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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCPH06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Obstruction/Occlusion (2422)
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| Event Date 10/16/2017 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence". 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".
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Event Description
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It was reported to gore that the patient underwent ventral incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh erosion to small bowel, bowel obstruction, bowel resection, mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: open repair of incisional hernia with placement of duo mesh and primary fascial defect closure as well as lysis of adhesions and repair of serosal tears in small bowel.Implant: gore® dualmesh® plus biomaterial [1dlmcph06/(b)(6), 18 x 24 cm] implant date: (b)(6) 2010 (hospitalization [ni]) ¿ (b)(6) 2010: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Assisting surgeon: (b)(6), md.Indications for surgery/procedure: mr.(b)(6) is a 32-year-old male who is status post small bowel resection, developed an incisional hernia and was seen and evaluated by dr.(b)(6) in the clinic.As he was symptomatic from his hernia it was discussed surgery to repair the hernia with placement of mesh was discussed with him and he decided to proceed to surgery.The patient presented on (b)(6) 2010 for the above stated procedure.Description of procedure: open repair of abdominal incisional hernia with placement of duo mesh, lysis of adhesions, repair of serosal tears in the small bowel, primary closure of fascial defect.Complications: none.Anesthesia: general endotracheal anesthesia.Specimen: none.Prosthetic device/implants: duo mesh was implanted.Narrative: ¿the patient was brought to the operating room and placed supine on the operating table.Antibiotics were administered prior to procedure start time.A time-out was taken to correctly identify the patient, the operative surgeon and the operative site.The patient was then prepped and draped in standard sterile surgical fashion.We began our surgery by making an incision through the previous abdominal incision.To do this we did excise the incisional scar and used bovie electrocautery to dissect down to the fascia as well as sharp dissection.Using sharp dissection, we dissected down to the fascial plane and eventually entered the abdomen under direct visualization.Upon entering the abdomen, it was obvious that we had extensive adhesions to the abdominal wall.We began taking down our adhesions with sharp dissection using metzenbaum scissors.This was quite difficult but we proceeded along the length of our incision to completely mobilize the intestine as well as omentum off of the abdominal wall.Once we had freed up our adhesions around the length of our incision, it was apparent that there were several areas in the small bowel where serosal tears had been inadvertently made because of lysis of adhesions.Those serosal tears were then repaired with 3-1 silk pop-off with interrupted lembert sutures.We freed up approximately 5 cm of fascia around out entire incision and then measured out our duo mesh.We used a 25 cm piece of duo mesh and trimmed it accordingly to the size of our abdominal defect.Using 0 prolene sutures we then placed interrupted sutures around the entire abdominal incision tacking our mesh to our fascia.The entire repair was done under direct visualization.The tension in the mesh was excellent at the end of out repair.Upon palpation after placement of the mesh there were no defects in our fascial sutures.We then placed figure-of-eight sutures to bring the fascial edges together at the midline at the linea alba.We were able to bring this completely together and closed in the midline with simple interrupted suture.Those sutures were used were 0 prolene sutures.We then copiously irrigated the abdominal wound.Sponge, needle and instrument counts were correct after our fascia was closed.We then used a running chromic suture to reapproximate scarpa fascia.We stapled the skin.Our needle and instrument counts as stated were correct at the end of the case as well as our sponge counts.Dr.(b)(6) was present for the entire case, directed the operative repair.The patient was then brought out from under general anesthesia and returned to the operating room in stable condition.¿ (b)(6) 2010: (b)(6) hospital [assigned].Implant record.Body site: abdomen.Device description: mesh dual plus 18 x 24 cm.Manufacturer: gore, william l and associates.Mfg catalog #: 1dlmcph06.Lot #: (b)(6).Date used: (b)(6) 2010.Item #: mgo55088.Quantity: 1.Physician: (b)(6) md.The records confirm a gore® dualmesh® plus biomaterial (1dlmcph06/(b)(6)) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2017: (b)(6)vmedical center.(b)(6), md.Discharge summary.Admit date: (b)(6)2017.Discharge diagnosis: status post exploratory laparotomy with bowel resection and removal of foreign body.Discharge condition: stable.History of two hernia repairs (inguinal 2009, ventral 2010), gastroesophageal reflux disease and asthma, presenting with abdominal pain, nausea, and vomiting.Surgery was asked to consult due to possible small bowel obstruction.Patient describes pain as a twisting pain what gets worse with eating and is similar to the pain, he felt in 2008 when he was diagnosed with an intestinal obstruction.Several episodes of emesis since tuesday.Not had a bowel movement or passed gas since monday night.Ct abdomen shows hernia mesh that appears to have fistulized to/eroded through small bowel loops in the anterior midline, now within a mid small bowel loop and likely causing obstruction.Associated symptoms: constipation.Hospital course: left lower quadrant pain.Patient found to have mesh from prior hernia repair eroded into small bowel causing obstruction on imaging in ed.Taken for exploratory laparotomy with a small bowel resection, loa, and removal of mesh from the bowel.He tolerated the operation well.Post op course uneventful.Completed course of iv antibiotics on (b)(6) and discharge back to (b)(6) facility on (b)(6) with wound vac for midline abdominal incision to be change monday/wednesday/friday.Follow up: dr.(b)(6) 1-2 weeks.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 with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial with holes 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 results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial with holes 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 preoperative complaints: (b)(6) 2017: dr (b)(6) indications.¿this 40-year-old male has a history of abdominal surgery for ¿twisted bowel¿ in 2008 and right inguinal hernia repair in 2009 in new york city columbia university.In 2010 the patient underwent abdominal wall hernia repair in syracuse upstate university hospital with a 25 cm dual mesh which was cut.The patient presented this time to erie county medical center with a 2-day history of abdominal pain.On physical examination there was a left mid abdominal tenderness but no rebound tenderness.Laboratory tests show no leukocytosis.The ct abdomen and pelvis were reviewed with the radiologist.When compared to ct with the previous one, it is obvious that the mesh was now not attached to the abdominal wall.There was a foreign body insight the small bowel lumen.The hernia mesh appears to have fistulized and eroded through small bowel loops in the anterior midline.¿ explant procedure: exploratory laparotomy, enterolysis x 4 hours, small bowel resection with end-to-end hand sewn anastomosis, enterorrhaphy x 1, removal of small bowel intraluminal foreign body (mesh).Explant date: (b)(6) 2017 [hospitalization dates (b)(6) 2017].(b)(6) 2017: dr.(b)(6).Operative report.Assistants: (b)(6).Preoperative diagnosis: mesh erosion into small bowel.Retained small bowel intraluminal foreign body.Postoperative diagnosis: hostile abdomen.Mesh erosion into small bowel.Retained small bowel intraluminal mesh.Enteroenteric fistula.Partial small bowel obstruction.Anesthesia: general.Estimated blood loss: 300.Specimens: small bowel resection.Retained intraluminal mesh.Complications: none.Wound classification: not provided.Findings: ¿dense scar tissue through abdominal wall with fused small bowel, retained intraluminal mesh from prior surgery, extensive adhesions throughout abdomen.Enteroenteric fistula, serosal small bowel tear, abdominal wall closed with sternotomy wires, 0 looped pds sutures and #1 prolene sutures.¿ procedure: ¿the patient lying supine on the operating table and under general anesthesia with endotracheal intubation.Preoperative antibiotics was [sic] given.A foley catheter and ng [nasogastric] tube were separately inserted.The abdomen was prepped and draped in usual sterile fashion.A midline incision was made along the previous surgical scar and carried down.There was extreme hard and calcified midline scar tissue.We encounter [sic] a significant amount of adhesion while entering the peritoneal cavity.The incision had to be extended inferiorly beyond the previous surgical incision.The peritoneal cavity was carefully entered.There was severe inflammatory change in the abdomen along the midline.We did not see the previously placed dual mesh.This is a hostile abdomen with dense adhesion and no dissecting plane.I spent at least 4 hours for the lysis of adhesion.There was a cavity in the mid-abdomen which communicated with 2 loops of small bowels.Obviously the mesh has eroded through the small bowel causing enteroenteric fistula.On the left side a small bowel intraluminal foreign body was palpated with proximal dilatation and distal collapse.The foreign body was able to be milked back to one of the enterotomy (erosion) site and retrieved with ring forceps.The foreign body turned out to be the abdominal wall mesh which is now contracted and shrunk.We could not fully lysed [sic] out the small bowel cause [sic] of the dense adhesion and no dissecting plane.The 2 erosion wounds on 2 separate small bowel were sharply debrided.Because of nonviable tissue, after the debridement, one of the enterotomy was not amenable to a primary repair.Therefore a 5 cm segment of the small bowel was transected.The mesentery was ligated with 2-0 vicryl sutures.The continuity was reestablished with an end-to-end hand sewn technique.First, interrupted lembert stitches of 3-0 vicryl sutures [sic] placed to form the posterior outer layer.A full-thickness contnuous over-and-over stitch with 3-0 vicryl sutures was placed for the posterior inner layer starting in the middle, and was carried toward either corner as a running suture.It was converted to a connell stitch at the corners and continued anteriorly.The final knot was tied in the middle of the anterior surface.Lastly, the anterior outer layer was reinforced with interrupted lembert stitches of 3-0 vicryl.The other enterotomy (erosion) was small.This was able to be primarily repaired with 3-0 vicryl sutures and reinforced with a seromuscular layer of interrupted 3-0 vicryl sutures.There were 2 small bowel serosal tears during the lysis of adhesion.These serosal tears were repaired with interrupted 3-0 vicryl sutures.We were unable to run the bowel from the ligament of treitz to the terminal ileum, nor check the ng tube position, because of the dense adhesion.The abdomen was copiously irrigated with warm normal saline solution.The midline fascia was closed with either 0 looped pds sutures or #1 prolene sutures in a figure-of-eight fashion.The closure of the midline fascia was unimaginably difficult because of dense and rock solid scar which were also extremely thick (2-3 cm).Due to that, i spent one hour for this endeavor.In the center of the fascia wound, we had to use 2 sternotomy metal wires for the closure.After that the skin was left open and packed with kerlix.The patient was sent to the icu for further resuscitation.It took me a total of 7 hours for this difficult challenging case.¿ (b)(6) 2017: dr (b)(6).Pathology report.Diagnosis: a.Foreign object, mesh from abdomen, removal: ¿foreign object, for gross examination only (see gross description.)¿ b.Small bowel, resection: ¿segment of small intestine with transmural chronic and acute inflammation, edema, focal muscular propria necrosis, acute serositis and serosal adhesions.¿ gross description: a.¿received in formalin labeled with patient¿s name and ¿mesh removed from abdomen¿ is a 15.5 x 10.0 x 0.3 cm, tan-brown, inorganic, rubber, ¿mesh like¿ material.No definitive soft tissue received, no sections are submitted, gross diagnosis only.¿ b.¿received in formalin labeled with patient¿s name and ¿small bowel¿ are two portions of tan-brown, unoriented small bowel averaging 4.5 x 4.0 x 2.0 cm.Each portion displays abundant serosal adhesion as well as moderate edematous change at the mucosal aspect.No definitive mass or lesions are noted, specimen are serially sectioned and representative sections are submitted for microscopic examination in three blocks.¿ 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 with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial with holes 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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C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial with holes 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Retract report number 3003910212-2021-01186 follow-up number 4.Retracting for incorrect lot number entered in report number.Correct lot number was previously reported correctly in follow-up's.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial with holes 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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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.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® plus biomaterial with holes instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device lost anchorage may be 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.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 records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product ( g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product ( g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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