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| Model Number 1DLMC08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/03/2013 |
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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 laparoscopic lower midline hernia repair on (b)(6) 2003 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, small bowel obstruction, abdominal wall reconstruction, abscess, open draining wound, devitalized tissue, scarring, severe and chronic pain/discomfort.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.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) 2002: (b)(6) medical center.(b)(6), md.Preoperative diagnosis: menorrhagia unresponsive to conservative medical therapy, dilatation and hysteroscopy.Postoperative diagnosis: menorrhagia unresponsive to conservative medical therapy, dilatation and hysteroscopy.Operation: total abdominal hysterectomy.(b)(6) 2002: (b)(6) medical center.(b)(6), md.Discharge summary.Total abdominal hysterectomy which was done on (b)(6) 2002.Weight 312 pounds.Tolerated procedure well.Postoperative course was unremarkable.Instructions: no lifting greater than 10-15 pounds for the next six weeks.(b)(6) 2002: (b)(6) medical center.(b)(6), md.Emergency room visit.Had an abdominal hysterectomy 10 days ago and developed a small abscess or seroma which was drained.Yesterday, wet-to-dry dressing changes were done.They are unable to get set up for home care nursing to come and do this, so presents here as it is over a week, and does complain of some pain over the area of the lower abdomen.Exam: abdomen bowel sounds are present, soft, and nontender.Has an abdominal wound below the umbilicus and a portion of the wound has dehisced.The abdomen is soft with palpation very laterally away from this area.Impression: abdominal pain ¿ status post abdominal hysterectomy.Wound dehiscence ¿ repacked.Low grade fever.(b)(6) 2003: (b)(6) associates.(b)(6), md.Office notes.Underwent hysterectomy (b)(6) 2002.Subsequently developed an infection and underwent laparotomy again in (b)(6) 2002.Since that time noticed about a month ago to have developed a bulge in the lower aspect of incision.Does not have any signs of incarceration.History of obesity.Exam: abdomen obese.Has a pannus on examination.Has fairly large reducible hernia just to the left of the incision below the umbilicus.Impression: ventral hernia.Plan: i have recommended that the patient wat to have hernia repair since it is quite early from previous operation.In the meantime, i have given her a binder and given her instructions about incarceration vs.Strangulation risk.Implant procedure: laparoscopic ventral hernia repair with dual mesh.Implant: gore® dualmesh® biomaterial [1dlmc08/01274682, 27 cm x 28 cm] implant date: april 30, 2003 (hospitalization [ni]) (b)(6) 2003: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: symptomatic large ventral hernia.Postoperative diagnosis: symptomatic large ventral hernia.Lysis of adhesions.Assistant: (b)(6), md.Anesthesia: general.Estimated blood loss: minimal.Counts: correct.Description of procedure: ¿the patient was brought to the operating room and placed in supine position, at which time her abdomen was prepped and draped in the usual sterile fashion after the patient underwent general endotracheal anesthesia.The patient had an ng tube and scds placed prior to induction.All trocar sites were anesthetized with a local anesthetic.An epigastric port site was chosen, and a 10-mm hasson port was placed, and the abdomen was insufflated.Two 5-mm trocars were placed in the lateral abdominal wall on both sides under direct visualization.Upon insufflation, it was clear that the patient had quite a bit of omentum incarcerated in the multiple hernia defects in the anterior abdominal wall.The adhesions were taken down carefully.The defect itself measured approximately 22 cm x 21 cm and included the area just above the umbilicus but clearly was away from the area of the pubic tubercle and proximity of the bladder.After adequate reduction of the hernia contents, a large piece of dual mesh that was approximately 27 cm x 28 cm in size was fashioned to allow at least a 3-cm redundant margin beyond the hernia defect itself.The mesh was secured using 0 ethibond sutures as well as the autosuture protack.After adequately securing the dual mesh in place with the sutures and protack, the abdomen was irrigated with saline and all the trocars were removed.The epigastric port site fascia was closed with 0 vicryl sutures.All skin sites were closed with absorbable suture.The patient tolerated the procedure well.¿ (b)(6) 2003: (b)(6) medical center.Implant sticker.Gore-tex dualmesh biomaterial.Item#: 1dlmc08.Lot#: 01274682.The records confirm a gore® dualmesh® biomaterial (1dlmc08/ 01274682) was implanted during the procedure.Relevant medical information: (b)(6) 2003: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis.Indication: history of recent abdominal wall hernia repair.Is experiencing severe left lower abdominal and pelvic pain.Findings: there are postoperative changes of an anterior abdominal wall hernia repair.A large goretex mesh is identified within the anterior abdominal wall.There is a small fluid collection noted deep to the mesh within the midline.There is a larger fluid collection identified superficial to the mesh.This measures approximately 15 x 10 cm.There is no air identified within these fluid collections to suggest a secondary infection or abscess.Impression: postoperative changes of anterior abdominal wall hernia repair.There is a large fluid collection located superficial to the gortex mesh and a much smaller fluid collection located deep to the mesh.There is no air identified within these fluid collections to suggest a secondary infection or abscess.No intraperitoneal abscess is identified.No evidence of a bowel obstruction.Bibasilar plate-like atelectasis.(b)(6) 2003: (b)(6) medical center.(b)(6) md.Discharge summary.Admit date: (b)(6) 2003.Underwent hysterectomy in 2002.Subsequently, developed intraabdominal and superficial abscess and underwent laparotomy again in (b)(6) 2002.Since that time, has developed a large symptomatic ventral hernia, and wished to have repair.Hospital course: admitted and taken to the operating room on (b)(6) 2003.Underwent laparoscopic ventral hernia repair with mesh, and lysis of adhesions.Was fairly slow to recover; however, was afebrile and up and ambulating, slowly.Diet was advanced and on postoperative day number four was doing much better.However, on postoperative day number five was having emesis and some left lower quadrant abdominal pain.Has not had a bowel movement for two or three days and was concerned that she was obstipated.Was given a bowel regimen and finally had some relief.Also underwent a ct scan of the abdomen to make sure there was no infection, given the vagueness of her left lower quadrant pain.On ct scan, had just a seroma overlying the dual mesh, which is to be expected in the postoperative period.There was no evidence of intraabdominal infection or bowel obstruction.Was kept overnight and white blood count was checked on (b)(6) 2003 and it was deemed to be normal at 11,000.Abdomen was soft, nontender.She was much improved.Had a bowel movement and was tolerating diet well.Was stable for discharge.(b)(6) 2003: (b)(6) medical center.(b)(6), md.Emergency room visit.Complains of bleeding from incision.Had a hernia repair on (b)(6) 2003 and was discharged yesterday.Today, was in a minor motor vehicle accident.Noticed spotting in her underwear.Denies any significant abdominal pain at this time.Exam: abdomen soft, normoactive bowel sounds; nondistended, nontender.Has an incision which is not actively bleeding at this time.Steri-strips are intact.Impression: recent hernia surgery; motor vehicle accident; bleeding from incision, resolved.(b)(6) 2005: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis.Indication: pelvic pain.Surgical history of hysterectomy, cholecystectomy, appendectomy and hernia.Findings: there is surgical material along the abdominal wall on the midline and left lateral side with thinning of entire abdominal wall through which large mesenteric fat and bowel herniates, especially at the lower mid and left abdomen.No evidence of bowel strangulation or obstruction.Right at the level of the symphysis pubis, there is anterior abdominal wall hernia measuring 20 x 13 cm in which mesenteric fat and bowel are located.Impression: large anterior abdominal wall hernia at the level of the symphysis pubis without bowel strangulation or obstruction.No evidence of inflammation or ascites within the pelvis to explain pelvic pain.Possible right colectomy along with appendectomy, hysterectomy, oophorectomy and cholecystectomy.Status post anterior abdominal wall hernia repair.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Emergency room visit.Has been having 2 days of abdominal pain.Started having mild nausea and the next morning started vomiting.Vomited throughout yesterday.Has not passed any gas or had a bowel movement since tuesday, today being thursday.Ordered a ct scan to be done and at the time that was performed, the radiologist called and spoke with primary care provider, stating the patient had an small bowel obstruction, at which point they recommend that she come to the er for further evaluation.She is diabetic and has not been paying attention to her blood sugar over the past couple days.Has never had a bowel obstruction before, but she has had multiple abdominal surgeries and appendectomy, cholecystectomy, hysterectomy, and 2 ventral hernia repairs.Does not smoke or drink.Exam: abdomen softly distended, hypoactive bowel tones throughout.She is diffusely tender to palpation, although not significantly.Slight bulge in the left mid-to-lower quadrant.Impression: small bowel obstruction.Plan: placement into observation.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Consultation.Began developing nausea and vomiting of mainly bilious material on tuesday, 48 hours ago.Also began developing epigastric pain at approximately the same time.Saw her primary care provider, dr.(b)(6), who provided oral pain medicine, as well as antinausea medicine.Pain and nausea did improve; however, had not passed any flatus or bowel movement since tuesday, and a cat scan of the abdomen and pelvis was ordered.The studies i reviewed personally and demonstrated a dilated small bowel up to 3.7 cm in caliber with multiple air-fluid levels, concerning for a partial small bowel obstruction.Was also found to have a ¿twisting appearance of the mesentery within the abdominal wall hernia¿.Also noted was enlargement of the ventral hernia defect.Surgical history of total abdominal hysterectomy and bilateral salpingo-oophorectomy approximately 6 years ago; this was followed by the development of an incisional hernia, for which an attempt to repair with mesh was performed, although the hernia apparently soon recurred.The repair was approximately 5 years ago.Also had an open cholecystectomy and appendectomy in the past.Exam: abdomen diffusely soft with perhaps tenderness in the region of the lower abdominal wall hernia and epigastric region.There is no obvious guarding or rebound.Bowel sounds are somewhat are normoactive.There is no redness in the skin overlying the hernia or the rest of the abdomen.There is no groin adenopathy or hernias present.Impression: at least partial small bowel obstruction.Morbid obesity; insulin-dependent diabetes mellitus; hypertension.Plan: concerned about wound healing in this morbidly obese diabetic patient and believe that conservative management should certainly be tried.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: nausea, vomiting, epigastric pain.Findings: there is a large ventral hernia defect located inferolaterally on the left which is slightly larger when compared to the previous exam.The ap dimension of the opening of the hernia is 5.1 cm.There is a small amount of increased density along the margin of the hernia within the subcutaneous fat of the patient¿s large abdominal pannus.There is dilatation of the small bowel measuring up to 3.7 cm in caliber.There are multiple small air-fluid levels.This may reflect changes of partial small bowel obstruction.There is a twisting appearance of the mesentery within the defect.There is the presence of both normal and dilated small bowel within the defect and therefore this may represent the transitional site.Impression: enlargement of the patient¿s ventral hernia defect in the lower left quadrant of the patient¿s large abdominal pannus.There appears to be a twisting of the mesentery at this location and there is probable transition at this point.This produces a partial small bowel obstruction.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-abdomen 2 views.Indication: pain.Impression: no significant interval change.Stable findings of ileus versus a partial distal small bowel obstruction.(b)(6) 2011: (b)(6) medical center.(b)(6) , do.Discharge summary.Discharge diagnosis: partial small bowel obstruction, resolved.Initially, refused the nasogastric tube put in the emergency department and on the floor stated that she was feeling somewhat better.However, later during the night, had an increase in abdominal pain again with associated nausea and vomiting and at that point, agreed to the nasogastric tube placement.Reported decreased abdominal distension and discomfort after the placement of the nasogastric tube.However did not have any bowel movement or passed gas until the day of discharge.Did have good ng tube output and continued nothing by mouth with only clear fluids until her last day of admission.On that day, the ng tube was clamped and found to have very little residuals, so was subsequently removed.Was then given clear fluid diet initially and then advanced as tolerated throughout the day.Did have a bowel movement on the day of discharge.Exam: abdomen soft and nontender.It is tympanic to percussion, and there are bowel sounds in all 4 quadrants.Discharged home.(b)(6) 2013: (b)(6) clinic.(b)(6), md.Office notes.Presents to discuss upcoming operation.Weight 299 lbs., bmi 45.63.Exam: abdomen soft, nontender, nondistended.Impression/plan: abdominal incisional hernia.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: recurrent incarcerated ventral hernia.Postoperative diagnosis: recurrent incarcerated ventral hernia.Operation: retrorectus repair of recurrent incarcerated ventral hernias with 12 inch x 12 inch polypropylene ultrapro mesh, utilizing 2 sheets of such mesh.Anesthesia: general.Assistant: stephen a.Reese, md.Indications for procedure: ¿this patient is a 54-year-old super morbidly obese woman with a large recurrent incarcerated ventral hernia containing multiple loops of small bowel within a large pannus.She has presented with bowel obstructions and has ongoing pain related to this hernia.Operative repair was advised.Recommendations for weight loss were made, but given her degree of symptomatology, operation was recommended.Description of procedure performed: ¿the patient was given preoperative antibiotics.She was taken to the operating suite, positioned supine.General anesthesia was provided.A vertical midline incision was made, extending slightly below the umbilicus, which was approximately at the level of the pubis.The incision was deepened through the skin and subcutaneous tissues.The upper portion of the incision was deepened to the level of the fascia.The anterior rectus fascia was cleared in the midline and carried to the level of underlying musculature as noted by cautery and pulse.The anterior rectus fascia was opened longitudinally, first on the patient¿s left side.The retrorectus plane was entered and fully developed for the full length of the incision.It was carried into the space of retzius below the pubis.Cooper¿s ligament was identified.The space of retzius was fully developed.There was evidence of prior intra-abdominal mesh placement with multiple metallic protac extending into the retrorectus space.Several of these were removed.The mesh was left in place.Then the identical dissection was performed on the patient¿s right side and carried into the pelvis.The incarcerated hernia was gradually dissected free from its large subcutaneous pocket within the pannus of the lower abdominal wall.This was difficult due to the patient¿s size and the size of the hernia.Gradually, i was able to fully reduce the hernia and complete the preperitoneal dissection, then the posterior rectus fascia was closed with 0 vicryl suture.The mesh prosthesis was prepared.The diameter of the posterior rectus space was measured at 30 cm transversely.The mesh was positioned.It was secured to the cooper ligament bilaterally with #1 prolene suture.It was secured to the cooper ligament bilaterally with #1 prolene suture.It was then draped anteriorly over the mesh extending from lateral edge of the rectus sheath on the right side to the lateral edge of the rectus sheath on the left side.It was secured to the undersurface of the anterior rectus fascia, lateral to the rectus musculature with individually placed stitches of 0 vicryl suture.A second piece of 12 inch x 12 inch mesh was used to reinforce the more superior abdominal wall, again extending the entire width of the retrorectus space.It was secured to the undersurface of the anterior rectus fascia lateral to the rectus musculature with 0 vicryl suture.It was draped into the lower abdomen.It was connected to the initially placed mesh with 0 vicryl suture.Then, the anterior rectus fascia was cleared of its subcutaneous attachments bilaterally.It was advanced to the midline in order to complete this and allow for a reasonably tension-free fascial closure.Component separation was performed and the anterior rectus fascia was reapproximated in the midline completely covering the mesh with #1 pds suture.Two drains were positioned into the subcutaneous space.They were exteriorized through stab wounds on the left and right abdomen where they were secured with silk suture and connected to bulb suction.The deep dermis was closed with 3-0 vicryl suture.The skin edges were reapproximated with dermal staples.Bacitracin was placed to the staple line and to the drain site.Sterile dressing was applied.Abdominal binder was placed.The patient was awakened and delivered to the recovery room in stable condition having tolerated the procedure well.¿.
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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: ¿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 material.¿ 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 warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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 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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