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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP02 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/10/2007 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.".
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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) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, mesh rolled up inside the abdomen, mesh stuck superiorly to omentum, severe pain, diarrhea, stomach cramps.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: implant preoperative complaints: (b)(6) 07: (b)(6) medical center, (b)(6) md, progress note, general surgery: ¿45 yo [year old] female presents with abdominal pain x 1 day.Says the pain woke her from sleep, and is located in the mid-abdomen.She says she feels as though the pain is associated with an umbilical hernia that she has.She denies n/v [nausea and vomiting], but has had some diarrhea.Additionally, it should be noted that she was in an altercation with her husband about a week ago and feels as though her hernia ¿moved¿ at that time.¿ ¿abd [abdomen]: soft, exquisitly [sic] tender area above umbilicus.Additionally, umbilical hernia (easily reducible) is quite tender.There is a small mass appreciated around tender area above umbilicus, but no fascial defect is appreciated due to the fact that the patient is resisting the exam.[positive] guarding.¿ ¿ct scan: small supra-umbilical ventral hernia with incarcerated abdominal fat¿ ¿a/p [assessment and plan]: 45 yo female with incarcerated ventral hernia, admit to general surgery, npo [nothing by mouth] and ivf [intravenous fluids] for now, pre-op for or to repair ventral and umbilical hernias laparoscopically¿ ¿ (b)(6) 2007: (b)(6) medical center, (b)(6) md, indications for surgery: ¿patient is a 45-year-old african american female.She came to the emergency room with a month history of upper abdominal pain and soreness that it has been getting worse in nature.Patient did not have any other gi symptoms, and upon ct scan, she was found to have an incarcerated ventral hernia repair with some fat incarceration in the hernia sac, and also she was found to have a reducible umbilical hernia which was not sore and tender in nature.However, her physical exam demonstrated upper midline abdominal tenderness and soreness consistent with this incarcerated hernia.At that point, the decision was made to take the patient to the or for repair and reduction of her hernia.The patient consented and agreed to the surgery.All the risks and benefits of the surgery were discussed with the patient, and patient was marked and agreed to the surgery.¿ implant procedure: laparoscopy and ventral hernia repair with gore-tex mesh and umbilical hernia repair.Implant: gore® dualmesh® plus biomaterial ((b)(6)/1dlmcp02) 8 x 12 cm.Implant date: (b)(6) 2007 [hospitalized (b)(6) 2007]: (b)(6) medical center, (b)(6) md, anesthesia: general, preoperative diagnosis: incarcerated ventral hernia, postoperative diagnosis: incarcerated ventral hernia, operation: ¿we initiated surgery with an incision above the umbilicus, and we entered the abdominal cavity successfully, and then at that point, the hasson technique was applied for incision of the first port for the laparoscope placement.The laparoscope was placed, and her full abdomen was inspected.There was no evidence of any injury.At that point, we shifted our attention to the midline, which was found [sic] hernia defect at the site of the falciform with some fat stranding inside the tissue inside the sac which was identified.After that, we inserted the two other ports in the lateral portion of her right side of her abdomen.Two 5 mm ports were inserted without any difficulty, and then the hernia sac contents were reduced.We identified small bleeding at the site of the falciform and hernia sac and hemostasis achieved with bovie cautery.At that point, we decided to place a gore-tex mesh on the hernia defect to cover this area which was placed and tacked down to the abdominal cavity without any difficulty.At that point, we removed all the ports, and we tried to repair the umbilical hernia at [sic] same time.After obtaining good fascia edge for closure of umbilical site, we closed that primarily and transversely with a #1 prolene.At that point, subcutaneous tissue was approximated with vicryl, and her port sites and her umbilical site and skin were closed with 4-0 biosyn suture.¿ relevant medical information: (b)(6) 2007: (b)(6) medical center, (b)(6) md, discharge summary for hospitalization (b)(6) 2007. ¿diagnosis: incarcerated ventral hernia¿ ¿operations/procedures: laparoscopic ventral hernia¿ ¿hospital course: the patient was taken to the operating room where a laparoscopic ventral hernia repair and an umbilical hernia repair were performed.She tolerated [sic] the procedure well, was extubated and transferred [sic] to the floor.Her pain was controlled with iv pain meds, and then po pain meds as her diet was advanced as tolerated.She was tolerating a po diet, moving her bowels, ambulatory, afebrile, and had adequate pain control on pod #2 and was thus discharged home.¿ (b)(6) 2007: (b)(6) medical center, (b)(6) md, discharge summary for hospitalization (b)(6) 2007. ¿diagnosis: recurrence of ventral hernia s/p ventral hernia repair¿ ¿hpi: 45 y/o female s/p lap ventral hernia repair with gortex mesh in (b)(6) 2007 who presents to er with 1 week h/o [history of] ¿feeling like the hernia came back¿.Pt refers that she has abdominal pain over the hernia.She refers that she has a fx [fractured] tooth, secondary to a blunt trauma, that got infected and has being treated with amoxicillin bid [twice a day] for 14 days and she also c/o [complains of] liquid diarrhea for the past couple of days and she has the cold at this time.She denies any fever or chills/n/v/c, dysuria, productive cough.¿ ¿ct abd/pelv [abdomen/pelvis] preliminary report there is a [sic] epigastric hernia which has some fat inside the hernia sac.There is no bowel seen inside the hernia, no bowel wall thickening.There is some stranding in the fat inside the hernia sac.¿ ¿abd: obese, soft, tender to light palpation in epigastric area.There is a 4 x 5 cm defect that is easily reducible, now bowel is palpated, no induration.Valsalva maneuver no evidence of hernia is seen.¿ ¿hospital course: after admission, cdiff [clostridioides difficile] was sent and was negative for toxin a and b.Patient tolerated her regular diet well and her wbc is now 10.5 down from 15.2.Flagyl was empirically [sic] started for the liquid diarrhea.Patient reports that her stool has been formed in the hospital, denies any nausea or vomiting.Patient has no complains at this time and no evidence of repeat fat/bowel incarceration.Patient is ready to go home and be followed up as an outpatient for an [sic] repeat elective lap ventral hernia repair surgery.¿ explant preoperative complaints: (b)(6) 2007: (b)(6) medical center, (b)(6) md, indications for surgery: ¿this is a 46-year-old female who has had a previous laparoscopic ventral hernia repair.She had a hernia recurrence after this.It appears that she has an omental herniation above her umbilicus.On computed tomography scan, it appeared that the mesh from her previous hernia repair had rolled up inside of her abdomen.We brought her to the operating room for an open hernia repair.¿ explant procedure: ventral hernia repair with polypropylene mesh overlay.Explant date: (b)(6) 2007 [hospitalized october (b)(6) 2007]: (b)(6) medical center, (b)(6) md, assistant: (b)(6), anesthesia: general, preoperative diagnosis: ventral hernia, postoperative diagnosis: ventral hernia, procedure: ¿the patient was prepped and draped in a sterile fashion.We made a small midline incision midway between the umbilicus and the xiphoid process.We dissected the subcutaneous tissues carefully down to the hernia sac.We then began to dissect the hernia sac free from the surrounding subcutaneous tissues.We were then able to come down to the fascia above and below the hernia sac.We also carefully delineated the margins of the sac.We raised flaps for a few centimeters laterally on each side.Once we had delineated the neck of the sac, we slowly incised the sac right where it came out of the fascia.We amputated the sac under direct vision.There was omentum in the hernia sac.We began to try to reduce this omentum back into the abdominal cavity.Some of the pedicles of omentum were quite vascular and adherent.We therefore amputated some of this omentum between kelly clamps and ligated with 2-0 silk ties.We were then able to reduce the omentum.We cleared the fascia for a few cm laterally and inferiorly on the inside of the abdomen.Superiorly we attempted to do this.She appeared to have a dense mat of her old gore-tex mesh stuck superiorly.It would have been a very difficult and extensive operation to try to free up this mesh.We decided that we could obtain our closure without having to excise it.Once we defined the defect, we closed it with four interrupted 0 prolene sutures.The defect was about the size of a quarter.We then measured the size of our subcutaneous tissue defect.It was about 6 x 9 cm.We cut a piece of polypropylene mesh to fit this.We set this on top of our fascia for additional reinforcement of our primary repair.We tacked this polypropylene mesh circumferentially using 2-0 prolene sutures.We also placed many sutures inside to approximate this mesh to the surface of the fascia and eliminate any air spaces.We hope that this will attain a good incorporation of the mesh into the fascia.Once we had secured our mesh, we then irrigated the pocket copiously.We placed a #10 blake drain to drain this space.We secured it with a 2-0 nylon suture.We then used a 3-0 vicryl to pack the flaps down to the surface of the fascia and mesh.We did this in order to eliminate any dead space in the pocket.We were carefully not to entrap our drain.We then also did some deep subcutaneous stitches using the 3-0 vicryl to secure the flaps to each other.We then did a running layer of deep dermal 3-0 vicryl sutures.We also did a superficial layer of 4-0 vicryl to close the epidermis.All sponge and instrument counts were correct.I was present and scrubbed for the entire procedure.We also did infiltrate the wound with 20 ml of 0.25% marcaine and 1 % lidocaine.¿ relevant medical information: (b)(6) 2007: (b)(6) medical center, (b)(6) md, general surgery progress note: ¿s [subjective]: pt complaining of pain in abd and back.¿ (b)(6) 2007: (b)(6) medical center, (b)(6) md, discharge summary for hospitalization (b)(6) 2007. ¿history of present illness: [the patient] is a 45 year old veteran who presents for preoperative evaluation prior to open ventral hernia repair with mesh scheduled for (b)(6) 2007.Pt was previously scheduled for this surgery (b)(6) 2007, but was postponed due to the need for dental clearance.Pt required extensive dental work under anesthesia.Pt with an additional history of htn, hep b, asthma, polysubstance abuse, and osteoarthritis.Review of medical record for this condition indicates vet is s/p [status post] umbilical and ventral hernia repair with mesh (b)(6) 2007.She presented to (b)(6) 2007 with c/o abdominal pain x 1 week, diarrhea, and n/v.She was found to have an elevated wbc.Ct abdomen (b)(6) 2007 showed an increase in size of a ventral hernia containing omental fat.C diff was negative for toxin a and b.Flagyl was empirically [sic] started for the liquid diarrhea.She was followed by general surgery who recommends an open ventral hernia repair.Currently, pt.Reports severe abominal [sic] pain.States ventral hernia has greatly increased in size.She no longer is able to reduce hernia.Pain is 10/10, sharp and sore.Pain increases when patient sneezes, coughs or bends.She was prescribed tylenol #3 again in aug.But states she ran out of pain meds and continues to drinks [sic] etoh [alcohol] daily to decrease the pain.Patient denies recent chest pain, fevers/chills, tooth pain.Reports some sob [shortness of breath] which is relieved by albuterol inhalers.¿ ¿hospital course: pt was admitted for an elective ventral hernia repair with mesh.The procedure went without complication and postop the pt was treated with pain control, strict i/o [input and output] monitoring, and jp [jackson-pratt] drainage.The pt did well, pain was well controlled with po pain meds, and diet was advanced as tolerated.On post op day 2, the pt is tolerating a regular diet, pain is controlled, and pt is deemed ready for discharge.The patient will be discharged with jp in place and on keflex until she is seen in clinic on thursday of next week.¿ (b)(6) 2009: (b)(6) medical center, (b)(6) md, discharge summary for hospitalization (b)(6) 2008 ¿ (b)(6) 2009: ¿discharge diagnosis: dka [diabetic ketoacidosis], new onset diabetes mellitus]¿ ¿hpi [history of present illness]: 47 yo f [female] w/ h/o [history of] htn [hypertension] and alcoholism (w/ no hx [history] of dm) admitted to hospital as she was noted to be in signs of early dka in the ed [emergency department].According to the patient she has been experiencing intermittent abdominal pain for the past 2 weeks which is accompanied by n/v/d [nausea, vomiting, diarrhea], polydipsia and polyuria.Abdominal pain worsen [sic] yesterday and it became constant, rated 6/10, and ¿hurts all over¿.At ed patient was noted to have bg [blood glucose] of 369, with 3+ glucose and ketones, 1+ blood acetone as well ag [anion gap] of 17.Pt started on ivf and ag has trended down to 10.Pt [patient] received 8 units bolus of insulin, which was run for 2 hours (at 8 units/hr), followed by 10 units of nph [insulin].Ros [review of symptoms] positive for diarrhea and occasional ¿dark stools¿, dysuria and headaches.Pt denied and visual changes, lightheadedness, chest pain, shortness of breath, hematuria, hematemesis, hematochezia or leg swelling.¿ ¿abd: soft, non-distended.Tender to palpation diffusely, although mostly on epigastrium [sic].No hsm or masses appreciated.No rebound or guarding.¿ ¿hospital course: [the patient] was admitted to the hospital for management of questionable dka/new onset diabetes mellitus.She was initially placed on an insulin drop in the emergency department, as her bg was in the 370s and she had 1+ acetones in blood, as well as 3+ glucose and ketones in urine and a gap of 17.Pt required insulin drop for 2 hours which was followed by 10 units of nph, she was also placed on ivf (which corrected the ag).Once patient was transferred to floor, she was placed on a sliding scale and evaluated by endocrinology, who recommended initiation of 25 units of lantus.Pt¿s abdominal pain (reason why patient seek [sic] medical care) subsided on hd#2 [hospital day # 2].She was instructed on the use of a blood glucose monitor as well as dietary changes and the use of lantus.Pt scheduled to follow up with pcp [primary care provider] on (b)(6) and diabetic clinic on (b)(6).¿ 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." 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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Updated results code.Conclusion code 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.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.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.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.¿ 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.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.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing 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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