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| Model Number 1DLMC07 |
| Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Purulent Discharge (1812); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Seroma (2069); Discharge (2225)
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| Event Date 08/31/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2014 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: open draining wound, granuloma, infected mesh, mesh removal.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Added patient medical history.Corrected results code.Code 3233 - sterilization results pending completion of the evaluation.Corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records prior to 10/8/2014 are not provided; however, history of past abdominal surgery is known given operative records from on (b)(6) 2014 include revisional procedures.Operative records dated on (b)(6) 2014 indicate the patient underwent gastric bypass revision, partial gastrectomy, small bowel resection x2, cholecystectomy, liver biopsies, and incarcerated incisional hernia repair.Post-operative diagnoses indicate: morbid obesity, previous gastric bypass surgery, incarcerated incisional hernia, and cholelithiasis.On (b)(6) 2014 records state: ¿an upper midline abdominal incision was used.On entering the subcutaneous tissue several large incisional hernias were encountered.The entirety of the upper midline essentially was hernia.Entry into the peritoneal cavity was difficult, but was achieved without damage to any structures.The omentum and portions of the small bowel had herniated through the old midline incision, and all of the herniated contents were reduced into the peritoneal cavity.Portions of the omentum were resected, with the omentum being tied off with ties of #2-0 vicryl.As well, there were very dense adhesions of small bowel and colon and omentum around the edges of the fascia, and these were all taken down by sharp dissection.The liver was bulky with the consistency of a fatty liver, and i took two tru-cut needle biopsies from the right lobe of the liver.Bleeding was minimal.These sites were cauterized and gave no further problems.¿ on (b)(6) 2014 records continue: ¿the gallbladder was densely encased with omental tissue, and adhesions here were taken down with sharp and blunt dissection.The gallbladder was very tense, and was packed with stones.A cholecystectomy was carried out.Dissection was begun in the region of the cystic artery and cystic duct.The structure was skeletonized and divided between hemoclips, taking care not to damage the common bile duct.The gallbladder was removed easily from the liver bed.All minor bleeders in the liver bed were cauterized.Hemostasis here was fine, and there was no sign of any bile leak from the cholecystectomy site at any point during the entire procedure.¿ on (b)(6) 2014 records indicate that during the procedure, it was noted: ¿there were very dense adhesions of small bowel to itself throughout the peritoneal cavity and to define the anatomy i had to lyse all of the adhesions off of the small bowel.¿ ¿there were dense adhesions in the left upper abdominal quadrant and these were taken down by sharp dissection.¿ ¿there were extremely dense adhesions of remnant to the liver, and adhesions to the liver were all taken down by sharp dissection.I knew from the preoperative egd that the upper gastric pouch was extremely large.¿ ¿adhesions between the gastric pouch and the gastric remnant were taken down by sharp dissection without damage to either structure.¿ revision of the gastric bypass included re-creation of the gastric pouch using a linear surgical stapler, re-attachment of the limb to the pouch using a circular stapler, and closure of the enterotomy incisions with a stapler.Regarding the repair of the hernia, on (b)(6) 2014 records state: ¿there was no way to repair the incisional hernia without the use of mesh.The fascia on either side was simply too far apart to be drawn together without massive excessive tension.A piece of gore dualmesh patch material was chosen.This was a large piece measuring 20 x 30 cm.It was trimmed appropriately and sewn in place to the fascial edges using running and interrupted sutures of #1 prolene.There were no problems with the patch application and the repair was solid.The hernia sac material on both sides of the incision into the subcutaneous tissue was all removed using cautery.There was excessive skin and i excised from the patient's left side an ellipse of skin.Again all bleeders were cauterized.A 19-french blake drain was inserted through a separate stab incision inferior to the main incision, but the drain laid over the patch material.Again the drain was sutured to the skin with #2-0 silk.The subcutaneous tissue and patch material were washed with bacitracin and saline solution.The subcutaneous tissue was closed with interrupted sutures of #2-0 vicryl.The skin was closed with staples.¿ the records confirm a gore dualmesh® biomaterial (1dlmc07/11777873) was used during the procedure.An addendum to the 10/8/2014 procedure states: ¿an additional finding at the time of laparotomy was of an internal hernia.There was complete twisting of a jejunojejunostomy from the previous gastric bypass such that the biliary pancreatic limb was passing completely under the roux limb causing partial obstruction of the roux limb causing the roux limb to be quite dilated.The internal hernia situation was repaired with the small bowel resection and revision of the jejunojejunostomy.¿ records between 10/8/2014 and 8/31/2017 were not provided to gore.Operative records dated on (b)(6) 2017 indicate the patient underwent excision of a ventral hernia mesh with excision of a sinus tract.Post-operative diagnosis states: ¿infected only mesh.¿ the records state: ¿this is a middle-aged male, who has prior onlay ventral hernia repair, who is started draining purulent material around the skin above the mesh.His ct scan showed what was likely an obvious mesh infection.¿ procedure findings state: ¿sinus tract from surface down to mesh, poorly encorporated but encapsulated with murky white fluid, multiple stitch granulomas.¿ additional procedure findings state: ¿1.Grossly infected gore-tex mesh.2.Extensive pseudo capsule.3.All prolene sutures removed.4.12 cm x 2 cm wide x 2 cm deep wound.¿ on (b)(6) 2017 records state: ¿a mid line incision was made over the prior scar site, we entered the pseudo capsule, there was a significant amount of purulent material.This was aspirated and sent off for culture.The wound was opened up in its entirety.The prolene sutures that were circumferentially placed prior were all excised.The mesh was removed.There was no obvious entry into the abdominal cavity.There was significant pseudocapsule in the midline.We debrided all grossly infected tissue and suture granuloma.Portion of the mesh was sent for culture.We irrigated with 3 l of normal saline with a pulsavac irrigator.We measured the wound to be 12 cm x 2 cm x 2 cm.We placed a negative pressure wound therapy.Black foam sponge in this position.The patient tolerated the procedure well.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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Conclusion code remains unchanged.
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Manufacturer Narrative
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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) 2017: vcu health.Stephanie l.Thorne, rn.Perioperative documentation.Explants: hernia mesh.Site: abdomen.Comments: small portion sent for culture; the remaining piece discarded per surgeon request.(b)(6) 2017: vcu health.Dielle l.Meyer, md.Surgery emergency gen ip progress note.Pod 1 s/p excision of infected ventral hernia mesh.Has had nausea, vomited this morning.Assessment: recovering well and has minimal pain.He is not tolerating a general diet and will go slowly with clears for now.We will work on getting home health and a home wound vac setup for discharge most likely early next week.Plan: pt/ot.Cont.Wound vac, change in 3 days.Po diet as tolerated.Arrangements for home wound vac.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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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: a pathology report dated (b)(6) 2014 regarding a specimen collected (b)(6) 2014 states: ¿specimen: 1.Incisional hernia sac.2.Gallbladder.3.Liver biopsy.4.Portion of stomach and omentum.¿ gross description of the hernia sac states: ¿specimen #1 is labeled incisional hernia sac.Received in formalin is a 17 x 16 x 4.5-cm aggregate of membranous congested rubbery tissue portions presenting a hernia sac, resected along with a large amount of attached lobulated adipose tissue.The specimen weighs 510 grams.On sectioning, no lesions suggesting malignancy can be identified grossly.¿ records dated (b)(6) 2014 state the patient was seen for follow up.¿says he is too weak to stand ¿ can¿t get his weight [sic].Is home from rehab.Using a [hospital] bed ¿ needs this for a while.Diet is good.Incision strong.¿ ¿patient reports weight loss (___lbs) [sic].He reports muscle weakness, arthralgias/joint pain, and back pain.¿ ¿postoperative exam: general appearance: morbidly obese.Level of distress: nad.General appearance: no swelling, tenderness, or warmth and wound clean and dry.¿ ¿patient doing well, in rehab.Incision is healing well, drain draining small amount of serous fluid.D/c drains.¿ records between 12/5/2014 and 8/31/2017 were not provided to gore.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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: 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: medical records dated(b)(6) 2017 state chief complaint ¿abdominal wall drainage.¿ the records state ¿ this is a 49-year-old male with an extensive medical and surgical history with procedures all performed at outside hospitals, who presents today as a new patient for evaluation of abdominal wall drainage.The patient has a history of obesity and is status post a gastric bypass procedure performed in 2000 at ohio state.The patient states that he had been 500 pounds in the past.In 2014, the patient returned to the operating room at munroe regional medical center in ocala, florida for revision of the gastric bypass and for extensive abdominal wall hernia repair with mesh.¿ medical records dated (b)(6) 2017 state: ¿the patient was referred here today, because he has noted some redness and itching on his abdominal wall superior to his umbilicus and also has noted drainage from the area.The patient states that this occurred starting on (b)(6) 2017.No abdominal pain.Tolerating a.Diet.No associated nausea or vomiting.Having bowel function.No associated fevers.He states that the area of concern is at the previous incision site in the midline superior to the umbilicus.He noticed that his primary care doctor recently saw him on (b)(6) 2017, and incised open the area of the incision, a small area, which allowed the drainage to occur.The site has been draining since that time.The primary care doctor also started the patient on bactrim.¿ medical records dated (b)(6) 2017 also state: ¿at this point, since the patient is not having any acute abdominal pain, not having any fevers, and there is no surrounding abdominal wall erythema, i would not recommend performing any further incision in this area, because the underlying anatomy is not clear at this time.The patient has had multiple operations and has a reoperative abdomen.The patient has had prior mesh repair.The patient also has an extensive amount of residual skin from all of the weight loss after his gastric bypass.It is unclear where the site that was opened by the primary care doctor tracks down to, and the source of the drainage is unclear at this time.Unknown if this is associated with any kind a chronic fluid collection associated with the mesh.Unclear if this is any evidence of any fistulous connection.Because the underlying anatomy is not clear would not recommend any kind of bedside incision prior to imaging to evaluate what is going on below the surface of the skin.¿ medical records dated (b)(6) 2017continue: ¿in addition, the patient is on eliquis and is a bleeding risk, and because of that i would also not recommend any bedside procedure at this time.Plan will be for a ct scan of the abdomen and pelvis with iv and oral contrast.The patient also stated that he will attempt to get recent outside ct imaging so the comparisons can be made.It would also be helpful to have outside medical records from his prior surgeries to have further details of what was performed during those procedures.¿ medical records dated (b)(6) 2017state: ¿i have seen this patient in followup.He was seen by my partner, dr.(b)(6) , who ordered a ct scan of his abdomen and pelvis.I have reviewed his scan and looked his imaging myself and read his report.I have reviewed the history done by my partner.I re-evaluated the history and examined him.In summary, he has an infected piece of gore-tex mesh.The wound is currently closed and i can see evidence of where it was opened.He showed me pictures of purulent material and it is confirmed in my partners note that there was purulent material draining from it.On the scan, it looks obviously infected.The entire piece of mesh has been balled up into the hernia sac.This needs to be removed.¿ medical records dated (b)(6) 2017state: ¿he has extensive smoking history, paraplegic, has chronic dvt with an ivc filter in place.I will have him see preop anesthesia.He needs to smoke as little as possible as we are going to do laparotomy mesh explantation, and a temp primary suture repair with wound vac therapy on top as his wound will not heal with primary closure or we will do a phasix or biologic mesh graft placement with subsequent wound va.C on top for soft tissue healing.¿ culture report dated (b)(6) 2017regarding a specimen collected (b)(6) 2017 states: ¿source: foreign body, infected mesh aerobic, anaerobic with grams.Final report: few candida albican¿.No anaerobes isolated.Gram stain: few fungal forms, many wbc¿s, no squamous epithelial cells¿ culture report dated (b)(6) 2017 for wound culture, deep collected (b)(6) 2017 states: ¿few candida albicans, no anaerobes isolated.Gram stain dated (b)(6) 2017 states: rare fungal forms, many wbc¿s, no squamous epithelial cells.¿ fungus culture dated(b)(6) 2017 for specimen obtain (b)(6) 2017 from intraoperative site/abdomen states: ¿few candida albicans.¿ discharge summary dated (b)(6) 2017 indicates patient was admitted to hospital on 8/31/207 for exploratory laparotomy.Discharge diagnosis: s/p explanation infected mesh.¿ the records state: ¿a wound vac was placed after the surgery in the midline of the patient's abdomen.The wound was measured to be 10 x 3 x 3 cm.The patient's post-operative course was unremarkable.He was discharged home with a home vac on 9/5/17.¿ medical records dated (b)(6) 2017state: ¿this is a 49-year-old male, who recently had excision of infected mesh.Hehas had a vac placed.He returns today wondering if the vac needs to still stay in place.He is being seen by home health.He has had no fevers.He said he has had very little drainage from the vac since this placement.On exam, he is alert and oriented x3.He is well nourished, well hydrated.Examination of his abdomen is soft, nondistended, and nontender.I removed the vac.The midline incision is granulating well.It is yet to collection.We will remove the vac and allow the wound to epithelialize at this stage.I have recommended xeroform dressing.¿ medical records dated (b)(6) 2017 state: ¿midline well healed, no remaining wound of any significance, no obvious hernia.¿ 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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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) 2014: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w/contrast.History: abdominal/pelvic pain.Findings: two ventral abdominal wall hernias.More superior supraumbilical location contains non-obstructed colon.Measures 12 cm right to left, 7 cm anterior/posterior.Abdominal wall defect appears to measure 4 cm in diameter.More inferior ventral hernia contains right periumbilical location and is filled with abnormal small bowel loops that appear to have luminal narrowing and wall thickening.Hernia defect measures 7 cm and the right to left dimension.Hernia apex measures 16 cm right to left as well as 7 cm anterior/posterior.Impression: two abdominal wall hernias, the more inferior right periumbilical contains distended small bowel loops with small bowel obstruction seen.Mild ascites.Distended gallbladder with gallstones present.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Emergency department note.Hpi: presents for abd.Pain; cramping pain across lower abd, with nausea and constipation; no actual vomiting.Hx chronic constipation; last bm 4 days ago.Exam: abdomen; no organomegaly, bowel sounds increased, abdomen moderately tender across lower abdomen.Large, nontender ventral hernia noted.Diagnosis: hernia of anterior abdominal wall, small bowel obstruction, acute abdominal pain, nausea.Dr.Casebolt will consult.Results: ct abdomen/pelvis; hernia with sbo.Disposition: hospitalized.(b)(6) 2014: (b)(6) medical center.[illegible].History & physical/consult.Cc: abdominal pain x 2-3 days.Pmh: dm, s/p gastric bypass, smoker, morbid obesity.Exam: abdomen; firm, periumbilical incisional hernia (irreducable [sic]), bs+.Assessment: sbo due to encarcerated [sic] small bowel in the periumbilical incisional hernia.Obvious mechanical obstruction, if didn¿t reduce, will need surgical repair to avoid strangulation; awaiting surgical evaluation.(b)(6) 14: (b)(6) medical center.(b)(6), md.Consultation.Hpi: with multiple medical problems and known ventral hernias; came in with nausea, vomiting and abdominal pain.Reports multiple episodes of vomiting.At time of interview reports no nausea, no vomiting, abdominal pain resolved and after ng tube placed, had several episodes of flatus.Admitted (b)(6) 2014 for venous ulcer w/cellulitis; undergoing treatment.Exam: gi; abdomen soft, nondistended, nontender.Has an easily reducible midline epigastric hernia, right inferolateral hernia at the umbilicus that is partly reducible, but not tender.No percussion, no rebound tenderness.Impression: incisional hernias x2, most likely one being chronically incarcerated with acute component.Bowel obstruction which appears to have resolved.Recommendations: does not appear to have acute obstruction; no acute need for surgery.He is at significant risk for surgery and for recurrence, based on the following factors: insulin dependent diabetes mellitus which has documented noncompliance, morbid obesity, tobacco use.Unless an acute need for surgery, recommend he should be referred to tertiary facility for consideration of hernia repair.Will follow and make further recommendations based on clinical course, but as obstruction has resolved, can be discharged home.(b)(6) 2014: (b)(6).(b)(6), md.Progress note: cc: ¿my doctor thinks i have a hernia.¿ hpi: returns with complaint of a definite ventral hernia with a couple of hernia defects.States onset of a bulge and diarrhea began 7 years ago and has been minimal.Admits to lap.Gastric bypass in 2000; reports no complications with surgery.Has had one hospitalization previously for these symptoms.Has had no previous repairs of this hernia.Evaluated in surgery for transient sbo from ventral hernia.Wishes to discuss revision of gastric bypass.Wt: 363 lbs, bmi: 46.61.Abdominal exam: soft, non-tender, no masses, no hernias.Ros: gastrointestinal; admits diarrhea, denies nausea, vomiting, change in abdominal girth, constipation, blood in stools.Plan: symptomatic ventral incisional hernia; recommended repair.Discussed pathology, indications, risks and complications regarding repair.Recurrence rates discussed.Repair with mesh placement will be scheduled.Referred to dr.Hoddinott for evaluation of gastric bypass revision; if this can be done, hernia can be fixed at the same time.(b)(6) 2014: (b)(6).(b)(6), md.Office note.Hpi: came for consideration of repeat gastric bypass weight loss surgery.Had laparoscopic rygb (possibly hand assisted) in 2000.Starting weight was 450 pounds; went to low of 260 pounds.Gaining weight now; up to 363 pounds; still severely morbidly obese.Current medications: glyburide, metformin.Social history: current every day smoker, 1 ppd for 30 plus years.Alcohol: 1-2 drinks/week.Review of systems: gastrointestinal; no dysphagia, heartburn, nausea, vomiting, abdominal pain, melena, diarrhea.Exam: abdomen; scars present, bowel sounds normal, abdomen soft, non-tender, 2 incisional hernias.Assessment: has a number of problems; developed 2 incisional hernias; first at midline incision, just above umbilicus; that is what makes me think it was a hand assisted procedure.The other is at the port site near the umbilicus.Plan: egd to evaluate gerd/gastric bypass.(b)(6) 2014: discharge medications: [included] dalteparin (fragmin) [blood thinner], metformin.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Discharge summary.Final diagnosis: morbid obesity, type 2 diabetes, degenerative disc disease, previous gastric bypass surgery, sleep apnea, chronic venous insufficiency.Procedures: revision of roux-en-y gastric bypass and assess partial gastrectomy, repair incarcerated incisional hernia, cholecystectomy, repair of internal hernia, tru-cut needle liver biopsies.Hospital course: had been investigated through our office for problems associated with morbid obesity.Previously had undergone gastric bypass which essentially has been unsuccessful.His bmi on admission was 47; weight 363 pounds.To or on 10/08 for above noted procedures; no intraoperative problems.Postoperatively he was slow to ambulate; for some time has been confined to a wheelchair.Discharged on 10/12 to rehab unit to be followed through our office.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Operative record.Date of surgery: (b)(6) 2014 [note from nurse reviewer: possible documentation error; other records indicate surgery (b)(6) 2014].Addendum: ¿please refer to original dictated operative report.An additional finding at the time of laparotomy was of an internal hernia.There was complete twisting of a jejunojejunostomy from the previous gastric bypass such that the biliary pancreatic limb was passing completely under the roux limb causing partial obstruction of the roux limb, causing the roux limb to be quite dilated.The internal hernia situation was repaired with the small bowel resection and revision of the jejunojejunostomy.¿ (b)(6) 2015: (b)(6) medical center.(b)(6), md.Radiology-ct abd/pelvis w/contrast.History: syncope, abdominal pain.Comparison: ct abd/pelvis (b)(6) 2014.Impression: 10 cm fluid collection seen in the antrum abdominal wall at the site of a previous abdominal wall hernia repair.I suspect that this represents some fluid possibly within the mesh of previous hernia repair.No bowel obstruction.Fatty infiltration of the liver.(b)(6) 2015: (b)(6) medical center.(b)(6), md.History & physical.Hpi: admitted to emergency department last night with complaint of passing out at home.Chronically wheelchair bound.Evaluation revealed a fluid collection in the anterior abdominal wall around 10.1 cm, ct chest showing bilateral pleural effusions.Admitted to icu.Ros: no hx of abdominal pain, abdominal distention, nausea, vomiting, diarrhea, fever, blood in stools.Exam: abdomen: soft, nontender, bowel sounds positive, no guarding, no rigidity.Assessment: [included] bilateral pulmonary embolus, altered mental status and syncope, increasing white blood cells, hypotension; on levophed, anterior abdominal wall fluid collection of 10.1 cm, history of anterior abdominal wall hernia repair with mesh placement (b)(6) 2014, bypass revision at same time of hernia repair, gastric bypass, type 2 diabetes mellitus; diet controlled, obesity.Plan: continue iv heparin, surgery evaluation appreciated with dr.Hoddinott, possible ct-guided aspiration of the fluid, start on levaquin and flagyl.Prognosis is guarded.(b)(6) 2015: (b)(6) medical center.(b)(6), md.Consultation.Elevated wbc.Ros: fatigue, abd pain.Exam: abdomen: soft, bs, nt.Assessment: septic shock, abdominal wall fluid collection r/o abscess, morbid obesity.Plan: blood cx, ct a/p noted, ir to see for drainage.(b)(6) 2015: (b)(6) medical center.(b)(6), md.Interventional radiology-ultrasound guided percutaneous fluid collection aspiration.History: postop fluid collection.Impression: successful ultrasound guided aspiration of a subcutaneous postoperative fluid collection.Approximately 250 ml of clear yellow fluid was aspirated.60 ml sent to lab for analysis.(b)(6) 2015: (b)(6).(b)(6), md.Cytopathology report.Cp15-00190.Specimen: left abdominal fluid; # of monolayers: 0.Final diagnosis: abdominal fluid, thinprep and cell block: paucicellular specimen, negative for malignancy.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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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A4: added patient weight.B7: added patient medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.See attachment for continuation of records.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: (b)(6) /14 consultation.¿reason for consultation: was seen by dr.Hoddinott as an outpatient.Gastric bypass surgery in 2000.He started with 450, he lost up to 250 pounds, and then, weight started gaining back.She [sic] has been in current weight of around 365 pounds.When dr.Hoddinott saw, the patient also had multiple problems like incisional hernia and also cholecystectomy and was getting worse.He was admitted by dr.Hoddinott today for elective gastric bypass surgery revision, which was done successfully.I was consulted for medical management.The patient takes glyburide and metformin at home.Laboratory data: hemoglobin a1c 6.0.¿ (b)(6) 14: follow up.¿chief complaint: followup: bariatric operative procedure.Medications: metformin 1000 mg tablet (entered (b)(6) /14).Past medical history: arthritis, diabetes, venous insufficiency.Social history: smoker (1 ppd/30 years), alcohol intake occasional.Wt: 262 lbs, bmi: 34.6.Hpi: post operative (b)(6) 2014.Procedure: gastric bypass revision.Incision healing well; no fever.Jp x 2, serous fluid.Physical exam: limited ambulation and in wheelchair (related to muscle weakness).Morbidly obese.Wound clean and dry.Discussion: patient doing well, in rehab.Incision is healing well, drain draining small amount of serous fluid.D/c drains.Return to office (b)(6) 2014.¿ (b)(6) 15: consultation.¿reason for consultation: pulmonary embolism and dvt.History: admitted with witnessed syncope in the setting of hypotension, leukocytosis and bilateral pulmonary embolism.Wbc was 24.6.Medications: glyburide, metformin.Laboratory data: ct of the abdomen and pelvis with iv contrast, 10 cm fluid collection seen in the anterior abdominal wall at the site of previous abdominal wall hernia repair.White count 12.7, albumin 2.4.Impression: leukocytosis.Fluid collection in the abdomen probably reactive.Recommendation: follow wbcs.Iv antibiotics have been started.¿ (b)(6) 15: discharge summary.¿admitted: (b)(6) 2015.Discharged: (b)(6) 2015.Discharge diagnosis: deep venous thrombosis with pulmonary emboli, on coumadin therapy.Questionable abdominal mesh infection.Diarrhea.Chronic pain.Diabetes mellitus.Obstructive sleep apnea.History of present illness: brought in with complaints of passing out at home.He is chronically wheelchair bound.The patient was found to have fluid in the anterior abdominal wall.A ct scan of the chest showed bilateral pleural effusions.Past medical history: deep venous thrombosis of left lower extremity after laminectomy; type 2 diabetes mellitus, diet controlled; wheelchair bound; obesity; obstructive sleep apnea.Hospital course: the patient had been admitted with bilateral pulmonary emboli, altered mental status with syncope, increasing wbc count, hypotension, anterior abdominal wall fluid collection 10.1 cm, history of anterior abdominal wall hernia repair with mesh in (b)(6) 2014, history of bypass revision at the same time of hernia repair, gastric bypass revision, fatty liver, history of gastric bypass, laminectomy, history of deep venous thrombosis of left lower extremity after laminectomy, type 2 diabetes mellitus (diet controlled), obesity (chronically wheelchair bound), obstructive sleep apnea, history of cholecystectomy, history of ivc filter.Ct scan of abdomen showed 10-cm fluid collection in the anterior abdominal wall with fatty infiltration.No bowel obstruction.The patient had been placed on antibiotic therapy.An ultrasound-guided abdominal drainage had been done with 250 cc obtained from interventional radiologist.The patient was to continue on antibiotic therapy.Abdominal fluid cytology showed paucicellular specimen.No evidence of malignancy.It was recommended 2 weeks of antibiotic therapy.At that point, the patient¿s condition continued to gradually stabilize.Wbc count on discharge was 10.7.The patient¿s blood and urine cultures continued to show no growth, and he was cleared for discharge.The patient was subsequently discharged to local rehab center to follow up with dr.Reisner as directed.¿ missing records; ct scan of abdomen and abdominal fluid cytology report.(b)(6) 15: client coordination note report.¿clinical summary: the patient was recently hospitalized @ mrmc (b)(6) 15 to (b)(6) 15 then went to rehab palm garden from (b)(6) 15 to (b)(6) 15.Had syncopal episode at home diagnosed with pe, dvt, and abdominal abscess which was drained and states was on iv abt and continued at rehab.New on warfarin.Iv abt completed and picc line discontinued in rehab before discharge.¿ (b)(6) 17: anesthesia preop evaluation.¿surgical diagnosis: infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, sequela.Home medications: apixaban (eliquis) (not taking-stopped taking 1 month ago for surgery).Social history: alcohol use: none, tobacco use: 1 packs/day, drug use: denies drug use.Anesthesiology co-morbidities/ros: past diagnosis of sleep apnea: yes.Other sleep apnea treatment: lost weight and no longer has it.Pulmonary: pulmonary embolus.Summary: asa class iii with complicated pmh including paraplegia, chronic dvt with ivc filter, pe, adult ftt, gastric bypass surgery and anemia presents for evaluation prior to repair of infected mesh balled in hernia sac.Anesthetic concerns: positive osa screen, hx of dvt/pe.¿ (b)(6) 17: admission history & physical.¿cc: mesh infection.Hpi: s/p rnygbp w/incisional hernia followed my [sic] mesh repair now with mesh infection, lots of pain, intermittent purulent drainage.Chronic nausea, no f/c/cp/soa/hematuria/melena.Past medical history: obesity, status post gastric bypass.Diabetes, which the patient says has resolved since the gastric bypass.Degenerative joint disease.Patient states that he has not been able to walk and has been in a wheelchair for the past 7 years.Dvt.Past surgical history: back surgery in 1996.Gastric bypass in 2000, ohio state university.Revision of gastric bypass in abdominal wall and repair and reconstruction with mesh in 2014 at munroe regional medical center, in ocala, florida.Social history: positive smoker of 1 pack per day.Denies alcohol use.Denies drug use.Review of systems: gi: positive abdominal wall drainage.Hematologic: on blood thinners, using eliquis.Examination: abd: midline scar w/firm mass overlying hernia recurrence, no peritonitis.A/p: mesh infection.Plan: exlap, mesh explant, possible sbr, possible mesh placement, possible wound vac.Pt not taking blood thinner.¿ (b)(6) 17: anesthesia preop evaluation.¿anesthesia co-morbidities/ros: gastric bypass surgery, abdominal hernia, adult ftt, gastric ulcer.Paraplegia.Anemia, anemia documented per outside medical records, dvt.¿ (b)(6) 17immediate brief op note.¿surgery performed: excision of ventral hernia mesh including excision of sinus tract.Description: as above through upper midline laparotomy.Procedure findings: sinus tract from surfact down to mesh, poorly encorporated but encapsulated with murky white fluid, multiple stitch granulomas.Estimated blood loss: 10 ml.Fluids: see anesthesia report.Urine output: nr.Specimens removed: fluid sent for gram stain and cultures.Postop diagnosis: infected abdominal wall mesh s/p vhr.¿ (b)(6) /17: surgery emergency gen ip progress note.¿pod 1 s/p excision of infected ventral hernia mesh.Assessment: recovering well and has minimal pain.He is not tolerating a general diet and will go slowly with clears for now.We will work on getting home health and a home wound vac setup for discharge most likely early next week.¿ (b)(6) 17: surgery emergency gen ip progress note.¿pod 2 from excision of infected ventral hernia mesh.Integ: wound vac is in place over midline incision.Serosanguinous drainage.Assessment: recovering well and has minimal pain.Plan: cont.Wound vac, change today.Lovenox and scd¿s for dvt prophylaxis.¿ (b)(6) 17: surgery emergency gen ip progress note.¿pod 3 from excision of infected ventral hernia mesh.Integ: wound vac is in place over midline incision.Serosanguinous drainage.Wound: extent of tissue damage: into muscle.Palpation: tissue is normothermic.Wound bed: blanchable.Granulation tissue: beefy red.% wound necrosis: 0%.Drainage: moderate, sanguineous.Odor: none.Surrounding skin: intact, non-pitting edema.¿ (b)(6) 17: surgery emergency gen ip progress note.¿pod 5 from excision of infected ventral hernia mesh.Integ: wound vac is in place over midline incision.Serosanguinous drainage.Wound: extent of tissue damage: into muscle.Palpation: tissue is normothermic.Wound bed: blanchable.Granulation tissue: beefy red.% wound necrosis: 0%.Drainage: moderate, sanguineous.Odor: none.Surrounding skin: intact, non-pitting edema.Recommendations for care: frequency: 2x weekly.Clean with: wound cleanser.Apply: small black vac sponge 10cm x 3cm x 3cm (cut to fit wound) directly into wound.Cover/pack with: vac therapy continuous.¿ ¿assessment: wound looks to be healing well.Plan: wound culture grew c.Albicans.No infected tissue currently present in the wound.No need for antifungal treatment.¿ 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 includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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H6: updated patient codes, additional patient code: 2419: infection, fungal.H6: updated device codes.H6: updated conclusion codes.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2014 through (b)(6) 2017, and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Medical records from (b)(6) 2015 through (b)(6) 2017 were not provided.Patient information.Medical history: type ii diabetes mellitus.(b)(6) 2014: hemoglobin a1c 6.0 [<6.0].Takes glyburide and metformin.(b)(6) 2017: ¿resolved since the gastric bypass.¿ sleep apnea.(b)(6) 2014: history of sleep apnea.(b)(6) 2015: obstructive sleep apnea.(b)(6) 2017: ¿lost weight and no longer has it.¿ chronic venous insufficiency.Methicillin resistant staphylococcus aureus [mrsa].Chronic deep venous thrombosis [dvt] with inferior vena cava [ivc] filter.(b)(6) 2017: eliquis.Baseline paraplegia impaired sensation from waist down.2010: wheelchair bound.Gastroesophageal reflux disease [gerd].Alcohol.(b)(6) 2014: 1-2 drinks per week [type not specified].(b)(6) 2014: alcohol intake occasional.(b)(6) 2017: denies alcohol use.Smoking.(b)(6) 2014: every day smoker, 1 pack daily for 30+ years.(b)(6) 2017: ¿he has extensive smoking history.¿ (b)(6) 2017: smokes 1 pack daily.Chronic obstructive pulmonary disease.Severe morbid obesity.2000: 450 lbs.Bmi 57.8.Unknown date: 260 lbs.Bmi 33.4.(b)(6) 2014: 363 lbs.Bmi 46.6.(b)(6) 2014: 262 lbs.Bmi 34.6.Prior surgical procedures: 2000: laparoscopic roux-en-y gastric bypass [rygb].Unknown dates: ¿revisional procedures.¿ implant preoperative complaints: (b)(6) 2014: ct abdomen: ¿two abdominal wall hernias, the more inferior right periumbilical contains distended small bowel loops with small bowel obstruction seen.Mild ascites.Distended gallbladder with gallstones present.¿ (b)(6) 2014: ¿returns with complaint of a definite ventral hernia with a couple of hernia defects.States onset of a bulge and diarrhea began 7 years ago and has been minimal.Admits to lap.Gastric bypass in 2000; reports no complications with surgery.Has had one hospitalization previously for these symptoms.Has had no previous repairs of this hernia.¿ ¿symptomatic ventral incisional hernia; recommended repair.¿ (b)(6) 2014: bariatrics: ¿came for consideration of repeat gastric bypass weight loss surgery.Had laparoscopic rygb (possibly hand assisted) in 2000.Starting weight was 450 pounds; went to low of 260 pounds.Gaining weight now; up to 363 pounds; still severely morbidly obese.Current medications: glyburide, metformin.Current everyday smoker of 1 pack daily.Abdomen; scars present, bowel sounds normal, abdomen soft, non-tender, 2 incisional hernias.Assessment: has a number of problems; developed 2 incisional hernias; first at midline incision, just above umbilicus.The other is at the port site near the umbilicus.Plan: egd [esophagogastroduodenoscopy] to evaluate gerd/gastric bypass.¿ implant procedure: partial gastrectomy, small bowel resection x2, cholecystectomy, liver biopsies, and incarcerated incisional hernia repair.Implant: gore® dualmesh® biomaterial (1dlmc07/11777873, 20cm x 30cm).Implant date: (b)(6) 2014 [hospitalization (b)(6) 2014].Description of hernia being treated: ¿an upper midline abdominal incision was used.On entering the subcutaneous tissue several large incisional hernias were encountered.The entirety of the upper midline essentially was hernia.Entry into the peritoneal cavity was difficult, but was achieved without damage to any structures.The omentum and portions of the small bowel had herniated through the old midline incision, and all of the herniated contents were reduced into the peritoneal cavity.Portions of the omentum were resected, with the omentum being tied off with ties of #2-0 vicryl.As well, there were very dense adhesions of small bowel and colon and omentum around the edges of the fascia, and these were all taken down by sharp dissection.The liver was bulky with the consistency of a fatty liver, and i took two tru-cut needle biopsies from the right lobe of the liver.Bleeding was minimal.These sites were cauterized and gave no further problems.¿ ¿the gallbladder was densely encased with omental tissue, and adhesions here were taken down with sharp and blunt dissection.The gallbladder was very tense, and was packed with stones.A cholecystectomy was carried out.Dissection was begun in the region of the cystic artery and cystic duct.The structure was skeletonized and divided between hemoclips, taking care not to damage the common bile duct.The gallbladder was removed easily from the liver bed.All minor bleeders in the liver bed were cauterized.Hemostasis here was fine, and there was no sign of any bile leak from the cholecystectomy site at any point during the entire procedure.¿ ¿there were very dense adhesions of small bowel to itself throughout the peritoneal cavity and to define the anatomy i had to lyse all of the adhesions off of the small bowel.¿ ¿there were dense adhesions in the left upper abdominal quadrant and these were taken down by sharp dissection.¿ ¿there were extremely dense adhesions of remnant to the liver, and adhesions to the liver were all taken down by sharp dissection.I knew from the preoperative egd that the upper gastric pouch was extremely large.¿ ¿adhesions between the gastric pouch and the gastric remnant were taken down by sharp dissection without damage to either structure.¿ revision of the gastric bypass included re-creation of the gastric pouch using a linear surgical stapler, re-attachment of the limb to the pouch using a circular stapler, and closure of the enterotomy incisions with a stapler.¿ ¿there was no way to repair the incisional hernia without the use of mesh.The fascia on either side was simply too far apart to be drawn together without massive excessive tension.¿ implant size and fixation: ¿a piece of gore dualmesh patch material was chosen.This was a large piece measuring 20 x 30 cm.It was trimmed appropriately and sewn in place to the fascial edges using running and interrupted sutures of #1 prolene.There were no problems with the patch application and the repair was solid.The hernia sac material on both sides of the incision into the subcutaneous tissue was all removed using cautery.There was excessive skin and i excised from the patient's left side an ellipse of skin.Again all bleeders were cauterized.A 19-french blake drain was inserted through a separate stab incision inferior to the main incision, but the drain laid over the patch material.Again the drain was sutured to the skin with #2-0 silk.The subcutaneous tissue and patch material were washed with bacitracin and saline solution.The subcutaneous tissue was closed with interrupted sutures of #2-0 vicryl.¿ ¿an additional finding at the time of laparotomy was of an internal hernia.There was complete twisting of a jejunojejunostomy from the previous gastric bypass such that the biliary pancreatic limb was passing completely under the roux limb causing partial obstruction of the roux limb causing the roux limb to be quite dilated.The internal hernia situation was repaired with the small bowel resection and revision of the jejunojejunostomy.¿ (b)(6) 2014: pathology report: ¿1.Incisional hernia sac.2.Gallbladder.3.Liver biopsy.4.Portion of stomach and omentum.¿ gross description of the hernia sac states: ¿specimen #1 is labeled incisional hernia sac.Received in formalin is a 17 x 16 x 4.5-cm aggregate of membranous congested rubbery tissue portions presenting a hernia sac, resected along with a large amount of attached lobulated adipose tissue. (b)(6) 2014: discharge summary: ¿no intraoperative problems.Postoperatively, he was slow to ambulate, for some time has been confined to a wheelchair.Discharged on 10/12 to rehab unit." relevant medical information: (b)(6) 2014: ¿limited ambulation and in wheelchair (related to muscle weakness).Morbidly obese.Wound clean and dry.Discussion: patient doing well, in rehab.Incision is healing well, drain draining small amount of serous fluid.D/c [discontinue] drains.(b)(6) 2014: ¿says he is too weak to stand.Is home from rehab.Incision strong.Reports weight loss.General appearance: no swelling, tenderness, or warmth and wound clean and dry.¿ (b)(6) 2015: hospitalization.Ct abdomen: ¿10 cm fluid collection seen in the antrum abdominal wall at the site of a previous abdominal wall hernia repair.I suspect that this represents some fluid possibly within the mesh of previous hernia repair.No bowel obstruction.¿ ¿admitted with witnessed syncope in the setting of hypotension, leukocytosis and bilateral pulmonary embolism.Wbc was 24.6.¿ (b)(6) 2015: discharge summary: ¿discharge diagnosis: deep venous thrombosis with pulmonary emboli, on coumadin therapy.Questionable abdominal mesh infection.Diarrhea.Chronic pain.Diabetes mellitus.Obstructive sleep apnea.An ultrasound-guided abdominal drainage had been done with 250 cc obtained from interventional radiologist.The patient was to continue on antibiotic therapy.Abdominal fluid cytology showed paucicellular specimen.No evidence of malignancy.It was recommended 2 weeks of antibiotic therapy.At that point, the patient¿s condition continued to gradually stabilize.Wbc count on discharge was 10.7.The patient¿s blood and urine cultures continued to show no growth, and he was cleared for discharge.The patient was subsequently discharged to local rehab center to follow up with dr.Reisner as directed.¿ (b)(6) 2017: ¿chief complaint of abdominal wall drainage.¿ ¿ extensive medical and surgical history with procedures all performed at outside hospitals, who presents today as a new patient for evaluation of abdominal wall drainage.¿ ¿referred here today, because he has noted some redness and itching on his abdominal wall superior to his umbilicus and also has noted drainage from the area.¿ ¿he states that the area of concern is at the previous incision site in the midline superior to the umbilicus.He noticed that his primary care doctor recently saw him on (b)(6) 2017, and incised open the area of the incision, a small area, which allowed the drainage to occur.The site has been draining since that time.The primary care doctor also started the patient on bactrim.¿ ¿it is unclear where the site that was opened by the primary care doctor tracks down to, and the source of the drainage is unclear at this time.Unknown if this is associated with any kind a chronic fluid collection associated with the mesh.Unclear if this is any evidence of any fistulous connection.Because the underlying anatomy is not clear would not recommend any kind of bedside incision prior to imaging to evaluate what is going on below the surface of the skin.¿ ¿in addition, the patient is on eliquis and is a bleeding risk, and because of that i would also not recommend any bedside procedure at this time.Plan will be for a ct scan of the abdomen and pelvis with iv and oral contrast.¿ explant preoperative complaints: (b)(6) 2017: ¿i have seen this patient in followup.He was seen by my partner, dr.Rossi, who ordered a ct scan of his abdomen and pelvis.I have reviewed his scan and looked his imaging myself and read his report.I have reviewed the history done by my partner.I re-evaluated the history and examined him.In summary, he has an infected piece of gore-tex mesh.The wound is currently closed and i can see evidence of where it was opened.He showed me pictures of purulent material and it is confirmed in my partners note that there was purulent material draining from it.On the scan, it looks obviously infected.The entire piece of mesh has been balled up into the hernia sac.This needs to be removed.¿ (b)(6) 2017: ¿status post rnygbp with incisional hernia followed my [sic] mesh repair now with mesh infection, lots of pain, intermittent purulent drainage.¿ ¿midline scar w/firm mass overlying hernia recurrence, no peritonitis.A/p: mesh infection.Plan: exlap, mesh explant, possible sbr [small bowel resection], possible mesh placement, possible wound vac.Pt not taking blood thinner.¿ ¿ has prior onlay ventral hernia repair, who is started draining purulent material around the skin above the mesh.His ct scan showed what was likely an obvious mesh infection.¿ explant procedure: open excision of a ventral hernia mesh including excision of a sinus tract.Explant date: (b)(6) 2017 [hospitalization (b)(6) 2017].¿a mid line incision was made over the prior scar site, we entered the pseudo capsule, there was a significant amount of purulent material.This was aspirated and sent off for culture.The wound was opened up in its entirety.The prolene sutures that were circumferentially placed prior were all excised.The mesh was removed.There was no obvious entry into the abdominal cavity.There was significant pseudocapsule in the midline.We debrided all grossly infected tissue and suture granuloma.Portion of the mesh was sent for culture.We irrigated with 3 l of normal saline with a pulsavac irrigator.We measured the wound to be 12 cm x 2 cm x 2 cm.We placed a negative pressure wound therapy.Black foam sponge in this position.The patient tolerated the procedure well¿ procedure findings state: ¿sinus tract from surface down to mesh, poorly encorporated [sic] but encapsulated with murky white fluid, multiple stitch granulomas.¿ additional procedure findings state: ¿1.Grossly infected gore-tex mesh.2.Extensive pseudo capsule.3.All prolene sutures removed.4.12 cm x 2 cm wide x 2 cm deep wound.¿ perioperative documentation.¿explants: hernia mesh.Site: abdomen.Comments: small portion sent for culture; the remaining piece discarded per surgeon request.¿ (b)(6) 2017: pathology report: wound culture: ¿few candida albicans, no anaerobes isolated.Gram stain dated (b)(6) 2017 states: rare fungal forms, many wbc¿s, no squamous epithelial cells.¿ (b)(6) 2017: discharge summary: ¿a wound vac was placed after the surgery in the midline of the patient's abdomen.The wound was measured to be 10 x 3 x 3 cm.The patient's post-operative course was unremarkable.He was discharged home with a home vac on (b)(6) 2017.¿ (b)(6) 2017: pathology: ¿source: foreign body, infected mesh aerobic, anaerobic with grams.Final report: few candida albican no anaerobes isolated.Gram stain: few fungal forms, many wbc¿s, no squamous epithelial cells.¿ relevant medical information: (b)(6) 2017: ¿examination of his abdomen is soft, nondistended, and nontender.I removed the vac.The midline incision is granulating well.It is yet to collection.We will remove the vac and allow the wound to epithelialize at this stage.I have recommended xeroform dressing.¿ (b)(6) 2017: ¿midline well healed, no remaining wound of any significance, no obvious hernia.¿ conclusion: 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.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿correct surface orientation is extremely important for gore® dualmesh® biomaterial to function as intended.One surface of the product has been textured for identification.This textured surface should be placed adjacent to those tissues where tissue ingrowth is desired.The other, smoother surface should be placed adjacent to those tissues where minimal tissue attachment is desired (i.E., serosal surfaces).¿ the gore® dualmesh® biomaterial instructions for use specifically warns: ¿improper positioning of the smoother, nontextured surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ ¿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.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.¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the material.Staged repairs should be considered when gore® dualmesh® biomaterial will be subjected to gross contamination or infection.¿ ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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 above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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