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| Model Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/01/2008 |
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported to gore that the patient underwent open supraumilical ventral hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted.If multiple explant dates are provided: the complaint alleges that on (b)(6) 2008 and (b)(6) 2008, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, abscess, mesh removal.Additional event specific information was not provided.
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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: relevant medical information: ¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: umbilical hernia.Postoperative diagnosis: umbilical hernia and hypertensive urgency.Operative procedure: aborted secondary to hypertensive urgency.Attending surgeon: (b)(6), md who was available for the procedure.Resident surgeon: (b)(6), md.Estimated blood loss: none.Replacement: intravenous fluids 300 cc.Specimens: none.Indications: the patient is a 41-year-old male who is morbidly obese at 460 pounds and 5 feet 10 inches tall.He has multiple other comorbidities including diabetes mellitus, uncontrolled hypertension, and congestive heart failure.He also has sleep apnea.He has previously incarcerated his umbilical hernia twice presenting with a small bowel obstruction in the emergency room requiring reduction in the emergency room.Because of this, we decided to take the patient to the operating room.Before taking him to the operating room he was cleared by ___ [sic] preoperative clearance clinic and we therefore consented him for an umbilical hernia repair.Technique: ¿the patient was taken to the operating room and placed in the supine position.Bilateral sequential compression devices were placed on his lower extremities.He was given 2 grams of intravenous ancef.The anesthesia staff was preparing to induce general anesthesia when they noted that his blood pressure was 220/100.His preoperative blood pressure was noted to be 130/100.The anesthesia staff placed an arterial line to confirm his blood pressure and indeed it was this high, in fact it reached as high as 240/120.Because of his uncontrolled hypertension the anesthesia staff decided it was most appropriate to cancel this case and control this patient's blood pressure, ___[sic] in the intensive care unit on a drip and bring him back when his blood pressure was better controlled.This concluded our procedure.The patient tolerated the procedure well.He was placed on nicardipine drip and left the operating room with a max in the 80s to 100s range, normal pulse in the 70s to 90s, and normal oxygen saturation of 95% on room air.Dr.(b)(6) was immediately available for the entirety of this procedure.The patient left the operating room and was sent to the post-anesthesia care unit in stable condition.¿ implant procedure: dualmesh patch repair (10 x 14 cm) of supraumbilical hernia/diastasis recti.Implant date: (b)(6), 2008 (hospitalization unknown) ¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: supraumbilical hernia.Exogenous obesity.Asthma.Hypertension.Postoperative diagnosis: supraumbilical hernia/diastasis recti.Same as above.Attending surgeon: (b)(6), md (present for and participated in the entire procedure).Resident surgeon: (b)(6), md.Anesthesia: general endotracheal tube anesthesia.Estimated blood loss: minimal.Urine output: 350.Replacement: 1050 cc of crystalloid.Specimens: none.Complications: none.Implants: 20x30 centimeter dual mesh.Indications: this is a 41-year-old male with morbid obesity, hypertension and diabetes, and asthma was previously attempted to have an operation earlier this year, but had a hypertensive crisis on the operating room table so the procedure was aborted.He was worked up by the medicine team and rescheduled for today.He understands the possible need for being admitted to the floor unit after the procedure.Technique: ¿the patient was brought to the operating room and placed on the operating room table in the supine position.All pressure points were padded and sequential compression devices placed.The patient was initially intubated after receiving peripheral iv and an a-line.His abdomen was prepped and draped in the normal sterile fashion.We incised the supraumbilical skin midline with hernia wall and carried this incision down to the hernia sac carefully.We peeled off the hernia sac from the fascia circumferentially and needed to extend the incision because he had diastasis of the linear alba and we did dissect down to the rectus muscle.We freed up about 2-3 centimeters superiorly over the fascia and a #2 centimeter medially.The abdomen was not opened so the peritoneal cavity was not opened.We cut dura-mesh to size and we placed multiple single 1-0 prolene stitches, big bites in the fascia in a standing mattress stitch.We placed this picture circumferentially and there was nice flattening of the mesh without pulling.We placed a couple of vicryi interrupted stitches at areas where there was some opening between the mesh and the fascia.We washed out the wound thoroughly and then placed 2 drains inferiorly #10 jackson-pratt drains.We then dosed the subcutaneous tissue with interrupted horizontal mattress 2-0 ethilon.The patient tolerated the procedure well and was brought to the pacu in excellent condition.¿ ¿ product identification records for the alleged ¿dual mesh patch¿ were not provided.Relevant medical information: ¿ (b)(6) 2008: (b)(6) hospital.[signature illegible].Perioperative record.[handwritten].Implant type: dual mesh 20.0 cm x 30.0 cm x 1.0 mm.Lot #: 04098841.Asa 3.Weight 206.8 kg.¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: infected polytetrafluorethylene abdominal mesh parch from supraumbilical hernia repair on (b)(6), 2008.Postoperative diagnosis: infected polytetrafluorethylene abdominal mesh parch from supraumbilical hernia repair on (b)(6), 2008.Operative procedures: wash out of supraumbilical polytetrafluoroethylene mesh and subcutaneous tissues with 15 liters of simpulse irrigation and genitourinary irrigation antibiotics.On block closure of subcutaneous tissues and skin over 10-french jackson-pratt drains times two.Anesthesia: general endotracheal intubation.Estimated blood loss: 15 cc.Complications: none.Incision: reopen supraumbilical midline.Drains: #10 jackson-pratt times two.Condition: to post anesthesia care unit stable.Vitals: pressure 140/88 mmhg and heart rate 90.Indications: this is a 41-year-old man, who had supraumbilical hernia repair with potytetrafluoroethylene mesh, 14 cm by 12 cm on (b)(6), 2008, and he came back to the emergency room on postoperative day 9 with wound infection.He was started on antibiotics but he did not improve and the computed tomography scan looked worse, and so fluid collection from the jackson-pratt output was consistent with infection.It grew out methicillin-resistant staphylococcus aureus from those drains.Technique: ¿the patient was taken to the operating room and placed supine on the operating table.Pressure paints were padded.Bilateral sequential compression devices placed and 1 gram on vancomycin was given.We prepped and draped the abdomen in the normal fashion.We removed the stitches from the previous closure and opened the wound down to the polytetrafluoroethylene mesh.We used total of 15 liters of gu irrigant with simpulse irrigation on the mesh and on the subcutaneous tissues.There was large area of necrotic tissue and there was some granulation tissue on the subcutaneous fat.The mesh looked fine, no obvious signs of infection.We removed the old jackson-pratt drains.We opened the polytetrafluoroethylene mesh in the midline for a total length about 4 cm and used a sponge to clean out the undersurface of the mesh as well as simpulse irrigation.We then used the same hand-soaked brush to thoroughly scrub the mesh topside and the subcutaneous tissues.We used the simpulse again for a total of about 18 liters.We then closed the skin with deep retention stitches 2-0 nylon and reinforced these with smaller bites in between.Before that, we cut the skin hole.We did put in two more jackson-pratt drains bilaterally on each side.The patient tolerated the procedure well and was sent back to the intensive care unit in stable condition.He remained intubated.¿ ¿ (b)(6) 2008: (b)(6) hospital.[signature illegible].Perioperative record.Weight 180 kg.¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; dr.(b)(6).Operative report.Preoperative diagnosis: infected ptfe abdominal mesh.Postoperative diagnosis: subcutaneous abscess at the inferior portion of the ptfe abdominal mesh.Operative procedure: incision, drainage, irrigation and open packing of subcutaneous abscess just inferior to the ptfe body wall patch.Attending surgeon: dr.(b)(6), who was present and participated for the entire procedure.Resident surgeon: dr.(b)(6).Anesthesia: general anesthesia.Estimated blood loss: 400 cc of crystalloid.Specimens: abscess aspirate and culture swabs for gram¿s stain, culture and sensitivities.Indication: the patient is a 41-year-old african-american male with multiple co-morbidities who originally underwent ventral hernia repair in (b)(6) of 2008 using ptfe mesh.The patient subsequently developed a mesh infection and was treated with local irrigation and debridement of the mesh with placement of jp drains.He was then managed conservatively with iv antibiotics.He was followed serially in the clinic for management of his jp drains and remained on p.O.Linezolid for the mrsa that grew out of the cultures.Eventually, both jp drains were removed as were the patient's retention sutures.He continued to follow in the clinic on a weekly basis.However, on his last weekly visit the patient was noted to have purulent drainage from the inferior aspect of his incision.There was concern that there was mesh involvement.As a result, the patient was admitted to the hospital and placed on iv antibiotics.A ct scan of the abdomen and pelvis was then performed that revealed a fluid connection along the inferior aspect of the mesh with high suspicion for mesh involvement.As a result, the patient was brought to the operating room on (b)(6) 2008 for possible removal of the infected mesh and possible abdominal wall reconstruction.The risks and benefits of the procedure were discussed at length with the patient.Informed consent was then obtained.Findings: the patient had a small abscess cavity along the inferior aspect of a previously placed ptfe body wall patch.There was no evidence of exposed mesh.Technique: ¿the patient was brought to the operating room and was placed in the supine position on the operating room table.Scd's were placed to the bilateral lower extremities.He was given an additional gram of vancomycin prior to incision for antibiotic prophylaxis, specifically given his history of mrsa.After administration of adequate general endotracheal anesthesia, the patient's entire abdomen was then prepped and draped in the usual sterile fashion.After an appropriate timeout and surgical pause was performed, we then proceeded with an incision through the patient's prior midline wound using a #10 blade scalpel.We then carried the incision down through the subcutaneous tissue sharply using the scalpel.We proceeded all the way down through approximately 2" of subcutaneous tissue without any evidence of exposed mesh.In fact, the mesh appeared to be adequately incorporated along the superior and mid aspects of the incision.However, as we proceeded toward the inferior aspect of the incision, we did encounter a pocket of purulent material.This was aspirated and also swabs were sent for gram's stain and culture.We continued to evacuate the entire collection.I tried to identify if this collection tracked more superficially towards the mesh, but there appeared to be no obvious connection.Additionally, we attempted to see if the infection tracked deeper toward the peritoneal cavity, but again this led to no additional sinus tract.Ultimately, the abscess cavity was felt to be contained along the inferior aspect of the mesh and involving the subcutaneous tissues.As a result, we debrided the additional infected tissue from the abscess cavity.Following this, we then irrigated the wound with approximately 9 liters of antibiotic solution.We simultaneously continued to d bride the abscess cavity until only healthy viable tissue remained at the base.Once we had adequate irrigation, we then proceeded to obtain hemostasis.Following this, we then proceeded to reapproximate the skin edges of the superficial portion of the wound using 2-0 nylon sutures in an interrupted vertical mattress fashion.We left the most inferior portion of the wound open, specifically overlying the abscess cavity.This portion of the wound was then packed using betadine soaked kerlix dressing.The wound was then cleaned and dried, sterile abd's were then applied to the wound.This was covered with medipore tape.The patient tolerated the procedure well without any acute complication.Needle, instrument and lap counts were all correct at the conclusion of the procedure.General anesthetic was reversed and he was taken in stable condition extubated to the recovery room.¿ ¿ (b)(6) 2008: (b)(6) hospital.[signature illegible].Perioperative record.Weight 434 lbs.Asa 3.Explant procedure: excision of 4-7 o'clock portion of infected non-incorporated exposed ptfe mesh in the midline of the abdomen.Explant date: (b)(6), 2008 (hospitalization unknown) ¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; (b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: status post ventral hernia repair.Infected/exposed ptfe mesh in midline wound of the abdomen.Postoperative diagnosis: status post ventral hernia repair.Infected/exposed ptfe mesh in midline wound of the abdomen.1st assistant: (b)(6), md.2nd assistant: (b)(6), md.Anesthesia: general endotracheal intubation.Estimated blood loss: 1500 ml.Fluids: 2000 ml crystalloid.Drains: none.Specimens: culture swab of abscess fluid collected x2.Excised mesh sent for culture.Complications: none.Indications: the patient is a 42-year-old african american gentleman whose history dates back to (b)(6) 2008 when he had ventral hernia repair with ptfe mesh.The patient since then has returned to the intensive care unit twice for local wound debridement and conservative attempts 10 salvage mesh.Most recently he underwent placement of jackson-pratt drains x2 with local wound care in an attempt to allow for wound healing.However, unfortunately, following a suitable period of healing, persistent drainage recurred.In spite of p.O.Linezolid for his known methicillin-resistant staphylococcus aureus infection, his drainage has persisted.The patient initially requested to delay surgery for a few weeks.However, he has been thoroughly evaluated in the clinic.Following detailed discussion of the risks, benefits, and alternatives, which included excision of non-incorporated mesh and leaving behind non-incorporated mesh versus excision of total mesh, the patient has provided the prompt consent to proceed.Technique: ¿the patient was brought to the operating room on a stretcher.He was placed supine on the operating room table.His __[sic] were laid out to the side.Preoperative antibiotics, 2 g of vancomycin were administered, perioperatively.Following induction and intubation, a foley catheter was placed.The patient's abdomen thereafter was prepped and draped in the usual sterile fashion.A call to order was observed, confirming patient identity and procedure.At this point using hemostat we were able to identify and draining sinus.Using both electrocautery, we dissected down the sinus and continued exteriorizing draining sinus as we followed deeper into anterior wall of abdomen.Sinus was traced into abscess fluid collection that appeared to lie both over and underneath the mesh.At this point upon opening of mesh over infected fluid cavity we were able to release at least 20 ml of purulent contents.This abscess fluid was subsequently drained.At this point border of cavity was identified and obvious non-incorporated mesh was identified.Using curved mayo scissors, we gradually excised off mesh.Additionally, all exposed prolene sutures were removed.Abscess cavity was drained widely.At this point we evaluated the wound cavity, that appeared to be well healed at the base.Clearly, the peritoneal cavity was not violated.All non-incorporated edges of the mesh were excised.Additionally, all wound tissue had formed initial draining sinus was excised by to help healthy bleeding subcutaneous tissue.The wound cavity was generously irrigated with 2 liters of warm saline and gu irrigant.With hemostasis assured, our wound cavity was packed with dry and subsequently moistened with iodine.Of note, our packing was intentionally very tight in order to keep wound cavity open, abo pads were placed followed by sterile dressing.The procedure was deemed complete.All lap, sponge, instrument and needle counts were announced correct dr.(b)(6) was present and participated in the entire procedure.At this point the patient taken to the pacu and will be scheduled to return in 2 days for intraoperative removal of packing and wound washout.The patient tolerated the procedure well.¿ relevant medical information: ¿ (b)(6) 2008: (b)(6) hospital.[signature illegible].Perioperative record.Weight 189.4 kg.Asa 4.¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: status post excision of infected abdominal wall mesh with packing with open abdominal wound.Postoperative diagnosis: status post excision of infected abdominal wall mesh with packing with open abdominal wound.Operative procedure: abdominal wound washout and packing.Anesthesia: general endotracheal tube anesthesia.Estimated blood loss: minimal.Replacement: 400 cc of crystalloid.Specimens: none.Drains: no drainage, good clean tissue.Complications: none.Indication: the patient is a 42-year-old male status post ventral hernia repair with mesh.Complicated by chronic draining sinus from the periumbilical region.The patient was scheduled to undergo excision of sinus tract and mesh.The risks and benefits were explained in detail to the patient.Technique: ¿after the informed consent was obtained, the patient was taken to the operating room suite, where he was placed supine on the operating room table.General anesthesia was established.The previous abdominal packing was removed.The abdomen was prepped and draped in the standard surgical fashion.The wound was inspected and revealed no evidence of any purulent drainage and the wound bed was clean and healing well.We proceeded to simpulse irrigate the wound with gu irrigant.Approximately 3 liters were used.After adequate hemostasis was verified, the wound was packed with kerlix moist with quarter percent dakin solution.A sterile dressing was applied to the wound.The patient tolerated the procedure well and was transferred to the pacu in stable condition.¿ 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® 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.
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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® 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.
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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® 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: ¿improper positioning of the smoother, nontextured surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ individual medical decisions and/or actions of healthcare professional or device user, 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.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.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.
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