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| Model Number 1DLMC03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Obstruction/Occlusion (2422); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/20/2016 |
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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® 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® biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal, small bowel obstruction, contracted mesh, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Evaluation codes: conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6)18: office notes.Cc: abdominal pain.Hpi: seen in er over the weekend.Ct abdomen/pelvis was normal.Abdominal pain, bloating, aching, dull, radiating around back, heartburn, diarrhea.Pmh: acid reflux.Psh: hernia repair, colon resection.Impression: possible ulcer.Gastroesophageal reflux disease.Plan: refer for egd.(b)(6)19: office notes.Cc: abdominal pain.Hpi: abdominal pain under left breast, bloating, fullness, sharp, since september.Nothing makes worse, nothing gives relief.Nausea, constipation.Exam: gastrointestinal: ttp [tender to palpation] left side at lower rib margin.Hernia: periumbilical.Impression: unspecified abdominal pain.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® 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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B7: added medical history.H6: updated results code.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: records prior to (b)(6) 2007, including records for the ¿repair of an umbilical hernia with mesh and a higher-up ventral hernia, not with mesh¿ as noted in the (b)(6) 2007 records, were not provided.History and physical records dated (b)(6) 2007 indicate ¿chief complaint: recurrent abdominal wall hernia.History of present illness: i saw this 55-year-old male nearly 2 years ago for recurrent hernia.He underwent repair of an umbilical hernia with mesh and a higher-up ventral hernia, not with mesh.His umbilical hernia repair seems fine, but his mid upper abdominal hernia has recurred.The patient has been having problems with progressive bulging and pain, especially when he does physical labor.¿ implant and product identification records for the prior hernia repairs were not provided.The (b)(6) 2007 history and physical records state: ¿physical examination:the abdomen is soft, nontender, and nondistended.The patient has a mid upper abdominal hernia, which is partly reducible.This is associated with a diastasis recti.His umbilical hernia repair is solid.Impression: recurrent mid upper abdominal hernia.Plan: i have detailed the nature of both open and laparoscopic repairs to the patient, and he wishes to proceed with a laparoscopic repair of this recurrent hernia.¿ operative records dated (b)(6) 2007 indicate the patient underwent ¿laparoscopic incisional hernia repair.An incision was made far on the right side of the abdomen and a veress needle was placed into the abdominal cavity.The abdomen was insufflated to a pressure 15 mmhg with carbon dioxide.An 11 mm port was placed in this location.Two 5 mm working ports were placed.The patient had a piece of mesh under the umbilicus with dense adhesions to it.There did not appear to be a hernia in this location.There was an obvious hernia superior to this with incarcerated omentum.The omentum was dissected out utilizing a scissors and electrocautery.A piece of dualmesh was cut to 9 cm round and 4 prolene stitches were anchored, one in each quadrant.The mesh was rolled up and placed into the abdomen.Stab incisions were made in 4 quadrants and the prolene sutures were brought up with a suture passer and tied.¿ the(b)(6) 2007 operative records state: ¿spiral tacks were used to tack the mesh circumferentially in 1 cm lengths.The bowel was again inspected and was without evidence of injury or abnormality.The field was dry and the ports were removed under direct visualization after the 11 mm port.The 11 mm port site was closed with o pds suture using a port site suture closure device.The skin was closed with 4-0 monocryl suture in subcuticular fashion.Mastisol and steri-strips were placed.Sterile dressings were applied.The patient was extubated and taken to the post anesthesia care unit in stable condition, having tolerated the procedure well.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmc03/05008960) was used during the procedure.Pertinent records between (b)(6) 2007 and (b)(6) 2016 were not provided.Admission records dated (b)(6) 2016 indicate: ¿patient with known incarcerated ventral hernia, now with acute obstructive symptoms.Had acute abdominal pain this morning with persistent vomiting.Pain comes in waves, quite severe.No hematochezia or hematemesis.¿ ¿assessment: obstructed ventral hernia, incisional.¿ ¿plan: obstructed ventral hernia, incisional will proceed with laparoscopy to see if the bowel is involved.Assuming patient is obstructed, will need herniorrhaphy.¿ ¿primary diagnosis: obstructed ventral hernia, incisional.¿ ¿incisional hernia with obstruction, without gangrene.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿1.Laparoacopy with lysis of adhesions.2.Mesh explantation.3.Small bowel resection with primary reanastomosis.¿ postoperative diagnosis states: ¿small bowel obstruction secondary to mesh erosion at the site of a previous umbilical herniorrhaphy.¿ ¿this 64-year-old male with previous umbilical and ventral hernia repair presents with acute symptoms consistent with a small bowel obstruction.¿ the (b)(6) 2016 operative records state: ¿an incision was made on the left side of the abdomen and a varese needle was placed into the abdomen.The abdomen was insufflated to a pressure of 15 mmhg with carbon dioxide and a 5 mm port was placed in this location.Two additional working ports were placed.There were very dense adhesions to the undersurface of the patient's abdominal wall.Two pieces of mesh were present, one of the umbilicus and one in the upper right aide of the abdomen.The piece of mesh off the midline had an associated hernia with incarcerated omentum.The omentum was dissected out of the hernia, revealing that the mesh appeared to be contracted and an edge had rolled over, allowing egress into the hernia site.The adhesions at the umbilicus were much more tenacious.A considerable amount of time was spent, in total greater than an hour, lysing adhesions.¿ the (b)(6) 2016 operative records continue: ¿most of this was omentum, but there were some adhesions but there were some small bowel adhesions and two loops of small bowel that were densely adherent to the undersurface of the umbilical mesh.As it was dissected off, i realized the type of mesh was polypropylene protected by gore-tex on the undersurface.However, the polypropylene side was exposed directly to the viscera, creating adhesions such that the mesh was inseparable from the small bowel.This was the point of the patient's small-bowel obstruction, with a transition point of dilated bowel to decompressed bowel.Of note, there was fecalization of the small bowel contents proximal to the small bowel obstruction, with the small bowel appearing chronically dilated and having very hard food stuff within it.The decision was made at this point to explant the mesh.¿ the (b)(6) 2016 operative records state: ¿an incision was made over the mesh and cautery was used to excise the mesh patch.The wound protector was placed and the small bowel was eviscerated.Again, it was inseparable from the mesh, with the mesh essentially having eroded into the bowel, creating an obstruction at this location.A decision was made to sacrifice this short piece of small intestine.Gia staplers were used to transect the bowel proximally and distally and the intervening mesentery was sacrificed between hemostats and oversewn with silk suture.The length of bowel removed was perhaps 2 inches.The bowel was reanastomosed by firing a 75 mm gia stapler between the two limbs of bowel.The stapler defect was closed with a ta 60 stapler and the bowel was replaced back into the abdomen.¿ the (b)(6) 2016 operative records continue: ¿the fascia was closed with pds suture in running fashion and then the laparoscope was replaced into the abdomen.The small bowel was then run from proximal to distal and no additional abnormalities were noted except some minimal adhesions remaining.The field was dry and the laparoscopic instrumentation was removed.4-0 monocryl suture was used to close the laparoscopy port sites and 4-0 nylon suture was used in interrupted vertical mattress fashion to reapproximate the skin edges of the mesh explantation site.Sterile dressings were applied and the patient was extubated and taken to the postanesthesia care unit.¿ discharge summary records dated (b)(6) 2016 indicate: ¿admission diagnosis: small bowel obstruction.Principal diagnosis at discharge: small bowel obstruction.¿ ¿secondary diagnoses: 1.Mesh erosion into intestine with resultant intestinal obstruction.2.Acute kidney injury secondary to dehydration.Procedores performed: small bowel resection with mesh explanation.¿ the (b)(6) 2016 discharge summary records state: ¿admission data: this 54-year-old male underwent an umbilical hernia repair in greenville many years ago.He now presents with acute severe abdominal pain and a small bowel obstruction.¿ the (b)(6) 2016 discharge summary records continue: ¿hospital course: the patient was taken to the operating room and found to have a mesh erosion with resultant small bowel obstruction.He underwent mesh explanation and small bowel resection with primary reanastomosis.Postoperatively, the patient had a rather significant abdominal distention.A nasogastric tube was placed and he was continued to be fluid resuscitated.The patient improved very dramatically over the ensuing 48 hours.His nasogastric tube was removed and he was given a diet, which was well tolerated.His bowel function returned and he was discharged to home in the care of his family.¿ 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® 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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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: (b)(6) 2015: (b)(6) health.(b)(6) md.Office note.Cc: presents with possible hernia.Hpi: had both an umbilical hernia and supraumbilical ventral hernia repaired many years ago.Had a recurrence of his ventral hernia, was repaired in 2007.It recurred several years ago and now has an incarcerated recurrent hernia.Ht: 5 ft, 7 in; wt: 195 lbs; bmi: 30.5.Exams: gastrointestinal: hernia present- incarcerated incisional, patient has diastasis of the rectus abdominus muscles.Assessment: incarcerated ventral incisional hernia.Plan: ct scan.(b)(6) 2015: (b)(6) health.(b)(6).Radiology-ct abdomen/pelvis.History: recurrent abdominal wall hernia.The epigastric mesh shows herniated mesenteric fat at the superior right region without contained bowel loop or fluid.Axial dimensions of herniated fat are 2.7 x 7.3 cm in length estimated at 5 cm.Bowel and mesentery are otherwise normal and normal appendix is identified.Impression: herniation of mesenteric fat at the superior and right lateral aspect of the epigastric hernia repair mesh demonstrating no incarceration, fluid collection or contained bowel loop.No additional abnormality on ct abdominal study.(b)(6) 2015: (b)(6) health.(b)(6) md.Office note.Cc: follow up visit after imaging studies to discuss results.Hpi: ct scan reveals incarcerated tissue that is not bowel at the upper portion of the patient¿s hernia repair.He is not interested in remedial surgery at the current time.(b)(6) 2016: (b)(6) health.(b)(6) md.Office note.Cc: follow up visit.Hpi: small bowel obstruction secondary to mesh erosion.Wound looks good.(b)(6) 2016: (b)(6) health.(b)(6) md.Office note.Cc: follow up visit.Hpi: sensation everything he eats immediately evacuated from his gastrointestinal tract.Exams: wound looks good.Lab results: c.Difficile was sent which was positive.(b)(6) 2016: (b)(6) health.(b)(6) md.Office note.Cc: follow up visit.Underwent laparoscopy with lysis of adhesions with small bowel resection.Hpi: diarrhea resolved with second round of flagyl.Abdomen benign, hernia repair solid.Other abdominal wall hernia is incarcerated, but asymptomatic.Seems to made a full recovery from surgery and i will see him back as needed.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® 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 health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.Previous patient codes (2422: bowel obstruction, 3191: appropriate term/code not available for ¿contracted mesh¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.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), 2019 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.¿ records from (b)(6), 2007 through (b)(6), 2015 were not provided.Patient information: medical history: ¿ gastroesophageal reflux disease.¿ smoker.¿ hyperlipidemia.¿ bladder outlet obstruction.¿ obesity.- 195 lbs; bmi 30.5.¿ clostridioides difficile infection.Prior surgical procedures: ¿ ¿repair of an umbilical hernia with mesh and a higher-up ventral hernia, not with mesh¿ [unknown date].Implant preoperative complaints: ¿ (b)(6) 2007: ¿recurrent abdominal wall hernia.¿ ¿i saw this 55-year-old male nearly 2 years ago for recurrent hernia.He underwent repair of an umbilical hernia with mesh and a higher-up ventral hernia, not with mesh.His umbilical hernia repair seems fine, but his mid upper abdominal hernia has recurred.The patient has been having problems with progressive bulging and pain, especially when he does physical labor.¿ ¿ (b)(6) 2007: ¿¿the abdomen is soft, nontender, and nondistended.The patient has a mid upper abdominal hernia, which is partly reducible.This is associated with a diastasis recti.His umbilical hernia repair is solid.¿ implant procedure: laparoscopic incisional hernia repair.Implant: gore® dualmesh® biomaterial ((b)(6)) 10 x 15 cm, oval.Implant date: (b)(6), 2007.¿ description of hernia being treated: ¿an incision was made far on the right side of the abdomen and a veress needle was placed into the abdominal cavity.The abdomen was insufflated to a pressure 15 mmhg with carbon dioxide.An 11 mm port was placed in this location.Two 5 mm working ports were placed.The patient had a piece of mesh under the umbilicus with dense adhesions to it.There did not appear to be a hernia in this location.There was an obvious hernia superior to this with incarcerated omentum.The omentum was dissected out utilizing a scissors and electrocautery.¿ ¿ implant size and fixation: a piece of dualmesh was cut to 9 cm round and 4 prolene stitches were anchored, one in each quadrant.The mesh was rolled up and placed into the abdomen.Stab incisions were made in 4 quadrants and the prolene sutures were brought up with a suture passer and tied.Spiral tacks were used to tack the mesh circumferentially in 1 cm lengths.The bowel was again inspected and was without evidence of injury or abnormality.The field was dry and the ports were removed under direct visualization after the 11 mm port.The 11 mm port site was closed with o pds suture using a port site suture closure device.The skin was closed with 4-0 monocryl suture in subcuticular fashion.Mastisol and steri-strips were placed.Sterile dressings were applied.¿ ¿ no post-operative records were provided.Relevant medical information: ¿ (b)(6) 2015: ¿had both an umbilical hernia and supraumbilical ventral hernia repaired many years ago.Had a recurrence of his ventral hernia, was repaired in 2007.It recurred several years ago and now has an incarcerated recurrent hernia.¿ ¿hernia present- incarcerated incisional, patient has diastasis of the rectus abdominus muscles.¿ ¿ (b)(6) 2015: ct abdomen/pelvis: ¿the epigastric mesh shows herniated mesenteric fat at the superior right region without contained bowel loop or fluid.Axial dimensions of herniated fat are 2.7 x 7.3 cm in length estimated at 5 cm.Bowel and mesentery are otherwise normal and normal appendix is identified.¿ ¿ (b)(6) 2015: ¿ct scan reveals incarcerated tissue that is not bowel at the upper portion of the patient¿s hernia repair.He is not interested in remedial surgery at the current time.¿ ¿ (b)(6) 2016: ¿patient with known incarcerated ventral hernia, now with acute obstructive symptoms.Had acute abdominal pain this morning with persistent vomiting.Pain comes in waves, quite severe.No hematochezia or hematemesis.¿ ¿assessment: obstructed ventral hernia, incisional.¿ ¿plan: obstructed ventral hernia, incisional will proceed with laparoscopy to see if the bowel is involved.Assuming patient is obstructed, will need herniorrhaphy.¿ ¿ (b)(6) 2016: laparoscopy with lysis of adhesions.Mesh explantation.Small bowel resection with primary reanastomosis.- ¿an incision was made on the left side of the abdomen and a varese [sic] needle was placed into the abdomen.The abdomen was insufflated to a pressure of 15 mmhg with carbon dioxide and a 5 mm port was placed in this location.Two additional working ports were placed.There were very dense adhesions to the undersurface of the patient's abdominal wall.Two pieces of mesh were present, one of the umbilicus and one in the upper right side of the abdomen.The piece of mesh off the midline had an associated hernia with incarcerated omentum.The omentum was dissected out of the hernia, revealing that the mesh appeared to be contracted and an edge had rolled over, allowing egress into the hernia site.The adhesions at the umbilicus were much more tenacious.A considerable amount of time was spent, in total greater than an hour, lysing adhesions.Most of this was omentum, but there were some adhesions but there were some small bowel adhesions and two loops of small bowel that were densely adherent to the undersurface of the umbilical mesh.As it was dissected off, i realized the type of mesh was polypropylene protected by gore-tex on the undersurface.However, the polypropylene side was exposed directly to the viscera, creating adhesions such that the mesh was inseparable from the small bowel.This was the point of the patient's small-bowel obstruction, with a transition point of dilated bowel to decompressed bowel.Of note, there was fecalization of the small bowel contents proximal to the small bowel obstruction, with the small bowel appearing chronically dilated and having very hard food stuff within it.The decision was made at this point to explant the mesh.An incision was made over the mesh and cautery was used to excise the mesh patch.The wound protector was placed and the small bowel was eviscerated.Again, it was inseparable from the mesh, with the mesh essentially having eroded into the bowel, creating an obstruction at this location.A decision was made to sacrifice this short piece of small intestine.Gia staplers were used to transect the bowel proximally and distally and the intervening mesentery was sacrificed between hemostats and oversewn with silk suture.The length of bowel removed was perhaps 2 inches.The bowel was reanastomosed by firing a 75 mm gia stapler between the two limbs of bowel.The stapler defect was closed with a ta 60 stapler and the bowel was replaced back into the abdomen.The fascia was closed with pds suture in running fashion and then the laparoscope was replaced into the abdomen.The small bowel was then run from proximal to distal and no additional abnormalities were noted except some minimal adhesions remaining.The field was dry and the laparoscopic instrumentation was removed.4-0 monocryl suture was used to close the laparoscopy port sites and 4-0 nylon suture was used in interrupted vertical mattress fashion to reapproximate the skin edges of the mesh explantation site.¿ ¿ (b)(6) 2016: discharge summary: ¿admission diagnosis: small bowel obstruction.Principal diagnosis at discharge: small bowel obstruction.¿ ¿secondary diagnoses: 1.Mesh erosion into intestine with resultant intestinal obstruction.2.Acute kidney injury secondary to dehydration.Procedures performed: small bowel resection with mesh explanation.¿ ¿hospital course: the patient was taken to the operating room and found to have a mesh erosion with resultant small bowel obstruction.He underwent mesh explanation and small bowel resection with primary reanastomosis.Postoperatively, the patient had a rather significant abdominal distention.A nasogastric tube was placed and he was continued to be fluid resuscitated.The patient improved very dramatically over the ensuing 48 hours.His nasogastric tube was removed and he was given a diet, which was well tolerated.His bowel function returned and he was discharged to home in the care of his family.¿ ¿ (b)(6) 2016: ¿small bowel obstruction secondary to mesh erosion.Wound looks good.¿ ¿ (b)(6) 2016: ¿sensation everything he eats immediately evacuated from his gastrointestinal tract.Exams: wound looks good.Lab results: c.Difficile was sent which was positive.¿ ¿ (b)(6) 2016: ¿diarrhea resolved with second round of flagyl.Abdomen benign, hernia repair solid.Other abdominal wall hernia is incarcerated, but asymptomatic.Seems to made a full recovery from surgery and i will see him back as needed.¿ ¿ (b)(6) 2018: ¿seen in er over the weekend.Ct abdomen/pelvis was normal.Abdominal pain, bloating, aching, dull, radiating around back, heartburn, diarrhea.¿ ¿possible ulcer.Gastroesophageal reflux disease.¿ ¿ (b)(6) 2019: ¿abdominal pain under left breast, bloating, fullness, sharp, since september.Nothing makes worse, nothing gives relief.Nausea, constipation.Exam: gastrointestinal: ttp [tender to palpation] left side at lower rib margin.Hernia: periumbilical.¿ conclusions: it should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, status of the device is unable to be confirmed and therefore not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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