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| Model Number 1DLMCP08 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Seroma (2069); Hernia (2240); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(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: ¿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 incisional hernia repair on (b)(6) 2007, whereby a gore dualmesh® plus biomaterial was implanted.It was reported the patient alleges the following injuries: debridement of seroma underlying the gore mesh, recurrent hernia, extensive adhesions, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Please note the initial medwatch indicates an incorrect date gore aware of 11/12/2018.The date gore aware of information for the initial report is 11/10/2018.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:
operative records dated 4/18/2007 state the patient underwent laparoscopic mesh repair of multiple incisional hernias.The records state: ¿four separate 5 mm ports were placed under direct visualization and then a 10-11 port was placed.Using multiple ports, an extensive adhesiolysis was performed bringing small bowel off the anterior abdominal wall and allowing it to fall down to the floor.This extensive adhesiolysis took approximately 1.5 hours to perform.Once this was accomplished and all the bowel had been reduced from the anterior abdominal wall, the anterior abdominal wall was examined.Multiple defects were encountered throughout the anterior abdominal wall in the midline from her prior incisions.Also the bladder was partially taken down to allow visualization of all edges of the defect in the lower midline.¿
the 4/18/2007 operative report states: ¿once this was accomplished, it was measured and the defect was measured out to be a 24 x 10 cm defect.Thus, a piece of gore-tex dualmesh measuring 34 x 26 cm had four fixation sutures placed in it.It was rolled and placed through the 10-11 port and introduced into the abdomen.After it was oriented appropriately the gore suture passer was advanced through the anterior abdominal wall through small hashmarks and these stay sutures were grasped and pulled, thus bringing the mesh to the anterior abdominal wall.Once these original four sutures were pulled up, the mesh was tacked to anterior abdominal wall using the pro tacker.Once this was accomplished four additional stay sutures were placed using the gore passer device.Once this was accomplished the 10 mm port site was closed with a o vicryl using the fascial closure device.All ports were removed under direct visualization.The wounds were closed with 4-0 monocryl and dermabond applied.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp08/04477782) was implanted during the procedure.Records between 4/18/2007 and 4/26/2010 were not provided.Operative records dated 4/26/2010 state the patient underwent: ¿1.Diagnostic laparoscopy.2.Extensive adhesiolysis laparoscopically.3.Laparoscopic mesh repair of recurrent incisional hernia.4.Debridement of seroma underlying prior mesh repair.¿ the records state: ¿¿the abdomen was insufflated with 15 mm of mercury.A second 5 mm port was placed and an approximate 1 hour and 1 s minute extensive adhesiolysis was performed, after placing 2 other 5 mm ports.The left upper quadrant port site was enlarged to a 12 mm step port.Multiple bovie of the bleeding points, as well as clipping of bleeding points, was performed.The 4/26/2010 operative report states: ¿as stated above, there were extensive adhesions due to her prior surgeries and mesh repairs.Once this massive adhesiolysis was performed, the patient had an area of seroma below the level of the prior mesh repair which was a gore-tex mesh repair.This was opened and approximately 30 ml of fluid was aspirated from the area and sent for a stat gram stain, as well as permanent culture and sensitivity.Stat gram stain did not reveal any organisms and just had occasional mononucleocytes per telephone report.Thus, this entire seroma cavity was debrided back, exposing the prior mesh.Once this was accomplished, there was thickened material within the fluid and this was all suctioned out with the 5 and 10 mm suction devices.Once this was accomplished, the hernia was easily identified lateral on the left side.Once this was accomplished, the defect was measured with spinal needles.It measured approximately 5 x 7 cm.¿
the 4/26/2010 operative report continues: ¿at this time, a piece of parietex composix mesh 15 circle was introduced into the abdomen, after placing stay sutures using gore-tex suture.Once this was accomplished, we fixated with a good 5 cm overlap superiorly and inferiorly on the defect first using the gore-tex passer and these were tied.Then , we tied more medially and then the lateral-most.First, we attempted a bone anchor, but it was apparent that this lesion was not lateral enough for a bone anchor, and placed a novofil suture and it holding it in place.At this time, the mesh was circumferentially tacked and then superior and inferior lateral quadrants were tacked with novofil, at least twice in each quadrant.Stay sutures in the medial quadrants were then placed and then a novofil suture was placed in the 12 mm port site.¿ there records indicate a parietex composite mesh (non-gore device) was used during the procedure.There was no mention of infection and no mention of gore device removal in the records.Additionally, there was no mention of the gore device in the records.Operative records dated 5/7/2010 state the patient underwent ¿excision and debridement of skin and soft tissue of left abdominal wall abscess.¿ indications state: ¿the patient is a 67- year-old white female who has previously undergone ventral hernia repair with mesh that was done laparoscopically on 04/26/2010 by dr.Rinkliff and dr.Cobb.The patient developed discharge from the left side of her abdomen over the course of the last several days and presented to the emergency department.Her ct scan revealed a large abscess in the subcutaneous tissue of the left abdomen.The patient was anticoagulated for atrial fibrillation.Her inr was reversed and once her inr was reversed, she was taken urgently to the operating room as she was hypotensive and appeared to be becoming more septic from this infection.¿ findings from the procedure state: ¿uncertain whether abdominal wall abscess extends intra-abdominally.¿ records for the ct scan showing a large abscess were not provided.The 5/7/2010 operative report states: ¿there was a large amount of erythema and induration noted over the left abdomen.There was also air and pus that was able to be expressed from a few small trocar sites that had been used to do her laparoscopic ventral hernia repair.An appropriate time-out was performed.At this point, an oblique incision was made over the left lower abdomen with a 10 blade scalpel.The soft tissue was dissected sharply with bovie cautery.Two vicryl sutures were placed as well to oversew some bleeding in the subcutaneous tissue.There was a large amount of pus that was expressed from the subcutaneous tissue and there was a pocket that was able to be entered posteriorly.There was a permanent suture noted at the bottom of this pocket and perhaps this was the fascia; it was uncertain because of the timeframe of the previous operation that was approximately 2 weeks ago, whether this pocket extended into the abdomen, although there was pus noted coming up from this pocket.There were also several pockets, superficial, in the subcutaneous tissue and there was some necrotic fat.This was debrided.¿
the 5/7/2010 operative report states: ¿once adhesions hemostasis [sic] was obtained , the wound was irrigated with copious amounts of warm saline until there was no additional pus able to be expressed.The 1 suture at the base of the wound was cut out using a scissors.A flat jackson-pratt drain was placed at the bottom of this cavity and was sewn to the skin using a nylon suture.The wound was inspected.Once again there was good hemostasis noted.The entire wound was an elliptical incision of approximately 20 x 7 cm and debridement of the skin and subcutaneous tissue was completed.The wound was then packed with a moist kerlix and this was covered with dry 4 x 4¿s and abd pads.¿ ¿¿a stat ct scan of the abdomen and pelvis without contrast will be pursed early this morning to reevaluate this abscess and hopefully determine whether there is an intra-abdominal component.¿ ¿there were no complications.¿ there was no mention of infection involving the gore device and no mention of gore device removal in the records.Operative records dated 5/8/2010 state the patient underwent ¿excision and debridement of skin and soft tissue of left abdominal wall abscess.¿ these records appear to be duplicative of the 5/7/2010 operative report.Operative records dated 5/6/2011 indicate the patient underwent amputation of a left third toe with gangrene.The records state the patient ¿is a 60-year-old white female with history of diabetes.She developed an ulcer on her third toe, which became gangrenous.Despite iv antibiotics, this has become worse.¿
records dated 5/9/2011 indicate the patient underwent amputation of a left third toe with gangrene.These records appear to be duplicative of the 5/6/2011 operative report.Records dated 9/2/2011 indicate the patient underwent cardiac catheterization for an indication of ¿pulmonary hypertension with volume overload and severe dyspnea.The patient had recently been on empiric treatment with sildenafil which caused worsening dyspnea.¿
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: ¿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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2020: (b)(4).Death certification.Death at age 76 years.Place of death: decedent¿s home.Immediate cause: portal systemic encephalopathy, pulmonary hypertension and biventricular systolic heart failure.Other significant conditions: chronic kidney disease.Coroner contacted: no.Autopsy: no.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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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (1695, 2069, 2240) were reported based on the original complaint and are no longer applicable per gore¿s investigation.No further investigation is required at this time.Based upon gore¿s investigation 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.This event will be closed as no problem detected.Medical records: ¿ the known medical records span (b)(6) 2007 through (b)(6) 2011, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.¿ records from (b)(6) 2007 through (b)(6) 2010 were not provided.Patient information: medical history: [none provided].Prior surgical procedures: [none provided].Implant preoperative complaints: [none provided].Implant procedure: laparoscopic mesh repair of multiple incisional hernias.Implant: gore® dualmesh® plus biomaterial (04477782/1dlmcp08) 26 x 34 cm, oval.Implant date: (b)(6) 2007.¿ description of hernia being treated: ¿multiple defects were encountered throughout the anterior abdominal wall in the midline from her prior incisions.Also the bladder was partially taken down to allow visualization of all edges of the defect in the lower midline.Once this was accomplished, it was measured and the defect was measured out to be a 24 x 10 cm defect.¿ ¿ implant size and fixation: ¿thus, a piece of gore-tex dualmesh measuring 34 x 26 cm had four fixation sutures placed in it.It was rolled and placed through the 10-11 port and introduced into the abdomen.After it was oriented appropriately the gore suture passer was advanced through the anterior abdominal wall through small hash marks and these stay sutures were grasped and pulled, thus bringing the mesh to the anterior abdominal wall.Once these original four sutures were pulled up, the mesh was tacked to anterior abdominal wall using the pro tacker.Once this was accomplished four additional stay sutures were placed using the gore passer device.¿ ¿ no post-operative records were provided.Relevant medical information: ¿ (b)(6) 2010: ¿1.Diagnostic laparoscopy.2.Extensive adhesiolysis laparoscopically.3.Laparoscopic mesh repair of recurrent incisional hernia.4.Debridement of seroma underlying prior mesh repair.¿ ¿there were extensive adhesions due to her prior surgeries and mesh repairs.Once this massive adhesiolysis was performed, the patient had an area of seroma below the level of the prior mesh repair which was a gore-tex mesh repair.This was opened and approximately 30 ml of fluid was aspirated from the area and sent for a stat gram stain, as well as permanent culture and sensitivity.Stat gram stain did not reveal any organisms and just had occasional mononucleocytes per telephone report.Thus, this entire seroma cavity was debrided back, exposing the prior mesh.Once this was accomplished, there was thickened material within the fluid and this was all suctioned out with the 5 and 10 mm suction devices.Once this was accomplished, the hernia was easily identified lateral on the left side.Once this was accomplished, the defect was measured with spinal needles.It measured approximately 5x 7 cm.At this time, a piece of parietex composix mesh 15 circle was introduced into the abdomen, after placing stay sutures using gore-tex suture.Once this was accomplished, we fixated with a good 5 cm overlap superiorly and inferiorly on the defect first using the gore-tex passer and these were tied.Then, we tied more medially and then the lateral-most.First, we attempted a bone anchor, but it was apparent that this lesion was not lateral enough for a bone anchor, and placed a novofil suture and it holding it in place.At this time, the mesh was circumferentially tacked and then superior and inferior lateral quadrants were tacked with novofil, at least twice in each quadrant.Stay sutures in the medial quadrants were then placed and then a novofil suture was placed in the 12 mm port site.¿ records confirm a non-gore device was implanted during the procedure on (b)(6) 2010.¿ (b)(6) 2010: ¿excision and debridement of skin and soft tissue of left abdominal wall abscess.¿ ¿the patient developed discharge from the left side of her abdomen over the course of the last several days and presented to the emergency department.Her ct scan revealed a large abscess in the subcutaneous tissue of the left abdomen.The patient was anticoagulated for atrial fibrillation.Her inr was reversed and once her inr was reversed, she was taken urgently to the operating room as she was hypotensive and appeared to be becoming more septic from this infection.¿ ¿there was a large amount of erythema and induration noted over the left abdomen.There was also air and pus that was able to be expressed from a few small trocar sites that had been used to do her laparoscopic ventral hernia repair.¿ ¿at this point, an oblique incision was made over the left lower abdomen with a 10 blade scalpel.The soft tissue was dissected sharply with bovie cautery.Two vicryl sutures were placed as well to oversew some bleeding in the subcutaneous tissue.There was a large amount of pus that was expressed from the subcutaneous tissue and there was a pocket that was able to be entered posteriorly.There was a permanent suture noted at the bottom of this pocket and perhaps this was the fascia; it was uncertain because of the timeframe of the previous operation that was approximately 2 weeks ago, whether this pocket extended into the abdomen, although there was pus noted coming up from this pocket.There were also several pockets, superficial, in the subcutaneous tissue and there was some necrotic fat.This was debrided.Once adhesions hemostasis [sic] was obtained, the wound was irrigated with copious amounts of warm saline until there was no additional pus able to be expressed.The 1 suture at the base of the wound was cut out using a scissors.A flat jackson-pratt drain was placed at the bottom of this cavity and was sewn to the skin using a nylon suture.The wound was inspected.Once again there was good hemostasis noted.¿ ¿ records do not indicate that either the gore device or non-gore device were explanted during the procedure on (b)(6) 2010.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.¿ 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, 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.Based upon the information received, the device remains in the patient and was not available 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 04477782.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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