recovery room.There were no intraoperative complications.¿ explant preoperative complaints: on (b)(6) 2016: (b)(6) medicine.(b)(6), md.Indications: ¿the patient is a (b)(6) year-old obese gentlemen, who had a massive recurrent incarcerated incisional hernia.He had 9 abdominal operations before.The most recent operation was done by dr.(b)(6) in 2013, which was debridement of infected mesh and skin graft.He has been having chronic abdominal pain and several episodes of small-bowel obstruction in the last couple of years, he eventually had insurance coverage and come to my clinic for surgical repair of his hernia.He understands the risks, which included infection, bleeding, abdominal compartment syndrome, and multiorgan failure.He is willing to proceed for surgery.¿ explant procedure: insertion of left subclavian double-lumen central line.Repair of recurrent incarcerate incisional hernia.Extensive enterolysis.Creation of bilateral abdominal, fascia flaps.Tissue reinforcing biological mesh underlay.Implantation of synthetic mesh overlay.Debridement of excessive skin and subcutaneous tissue including old mesh with area more than 30x 20 cm.Negative -pressure wound vac therapy.[implant: surgimend biologic.Implant: mesh prolene soft].Explant date: (b)(6) 2016 [hospitalization dates unknown].On (b)(6) 2016: (b)(6) medicine.Surgeon #1 (b)(6), md.Surgeon #2: (b)(6), md.Operative report.Assistant #1: dr.(b)(6), assistant #2: (b)(6), md.Pre-and postoperative diagnosis: massive recurrent incarcerated incisional hernia.Anesthesia: general.Estimated blood loss: minimal.Specimens: hernia sac with extensive skin and subcutaneous tissue and old mesh en block.Wound classification: not provided.Findings: ¿large ventral hernia with >20cm abdominal wall defect.¿ procedure: ¿the patient was brought back to the or and placed on the table in a supine position after he received epidural catheter in the preop area.He underwent general anesthesia and intubation.The anesthesia team put in several large-bore peripheral intravenous lines and invasiva arterial line.I put in a left subclavian double-lumen central line using sterile techniques.Foley was also placed sterilely.Time-out was performed and he received 2 grams cefotetan before the skin incision.His skin was prepped and draped in a sterile fashion.This patient was extremely obese with a large 20 x 25 cm recurrent incisional hernia.So we chose to have a transverse oblique incision along his major hernia defect.The incision was started with a sharp #10 blade and it was carried down using bovie cautery.Once we reached to the normal fascia level, then we started mobilizing the skin soft tissue flap to the cephalad direction until we could reach the xiphoid and ribcage.Inferiorly, we started mobilizing the flap just above the fascial level all the way down to bilateral inguinal ligaments.Then, moving from lateral to medial above the fascial layer, we mobilized the flaps until we saw the edge of the hernia.Then, we entered the hernia sac safely using scissor.There was extensive adhesion of the omentum to the abdominal wall.This was taken down sharply with a combination of scissor and bovie.Inferiorly, there was also extensive dense adhesion between the loop of small bowel and the previous implanted old mesh.This was also taken down very carefully using cautery and scissor.There was no serosal tear or any potential injury to the bowel.Once we entered the hernia sac and released all the dense adhesions, we were able to run his bowel, from the ligament of treitz all the way to the terminal ileum.All the dense adhesions in between bowels were also lysed sharply with scissor.Then, we carefully used cautery to transect the whole hernia sac including the superficial skin and subcutaneous fatty tissue and the previous implanted mesh.Once the excess skin and subcutaneous tissue were removed from the patient, the hernia defect was measured about 20 x 25 cm.There was no possibility to primarily close the fascial, so we decided to place a biological mesh as a bridge to reconstruct his abdominal wall.We chose a 2mm thick 20 x 30 cm surgimend biological mesh to do this.The surgimend mesh was cut into a round shape, which measured about 20-25 cm in diameter.Then, we used #1 prolene suture to secure the edge of the mesh to the normal fascia in a circular direction.There was at least 3-5 cm overlap between the edge of the fascia and the edge of the surgimend mesh.Once the mesh was secured circumferentially, the mesh looked very flat with no tension.Then, we did extensive hemostasis and irrigation of the subcutaneous tissue.Then, we placed another 14 x 16 inch soft polypropylene mesh on top of this fascia and surgimend.This soft polypropylene mesh was secured down to the fascial level using multiple 0 prolene sutures at the edge.The interval between each suture was about 3 cm.The mesh was looking really flat at the end of the suturing process.Then, we applied another 10 cubic centimeter tisseel to seal any potential space between the fascia and the soft polypropylene mesh.This overlay placement of synthetic mesh looked really nice at the end of the case.Then, we placed five 19-french blake drains just on top of the synthetic mesh.At this time, the counting of needle, instrument, and equipment was correct.The patient tolerate (sic) the mesh placement with no significant increase of respiratory pressure.We then closed the subcutaneous skin using multiple 3-0 vicryl sutures in an interrupt fashion.On top of the skin, we also placed a layer of silver restore dressing and then we placed a negative-vacuum system just on top of the skin level.The patient tolerated this very complex hernia repair very well.Due to the extensive enterolysis and the complexity of this difficult recurrent hernia repair, dr.(b)(6) was present is a second attending surgeon to assist this case as no other qualified surgical residents or fellows available.The patient was kept intubated and then transferred to wicu in very stable condition.¿ on (b)(6) 2016: (b)(6) medicine.(b)(6), md.Brief operative note: ¿wound vac on until pod4 (postoperative day 4).Do not inject heparin into abdomen.No pressors.Cck (cholecystokinin) to decompress gallbladder.Pain per aps (abby pain scale).Bladder pressure q4h (every 4 hours).Peak airway pressure q1h (every hour).¿ pathology report not provided.On (b)(6) 2016: (b)(6) medicine.Implant record: surgimend biologic.On (b)(6) 2016: (b)(6) medicine.Implant record: mesh prolene soft.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 with holes 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 with holes 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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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial with holes 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 with holes 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.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.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 with holes 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.
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