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Catalog Number 1DLMC02 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Abscess (1690); Unspecified Infection (1930); Hernia (2240)
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Event Date 12/12/2004 |
Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.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 umbilical hernia repair on (b)(6) , 2004 whereby a gore dualmesh biomaterial was implanted.The complaint alleges that on (b)(6) 2014 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: chronic infection, recurrence; abscess, mesh migration, mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair of umbilical hernia.Repair of epigastric hernia.Implant: gore® dualmesh® biomaterial [1dmc02/03044692, 8.0 cm x 12.0 cm x 1.0 mm].Implant date: (b)(6) 2004 (hospitalization unknown).¿ (b)(6) 2004: (b)(6), md.Operative report.Indication: patient presented with a large umbilical hernia, and he was scheduled for repair.Findings: umbilical hernia with a defect in the umbilical area which measured about 2 cm in size.The hernial sac contained omentum.Another defect was present above this in the epigastric region in the mid-line.This defect measured about 1 cm in size, and extraperitoneal fat protruded through the defect in the linea alba.Procedure: ¿the patient was brought to the operating room, identified as kenneth c.Bryant.He was placed in a supine position.General anesthesia with endotracheal intubation was given.The abdomen was prepped and draped in a standard sterile manner.Using a subumbilical curvilinear incision, the incision was deepened down to the anterior rectus sheath and the linea alba, and the hernial sac dissected off the surrounding fatty tissues.A portion of the omentum which was adherent to the hernial sac was excised with the sac.The specimen was sent for histological examination.The edges of the defect in the mid-line were identified, and the anterior rectus sheath freed off fatty tissue for a distance of about 3 cm around the defect.Dissection superiorly revealed the epigastric hernia.The two defects were then connected.The peritoneum was dissected off the posterior rectus sheath, and the defect in the peritoneum was closed with a continuous #2-0 vicryl suture.A dual mesh of gore-tex was placed in the extraperitoneal space between the peritoneum and the rectus sheath, and this was secured using gore-tex interrupted sutures place about 2.5 cm from the edges of the defect in the abdominal wall.The edges of the defect were then closed over the goretex mesh using a continuous suture of gore-tex.The incision was irrigated with antibiotic solution containing ciprofloxacin.The subcutaneous tissues were then closed using #2-0 and #3-0 vicryl interrupted sutures.The umbilical depression was recreated.1% xylocaine local anesthesia with epinephrine was infiltrated into the incision, and the skin was then closed with #4-0 pds subcuticular suture.Steri-strips and sterile dressings were applied.Patient remained stable throughout the procedure.He was extubated at the end of the procedure and transferred to the recovery room in a stable condition.¿ blood loss was about 25 cc.The excised omentum with the hernia sac was sent for histological examination.¿ (b)(6) 2004: (b)(6).Nursing intraoperative report.Operation performed: repair of umbilical hernia.Repair of epigastric hernia.Wound classification: clean.¿ (b)(6) 2004: (b)(6).Implant record.Gore-tex dual mesh.Model: ref# 1dmc02.Lot/serial number: (b)(6).Size: 8.0 cm x 12.0 cm x 1.0 mm.Quantity: 1.¿ the records confirm a gore® dualmesh® biomaterial (1dmc02/ 03044692) was implanted during the procedure.Explant procedure: removal of infected mesh and drainage intraperitoneal abscess cavity, culture of abscess cavity with washout.Explant date: december 12, 2014 (hospitalization unknown).¿ (b)(6) 2014: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: infected mesh after umbilical hernia repair in 2004.Diabetes.Obesity.Postoperative diagnosis: infected mesh after umbilical hernia repair in 2004.Diabetes.Obesity.Cosurgeon: dr.Maddineni.Anesthesia: general.Wound class: infected.Estimated blood loss: less than 5 ml.Complications: none.Specimens: culture and sensitivity of abscess cavity.Infected gore-tex mesh.Drains: none.Packs: none.Disposition: recovery room stable and extubated.Indications: the patient is a 51-year-old man, who underwent a mesh umbilical hernia repair in 2004, at another va facility.Apparently over the past 6 to 8 months he has some firmness and then drainage.The firmness and discomfort lead to an i and d at another va facility and since that time he has had spontaneous drainage, copious amounts of pus through the tract connected to the i and d site.Ct scan confirmed a fluid collection subfascial in location with what appears to be mesh floating in it.We offered him removal of the mesh and incision and drainage of the abscess cavity and he agreed.The risks that were discussed included bowel injury with fistula, bleeding, pain, infection, recurrent hernia, need for further surgery, the anesthetic and many others and he agreed to proceed, and signed the consent form after his questions were answered.Findings: we could palpate abdominal wall firmness, although there was no redness or tenderness associated with this.We mapped this out from 0.5 cm below the umbilicus to approximately 6 cm above the umbilicus and 5 cm at least wide.We entered into the abscess cavity, drained a large volume of purulent material.This was also cultured.A piece of gore-tex mesh was removed without having to really cut ant sutures.It was free floating and not attached to any tissue.Posterior aspect of the abscess cavity appeared to be omentum and possibly some small bowel.Description of procedure: ¿patient was brought to the operating room, given general anesthetic.He was intubated.He was on keflex at home already.He was on lantus insulin and oral hypoglycemics.He did not take his oral hypoglycemics this morning.We gave him additional ancef 2 gm, placed scds, foley catheter was also placed.The abdomen was clipped, prepped and draped.We did our final time-out confirming the procedure to be performed, the patient¿s identity.We mapped out the defects using a sterile pen and made an incision in the midline from the pinpoint hole from which he had his drainage down to just above the umbilicus.I attempted to probe through the sinus tract but could not enter into the abscess cavity.We cut down through the skin and indurated subcutaneous tissue until we entered the abscess cavity.A copious amount of pus was drained, cultured, irrigated.The mesh was free floating, was removed.Additional gore-tex suture was also found and was debrided out.Incision extended to below umbilics.We then coarsely debrided the abscess cavity using a lap sponge and then rubbing it along all aspects of the abdominal wall anteriorly and the omentum posteriorly.Bleeding was controlled with cautery.We copiously irrigated until the effluent came back clear.At this point, we made a decision to close the fascia over the cavity by trying to cinch as tissue up to close down the dead space as much as possible.This was done mostly with #1 interrupted prolene sutures.We irrigated the subcutaneous tissue and then closed the skin very loosely with staples and an absorbant dressing was then placed and this represented the completion of the procedure.There were no complications.Patient was allowed to recover from the anesthetic, was extubated and then transferred to recovery room stable, having tolerated the procedure well.As the attending surgeon of record for this procedure, i was present and scrubbed for the case in its entirety including positioning, prepping and draping, the incision and drainage of the abscess, the removal of the infected mesh and debridement of the abscess cavity, and the closure.¿ relevant medical information: ¿ (b)(6) 2014: (b)(6) medical center.(b)(6), md.Pathology.Accession no.: (b)(6).Specimen: infected abdominal mesh.Gross description: the patient¿s identification information on the sf 515 is identical to the information submitted on the specimen container label.Received in formalin and labeled ¿infected abdominal wall mesh¿ is a single 8 cm in diameter specimen of mesh for gross examination only.Diagnosis: ¿infected abdominal wall mesh¿ (removal): medical device received for gross examination only.¿ (b)(6) 2015: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: large recurrent umbilical hernia.Diabetes.Obesity.Hypertension.Obstructive sleep apnea.Postoperative diagnosis: large recurrent umbilical hernia.Diabetes.Obesity.Hypertension.Obstructive sleep apnea.Procedure performed: laparoscopic repair of recurrent umbilical hernia with mesh.Co-surgeon: sridevi maddineni, md.Anesthesia: general.Wound class: a ¿ clean.Estimated blood loss: less than 2 ml.Drains: no drains.Specimen: no specimen.Complications: no complications.Disposition: extubated to recovery room.Indications: the patient is a 52-year-old man with multiple stable medical problems.He had an umbilical hernia repair with mesh in 2004 and then had chronic mesh infection over the ensuing 10 years.We did a mesh removal procedure in december of 2014.The wound healed, and he has now developed a recurrence and desires repair.Due to his obesity we quoted very high recurrence rate in the order of 50%, and he understands.Because of symptoms, job changes and other social reasons, her desires repair.Other risks discussed beside recurrence including bleeding, pain, infection, anesthetic, bowel injury, various recurrent infections, and many others, and he agreed to proceed and signed the consent form after his questions were answered.Findings: an approximately 7 x 8 or so centimeter defect was identified at laparoscopy.There was omentum adherent into the hernia sac.It was reduced with dissection and cautery dissection.No other abnormalities were noted.However, he did have a significantly fatty liver with precirrhotic changes, and i have informed his wife of this finding.Description of operation: ¿patient was brought to the operating room and given a general anesthetic and was intubated.Scds were placed.Vancomycin was started as he is allergic to penicillin.We did not place a foley catheter as he voided in the ascu.Ioban was placed after prepping.We did our final time-out at this point confirming the patient¿s identity and the procedure to be performed.A small incision was made in the left upper quadrant just below the costal margin after infiltrating the skin and tissue with local anesthetic.We used a 5 mm optiview type port with a 0 degree 5 mm scope and entered the abdominal cavity without any difficulty.We then created our pneumoperitoneum.A 5 mm port was placed in the far left abdomen and left lower quadrant under direct vision.These were ballooned 5 mm ports.We then exchanged the 5 mm port in the left upper quadrant to a 10-12 balloon port.Performed our exploration with the findings as noted above.Omentum stuck into the hernia sac, was taken down mostly with electrocautery.There was no significant bleeding.We then reduced the pressure, first to 10, then to 8 cm of water and then marked out the hernia defect with a spinal needle.We measured 4 cm out from this giving us roughly 17 x 18 near circular piece of mesh for the defect.We marked off 6 points for suspensory 0 prolene sutures at appropriate places and then cut the mesh.I placed the 6 suspensory sutures onto the mesh.The mesh was then coiled, placed in through the 10-12 port.We then flattened out the mesh, oriented it appropriately.We made 6 stab incisions 1-1/2 cm outside of the mesh edge marking on the ioban and then passed a suture passer through to pull the suspensory sutures up.Once these were all done we pulled these up tightly, tied them giving us an excellent-looking suspension of mesh over the defect.We then used the tacker to circumferentially tack the mesh to the abdominal wall and then an additional 5 or 6 tacks were placed more centrally to tack the mesh down right at the edge of the defect.This represented a completion of the procedure.All counts were correct.No complications, and the repair looked excellent.We then placed a prolene figure-of-eight using the suture passer at the 10-12 port site under direct vision.The two 5 mm ports were removed under direct vision, and there was no bleeding, and the pneumoperitoneum was reduced.A 10-12 port was removed, and the suture was tied.It should be noted that we did inject local anesthetic at the two 5 mm ports.Skin at the 3 ports sites was closed with 4-0 monocryl and skin glue.Skin glue was also placed at the 6 suspensory sites.This represented a completion of the procedure.All counts were correct.The patient was allowed to recover from the anesthetic, was extubated the transferred to the recovery room stable.As the attending surgeon of record for this procedure i was present and scrubbed for the case in its entirety including positioning, prepping, draping, final time-outs, the creation of a pneumoperitoneum with port site placement, the laparoscopy, the reduction of the omentum, the placement of the mesh and the closure.¿ ¿ (b)(6) 2015 [assigned]: (b)(6) medical center.Implant record.Prolene mesh.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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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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: explant procedure: removal of infected mesh and drainage intraperitoneal abscess cavity, culture of abscess cavity with washout.Explant date: (b)(6) 2014 [hospitalization dates unknown] (b)(6) 2014: wound classification: ¿dirty/infected.¿ relevant medical information: (b)(6) 2014: (b)(6) medical center.No provider listed.Microbiology: ¿specimen: peritoneal fluid.Gram stain: moderated wbc¿s [white blood cells], few red blood cells, no organisms seen.¿ (b)(6) 2014: (b)(6) medical center.(b)(6), md.Office note.¿f/u [follow-up] after infected mesh removal.Worried about drainage.No redness or fever.Minimal pain.Exam: redness around staples only.2 skin gaps probed ¿ peroxide; no tunnel.Staples removed and wound dressed.Have asked him to clean gaps with peroxide daily and after showering; may shower with incision uncovered.Will call next week.See me mid jan.Final intraoperative culture was negative.¿ 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 health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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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