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| Model Number 1DLMCP04 |
| Device Problems
Microbial Contamination of Device (2303); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
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| Event Date 08/30/2012 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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 open incisional and ventral hernia repair on (b)(6) 2012 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: infected mesh, hernia recurrence, adhesions, wound vac placement with home care required, removal of mesh.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: corrected results code.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 3/1/2012, including records detailing the prior sigmoid resection mentioned in the 3/1/2012 records, were not provided.Operative records dated 3/1/2012 indicate the patient underwent ¿diagnostic laparoscopy, laparoscopic adhesiolysis, open cholecystectomy, incisional hernia repair with mesh greater than 14 cm defect.¿ postoperative diagnoses are noted as ¿gangrenous cholecystitis, incisional hernia, extensive intraabdominal adhesions.¿ findings from the procedure state: ¿large ventral wall defect in the location of her previous incision for sigmoid resection.Multiple intraabdominal adhesions.Contracted, thickened and intrahepatic gallbladder with large 2 cm gallstone impacted within the infundibulum.No evidence of ovarian cyst.¿ the 3/1/2012 operative report states: ¿a 1.5 cm infraumbilical incision was created and electrocautery performed to the fascia.The fascia was lifted superiorly at the umbilicus and incised in a longitudinal position.Puncture into the peritoneal cavity was performed using a cystic instrument and safe entry into the abdominal cavity was assured.Two #1 vicryls were placed on either side of the facial defect and an hasson trocar placed.A pneumoperitoneum to 15 mmhg was insufflated.A 30 degree scope was inserted into the abdominal cavity and the abdomen was evaluated.There were multiple extensive adhesions in the lower abdomen and multiple loops of bowel stuck within this hernia.We were unable to evaluate the pelvis to evaluate for hemorrhagic ovarian cysts as requested by gynecology; therefore, adhesiolysis was planned as well as for hernia repair.¿ the 3/1/2012 operative report continues: ¿three further 5 mm incisions were created, one in the left subxiphoid region and two in the right upper quadrant in the standard fashion as for a laparoscopic cholecystectomy.With careful and slow dissection we were able to then dissect out all of the bowel free from the hernia defect extensive adhesiolysis was performed.Small bleeding points were coagulated as appropriate.In evaluating the pelvis the uterus was enlarged but otherwise there was no large ovarian cyst.The left ovary and fallopian tube were stuck within the hernia sac and this was dissected free.We then proceeded to attempt laparoscopic cholecystectomy.The gallbladder was lifted superiorly at its fundus and was completely intrahepatic and contracted and there was no way to tent it laterally.Careful dissection in the region of the peritoneal lining overlying the cystic duct was performed; however, this was completely adhesed.A top-down approach was attempted and the gallbladder was such intrahepatic there was no plane to separate.¿ the 3/1/2012 operative records continue: ¿after slow and careful dissection along the region of the cystic duct it was definitely unclear whether this represented the cystic duct and therefore the decision for an open procedure was made.All of the ports were removed and a large upper midline incision was created using a knife and then electrocautery.A bookwalter was placed for retraction purposes and the gallbladder was slowly and carefully dissected from a top-down approach.Still, due to its intrahepatic nature, this proved quite difficult.At the base there were very thick adhesions that were unable to be separated with slow and careful dissection.Therefore, we dissected it overlying the cystic common bile duct slowly and carefully until we were able to see the very foreshortened cystic duct.A large impacted stone was present at the base of the infundibulum and cystic duct.Upon removal, the cystic duct was more readily visualized.This was then ligated using #0 silk and transected slow and careful.Further dissection provided access to the cystic artery, which was then circumferentially dissected free and ligated using 2-0 silk suture.¿ the 3/1/2012 operative report states: ¿the gallbladder was split in two at this point and was removed from the hepatic bed.Once again this still proved difficult.Multiple stones had been expressed during the case laparoscopically and these had been removed laparoscopically.However, further stones were found while we were open.We then proceeded to place a 19 x 15 cm biologic mesh over the infraumbilical incisional defect.This was performed using #1 prolene in the four corners of the mesh through the anterior wall using the endostitch as well as the most inferior portion.These were tied and then a laparoscopic protack was used to adhere the remaining segment of mesh.The upper midline incision was then closed using #1 looped pds in a running fashion with #1 intermittent figure-of-eight prolenes.The wound was cleansed and the skin stapled.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp04/9483448) was used during the procedure.A surgical record dated 3/1/2012 states: ¿gallbladder opened during procedure, thick cream material oozed out multiple stones as well, wound class changed to contaminated.¿ discharge summary records dated 3/6/2012 state the patient ¿¿presented for cholecystectomy given with known acute on chronic cholecystitis on 3/1/12.She was taken to or for diagnostic laparoscopy, laparoscopic adhesiolysis.Due to extensive disease conversion to open cholecystectomy was necessary.In addition, the large incisional hernia was repaired with mesh, > 14cm defect.She tolerated the procedure without complication and was admitted for pain control.She was treated with a patient controlled epidural and intravenous narcotics.¿ records between 3/6/2012 and 8/30/2012 were not provided.Operative records dated 8/30/2012 indicate the patient underwent an abdominal wound washout, exploratory laparotomy, excision of mesh, herniorrhaphy, and adhesiolysis.Postoperative diagnoses state: ¿primary: wound infection.Secondary: infected mesh.Tertiary: incisional hernia.¿ the records state the patient ¿¿is a 40 year old female with previous gangrenous cholecystitis and hernia repair.She developed a chronic wound infection with involvement of the mesh requiring exploration.¿ the 8/30/2012 records state: ¿a periumbilical incision was created along the area of wound purulence and dissection performed to the fascia.There was a significant amount of inflammation of the subcutaneous tissue.A probe was used to follow the skin opening and this lead to a 5cm pocket of purulent material beneath which the mesh was seen poking through.The mesh was slowly and carefully excised from the overlying fascia.Adhesions were taken down with slow and careful sharp dissection.A single serosal tear was created which was closed using 3-0 silk suture in a lembert fashion.The abdomen was copiously irrigated until the effluent clear.The edges of the fascia were thickened and contaminated, therefore they were excised as appropriate until healthy fascia was encountered.Due to the necessary debridement and removal of the mesh, a large defect remained.Dr.Langstein from plastic surgery was called to assist with closure of the wound.He performed a lateral component separation.Please see his separate dictation for details.¿ the 8/30/2012 operative report continues: ¿once the component separation was performed, the fascial edges were able to be approximated.The fascia was closed using intermittent #1 prolene in a figure of eight fashion.Two #15 blake drains were placed laterally in the subcutaneous tissues through separate puncture sites, one on either side.The subcutaneous tissues were pulse lavaged using the pulsavac.To decrease the subcutaneous tissue depth, intermittent sutures were placed approximating the scarpas fascia and the anterior rectus sheath.The umbilicus was reapproximated using a deep dermal stitch.A wound vacuum dressing was then placed in two segments above and below the umbilicus.¿ dr.Langstein¿s records for the 8/30/2012 plastic surgery portion of the procedure state the following procedures were performed: ¿1.Right-sided component separation.2.Left-sided component separation.¿ postoperative diagnoses state: ¿infected mesh and new onset abdominal wall defect.¿ the 8/30/2012 records state: ¿this is a 40-year-old woman who has been operated on by dr.Eva galka who consulted me to assist in abdominal wall reconstruction.The patient had a bowel prosthetic placed but she had been having problems with drainage.The patient was taken to the operating room today by dr.Galka and her portion will be dictated under separate cover.At this time she performed a laparotomy because the previous mesh that had been placed was grossly infected and needed to be removed.As such, this left the patient with a new abdominal wall defect.I was called in to assist in this situation.¿ the 8/30/2012 records state: ¿there was a defect in the central abdomen that measured approximately 7 cm x approximately 15 cm.The patient had grossly infected mesh resected today and so it was decided that synthetic mesh was not appropriate to replace and so we were trying to get the wound closed without the addition of any foreign bodies at this point.Accordingly the fascial edges were then trimmed until we got to good healthy fascial tissue.We separated the skin and fat off of the left rectus abdominis muscle until we got to the linea semilunaris.This area was then opened up first with a pilot hole and then all the way from above and below, above on the rib cage down to the anterior aspect of the incision.Then we dissected laterally to the anterior axillary line.This gave us a modest amount of medialization with a neurotized rectus abdominis segment.But, unfortunately this was insufficient.Therefore, a separate and distinct right-sided component separation was performed in the same manner.¿ the 8/30/2012 operative report continues: ¿the abdominal skin and fat were then elevated off of the rectus abdominis muscle and the linea semilunaris was then encountered.It was then opened and then opened superiorly and inferiorly in the same way that we did on the other side.Having dissected this all of the way to the anterior axillary line, we were able to then move this neurotized segment to the midline to meet its other side.We kept finding additional defects superiorly so we had to continue the fascial incision, but ultimately with the extension of the component separation on both sides we were able to perform a direct repair of the linea alba.Again, it is typically my preference to think about reinforcing these with some sort of mesh, but the patient had gross infection today and the fascial edges that we sought were quite healthy and the decision was made to not reinforce but to simply close primarily as it came together very comfortably.The case was then turned back over to dr.Galka's service and the remainder of it will be dictated under separate cover.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (2240, 1695, 3191 used for ¿wound vac placement with home care required¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span march 1, 2012 through august 30, 2012 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Patient information: medical history: [none provided].Prior surgical procedures: sigmoid resection [unknown date].Implant preoperative complaints: [none provided].Implant procedure: diagnostic laparoscopy, laparoscopic adhesiolysis, open cholecystectomy, incisional hernia repair with mesh greater than 14cm defect.Implant: gore® dualmesh® plus biomaterial (1dlmcp04/9483448) 15 cm x 19 cm, oval.Implant date: on (b)(6) 2012 [hospitalized on (b)(6) 2012].Description of hernia being treated: ¿30 degree scope was inserted into the abdominal cavity and the abdomen was evaluated.There were multiple extensive adhesions in the lower abdomen and multiple loops of bowel stuck within this hernia.We were unable to evaluate the pelvis to evaluate for hemorrhagic ovarian cysts as requested by gynecology; therefore, adhesiolysis was planned as well as for hernia repair.Three further 5 mm incisions were created, one in the left subxiphoid region and two in the right upper quadrant in the standard fashion as for a laparoscopic cholecystectomy.With careful and slow dissection we were able to then dissect out all of the bowel free from the hernia defect extensive adhesiolysis was performed.Small bleeding points were coagulated as appropriate.¿ ¿after slow and careful dissection along the region of the cystic duct it was definitely unclear whether this represented the cystic duct and therefore the decision for an open procedure was made.All of the ports were removed and a large upper midline incision was created using a knife and then electrocautery.A bookwalter was placed for retraction purposes and the gallbladder was slowly and carefully dissected from a top-down approach.Still, due to its intrahepatic nature, this proved quite difficult.At the base there were very thick adhesions that were unable to be separated with slow and careful dissection.¿ ¿the gallbladder was split in two at this point and was removed from the hepatic bed.Once again this still proved difficult.Multiple stones had been expressed during the case laparoscopically and these had been removed laparoscopically.However, further stones were found while we were open.¿ implant size and fixation: ¿we then proceeded to place a 19 x 15 cm biologic mesh over the infraumbilical incisional defect.This was performed using #1 prolene in the four corners of the mesh through the anterior wall using the endostitch as well as the most inferior portion.These were tied and then a laparoscopic protack was used to adhere the remaining segment of mesh.The upper midline incision was then closed using #1 looped pds in a running fashion with #1 intermittent figure-of-eight prolenes.The wound was cleansed and the skin stapled.¿ post-operative period: [5 days].On (b)(6) 2012: ¿gallbladder opened during procedure, thick cream material oozed out multiple stones as well, wound class changed to contaminated.¿ on (b)(6) 2012: discharge summary: ¿she was taken to operating room for diagnostic laparoscopy, laparoscopic adhesiolysis.Due to extensive disease conversion to open cholecystectomy was necessary.In addition, the large incisional hernia was repaired with mesh, > 14cm defect.She tolerated the procedure without complication and was admitted for pain control.She was treated with a patient controlled epidural and intravenous narcotics.¿ explant preoperative complaints: [the patient] ¿is a 40 year old female with previous gangrenous cholecystitis and hernia repair.She developed a chronic wound infection with involvement of the mesh requiring exploration.¿ explant procedure: abdominal washout, exploratory laparotomy, excision of mesh, herniorrhaphy and adhesiolysis.Explant date: on (b)(6) 2012 [hospitalization dates unknown].¿a periumbilical incision was created along the area of wound purulence and dissection performed to the fascia.There was a significant amount of inflammation of the subcutaneous tissue.A probe was used to follow the skin opening and this lead to a 5cm pocket of purulent material beneath which the mesh was seen poking through.The mesh was slowly and carefully excised from the overlying fascia.Adhesions were taken down with slow and careful sharp dissection.A single serosal tear was created which was closed using 3-0 silk suture in a lembert fashion.The abdomen was copiously irrigated until the effluent clear.The edges of the fascia were thickened and contaminated, therefore they were excised as appropriate until healthy fascia was encountered.Due to the necessary debridement and removal of the mesh, a large defect remained.Dr.(b)(6) from plastic surgery was called to assist with closure of the wound.He performed a lateral component separation.Please see his separate dictation for details.¿ dr.(b)(6) (plastic surgeon) operative notes: ¿1.Right-sided component separation.2.Left-sided component separation.¿ postoperative diagnoses state: ¿infected mesh and new onset abdominal wall defect.¿ ¿this is a 40-year-old woman who has been operated on by dr.(b)(6) who consulted me to assist in abdominal wall reconstruction.The patient had a bowel prosthetic placed but she had been having problems with drainage.The patient was taken to the operating room today by dr.(b)(6) and her portion will be dictated under separate cover.At this time she performed a laparotomy because the previous mesh that had been placed was grossly infected and needed to be removed.As such, this left the patient with a new abdominal wall defect.I was called in to assist in this situation.¿ ¿there was a defect in the central abdomen that measured approximately 7 cm x approximately 15 cm.The patient had grossly infected mesh resected today and so it was decided that synthetic mesh was not appropriate to replace and so we were trying to get the wound closed without the addition of any foreign bodies at this point.¿ ¿again, it is typically my preference to think about reinforcing these with some sort of mesh, but the patient had gross infection today and the fascial edges that we sought were quite healthy and the decision was made to not reinforce but to simply close primarily as it came together very comfortably.The case was then turned back over to dr.(b)(6) service and the remainder of it will be dictated under separate cover.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes 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 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.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the device.¿ the gore® dualmesh® plus biomaterial instructions for use also states, "when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary." individual medical decisions, 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.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 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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 records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer / compounder: w.L.Gore & associates, inc.Lot number: 9483448.Additional manufacturer narrative: 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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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (2240, 1695, 3191 used for ¿wound vac placement with home care required¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2012 through (b)(6) 2012 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Patient information: medical history: none provided.Prior surgical procedures: sigmoid resection (unknown date) implant preoperative complaints: none provided.Implant procedure: diagnostic laparoscopy, laparoscopic adhesiolysis, open cholecystectomy, incisional hernia repair with mesh greater than 14cm defect.Implant: gore® dualmesh® plus biomaterial (1dlmcp04/9483448) 15 cm x 19 cm, oval implant date: (b)(6), 2012 [hospitalized (b)(6) 2012].Description of hernia being treated: ¿30 degree scope was inserted into the abdominal cavity and the abdomen was evaluated.There were multiple extensive adhesions in the lower abdomen and multiple loops of bowel stuck within this hernia.We were unable to evaluate the pelvis to evaluate for hemorrhagic ovarian cysts as requested by gynecology.Therefore, adhesiolysis was planned as well as for hernia repair.Three further 5 mm incisions were created, one in the left subxiphoid region and two in the right upper quadrant in the standard fashion as for a laparoscopic cholecystectomy.With careful and slow dissection we were able to then dissect out all of the bowel free from the hernia defect extensive adhesiolysis was performed.Small bleeding points were coagulated as appropriate.¿ ¿after slow and careful dissection along the region of the cystic duct it was definitely unclear whether this represented the cystic duct and therefore the decision for an open procedure was made.All of the ports were removed and a large upper midline incision was created using a knife and then electrocautery.A bookwalter was placed for retraction purposes and the gallbladder was slowly and carefully dissected from a top-down approach.Still, due to its intrahepatic nature, this proved quite difficult.At the base there were very thick adhesions that were unable to be separated with slow and careful dissection.¿ ¿the gallbladder was split in two at this point and was removed from the hepatic bed.Once again this still proved difficult.Multiple stones had been expressed during the case laparoscopically and these had been removed laparoscopically.However, further stones were found while we were open.¿ implant size and fixation: ¿we then proceeded to place a 19 x 15 cm biologic mesh over the infraumbilical incisional defect.This was performed using #1 prolene in the four corners of the mesh through the anterior wall using the endostitch as well as the most inferior portion.These were tied and then a laparoscopic protack was used to adhere the remaining segment of mesh.The upper midline incision was then closed using #1 looped pds in a running fashion with #1 intermittent figure-of-eight prolenes.The wound was cleansed and the skin stapled.¿ post-operative period: [5 days] (b)(6) 2012: ¿gallbladder opened during procedure, thick cream material oozed out multiple stones as well, wound class changed to contaminated.¿ (b)(6) 2012: discharge summary: ¿she was taken to or for diagnostic laparoscopy, laparoscopic adhesiolysis.Due to extensive disease conversion to open cholecystectomy was necessary.In addition, the large incisional hernia was repaired with mesh, > 14cm defect.She tolerated the procedure without complication and was admitted for pain control.She was treated with a patient controlled epidural and intravenous narcotics.¿ explant preoperative complaints: [the patient] ¿is a 40 year old female with previous gangrenous cholecystitis and hernia repair.She developed a chronic wound infection with involvement of the mesh requiring exploration.¿ explant procedure: abdominal washout, exploratory laparotomy, excision of mesh, herniorrhaphy and adhesiolysis.Explant date: (b)(6) 2012 [hospitalization dates unknown].¿a periumbilical incision was created along the area of wound purulence and dissection performed to the fascia.There was a significant amount of inflammation of the subcutaneous tissue.A probe was used to follow the skin opening and this lead to a 5cm pocket of purulent material beneath which the mesh was seen poking through.The mesh was slowly and carefully excised from the overlying fascia.Adhesions were taken down with slow and careful sharp dissection.A single serosal tear was created which was closed using 3-0 silk suture in a lembert fashion.The abdomen was copiously irrigated until the effluent clear.The edges of the fascia were thickened and contaminated, therefore they were excised as appropriate until healthy fascia was encountered.Due to the necessary debridement and removal of the mesh, a large defect remained.Dr.Langstein from plastic surgery was called to assist with closure of the wound.He performed a lateral component separation.Please see his separate dictation for details.¿ dr.(b)(6) (plastic surgeon) operative notes: ¿1.Right-sided component separation.2.Left-sided component separation.¿ postoperative diagnoses state: ¿infected mesh and new onset abdominal wall defect.¿ ¿this is a 40-year-old woman who has been operated on by dr.(b)(6) who consulted me to assist in abdominal wall reconstruction.The patient had a bowel prosthetic placed but she had been having problems with drainage.The patient was taken to the operating room today by dr.(b)(6) and her portion will be dictated under separate cover.At this time she performed a laparotomy because the previous mesh that had been placed was grossly infected and needed to be removed.As such, this left the patient with a new abdominal wall defect.I was called in to assist in this situation.¿ ¿there was a defect in the central abdomen that measured approximately 7 cm x approximately 15 cm.The patient had grossly infected mesh resected today and so it was decided that synthetic mesh was not appropriate to replace and so we were trying to get the wound closed without the addition of any foreign bodies at this point.¿ ¿again, it is typically my preference to think about reinforcing these with some sort of mesh, but the patient had gross infection today and the fascial edges that we sought were quite healthy and the decision was made to not reinforce but to simply close primarily as it came together very comfortably.The case was then turned back over to dr.Galka's service and the remainder of it will be dictated under separate cover.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes 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 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.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the device.¿ the gore® dualmesh® plus biomaterial instructions for use also states, "when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary." individual medical decisions, 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.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 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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 records verified that the lot met all pre-release specifications.C1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 9483448 additional manufacturer narrative: 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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