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| Model Number 1DLMCP06 |
| Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Seroma (2069); Infection, Pyrogenic (2246); No Code Available (3191)
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| Event Date 06/21/2011 |
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Event Type
Injury
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Manufacturer Narrative
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Added medical history.(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: ¿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 laparoscopic incisional and umbilical hernia repair on (b)(6) 2010 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: debridement of chronically infected abdominal wound, infections, additional surgeries, mesh removal, and mesh failure.Additional event specific information was not provided.
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Manufacturer Narrative
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Added medical history.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) 2011: (b)(6) medical center.(b)(6), md.Ct guided needle placement.History: infected postop seroma.Findings: there is an oval collection of low attenuation measuring up to 11.1 x 5.5 cm.Radiopaque rim of the collection is seen and may represent some type of surgical radiopaque mesh used to repair and anterior abdominal wall hernia.The fluid was grossly purulent.A single incompletely healed skin site is demonstrated and may have represented the site of a draining sinus tract.Impression: ct guided percutaneous drainage of an infected seroma was performed.Fluid sample pending.(b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided.] (b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis without contrast.Indication: abscess.Findings: there has been a ventral hernia repair with surgical mesh.A new percutaneous drainage catheter courses through the mesh and has markedly decreased the fluid collection underlying the mesh.There is no identifiable residual with unopacified small bowel loops deep to the mesh.Just superior to the surgical mesh, ventral hernia remains containing fat and bowel loops.Surgical suture in the right lower quadrant abdomen at the cecum.Impression: evacuation of the fluid collection just deep to the surgical mesh without residual fluid collection.Left hydrosalpinx.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abscess.Procedure: abscessogram.Findings: fluoroscopic evaluation demonstrates an amorphous collection filling what appears to be at least a moderate size cavity.No evidence of fistula.The output has been approximately 20 cc per day.The catheter was left in place.Impression: abscessogram demonstrates a moderate-sized cavity.The patient still reports significant output.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Interventional radiology.Injection of abdominal wall abscess catheter and subsequent removal.Indication: patient is approximately 3 weeks status post placement of a drainage catheter just below the abdominal wall mash [sic].Patient states that she has been recently a febrile [sic, afebrile].The drainage from the catheter has been approximately 15 cc per day of relatively mild serosanguinous fluid.Impression: removal of abdominal wall fluid collection drainage catheter.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology- ct abdomen with contrast.History: peritoneal abscess.Findings: on the previous study, the patient had a pigtail catheter placed into a seroma in the anterior abdominal wall.This is seen related to surgical mesh from a previous hernia repair.The fluid collection has reaccumulated following removal of the pigtail catheter.It now measures 4.4 x 9.8 cm in size on image 64.It has hounsfield numbers of 27 which is a little more than would be expected for simple fluid.The umbilical hernia remains containing fat and there are some bowel loops which may be related to the hernia as well.Overall, the size of the hernia has not increased since the previous study.There is no adenopathy in the abdomen.No abnormal fluid collections are seen other than the presumed seroma at the hernia site, but a residual ventral hernia is seen.Impression: reaccumulation of fluid at the site of the previous percutaneous drainage.This is probably a recurrent seroma measuring 9.8 x 4x4 cm in size.It is related to the surgical mesh placed at hernia repair.There is still residual hernia as discussed above.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Ct guided needle placement.History: recurrent postop seroma.Procedure: ct-guided drainage.Operator: (b)(6) np.Supervisor: harp, md.Findings: limited unenhanced ct examination demonstrates a postop seroma with mesh.Successful catheter placement in good location.(b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided.] (b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: status post hernia repair with jackson-pratt drain in place.There is purulent fluid about the drain.Ct abdomen with contrast: there is now a surgical drain in place at the midline ventral wall.A fluid collection with surrounding rim calcification at this site is now collapsed.Herniated mesenteric fat through the ventral wall defect appears stable.No new suspicious enhancing mass of fluid collection otherwise is seen.The small bowel and colon are not remarkable.There is no evidence of any free air in the abdomen.Impression: post surgery change at the ventral wall periumbilical region with a surgical drain in place.The fluid collection seen before with surrounding rim calcifications is collapsed and there are otherwise is no new acute appearing abnormality seen in the abdomen and pelvis, as above.(b)(6) 2012: (b)(6) medical park.(b)(6), md.Office notes.Low grade fever, nausea, abdominal pain, etiology uncertain with recent tick bite.(b)(6) 2012: (b)(6) medical center.(b)(6), md.Ct guided needle placement.History: abdominal abscess, status post abdominal wall hernia repair.Procedure: ct scan guided percutaneous drainage of the anterior abdominal fluid collection.Grossly purulent fluid was removed to a volume of approximately 100 ml.Samples submitted to laboratory for microbiology.(b)(6) 2012: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2012 procedure was not provided.] (b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abdominal abscess.Impression: successful abscess catheter check which still demonstrates residual abscess remaining and thus the catheters left in place.(b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.Indication: treatment of infection the adjacent to anterior abdominal wall mash [sic].Impression: slight reduction in overall size of fluid collection.Catheter changed.(b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abdominal abscess.Percutaneous drainage.Impression: improvement with a small amount of residual abscess.(b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.Impression: essentially, there is marked reduction in the patient¿s collection.However a potential space still exists which can be filled with contrast.The tube was left in place as discussed with dr.(b)(6).(b)(6) 2012: (b)(6) medical center.(b)(6), md.Radiology-us-abdominal.Indication: abdominal pain.Impression: at site of pain, there is a complex collection of uncertain etiology by ultrasound.Ct could be performed.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: nausea vomiting fever chills epigastric pain.Evaluate for abdominal wall abscess.Abdomen: patient apparently has had an anterior abdominal wall hernia repair.There is a thick walled gas and fluid collection deep to the hernia repair in the anterior abdomen measuring about 7.2 x 2.6 cm.This is in an area of prior drainage.There is good opacification of adjacent bowel loops and i do not believe this represents of bowel.There does appear to be a small residual hernia containing adipose tissue.Pelvis: there is a 4.7 cm left adnexal cystic structure.Along its inferior extent it appears to be somewhat tubular extending to the right above the bladder and the question is raised whether this could be a combination of ovarian cyst and hydrosalpinx.No free fluid.Impression: deep to an anterior abdominal wall hernia repair there is a thick walled gas and to a lesser extent fluid collection measuring 7.2 x 2.6 cm that does not appear to be bowel and would be concerning for recurrent/residual abscess.There is a small residual anterior abdominal wall hernia containing adipose tissue.Question left-sided hydrosalpinx/ovarian cyst.Consider a follow up.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Interventional radiology.History: recurrent midline abdominal abscess status post mesh repair of an abdominal wall hernia.Patient presents for repeat percutaneous drainage.Impression: difficult drain placement due to the extensive scar tissue and/or thickening from the mesh.However, an 8-french tube was placed into the collection and only a scant amount of drainage fluid could be aspirated and sent for microbiology.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Interventional radiology.Catheter check and limited abdominal ultrasound.Vacation: anterior abdominal wall abscess treated with catheter drainage approximately 19 days ago.Impression: fistula to small bowel.[(b)(4)] (b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-mri pelvis with and without contrast.Clinical information: history of intracutaneous fistula status post drainage.Impression: complex enhancing soft tissue along the anterior abdominal wall involving the right greater than left rectus sheath is likely in keeping with history of enterocutaneous fistula.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: enterocutaneous fistula status post drainage.Impression: similar appearance of left hydrosalpinx.Resolution fluid collection anterior lower abdomen with only residual present scar tissue remaining.No drainable collection on today¿s study.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.History: pelvic pain, history cesarean section, tubal ligation, appendectomy.Impression: findings could represent acute mild uncomplicated sigmoid diverticulitis in the appropriate clinical setting.Interval slight increase in size of probable left hydrosalpinx.[(b)(4)] (b)(6) 2015: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: abdominal pain.Impression: chronic left hydrosalpinx, hepatic steatosis.(b)(6) 2017: medical group of (b)(6).(b)(6), md.Office visit.Presents on referral secondary to a history of enterocutaneous fistula.This was noticed on mri in 2013.At that time she had a [sic] abdominal wound infection.However this is healed.She does state periodic 5 out of 10 abdominal pain occasional nausea no vomiting occasional constipation no diarrhea no melena no hematochezia no dysuria no hematuria no fevers or sweats.Positive occasional chills.She denies any open wounds on her abdomen.Assessment/plan: fistula of intestine.This appears to have healed completely.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.¿ 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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Manufacturer Narrative
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H6: updated results code for manufacturing evaluation.H6: conclusion code remains unchanged.
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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: records prior to (b)(6)2010, including records for perforated appendicitis with pelvic abscess, were not provided.Operative records dated (b)(6)2010 indicate the patient underwent laparoscopic incisional hernia repair with gore-tex dualmesh plus.¿she had a previous perforated appendicitis with pelvis abscess and had developed an incisional hernia in the area of her midline infraumbilical incision.Ct scan also demonstrated that she had an umbilical hernia.¿ the operative records dated (b)(6)2010 state: ¿a 5-mm bladeless trocar was placed at this site with the camera visualizing the trocar going through the layers of the abdominal wall.Four additional trocars were then placed under direct vision.Two trocars were placed on the right side of the abdomen and 2 in the left upper and lower quadrants.The patient had omentum in the hernia sac.This was reduced and dissected free.There was also a loop of bowel which was carefully dissected away from the hernia sac.¿ records dated(b)(6)2010 continue: ¿there was a large defect in the lower abdomen in the midline and then a small umbilical hernia.The umbilical hernia was also reduced and had only omentum present.The dissection of the omentum was performed using the scissors and minimal cautery was used on some bleeding points.An 18 x 24 cm gore-tex dualmesh plus was used for the hernia repair.0 gore-tex sutures were placed on the mesh in the north, south, east, and west positions.¿ operative records dated (b)(6)2010 state: ¿the mesh was inserted into the peritoneal cavity.Using the suture passer, the strands of the gore-tex suture were brought through the abdominal wall and the mesh was secured in place.Absorbatacks were then placed along the periphery of the mesh to further secure the mesh to the abdominal wall.The abdomen was then irrigated.The irrigation was evacuated.¿ records dated (b)(6)2010 continue: ¿the mesh provided good coverage of both of the hernias.¿ ¿the skin was closed at each of the port sites with skin staples and staples were also used at the gore-tex.Suture site.The abdomen was cleaned and band-aids were applied.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmcp06/06306940) was used during the procedure.Operative records dated (b)(6)2010 indicate the patient underwent excisional debridement of chronically infected abdominal wound.The patient ¿was given some iv vancomycin for antibiotic prophylaxis and she had mrsa grow out of the cultures a few weeks ago.¿ operative records dated (b)(6)2010 continue: ¿the area of recurrent infections was at the superior aspect of a midline laparotomy scar.The patient had some gore-tex dual mesh and therefore the decision for excisional debridement to avoid any further infections was made.An elliptical incision was made over the superior aspect of the incision where the recurrent infections had occurred.This measured approximately 3cm in length.¿ the records dated (b)(6)2010continue: ¿the subcutaneous tissues were dissected using bovie cautery.The patient was noted to have a sinus tract that extended from the level of the incision down to a prolene suture.The suture was removed.There was no evidence of purulent fluid within the tissues at this time.There was some thickened tissue.¿ operative records dated (b)(6) 2010 state: ¿the tissue in this area was completely removed and sent to pathology in formalin for review.The wound was irrigated.The irrigation was evacuated.¿ ¿the skin was them reapproximated using interrupted 2-0 nylon sutures.The wound was cleaned and then aquacel surgical dressing was applied.¿ pathology report for specimen obtained during (b)(6)2010 procedure was not provided.Operative records dated (b)(6)2011 indicate the patient underwent exploratory laparotomy with removal of mesh, lysis of adhesions and open drainage of abdominal abscess for ventral abdominal hernia, recurrent, infected abdominal wall mesh, and abdominal wall abscess with methicillin-resistant staphylococcus aureus.The operative records dated (b)(6)2011 state: ¿the abdominal wall had a drain in it, which was removed.¿ ¿there was a large midline scar with a drain tract and abscess cavity.This scar was excised.There was a hernia both above and below surrounding the umbilicus.The umbilicus was therefore excised with this scar.Once the incision had been made around the scar, dissection was carried down to the hernia sac using electrocautery.¿ the records dated (b)(6)2011 continue: ¿during the dissection, abscess cavity of the abdominal wall was encountered.It was opened and the infected mesh was seen.The mesh sutures were cut and the mesh was pulled out and fluid from the mesh cavity, which was purulent in nature, was sent for culture.¿ operative records dated (b)(6)2011 state: ¿we continued to dissect to the fascial edges with electrocautery encountering sutures of prolene where the abdominal wall had been previously closed and sutures were removed and the abdominal wall opened.The hernia was incised superiorly and opened.Contents were mobilized with gentle traction, sharp dissection and reduced into the abdomen.¿ records dated (b)(6)2011 continue: ¿the entire hernia sac was then dissected free of the fascial edge and excised.There were loops of small bowel and omentum that were densely adherent to the abdominal wall.These were mobilized away from the abdominal wall with a combination of blunt dissection, traction, electrocautery and sharp dissection.¿ operative records dated (b)(6)2011 state: ¿there was one area of serosal tear in the small bowel.This was repaired with a lambert sutures of 3-0 silk.Once this portion of the procedure had been completed and all abdominal adhesions were freed, the hernia was completely reduced and the hernia sac excised.At this point, plastic surgery came for his portion of the procedure.¿ the operative records dated (b)(6)2011 continue: ¿the procedure was turned over to plastic surgery service.First, attention was turned to making the abdominal wall flaps.Subcostal incision was made and dissected down to the level of the abdominal wall fascia.Lateral to the linea semilunaris, the external oblique fascia was incised cephalad and caudal directions.The external oblique fascia was widely elevated off the abdominal wall mobilizing the abdominal wall flap.¿ operative records dated (b)(6)2011 state: ¿next, this was done on the left side again with the same type of incision widely incising and mobilizing the external oblique fascia.Once both of the abdominal wall muscle flaps were widely mobilized, the skin and subcutaneous tissue were elevated off the abdominal wall from the midline incision just to the lateral border of the rectus abdominis muscle.Once this was done, the strattice biologic membrane 20 x 25cm was cut to fit and sutured in every 1cm with a through-and-through #1 prolene suture every 1cm.¿ records dated (b)(6)2011 continue: ¿physiologic tension was placed on the mesh so the fascial edges were just kissing together before closure.Herniorrhaphy was performed using #1 looped pds starting cephalad and cephalic and tied in the middle.¿ ¿next the wounds were widely irrigated again.Please note that a drain was placed between the fascia and the strattice.¿ operative records dated (b)(6)2011 state: ¿next, #1 vicryl was used to tack down the abdominal skin and subcutaneous tissue down to the abdominal wall.Next, two #19 round jps were placed.Scarpa fascia was closed with 2-0 pds, deep dermal layer with 3-0 monocryl and the skin was closed with skin clips.The lateral incisions had drains placed in them and exited in the lower abdomen.These wounds were closed with 3-0 monocryl.¿ culture reports for the procedure dated (b)(6)2011 were not provided.Undated operative report (date dictated (b)(6)2012) indicates the patient underwent i and d of abdominal wall cellulitis.The patient ¿had prior cellulitis of the abdominal wall.There was some question of this being an abscess.¿ ¿the area indurated with opened up.There really was no evidence of any abscess.I did some deep tissue cultures.There was no induration of pocket, the fluids were needed to be drained.¿ ¿procedure was incision and debridement sharply was done with a knife and taken all the way down to the deep fascia.There was once again no abscess seen, just some surrounding cellulitis.¿ 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.¿ 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.¿ 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: added method/results/conclusions code 2 for sterilization evaluation.
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Manufacturer Narrative
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Added medical history.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: on (b)(6) 2011: (b)(6), md.Ct guided needle placement.History: infected postop seroma.Findings: there is an oval collection of low attenuation measuring up to 11.1 x 5.5 cm.Radiopaque rim of the collection is seen and may represent some type of surgical radiopaque mesh used to repair and anterior abdominal wall hernia.The fluid was grossly purulent.A single incompletely healed skin site is demonstrated and may have represented the site of a draining sinus tract.Impression: ct guided percutaneous drainage of an infected seroma was performed.Fluid sample pending.On (b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided].On (b)(6) 2011: (b)(6), md.Radiology-ct abdomen/pelvis without contrast.Indication: abscess.Findings: there has been a ventral hernia repair with surgical mesh.A new percutaneous drainage catheter courses through the mesh and has markedly decreased the fluid collection underlying the mesh.There is no identifiable residual with unpacified small bowel loops deep to the mesh.Just superior to the surgical mesh, ventral hernia remains containing fat and bowel loops.Surgical suture in the right lower quadrant abdomen at the cecum.Impression: evacuation of the fluid collection just deep to the surgical mesh without residual fluid collection.Left hydrosalpinx.On (b)(6) 2011: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abscess.Procedure: abscessogram.Findings: fluoroscopic evaluation demonstrates an amorphous collection filling what appears to be at least a moderate size cavity.No evidence of fistula.The output has been approximately 20 cc per day.The catheter was left in place.Impression: abscessogram demonstrates a moderate-sized cavity.The patient still reports significant output.On (b)(6) 2011: (b)(6) medical center.(b)(6), md.Interventional radiology.Injection of abdominal wall abscess catheter and subsequent removal.Indication: patient is approximately 3 weeks status post placement of a drainage catheter just below the abdominal wall mash [sic].Patient states that she has been recently a febrile [sic, afebrile].The drainage from the catheter has been approximately 15 cc per day of relatively mild serosanguinous fluid.Impression: removal of abdominal wall fluid collection drainage catheter.On (b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology- ct abdomen with contrast.History: peritoneal abscess.Findings: on the previous study, the patient had a pigtail catheter placed into a seroma in the anterior abdominal wall.This is seen related to surgical mesh from a previous hernia repair.The fluid collection has reaccumulated following removal of the pigtail catheter.It now measures 4.4 x 9.8 cm in size on image 64.It has hounsfield numbers of 27 which is a little more than would be expected for simple fluid.The umbilical hernia remains containing fat and there are some bowel loops which may be related to the hernia as well.Overall, the size of the hernia has not increased since the previous study.There is no adenopathy in the abdomen.No abnormal fluid collections are seen other than the presumed seroma at the hernia site, but a residual ventral hernia is seen.Impression: reaccumulation of fluid at the site of the previous percutaneous drainage.This is probably a recurrent seroma measuring 9.8 x 4x4 cm in size.It is related to the surgical mesh placed at hernia repair.There is still residual hernia as discussed above.On (b)(6) 2011: (b)(6) medical center.(b)(6), md.Ct guided needle placement.History: recurrent postop seroma.Procedure: ct-guided drainage.Operator: (b)(6).Supervisor: (b)(6), md.Findings: limited unenhanced ct examination demonstrates a postop seroma with mesh.Successful catheter placement in good location.On (b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided].On (b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: status post hernia repair with jackson-pratt drain in place.There is purulent fluid about the drain.Ct abdomen with contrast: there is now a surgical drain in place at the midline ventral wall.A fluid collection with surrounding rim calcification at this site is now collapsed.Herniated mesenteric fat through the ventral wall defect appears stable.No new suspicious enhancing mass of fluid collection otherwise is seen.The small bowel and colon are not remarkable.There is no evidence of any free air in the abdomen.Impression: post surgery change at the ventral wall periumbilical region with a surgical drain in place.The fluid collection seen before with surrounding rim calcifications is collapsed and there are otherwise is no new acute appearing abnormality seen in the abdomen and pelvis, as above.On (b)(6) 2012: (b)(6), md.Office notes.Low grade fever, nausea, abdominal pain, etiology uncertain with recent tick bite.On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Ct guided needle placement.History: abdominal abscess, status post abdominal wall hernia repair.Procedure: ct scan guided percutaneous drainage of the anterior abdominal fluid collection.Grossly purulent fluid was removed to a volume of approximately 100 ml.Samples submitted to laboratory for microbiology.On (b)(6) 2012: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2012 procedure was not provided].On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abdominal abscess.Impression: successful abscess catheter check which still demonstrates residual abscess remaining and thus the catheters left in place.On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.Indication: treatment of infection the adjacent to anterior abdominal wall mash [sic].Impression: slight reduction in overall size of fluid collection.Catheter changed.On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.History: abdominal abscess.Percutaneous drainage.Impression: improvement with a small amount of residual abscess.On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Interventional radiology.Impression: essentially, there is marked reduction in the patient¿s collection.However a potential space still exists which can be filled with contrast.The tube was left in place as discussed with dr.(b)(6).On (b)(6) 2012: (b)(6) medical center.(b)(6), md.Radiology-us-abdominal.Indication: abdominal pain.Impression: at site of pain, there is a complex collection of uncertain etiology by ultrasound.Ct could be performed.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: nausea vomiting fever chills epigastric pain.Evaluate for abdominal wall abscess.Abdomen: patient apparently has had an anterior abdominal wall hernia repair.There is a thick walled gas and fluid collection deep to the hernia repair in the anterior abdomen measuring about 7.2 x 2.6 cm.This is in an area of prior drainage.There is good opacification of adjacent bowel loops and i do not believe this represents of bowel.There does appear to be a small residual hernia containing adipose tissue.Pelvis: there is a 4.7 cm left adnexal cystic structure.Along its inferior extent it appears to be somewhat tubular extending to the right above the bladder and the question is raised whether this could be a combination of ovarian cyst and hydrosalpinx.No free fluid.Impression: deep to an anterior abdominal wall hernia repair there is a thick walled gas and to a lesser extent fluid collection measuring 7.2 x 2.6 cm that does not appear to be bowel and would be concerning for recurrent/residual abscess.There is a small residual anterior abdominal wall hernia containing adipose tissue.Question left-sided hydrosalpinx/ovarian cyst.Consider a follow up.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Interventional radiology.History: recurrent midline abdominal abscess status post mesh repair of an abdominal wall hernia.Patient presents for repeat percutaneous drainage.Impression: difficult drain placement due to the extensive scar tissue and/or thickening from the mesh.However, an 8-french tube was placed into the collection and only a scant amount of drainage fluid could be aspirated and sent for microbiology.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Interventional radiology.Catheter check and limited abdominal ultrasound.Vacation: anterior abdominal wall abscess treated with catheter drainage approximately 19 days ago.Impression: fistula to small bowel.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-mri pelvis with and without contrast.Clinical information: history of intracutaneous fistula status post drainage.Impression: complex enhancing soft tissue along the anterior abdominal wall involving the right greater than left rectus sheath is likely in keeping with history of enterocutaneous fistula.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: enterocutaneous fistula status post drainage.Impression: similar appearance of left hydrosalpinx.Resolution fluid collection anterior lower abdomen with only residual present scar tissue remaining.No drainable collection on today¿s study.On (b)(6) 2014: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.History: pelvic pain, history cesarean section, tubal ligation, appendectomy.Impression: findings could represent acute mild uncomplicated sigmoid diverticulitis in the appropriate clinical setting.Interval slight increase in size of probable left hydrosalpinx.On (b)(6) 2015: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: abdominal pain.Impression: chronic left hydrosalpinx, hepatic steatosis.On (b)(6) 2017: (b)(6), md.Office visit.Presents on referral secondary to a history of enterocutaneous fistula.This was noticed on mri in 2013.At that time she had a [sic] abdominal wound infection.However this is healed.She does state periodic 5 out of 10 abdominal pain occasional nausea no vomiting occasional constipation no diarrhea no melena no hematochezia no dysuria no hematuria no fevers or sweats.Positive occasional chills.She denies any open wounds on her abdomen.Assessment/plan: fistula of intestine.This appears to have healed completely.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.¿ 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.¿ 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 (1930, 3191: appropriate term/code not available for ¿mesh failure¿ and ¿abdominal wound¿) 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) 2010 through (b)(6) 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: 2009: perforated appendicitis with pelvic abscess.Smoker ¿ quit 2009.Prior surgical procedures: 1992, 1999, 2001: cesarean section.2009: appendectomy.Implant preoperative complaints: (b)(6)2010: ¿she had a previous perforated appendicitis with pelvis abscess and had developed an incisional hernia in the area of her midline infraumbilical incision.Ct scan also demonstrated that she had an umbilical hernia.¿ implant procedure: laparoscopic incisional hernia repair with gore-tex dualmesh plus.Implant: gore® dualmesh® plus biomaterial (06306940/1dlmcp06) 18 x 24 cm.Implant date: (b)(6) 2010 description of hernia being treated: ¿the patient had omentum in the hernia sac.This was reduced and dissected free.There was also a loop of bowel which was carefully dissected away from the hernia sac.There was a large defect in the lower abdomen in the midline and then a small umbilical hernia.The umbilical hernia was also reduced and had only omentum present.The dissection of the omentum was performed using the scissors and minimal cautery was used on some bleeding points.¿ implant size and fixation: ¿an 18 x 24 cm gore-tex dualmesh plus was used for the hernia repair.0 gore-tex sutures were placed on the mesh in the north, south, east, and west positions.The mesh was inserted into the peritoneal cavity.Using the suture passer, the strands of the gore-tex suture were brought through the abdominal wall and the mesh was secured in place.Absorbatacks were then placed along the periphery of the mesh to further secure the mesh to the abdominal wall.The abdomen was then irrigated.The irrigation was evacuated.The mesh provided good coverage of both of the hernias.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2010: excisional debridement of chronically infected abdominal wound [the patient] ¿was given some iv vancomycin for antibiotic prophylaxis and she had mrsa [methicillin resistant staphylococcus aureus] grow out of the cultures a few weeks ago.¿ ¿the area of recurrent infections was at the superior aspect of a midline laparotomy scar.The patient had some gore-tex dual mesh and therefore the decision for excisional debridement to avoid any further infections was made.An elliptical incision was made over the superior aspect of the incision where the recurrent infections had occurred.This measured approximately 3cm in length.The subcutaneous tissues were dissected using bovie cautery.The patient was noted to have a sinus tract that extended from the level of the incision down to a prolene suture.The suture was removed.There was no evidence of purulent fluid within the tissues at this time.There was some thickened tissue.The tissue in this area was completely removed and sent to pathology in formalin for review.¿ pathology for the specimen obtained in the (b)(6) 2010 procedure was not provided.(b)(6) 2011: ct guided drainage of infected postop seroma ¿there is an oval collection of low attenuation measuring up to 11.1 x 5.5 cm.Radiopaque rim of the collection is seen and may represent some type of surgical radiopaque mesh used to repair and [sic] anterior abdominal wall hernia.The fluid was grossly purulent.A single incompletely healed skin site is demonstrated and may have represented the site of a draining sinus tract¿ ¿ct guided percutaneous drainage of an infected seroma was performed.Fluid sample pending.¿ microbiology report of specimens obtained during the 3/15/11 procedure were not provided.(b)(6) 2011: ct abdomen/pelvis: ¿there has been a ventral hernia repair with surgical mesh.A new percutaneous drainage catheter courses through the mesh and has markedly decreased the fluid collection underlying the mesh.There is no identifiable residual with unpacified small bowel loops deep to the mesh.Just superior to the surgical mesh, ventral hernia remains containing fat and bowel loops.Surgical suture in the right lower quadrant abdomen at the cecum.¿ (b)(6) 2011: abscessogram: ¿fluoroscopic evaluation demonstrates an amorphous collection filling what appears to be at least a moderate size cavity.No evidence of fistula.The output has been approximately 20 cc per day.The catheter was left in place.¿ (b)(6) 2011: ct abdomen: ¿on the previous study, the patient had a pigtail catheter placed into a seroma in the anterior abdominal wall.This is seen related to surgical mesh from a previous hernia repair.The fluid collection has reaccumulated following removal of the pigtail catheter.It now measures 4.4 x 9.8 cm in size on image 64.It has hounsfield numbers of 27 which is a little more than would be expected for simple fluid.The umbilical hernia remains containing fat and there are some bowel loops which may be related to the hernia as well.Overall, the size of the hernia has not increased since the previous study.There is no adenopathy in the abdomen.No abnormal fluid collections are seen other than the presumed seroma at the hernia site, but a residual ventral hernia is seen.¿ (b)(6) 2011: ct guided drain placement ¿limited unenhanced ct examination demonstrates a postop seroma with mesh.Successful catheter placement in good location.¿ explant preoperative complaints: (b)(6) 2011: ct abdomen/pelvis: ¿there is now a surgical drain in place at the midline ventral wall.A fluid collection with surrounding rim calcification at this site is now collapsed.Herniated mesenteric fat through the ventral wall defect appears stable.No new suspicious enhancing mass of fluid collection otherwise is seen.The small bowel and colon are not remarkable.There is no evidence of any free air in the abdomen.¿ explant procedure: ¿exploratory laparotomy with removal of mesh, lysis of adhesions and open drainage of abdominal abscess for ventral abdominal hernia, recurrent, infected abdominal wall mesh, and abdominal wall abscess with methicillin resistant staphylococcus aureus.¿ explant date: (b)(6) 2011 ¿there was a large midline scar with a drain tract and abscess cavity.This scar was excised.There was a hernia both above and below surrounding the umbilicus.The umbilicus was therefore excised with this scar.Once the incision had been made around the scar, dissection was carried down to the hernia sac using electrocautery.During the dissection, abscess cavity of the abdominal wall was encountered.It was opened and the infected mesh was seen.The mesh sutures were cut and the mesh was pulled out and fluid from the mesh cavity, which was purulent in nature, was sent for culture.We continued to dissect to the fascial edges with electrocautery encountering sutures of prolene where the abdominal wall had been previously closed and sutures were removed and the abdominal wall opened.The hernia was incised superiorly and opened.Contents were mobilized with gentle traction, sharp dissection and reduced into the abdomen.The entire hernia sac was then dissected free of the fascial edge and excised.There were loops of small bowel and omentum that were densely adherent to the abdominal wall.These were mobilized away from the abdominal wall with a combination of blunt dissection, traction, electrocautery and sharp dissection.There was one area of serosal tear in the small bowel.This was repaired with a lambert sutures of 3-0 silk.Once this portion of the procedure had been completed and all abdominal adhesions were freed, the hernia was completely reduced and the hernia sac excised.At this point, plastic surgery came for his portion of the procedure.¿ ¿once both of the abdominal wall muscle flaps were widely mobilized, the skin and subcutaneous tissue were elevated off the abdominal wall from the midline incision just to the lateral border of the rectus abdominis muscle.Once this was done, the strattice biologic membrane 20 x 25cm was cut to fit and sutured in every 1cm with a through-and-through #1 prolene suture every 1cm.¿ records indicate that a non-gore device was implanted during the (b)(6) 2011 procedure.Microbiology reports for specimens obtained during the (b)(6) 2011 procedure were not provided.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 warns, ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further warn, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.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.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 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.The investigation concluded that there is no relationship between the device history record findings and the event.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: 06306940 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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Previous patient code (3191: appropriate term/code not available for ¿mesh failure¿ and ¿abdominal wound¿) was reported based on the original complaint and is 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.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: 2009: perforated appendicitis with pelvic abscess.Smoker ¿ quit 2009.Prior surgical procedures: 1992, 1999, 2001: cesarean section.2009: appendectomy.Implant preoperative complaints: (b)(6) 2010: ¿she had a previous perforated appendicitis with pelvis abscess and had developed an incisional hernia in the area of her midline infraumbilical incision.Ct scan also demonstrated that she had an umbilical hernia.¿ implant procedure: laparoscopic incisional hernia repair with gore-tex dualmesh plus.Implant: gore® dualmesh® plus biomaterial (06306940/1dlmcp06) 18 x 24 cm.Implant date: (b)(6) 2010.Description of hernia being treated: ¿the patient had omentum in the hernia sac.This was reduced and dissected free.There was also a loop of bowel which was carefully dissected away from the hernia sac.There was a large defect in the lower abdomen in the midline and then a small umbilical hernia.The umbilical hernia was also reduced and had only omentum present.The dissection of the omentum was performed using the scissors and minimal cautery was used on some bleeding points.¿ implant size and fixation: ¿an 18 x 24 cm gore-tex dualmesh plus was used for the hernia repair.0 gore-tex sutures were placed on the mesh in the north, south, east, and west positions.The mesh was inserted into the peritoneal cavity.Using the suture passer, the strands of the gore-tex suture were brought through the abdominal wall and the mesh was secured in place.Absorbatacks were then placed along the periphery of the mesh to further secure the mesh to the abdominal wall.The abdomen was then irrigated.The irrigation was evacuated.The mesh provided good coverage of both of the hernias.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2010: excisional debridement of chronically infected abdominal wound [the patient] ¿was given some iv vancomycin for antibiotic prophylaxis and she had mrsa [methicillin resistant staphylococcus aureus] grow out of the cultures a few weeks ago.¿ ¿the area of recurrent infections was at the superior aspect of a midline laparotomy scar.The patient had some gore-tex dual mesh and therefore the decision for excisional debridement to avoid any further infections was made.An elliptical incision was made over the superior aspect of the incision where the recurrent infections had occurred.This measured approximately 3cm in length.The subcutaneous tissues were dissected using bovie cautery.The patient was noted to have a sinus tract that extended from the level of the incision down to a prolene suture.The suture was removed.There was no evidence of purulent fluid within the tissues at this time.There was some thickened tissue.The tissue in this area was completely removed and sent to pathology in formalin for review.¿ pathology for the specimen obtained in the (b)(6) 2010 procedure was not provided.(b)(6) 2011: ct guided drainage of infected postop seroma.¿there is an oval collection of low attenuation measuring up to 11.1 x 5.5 cm.Radiopaque rim of the collection is seen and may represent some type of surgical radiopaque mesh used to repair and [sic] anterior abdominal wall hernia.The fluid was grossly purulent.A single incompletely healed skin site is demonstrated and may have represented the site of a draining sinus tract¿ ¿ct guided percutaneous drainage of an infected seroma was performed.Fluid sample pending.¿ microbiology report of specimens obtained during the (b)(6) 2011 procedure were not provided.(b)(6) 2011: ct abdomen/pelvis: ¿there has been a ventral hernia repair with surgical mesh.A new percutaneous drainage catheter courses through the mesh and has markedly decreased the fluid collection underlying the mesh.There is no identifiable residual with unopacified small bowel loops deep to the mesh.Just superior to the surgical mesh, ventral hernia remains containing fat and bowel loops.Surgical suture in the right lower quadrant abdomen at the cecum.¿ (b)(6) 2011: abscessogram: ¿fluoroscopic evaluation demonstrates an amorphous collection filling what appears to be at least a moderate size cavity.No evidence of fistula.The output has been approximately 20 cc per day.The catheter was left in place.¿ (b)(6) 2011: ct abdomen: ¿on the previous study, the patient had a pigtail catheter placed into a seroma in the anterior abdominal wall.This is seen related to surgical mesh from a previous hernia repair.The fluid collection has reaccumulated following removal of the pigtail catheter.It now measures 4.4 x 9.8 cm in size on image 64.It has hounsfield numbers of 27 which is a little more than would be expected for simple fluid.The umbilical hernia remains containing fat and there are some bowel loops which may be related to the hernia as well.Overall, the size of the hernia has not increased since the previous study.There is no adenopathy in the abdomen.No abnormal fluid collections are seen other than the presumed seroma at the hernia site, but a residual ventral hernia is seen.¿ (b)(6) 2011: ct guided drain placement: ¿limited unenhanced ct examination demonstrates a postop seroma with mesh.Successful catheter placement in good location.¿ explant preoperative complaints: (b)(6) 2011: ct abdomen/pelvis: ¿there is now a surgical drain in place at the midline ventral wall.A fluid collection with surrounding rim calcification at this site is now collapsed.Herniated mesenteric fat through the ventral wall defect appears stable.No new suspicious enhancing mass of fluid collection otherwise is seen.The small bowel and colon are not remarkable.There is no evidence of any free air in the abdomen.¿ explant procedure: ¿exploratory laparotomy with removal of mesh, lysis of adhesions and open drainage of abdominal abscess for ventral abdominal hernia, recurrent, infected abdominal wall mesh, and abdominal wall abscess with methicillin resistant staphylococcus aureus.¿ explant date: (b)(6) 2011.¿there was a large midline scar with a drain tract and abscess cavity.This scar was excised.There was a hernia both above and below surrounding the umbilicus.The umbilicus was therefore excised with this scar.Once the incision had been made around the scar, dissection was carried down to the hernia sac using electrocautery.During the dissection, abscess cavity of the abdominal wall was encountered.It was opened and the infected mesh was seen.The mesh sutures were cut and the mesh was pulled out and fluid from the mesh cavity, which was purulent in nature, was sent for culture.We continued to dissect to the fascial edges with electrocautery encountering sutures of prolene where the abdominal wall had been previously closed and sutures were removed and the abdominal wall opened.The hernia was incised superiorly and opened.Contents were mobilized with gentle traction, sharp dissection and reduced into the abdomen.The entire hernia sac was then dissected free of the fascial edge and excised.There were loops of small bowel and omentum that were densely adherent to the abdominal wall.These were mobilized away from the abdominal wall with a combination of blunt dissection, traction, electrocautery and sharp dissection.There was one area of serosal tear in the small bowel.This was repaired with a lambert sutures of 3-0 silk.Once this portion of the procedure had been completed and all abdominal adhesions were freed, the hernia was completely reduced and the hernia sac excised.At this point, plastic surgery came for his portion of the procedure.¿ ¿once both of the abdominal wall muscle flaps were widely mobilized, the skin and subcutaneous tissue were elevated off the abdominal wall from the midline incision just to the lateral border of the rectus abdominis muscle.Once this was done, the strattice biologic membrane 20 x 25cm was cut to fit and sutured in every 1cm with a through-and-through #1 prolene suture every 1cm.¿ records indicate that a non-gore device was implanted during the (b)(6) 2011 procedure.Microbiology reports for specimens obtained during the (b)(6) 2011 procedure were not provided.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 warns, ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further warn, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.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.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 device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 06306940.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.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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Search Alerts/Recalls
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