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| Model Number 1DLMCP03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)
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| Event Date 02/06/2014 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The initial reporter's complete address is (b)(6).It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2002 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions, removal of mesh, mesh failure, additional surgery, pain.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Added patient weight.Conclusion code remains unchanged.
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Manufacturer Narrative
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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) 2007: redington-fairview general hospital.(b)(6).Radiology-ct abdomen/pelvis w/ contrast.Impression: no acute abdominal or pelvic pathology status post hysterectomy and cholecystectomy.Slightly prominent remaining left ovary.Ultrasound may be of further assistance to clarify.Prior anterior pelvic wall hernia surgery with what may be slight prolapsing of the hernia mesh into a recurrent or residual hernia of small size containing mesenteric fat.(b)(6) 2007: redington-fairview general hospital.(b)(6).Consultation.Hpi: she had a partial hysterectomy, meaning one ovary was left in place and that was done a few years ago.Two to three months after that she developed a hernia and this was repaired using an open technique and using a mesh.The symptoms she is having now which is nausea but not so much vomiting and the abdominal pain and back pain was identical to what she had when she developed a hernia after the partial hysterectomy.Exam: abdomen: soft, diffusely tender with tenderness referred back to the lower midline surgical site.There is a lower midline surgical scar between the umbilicus and the symphysis pubis and there is a transverse scar on the right side starting at the upper third of the lower midline surgical site.The abdomen is otherwise nondistended.There is no hepatomegaly.There is no guarding.Bowel sounds are present and of normal character.Laboratory & x-ray data: i reviewed the ct scan with the radiologist and this demonstrates an obvious mesh repair that is intact more cephalad; however, more caudad [sic] there is another fascial defect and it appears that the mesh has migrated and is up into the subcutaneous fatty tissues with herniation of either bowel or mesentery.There is no evidence of obstruction with this herniation.Assessment: incarcerated recurrent incisional hernia that is highly likely contributing to her nausea, vomiting and abdominal pain.Although her metabolic derangements could partially explain some of these symptoms i think it is more likely that the incarcerated hernia is doing so since the symptoms are identical to what she had previously.Recommendations: laparoscopic incisional herniorrhaphy with mesh.(b)(6) 2007: redington-fairview general hospital.(b)(6).Discharge summary.Discharge plan: she will also be scheduled to see (b)(6) for repair of incisional hernia in two weeks¿ time.Hospital course: because of this and mild abdominal discomfort an abdominal ct scan was performed revealing an incisional hernia that was thought to be related to their symptoms.(b)(6) was consulted who agreed and discussed and planned the surgery with the patient.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 6/25/2007, including records for cholecystectomy, appendectomy, cesarean section, partial hysterectomy and previous hernia repair, were not provided.Hospital records for admission (b)(6) 2007 indicate patient was admitted for treatment for low blood sugar.Hospital records dated for admission (b)(6) 2007 indicate the patient ¿was admitted to the hospital and treated with iv glucose until her blood sugar stabilized.¿ ¿insulin was held and she was continued on metformin 1 g bid and started on glyburide 10 mg daily.This was eventually discontinued as she continued to have nausea and anorexia.Because of this and mild abdominal discomfort an abdominal ct scan was performed revealing an incisional hernia that was thought to be related to her symptoms.¿ records dictated (b)(6) 2007 state: ¿this is a 36-year old white female referred from dr.(b)(6) office with a recurrent incisional hernia.She was admitted to (b)(6) general hospital a few weeks ago with hypoglycemia (she is a known diabetic).At that time a cat scan was done that showed an incisional hernia in the lower abdomen with some omentum and bowel in it.She also had a mesh repair above and around the umbllicus.She had developed the hernia as the result of a cesarean section and had it repaired about lhree years ago in (b)(6).¿ operative records dated (b)(6) 2007 indicate the patient underwent laparoscopic repair of incisional hernia with mesh, lysis of adhesions (1 hour, 30 minutes) for recurrent incisional hernia.Operative findings: ¿extensive peritoneal adhesions.¿ ¿the patient ¿has had multiple abdominal operations.She has a mesh placed in the periumbilical area and another one in the lower abdomen.The lower abdomen mesh has failed.The mesh is now partially into the sac.There is small bowel adherent to the mesh.All adhesions ware lysed and then a new piece of mesh was placed.The lysis of adhesions was very tedious because there was a good deal of small bowel attached to the mesh.¿ operative records dated (b)(6) 2007 state: ¿the abdominal cavity was entered through the left upper quadrant utilizing 1he 5-mm visiport with the 5-mm scope in it.Once the visiport entered the abdominal cavity, the scope was removed and the abdomen insufflated with co2 lo a pressure of 15 mmhg.Once adequate pneumoperitoneum was obtained the scope was reinserted and the abdominal cavity inspected.Extensive adhesions were found in the midline from the supraumbilical area all the way down into the lower abdomen.¿ records dated (b)(6) 2007 continue: ¿2 other 5 mm trocars were inserted in the left side.Trocar sites were infiltrated with 0.5% marcaine.The adhesions were slowly and painstakingly lysed with scissors.Especially tedious was the dissection of the small bowel that was attached to the mesh.Once all the adhesions were cleared, we saw the mesh placed in the lower abdomen had failed and was being drawn into the hernial sac.¿ operative records dated (b)(6) 2007 state: ¿a 10 x 15 dualmesh plus was chosen for the repair.Another port, a 12-mm, was placed in the epigastrium.0 prolene sutures were placed in the four cardinal points of the mesh.The mesh was passed into the abdomen via the 12-mm port utilizing the suture passer, the sutures were drawn through the abdominal wall and tied, anchoring the mesh at the four points.¿ the operative records dated (b)(6) 2007 state: ¿with the 5-mm protack the mesh was then anchored all around the circumference of the mesh.Sutures of a prolene were then passed every 3 cm or so through the abdominal wall and into the mesh and then back out through the abdominal wall.Before the mesh was placed, the gas was allowed to escape and the intraabdominal pressure decreased to 10 mmhg.The mesh lay in a good position and we were happy with the results.¿ records dated (b)(6) 2007 state: ¿two other trocars were placed in the right side of the abdomen to work on the left side-of the mesh.All trocars were removed under direct vision and all the gas was allowed to escape.All the incisions were closed with staples.The counter incisions fur the sutures were approximated with dermabond, sterile dressing were applied.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmcp03/04803391) was used during the procedure.Records between 7/25/2007 and 2/6/2014 were not provided.Operative records dated (b)(6) 2014 indicate the patient underwent exploratory laparotomy, lysis of adhesions, explant of mesh x2.Mesh explant: dualmesh, ventralight st mesh.Operative records dated(b)(6) 2014 state: ¿a midline laparotomy incision was made with a 10-blade scalpel extending from the mid upper abdomen to several finger breadths above the pubic symphysis.This was carried down to the tissues using a combination of sharp dissection and bovie electrocautery.The fascia was encountered and carefully entered.The upper portion of the abdomen was entered just above the mesh placed.¿ operative records dated (b)(6) 2014 continue: ¿she had previously had two hernia repairs done via laparoscopic approach.She had a dual mesh.This was known prior to the procedure.Once entering the abdomen, any adhesions of the intestine to the anterior abdominal wall were taken down using metzenbaum scissors.Care was taken to not injure any bowel or make any serosal tears.The adhesions to the overlying mesh, the ventralight st, were minimal.¿ records dated (b)(6) 2014 state: ¿the sorbafix spiral tacks that had been used to affix the ventralight st mesh to the anterior abdominal wall were removed using a kocher clamp and the mesh peeled away from the anterior abdominal wall.Beneath this, there was a dual mesh that had been affixed to the anterior abdominal wall using protack titanium spiral tacks.This was a bit more difficult to remove from the anterior abdominal wall and required excision of portion of the anterior abdominal wall fascia.¿ the records dated(b)(6) 2014 state: ¿the tacks were tom out of the fascia also using a kocher clamp.Each mesh was fully excised from the anterior abdominal wall.These were passed off the table as specimen.The anterior abdominal wall was palpated in its entirety, and one additional protack was found and removed.Good hemostasis was noted.¿ pathology records for the(b)(6) 2014 procedure were not provided.Radiology records dated (b)(6) 2014 indicate the patient ¿underwent successful placement of a 10 french pigtail drain with additional side holes into a abdominal wall fluid collection using ultrasound and fluoroscopic guidance.¿ indication: ¿abdominal wall fluid collection after mesh repair.Suspicious for infection.¿ radiology records dated (b)(6) 2014 state: ¿abdominal wall abscess after mesh repair for abdominal wall hernia.The patient headache [sic] percutaneous drain placed on (b)(6) 2014.She initially did well.Her symptoms have worsened recently.There is a large residual collection and there is concern the drain is not working properly.¿ findings: ¿abdominal wall abscess drain change.Abdominal wall abscess drain placement.¿ the radiology records dated (b)(6) 2014 continue: ¿fluid was aspirated from each drain.130 cc of purulent fluid was removed from the biliary type drain.This drain was labeled #1.35 cc of per limit care was removed from the nephrostomy-type drain which was labeled #2.Findings.The fluoroscopic images reveal the abscess cavity outlined by contrast material.No fistula is seen.Some contrast is noted in the urinary bladder from recent ct scan.Impression: ¿successful exchange and upsizing of the existing abdominal wall pigtail drain for a new 14 french pigtail catheter with sideholes.Successful placement of an additional 14 french pigtail drain with sideholes.¿ operative records dated (b)(6) 2014 indicate the patient underwent incision and drainage abdominal wall subcutaneous abscess measuring 6 cm in depth, 11 cm in length and 4.2 cm in width with 16 cm of tunneling.Application of negative pressure wound vac.Patient ¿is a 42-year-old female who is one month status post abdominal hernia repair with component separation.¿ the operative records dated (b)(6) 2014 continue: ¿the patient's postoperative course was complicated by subcutaneous fluid collections, which have grown staph aureus in the past.These fluid collections had been drained by interventional radiology twice in the past.The most recent drainage was two days ago.Then she had a successful placement of another biliary tube into the subcutaneous left abdominal wall.¿ records dated (b)(6) 2014: ¿the patient presented to the emergency department this morning with complaints of increasing pain and erythema of the left abdomen.The patient with fevers and had chills.On physical examination, she had a significant amount of tenderness to palpation on the left abdomen near the drain sites.Rather than repeat another cat scan which would have been her fourth since her initial operation, i elected to proceed to the operating room for a surgical incision and drainage of this abscess with washout and a vac placement.¿ operative records dated (b)(6) 2014 state: ¿the two interventional radiology tubes, which have been placed into the abdomen removed without difficulty¿ ¿the skin was then incised with a 15-blade scalpel.The scalpel was used to dissect through the subcutaneous tissue to an obvious pocket of fluid collection which was not been drained by the drains placed by interventional radiology.This fluid pocket was quite extensive and tunneled 14 cm to the left and 2 cm to the right of the mid line.¿ the operative records dated (b)(6) 2014 continue: ¿wound cultures were sent aerobic and anaerobic to microbiology.I then used a 3 l bag of normal saline solution mixed to 50,000 units of bacitracin to irrigate the wound with a pulsed lavage.The underlying hernia repair and fascia were intact and there was no evidence of abdominal wall dehiscence.After the wound was irrigated, measurements were taken.Again the wound measured 11 cm in length by 6 cm in depth by 4.2 cm of width.The wound also tunneled 14 cm to the left of the midline and 2 cm to the right of the midline.A silver sponge wound vac was then placed into the patient's wound.This vac was connected to 125 mmhg, suction continuous.¿ consultation records dated (b)(6) 2014 state: ¿ms.(b)(6) is a 42.-year-old female who is approximately 2 months status post abdominal hernia repair with component separation.Her postoperative course has been complicated with subcutaneous fluid collections and abscesses which initially were drained with an interventional radiology procedure.After multiple attempts were made at draining the abscesses, she eventually underwent a second option which was an incision and drainage of the left-sided abscess with a vac placement.¿ records dated (b)(6) 2014 continue: the patient ¿has had intermittent pain since the vac was placed.Today she comp]ains of worsening pain around the top and right side of the wound vac.She complains of feeling hot and cold and adds that she has been taking her temperature at home which has been 98.4 and 98.6.She denies having an actual fever over the last few days.Her appetite is okay.She admits that her sugars have been out of control in the 300s-400s.She denies nausea and vomiting.She denies diarrhea.She states that she has been taking between 2 and 3 tablets of 2 mg dilaudids every 4-6 hours for pain.¿ records dated (b)(6) 2014 state: ¿the vac was removed.There is a foul-smelling odor emanating from the wound itself.The wound cavity was irrigated with a lidocaine-based normal saline solution, and i used a sterile glove to probe the wound with my finger.There were no additional cavities which were entered, and there was no evidence of an abscess fluid or purulent fluid emanating from the wound after probing it.There is a healthy red granulation base which is forming at the base and on either side of the wound.¿ the records dated (b)(6) 2014 state: ¿the patient is exquisitely tender to palpation at the superficial surface of the wound on the right side.I injected this area with the 1% lidocaine and saline solution.I then used a 15-blade scalpel to incise the soft tissue and the fat to assure that there was not a more superficial abscess pocket.This was negative, and there was no pocket of fluid encountered.The wound vac was replaced with the white foam as the deep layer in direct contact with the anterior rectus fascia, and the black sponge was used more superficially.The wound vac was connected to 125 mm of suction, and there was no leak.¿ records dated (b)(6) 2014 continue: ¿i see no evidence that there is a new abscess forming.The patient's pain is superficial and likely related to the vac itself.The foul smell from the wound is concerning, and the patient will see me back in 3 days for a repeat evaluation.She may need a return trip to the operating room for a repeat washout.Antibiotics were not given today as i do not see an identifiable fluid collection, and the wound is open and draining appropriately.I do not feel that antibiotics will offer any benefit at this time.The patient is agreeable with the plan, and she will see me back in the office in 3 days for a vac change and followup.¿ plastic surgery consult records dated (b)(6) 2014 for postoperative wound dehiscence with bleeding.¿43 y/o female pt here with a history of multiple midline hernias with most recent on (b)(6) 2014.Per pt has been having concern with increased bleeding, and localized abdominal pain from low anterior midline surgical incision that has been left open.She was scheduled for wound vac placement on (b)(6) 2014.¿ records dated (b)(6) 2014 continue: ¿she has no other complaints at this time.Abdomen: soft, non-tender; bowel sounds normal; no masses, no organomegaly, low midline.Low midline open wound dehiscence without purulence or active bleeding.¿ operative report dated (b)(6) 2014 indicates patient underwent debridement of skin and subcutaneous tissue associated with open wound of abdomen, placement of negative-pressure wound management device on abdominal wound 18 square cm in size.Patient ¿is a 43-year-old woman who had an abdominal hernia reconstruction with prosthetic mesh.Since that time, this wound has broken down and she has an open wound of the abdomen with exposed prosthetic mesh.She presents to the operating room today for debridement of the wound and placement of a negative-pressure wound management device.¿ records between 11/28/2014 and 11/12/2016 were not provided.History and physical note dated (b)(6) 2016 states: ¿45 y.O.Female with a h/o dm, obesity, and recurring periumbilical hernia now presenting with one day of worsening pain at her hernia site, with elevated lactate and ct imaging showing a significant, though non strangulated nor incarcerated ventral hernia.Regarding her hernia it is easily reducible on exam.With an otherwise benign abdominal examination, and as such there is no indication for surgical intervention urgently.She would certainly benefit from surgical intervention in the future, likely complicated in scope given her habitus and surgical history.¿ records dated (b)(6) 2016 state: ¿the patient has had significantly decreased po intake and appears dehydrated on exam, which may in part explain her elevated lactate given that she is normotensive and non tachycardic otherwise.She remains in moderate amount of pain in the ed, and does not live locally, and as such we will admit the patient to acs for pain control and iv hydration.¿ operative records dated (b)(6) 2016 indicate the patient underwent recurrent incisional hernia repair with mesh.This is ¿a 45-year-old woman who initially had a hysterectomy for endornetriosis and then developed an incisional hernia.Dr crookes had repaired her hernias back in 2005.She had a laparoscopic umbilical and a laparoscopic incisional hernia repair.Dr (b)(6) was following this patient when she was recently admitted to the hospital with abdominal pain.She had a recurrent hernia in the midiine just below the umbilicus.She states, between here, (b)(6), she has had at least 6 hernia operations for this.She remains morbidly obese, but did lose a significant amount of weight (50 pounds) in the last year and a half.She then presented to me and have offered her a repair of this hernia.¿ there is no mention of a gore device in the 12/6/2016 records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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 between (b)(6)2007 and (b)(6)2010 were not provided.(b)(6) 2010: (b)(6) hospital.(b)(6)md.Radiology-ct abdomen w/o contrast.Impression: fat containing ventral hernia seen at the midline of the pelvis.(b)(6) 2010: champlain valley physicians hospital.David hammack, md.Radiology-ct pelvis w/o contrast.Impression: evidence of prior ventral hernia repair.A small ventral hernia persists at the inferior aspect of the surgical mesh with no abnormal stranding of fat.No bowel is seen within the hernia.(b)(6) 2010: (b)(6) medical center.(b)(6) md.History & physical.Was referred for ventral incisional hernia which is recurrent.Patient states that she started having this abdominal pain in the lower abdomen from last 2 or 3 weeks.She had it for many months, but last couple of weeks, she has been getting worse.Patient¿s surgical history started with the hernia, started in 2005 when she had hysterectomy, the wound was complicated with infection which was treated in fletcher allen hospital and subsequently, she underwent laparoscopic ventral incisional hernia and umbilical hernia laparoscopically in fletcher allen in 2005 where the mesh was placed approximately 12 x 12 cm in size.It was tacked with protack metallic tackers.Patient recovered uneventfully and later on she developed hernia 2 years later for which she underwent surgery in fairview general hospital in maine, and she claims that she was living in maine at that time.Now she has moved back to plattsburgh area, and that¿s the reason for consultation up here.Past surgical history: [included} hernia repair with 10 x 12 and 10 x 15 cm of mesh.Physical examination: abdomen obese, soft, nondistended, nontender except in the lower abdominal tenderness which is vague at no specific point and mild tenderness in periumbilical region.No palpable real hernias in umbilical area.However, there is small questionable palpable defect.However, it¿s very difficult to examine due to patient¿s body habitus.No indication of incarceration or strangulation at this time.Midline wound is well healed from c-section ventrally.Assessment: 1) patient with recurrent ventral incisional hernia.2) i suspect that either hernia is causing her abdominal pain or other possibility is chronic adhesions and probably a lot of them from previous surgeries like hysterectomy, appendectomy, cholecystectomy, and 2 ventral incisional hernias.Plan: will schedule patient for ventral incisional recurrent hernia repair laparoscopically, possible open, possible lysis of adhesions.Risks, benefits, and alternatives were discussed with the patient in detail which she understands very clearly which include, but no limited to infection, bleeding, bowel injury.Ct is also reviewed which shows a small ventral recurrent incisional hernia.(b)(6) 2010: (b)(6) hospital medical center.(b)(6) md.Operative report.Procedure: diagnostic laparoscopy, extensive lysis of adhesions, and repair of abdominal wall weakness.Details of the procedure: ¿the patient is a 39-year-old female who has chronic lower abdominal pain which got worse over the last one week period of time and on the ct scan was found to have a small incisional ventral recurrent hernia at the bottom of the previous repair.The patient was taken to the operating room and preop antibiotics were administered.The patient was placed supine and venodynes were applied and the patient was induced and intubated without any difficulty.The abdomen was shaved, prepped and draped in a sterile fashion.Ioban was applied over the draped area.Right upper quadrant incision was made and using open technique, the peritoneal cavity was reached and hassan trocar was inserted.Gas was insufflated into the abdomen.Camera was inserted and multiple dense adhesions from previous surgeries (2 hernia repair) were identified.The left upper quadrant incision was then made and a 10-12 port was inserted in an area clear of adhesions.After this, two 5 mm ports were inserted in the left side of the abdomen under direct vision without any difficulty.Of not, most of her adhesions were identified in the midline, attached to the previous endo-tack and the previous mass.Extensive lysis of adhesions were performed with extreme care towards intestines.These were separated quite tediously from the scar tissue.Finally after freeing all of the adhesions, mesh repair was found to be intact.However, at the end lower end where the ct scan showed incisional hernia, this was inspected and no obvious defects were identified, however, there was small weakness in the lower part of the incision.Decision was made not to place the mesh in there for 2 reasons, one we possibly have to take out the mesh from the previous repair which appears to be intact, second there was no obvious holes or defects so decision was made to place a prolene suture.Prolene suture was placed in a figure of eight fashion i the lower part of the repair where the weakness was felt.Also, this area was extremely close to the urinary bladder, approximately 6 cm from the urinary bladder itself.After placing this suture through the stab incision on the midline which was performed under direct vision, small bowel was inspected one more time.No enterotomies or even serosal tears were identified.After this, a few adhesions in the pelvic area were also identified which were small bowel adhesions which were freed using scissors.Finally tow 5 mm ports were removed under direct vision without any active bleeding.The right upper quadrant port site was closed using heavy vicryl in a figure of eight stitch, interior of which was inspected one more time through the left upper quadrant port.Finally, left upper quadrant was removed and gas was desufflated from the abdomen.All port site skin incisions were closed using chromic and monocryl interrupted and running sutures.Local anesthesia as injected in all port sites.Sterile dressing and steri-strips were applied at the end of the procedure.The patient tolerated the procedure well and was extubated in the operating room and was transferred to the recovery room in a stable condition.Foley catheter was removed before the end of the procedure.Also of not, all the adhesions were lysed using endoshears.No cautery was used during the lysis of adhesions.Sponge, needle, and instrument counts were correct at the end of the procedure.Blood loss was less than 20 cc.¿ (b)(6) 2013: (b)(6) medical.(b)(6) md.Office visit.History of present illness: she continues to be very uncomfortable with abdominal discomfort and irregular bowel habits.She worries that she may have need for another ventral hernia repair.She has had over the past 4 years or so.Most recently this was done by dr.(b)(6) in 2010, before that at fletcher allen and apparently she had one somewhat remote past done in maine.Impression & recommendations: ventral hernia.Pain not entirely sure that her hernia explains her current pain.On recent ct scan the hernia was noted to contain fat only.(b)(6) 2013:(b)(6) md.History & physical.Hpi: recurrent hernia.She has had abdominal pain since (b)(6)2013.The pain is getting worse-more severe, worse with activity or lifting, such as laundry.Exam: abdomen: soft, obese, nd; no palpable masses or bulges; moderately tender to palpation midline lower abd, scar lower midline well healed.Studies reviewed: ct scan (b)(6) 2013: recurrent incisional hernia lower end of lower mesh.Assessment & plan: hernia, incisional/recurrent ventral.Ms.Cushing has a symptomatic incisional hernia and would benefit from repair.After a full discussion of the risks, benefits and alternatives to laparoscopic incisional hernia repair with mesh placement, i believe that ms.Cushing fulling understands the surgery as outlined and wishes to proceed.She had a small pe after surgery las year.I will dose preop heparin sq.We discussed making a small lower midline incision to remove the previous mesh.(b)(6) 2013: (b)(6) general surgery.Phone notes.Pt called with c/o vomiting, weakness, diarrhea x 2.She also c/o chills.Pt went to the ecc last week.Pt stated the dr.Pushed the hernia back in.Did a ct scan and that everything was normal.I spoke with dr.Mark she states that these sx have nothing to do with her hernia.(b)(6) 2013: (b)(6)general surgery.(b)(6) md.Operative report.Pre/postop diagnosis: recurrent incisional hernia.Procedure: laparoscopic recurrent incisional hernia repair with mesh.Complications: none.Procedure: ¿the patient was taken to the operating room and placed in the supine position.After general endotracheal tube anesthesia was achieved, the patient was positioned with arms tucked at both sides.Ulnar protection was utilized.The abdomen was then prepped and draped in the standard sterile fashion.An ioban drape was utilized.Quarter-percent bupivacaine with epinephrine was used as subcutaneous anesthesia at all port sites prior to port placement.In the left upper quadrant, a transverse 2-cm incision was made with an 11-blade scalpel.A 12-mm applied optiview access trocar was made with an 11-blade scalpel.A 12-mm applied optiview access trocar was used with a 10-mm, 0-degree laparoscope to gain access to the abdomen under direct vision.Gas tubing was attached and pneumoperitoneum achieved.A 5-mm, 30-degree laparoscope was introduced into the abdomen, and noting no injury, attention was turned to the midline.There were multiple loops of bowel and omentum adherent to the previously placed mesh.Two additional 5-mm trocars were placed under direct vision without incident.One was placed in the left mid-abdomen and one in the left lower quadrant.A careful lysis of adhesions was undertaken, separating bowel carefully from the mesh.Once complete, a hernia recurrence could be seen along the lower border of the mesh.The mesh was otherwise intact and lay flat against the abdominal wall.Once the abdominal wall was cleared of all fat and adhesions, the fascial defect was measured.The trocar from an 18 gauge spinal needle was inserted on all 4 sides of the fascial defect.This was measured on the anterior abdominal wall, and it was found to be 3 cm x 3 cm.A 15 cm x 20 cm piece of ventralight mesh with echo was then chosen.The mesh was then rolled and placed through the left upper quadrant port into the abdomen under direct vision.It was unrolled and positioned under the hernia.The tubing was brought out of a small stab in the skin centered over the hernia.The balloon was insufflated and the mesh positioned under the defect.It lay very nicely centered over the fascial defect and lay flat against the anterior abdominal wall.The mesh overlapped the inferior edge of the defect by 6 cm.A sorbafix spiral tacker was then used to place tacks every 1-2cm around the periphery of the mesh into the anterior abdominal wall.Five 31 prolene sutures were then placed equidistant around the periphery of the mesh through small stab incisions in the abdominal wall using a suture passing technique.Excellent hemostasis was noted at the end of the case.The tow 5-mm trocars were removed under direct vision with no bleeding noted.The final trocar was removed and pneumoperitoneum released.The 5 prolene sutures were cut at ski level on the outside of the abdominal wall.All skin incisions were closed using 4-0 monocryl in a running subcuticular fashion.Sponge and needle counts are correct at the end of the case.The abdomen was washed and dried and steri-strips and band-aids applied.Patient tolerated the procedure well and was taken to the recovery room, extubated and in stable condition.(b)(6) 2013: (b)(6)general surgery.(b)(6)md.Office visit.Hpi: she fell at home on her left side about 3 days after surgery.Her left side continues to be sore and uncomfortable, but slowly getting better.(b)(6) 2013: (b)(6) md.History & physical.Hpi: returns today with worsening left lower abdominal pain.She says it started getting worse 1-2 weeks ago.Doing housework makes it worse.Exam: abdomen: soft, obese, nd, moderately tender mid lower abdomen, particularly at the suture fixation sites.Nt over the left lateral port sites.No palpable bulge or defect, but exam is difficult due to body habitus.Assessment and plan: hernia, incisional/recurrent ventral.Abdominal pain.I will order a ct scan to evaluate for possible disruption of the mesh.(b)(6) 2013: [missing records: records for the ct scan showing ¿recurrent ventral hernia¿ were not provided.] (b)(6) 2013: (b)(6) md.History & physical.She returns after ct scan.This shows evidence of recurrent hernia.Assessment & plan: hernia, incisional/recurrent ventral.Has a symptomatic incisional hernia and would benefit from repair.This hernia is recurrent several times over, and now i believe the best approach is component separation and mesh underlay.I will refer her to dr.Marshall, in anticipation of a combined surgical effort torepair [sic] the hernia.(b)(6) 2013: (b)(6)general surgery.Phone note.Pt called stating she was vomiting 3 times today.Her pain level has increased more than her normal.Pt states the hernia is stuck out will not go back in.I advised she go to the ecc to be evaluated.(b)(6) 2013: (b)(6) surgery service (b)(6) office visit.Hpi: abdominal pain, lower abdomen.The patient states his [sic] has been present for a number of months.She feels as if something is catching at the lower part of her abdominal incision when she rises from a sitting or recumbent position.She has failed multiple attempts, 4, at herniorrhapy with mesh.Assessment and plan: ventral hernia.Coordinate her surgery with dr.Lisa mark to excise the existing mesh, repair the hernia, and close the abdomen with component separation and the use of acellular dermal matrix.(b)(6) 2014: (b)(6)general surgery.(b)(6) md.History & physical.Hpi: comes to the emergency room via ambulance because of abdominal pain.She tells me that she has been feeling worse over the past couple of days with intense abdominal pain thought to be due to an abdominal hernia and unresponsive to treatment with oral hydrocodone.She states she had her last bowel movement approximately 6 hours ago, does not think that she is passing any flatus and vomited x 1 this morning.She is scheduled to have large abdominal wall surgery with a combined effort by dr.Mark and dr.Marshall.This is due to failure of her previous hernia repair (actually i believe she has had three prior abdominal hernia repairs).In december, i expressed my concern to the surgeons that she had very poorly controlled diabetes and was likely to not do well with a large abdominal procedure until her sugars were better controlled.(b)(6) 2014: (b)(6) general surgery.(b)(6) md.Discharge summary.Discharge diagnoses: abdominal pain, known abdominal hernia with surgery planned in early (b)(6) 2014.Hospital course: came to the emergency room, abdominal pain.This has been a chronic problem recently and has stimulated plans for repair of her ventral hernia.This will be the third operative repair and will be a major procedure combining forces from general surgery and plastic surgery.Her belly exam in [sic] itself was not terribly remarkable and her plain films did not support any suggestion of either ileus or bowel obstruction.However, due to the severity of her pain, which is requiring intravenous narcotics, i admitted her to observation status.Her abdominal pain improved considerably and then 12 hours before discharge, she did not receive any pain medication.(b)(6) 2014: (b)(6) general surgery.(b)(6) md.Surgical h&p.Exam: abdomen: soft, obese, nd; moderately tender mid lower abdomen, particularly at the suture fixation sites.Nt over the left lateral port sites.No palpable bugle or defect, but exam is difficult due to body habitus.Assessment/plan: hernia, incisional/recurrent ventral.Has a symptomatic incisional hernia and would benefit from repair.After a full discussion of the risks, benefits and alternatives to laparoscopic incisional hernia repair with mesh placement, i believe that ms.Cushing fully understand the surgery as outlined and wishes to proceed.This hernia is recurrent several times over, and now i believe the best approach is component separation and mesh underlay.She has seen dr.Marshall, in anticipation of a combined surgical effort to repair the hernia.He is in agreement.I have discussed the risks, benefits, complications and alternatives of the patient¿s operative procedure.These were discussed in detail and included but were not limited to bleeding, infection, need for open surgery, need for further surgery, anesthetic complications and associated organ injury.Additional cardiopulmonary risks include but are not limited to cardiac events, deep vein thrombosis and pulmonary embolism, or need for reintubation.These were all discussed with the patient in detail, in plain language and the patient expressed understanding.(b)(6) 2014: (b)(6)general surgery.(b)(6) md.Operative report.Addendum: description of procedure: ¿dr.(b)(6) scrubbed into the case as the second piece of mesh was being excised and assisted with this portion of the procedure.¿ there is no mention of infection involving the gore device.(b)(6) 2014: (b)(6) general surgery.(b)(6) operative report.Pre/postop diagnosis: a large ventral and incisional recurrent hernia of the lower abdominal wall and loss of the abdominal wall domain.Operative procedures: excisional debridement of the skin, subcutaneous tissue, and muscle of the anterior abdominal wall and excision of hernia sac.Reconstruction of the abdominal wall muscle defect with a left rectus muscle advancement flap.Repair of the hernia with 20 cm in length by 15 cm in width acellular porcine matrix biological mesh.Complex closure of 20 cm of the anterior abdominal wall skin and subcutaneous tissue from the defect created by the general surgeon during the lysis of adhesions.Drains: 3 jp drains, size 19 french, round, were placed beneath the scarpa fascia.Complications: none.Indications: presented to my office as an outpatient with complaints of lower abdominal pain.The patient has undergone 4 hernia repairs in the past.Two of these repairs have been with a non-absorbable mesh.Onphysical [sic] examination the patient was felt to have a hernia defect at the lower midline incision.This defect was most prominent with valsalva maneuver.Ct scan of the abdomen and pelvis showed evidence of a hernia defect with a loop of small bowel herniating through the portion of the mesh.I discussed the case with the patient and dr.(b)(6) in detail.It was our recommendation that we procced to the operating room for surgical excision of the existing mesh, repair of the hernia, and a component separation with an acellular dermal matrix to complete the repair.The risks and benefits of this were discussed with the patient.The risks of surgery include bleeding, infection, wound dehiscence, hernia recurrence, subcutaneous abscess and seroma formation, and postoperative pain.The patient was agreeable to proceed and a signed consent was obtained.Operative detail: ¿the patient¿s name and consent were verified in the preoperative area.The patient was brought to the operating room.Dr.(b)(6)performed the majority of the lysis of adhesions.I assisted her with removal of the existing mesh.The fascia and muscle edges of the rectus abdominis were noted to be quite scarred and adherent to the mesh.These fascial edges were excised with a curved mayo scissors in order to have a clean bleeding margin.After the hernia sac and mesh were removed, skin flaps were raised about the left rectus abdominis muscle laterally to the external oblique.The perforators to the skin were maintained as much as possible.The external oblique fascia was incised with a 15 blade scalpel, and the avascular layer between the external oblique and internal oblique was entered.I used a right-angle clamp to dissect cranially and caudally, and incised the external oblique in a step-wise fashion.Careful attention was paid not to enter or incise the internal oblique.Meticulous hemostasis was obtained with the bovie cautery.Once the external oblique was incised 5 cm superior to the incision and inferiorly to the inguinal ligament, i was able to mobilize the rectus abdominis sufficiently to close the wound without needing the release of the right external oblique.We then took a piece of 20 x 15 cm matrix acellular porcine dermis to reinforce our hernia repair as an underlay.We advanced the flaps to the midline and used interrupted 0 pds sutures to fashion the adm as an underlay.We protected the bowels with a sterile towel and a malleable retractor, and used the interrupted pds sutures 5 cm in from the rectus abdominis muscle edges all the way around the perimeter of the adm.Once the biological mesh was sewn in, we advanced the flaps more into the midline and started to close the hernia defect and then centered the muscle flaps over the biological mesh.We used figure-of-8 interrupted 0 pds sutures for this.The patient¿s airway pressures were stable, and the abdomen did not feel tight to cause a compartment syndrome.The umbilicus was then tackeddown [sic] to the anterior fascia with a 2-0 vicryl suture x 2.The 19 french blade drains were placed x 3.Once was along the right rectus abdominis muscle.A second drain was placed x 3.One was along the right rectus abdominis muscle.A second drain was placed over the left rectus abdominis muscle, and the third drain was placed into the pocket which was undermined in order to release the external oblique laterally.We then used 300 ml of exparel and injected this into the anterior rectus sheath and the external oblique fascia.We closed scarpa fascia with 3-0 vicryl sutures.3-0 vicryl sutures were also used to close the deep dermis, and the skin was closed with skin staples.The patient tolerated the procedure well.There were no complications.She was transferred to the pacu i stable condition.¿ (b)(6) 2014: champlain valley physicians hospital medical center.[illegible signature].Procedure note.Procedure: dr.(b)(6): exploratory laparotomy, lysis of adhesions, explant of mesh x 2.Dr.(b)(6) excisional debridement skin/subcutaneous tissue/muscle anterior abd wall, l rectus muscle advancement flap, repair of hernia, complex abd wall closure.Preoperative/post-op diagnosis: recurrent incisional hernia.Wound classification: clean.Specimens: mesh explant: dualmesh and ventralight st.(b)(6) 2014: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2014 procedure was not provided.] (b)(6) 2014: (b)(6)general surgery.(b)(6)md.Office visit.Hpi: drains are putting out 25-35 ml per day.She is complaining of abdominal pain, starting yesterday.It is in her lower abdomen, on the lower side of her pannus, and towards the right.She has chills and sweats.She started having diarrhea also 2 days ago.Assessment and plan: hernia, incisional/recurrent ventral: drain rlq removed because output is low.Maintain other two drains.Abdominal pain, rlq: this is concerning, particularly with sweats and chills.Will order ct to rule out undrained or infected fluid collection.Continued on attachment - attachment: [st240878.Zip].
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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) 2007: (b)(6) medical associates.(b)(6) md.Office visit.While in hospital, found to have recurrent incisional hernia.Developed incisional hernia that was repaired with mesh about 2 or 3 years ago.As of late, has complained of pain in area, ct done showed recurrence of incision hernia with some mesenteric fat.In need of repair.Exam: abdomen; prominent.Several scars from previous surgeries.The main scar is mid line between umbilicus and symphysis.Also, there is a right-sided scar.Tender lower abdomen, mid line.Because of obesity, i cannot feel the hernia defect.The defect is demonstrated by ct scan.(b)(6) 2007: (b)(6) medical associates.(b)(6) md.Office visit.Abdomen looks good.All of the incisions healing well, no signs of infection.All staples were removed today.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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A1: updated patient identifier.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (1695, 1994, 3191: appropriate term/code not available for ¿mesh failure¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2007 through (b)(6) 2016 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6) 2007 through (b)(6) 2010; from (b)(6) 2010 through (b)(6) 2013 were not provided.Patient information: medical history: obesity, on (b)(6) 2007: 250 lbs; bmi 45.7, diabetes, hypercholesterolemia, gastroesophageal reflux disease.Prior surgical procedures: in 1995: cesarean section, cholecystectomy, appendectomy, in 2005: partial hysterectomy, in 2005: hernia repair.Implant preoperative complaints: on (b)(6) 2007: ct abdomen/pelvis: ¿no acute abdominal or pelvic pathology status post hysterectomy and cholecystectomy.Slightly prominent remaining left ovary.Ultrasound may be of further assistance to clarify.Prior anterior pelvic wall hernia surgery with what may be slight prolapsing of the hernia mesh into a recurrent or residual hernia of small size containing mesenteric fat.¿ on (b)(6) 2007: ¿she had a partial hysterectomy, meaning one ovary was left in place and that was done a few years ago.Two to three months after that she developed a hernia and this was repaired using an open technique and using a mesh.The symptoms she is having now which is nausea but not so much vomiting and the abdominal pain and back pain was identical to what she had when she developed a hernia after the partial hysterectomy.Exam: abdomen: soft, diffusely tender with tenderness referred back to the lower midline surgical site.There is a lower midline surgical scar between the umbilicus and the symphysis pubis and there is a transverse scar on the right side starting at the upper third of the lower midline surgical site.¿ ¿i reviewed the ct scan with the radiologist and this demonstrates an obvious mesh repair that is intact more cephalad; however, more caudad [sic] there is another fascial defect and it appears that the mesh has migrated and is up into the subcutaneous fatty tissues with herniation of either bowel or mesentery.There is no evidence of obstruction with this herniation.¿ ¿incarcerated recurrent incisional hernia that is highly likely contributing to her nausea, vomiting and abdominal pain.Although her metabolic derangements could partially explain some of these symptoms i think it is more likely that the incarcerated hernia is doing so since the symptoms are identical to what she had previously.¿ on (b)(6) 2007: ¿while in hospital, found to have recurrent incisional hernia.Developed incisional hernia that was repaired with mesh about 2 or 3 years ago.As of late, has complained of pain in area, ct done showed recurrence of incision hernia with some mesenteric fat.In need of repair.¿ ¿because of obesity, i cannot feel the hernia defect.The defect is demonstrated by ct scan.¿ on (b)(6) 2007: ¿this is a 36-year old white female referred from dr.(b)(6) office with a recurrent incisional hernia.She was admitted to (b)(6) general hospital a few weeks ago with hypoglycemia (she is a known diabetic).At that time a cat scan was done that showed an incisional hernia in the lower abdomen with some omentum and bowel in it.She also had a mesh repair above and around the umbilicus.She had developed the hernia as the result of a cesarean section and had it repaired about three years ago in (b)(6).¿ implant procedure: laparoscopic repair of incisional hernia with mesh, lysis of adhesions (1 hour, 30 minutes) for recurrent incisional hernia.Implant: gore® dualmesh® plus biomaterial (04803391/1dlmcp03, 10 x 15 cm, oval).Implant date: (b)(6) 2007.Description of hernia being treated: ¿the abdominal cavity was entered through the left upper quadrant utilizing the 5-mm visiport with the 5-mm scope in it.Once the visiport entered the abdominal cavity, the scope was removed and the abdomen insufflated with co2 to a pressure of 15 mmhg.Once adequate pneumoperitoneum was obtained the scope was reinserted and the abdominal cavity inspected.Extensive adhesions were found in the midline from the supraumbilical area all the way down into the lower abdomen.2 other 5 mm trocars were inserted in the left side.Trocar sites were infiltrated with 0.5% marcaine.The adhesions were slowly and painstakingly lysed with scissors.Especially tedious was the dissection of the small bowel that was attached to the mesh.Once all the adhesions were cleared, we saw the mesh placed in the lower abdomen had failed and was being drawn into the hernial sac.¿ implant size and fixation: ¿a 10 x 15 dualmesh plus was chosen for the repair.Another port, a 12-mm, was placed in the epigastrium.0 prolene sutures were placed in the four cardinal points of the mesh.The mesh was passed into the abdomen via the 12-mm port utilizing the suture passer, the sutures were drawn through the abdominal wall and tied, anchoring the mesh at the four points.With the 5-mm protack the mesh was then anchored all around the circumference of the mesh.Sutures of a prolene were then passed every 3 cm or so through the abdominal wall and into the mesh and then back out through the abdominal wall.Before the mesh was placed, the gas was allowed to escape and the intraabdominal pressure decreased to 10mmhg.The mesh lay in a good position and we were happy with the results.Two other trocars were placed in the right side of the abdomen to work on the left side-of the mesh.All trocars were removed under direct vision and all the gas was allowed to escape.All the incisions were closed with staples.The counter incisions fur the sutures were approximated with dermabond, sterile dressing were applied.¿ no post-operative records were provided.Relevant medical information: on (b)(6) 2007: ¿abdomen looks good.All of the incisions healing well, no signs of infection.All staples were removed today.¿ on (b)(6) 2010: ct abdomen/pelvis: ¿fat containing ventral hernia seen at the midline of the pelvis.¿ on (b)(6) 2010: ct pelvis: ¿evidence of prior ventral hernia repair.A small ventral hernia persists at the inferior aspect of the surgical mesh with no abnormal stranding of fat.No bowel is seen within the hernia.¿ on (b)(6) 2010: ¿was referred for ventral incisional hernia which is recurrent.Patient states that she started having this abdominal pain in the lower abdomen from last 2 or 3 weeks.She had it for many months, but last couple of weeks, she has been getting worse.Patient¿s surgical history started with the hernia, started in 2005 when she had hysterectomy, the wound was complicated with infection which was treated in fletcher allen hospital and subsequently, she underwent laparoscopic ventral incisional hernia and umbilical hernia laparoscopically in (b)(6) in 2005 where the mesh was placed approximately 12 x 12 cm in size.It was tacked with protack metallic tackers.Patient recovered uneventfully and later on she developed hernia 2 years later for which she underwent surgery in (b)(6) hospital in (b)(6), and she claims that she was living in (b)(6) at that time.Now she has moved back to (b)(6) area, and that¿s the reason for consultation up here.¿ ¿physical examination: abdomen obese, soft, nondistended, nontender except in the lower abdominal tenderness which is vague at no specific point and mild tenderness in periumbilical region.No palpable real hernias in umbilical area.However, there is small questionable palpable defect.However, it¿s very difficult to examine due to patient¿s body habitus.No indication of incarceration or strangulation at this time.Midline wound is well healed from c-section ventrally.¿ ¿assessment: 1) patient with recurrent ventral incisional hernia.2) i suspect that either hernia is causing her abdominal pain or other possibility is chronic adhesions and probably a lot of them from previous surgeries like hysterectomy, appendectomy, cholecystectomy, and 2 ventral incisional hernias.¿ on (b)(6) 2010: diagnostic laparoscopy, extensive lysis of adhesions, and repair of abdominal wall weakness. ¿the patient is a 39-year-old female who has chronic lower abdominal pain which got worse over the last one week period of time and on the ct scan was found to have a small incisional ventral recurrent hernia at the bottom of the previous repair.¿ ¿right upper quadrant incision was made and using open technique, the peritoneal cavity was reached and hassan trocar was inserted.Gas was insufflated into the abdomen.Camera was inserted and multiple dense adhesions from previous surgeries (2 hernia repair) were identified.The left upper quadrant incision was then made and a 10-12 port was inserted in an area clear of adhesions.After this, two 5 mm ports were inserted in the left side of the abdomen under direct vision without any difficulty.Of not [sic], most of her adhesions were identified in the midline, attached to the previous endo-tack and the previous mass [sic].Extensive lysis of adhesions were performed with extreme care towards intestines.These were separated quite tediously from the scar tissue.Finally after freeing all of the adhesions, mesh repair was found to be intact.However, at the end lower end where the ct scan showed incisional hernia, this was inspected and no obvious defects were identified, however, there was small weakness in the lower part of the incision.Decision was made not to place the mesh in there for 2 reasons, one we possibly have to take out the mesh from the previous repair which appears to be intact, second there was no obvious holes or defects so decision was made to place a prolene suture.Prolene suture was placed in a figure of eight fashion i the lower part of the repair where the weakness was felt.Also, this area was extremely close to the urinary bladder, approximately 6 cm from the urinary bladder itself.After placing this suture through the stab incision on the midline which was performed under direct vision, small bowel was inspected one more time.No enterotomies or even serosal tears were identified.After this, a few adhesions in the pelvic area were also identified which were small bowel adhesions which were freed using scissors.Finally tow 5 mm ports were removed under direct vision without any active bleeding.The right upper quadrant port site was closed using heavy vicryl in a figure of eight stitch, interior of which was inspected one more time through the left upper quadrant port.Finally, left upper quadrant was removed and gas was desufflated from the abdomen.All port site skin incisions were closed using chromic and monocryl interrupted and running sutures.¿ on (b)(6) 13: ¿she continues to be very uncomfortable with abdominal discomfort and irregular bowel habits.She worries that she may have need for another ventral hernia repair.She has had over the past 4 years or so.Most recently this was done by dr.(b)(6) in 2010, before that at (b)(6) and apparently she had one somewhat remote past done in (b)(6).¿ ¿ventral hernia.Pain not entirely sure that her hernia explains her current pain.On recent ct scan the hernia was noted to contain fat only.¿ on (b)(6) 2013: ¿recurrent hernia.She has had abdominal pain since (b)(6) 2013.The pain is getting worse-more severe, worse with activity or lifting, such as laundry.Exam: abdomen: soft, obese, nd; no palpable masses or bulges; moderately tender to palpation midline lower abd, scar lower midline well healed.Studies reviewed: ct scan.On (b)(6) 2013: recurrent incisional hernia lower end of lower mesh.Assessment & plan: hernia, incisional/recurrent ventral.[the patient] has a symptomatic incisional hernia and would benefit from repair.After a full discussion of the risks, benefits and alternatives to laparoscopic incisional hernia repair with mesh placement, i believe that [the patient] fulling [sic] understands the surgery as outlined and wishes to proceed.She had a small pe after surgery las [sic] year.I will dose preop heparin sq.We discussed making a small lower midline incision to remove the previous mesh.¿ on (b)(6) 2013: ¿pt [patient] called with c/o [complaining of] vomiting, weakness, diarrhea x 2.She also c/o chills.Pt went to the ecc [unknown facility] last week.Pt stated the dr.Pushed the hernia back in.Did a ct scan and that everything was normal.I spoke with dr.(b)(6) she states that these sx [symptoms] have nothing to do with her hernia.¿ on (b)(6) 13: laparoscopic recurrent incisional hernia repair with mesh. ¿a careful lysis of adhesions was undertaken, separating bowel carefully from the mesh.Once complete, a hernia recurrence could be seen along the lower border of the mesh.The mesh was otherwise intact and lay flat against the abdominal wall.Once the abdominal wall was cleared of all fat and adhesions, the fascial defect was measured.The trocar from an 18 gauge spinal needle was inserted on all 4 sides of the fascial defect.This was measured on the anterior abdominal wall, and it was found to be 3 cm x 3 cm.A 15 cm x 20 cm piece of ventralight mesh with echo was then chosen.The mesh was then rolled and placed through the left upper quadrant port into the abdomen under direct vision.It was unrolled and positioned under the hernia.The tubing was brought out of a small stab in the skin centered over the hernia.The balloon was insufflated and the mesh positioned under the defect.It lay very nicely centered over the fascial defect and lay flat against the anterior abdominal wall.The mesh overlapped the inferior edge of the defect by 6 cm.A sorbafix spiral tacker was then used to place tacks every 1-2cm around the periphery of the mesh into the anterior abdominal wall.Five 31 prolene sutures were then placed equidistant around the periphery of the mesh through small stab incisions in the abdominal wall using a suture passing technique.Excellent hemostasis was noted at the end of the case.The tow 5-mm trocars were removed under direct vision with no bleeding noted.The final trocar was removed and pneumoperitoneum released.The 5 prolene sutures were cut at ski [sic] level on the outside of the abdominal wall.All skin incisions were closed using 4-0 monocryl in a running subcuticular fashion.¿ records indicate a non-gore device was implanted during the (b)(6) 2013 procedure.On (b)(6) 2013: ¿she fell at home on her left side about 3 days after surgery.Her left side continues to be sore and uncomfortable, but slowly getting better.¿ on (b)(6) 2013: ¿returns today with worsening left lower abdominal pain.She says it started getting worse 1-2 weeks ago.Doing housework makes it worse.¿ on (b)(6) 2013: ¿she returns after ct scan.This shows evidence of recurrent hernia.¿ ¿hernia, incisional/recurrent ventral.Has a symptomatic incisional hernia and would benefit from repair.This hernia is recurrent several times over, and now i believe the best approach is component separation and mesh underlay.I will refer her to dr.(b)(6), in anticipation of a combined surgical effort to repair [sic] the hernia.¿ on (b)(6) 2013: ¿pt called stating she was vomiting 3 times today.Her pain level has increased more than her normal.Pt states the hernia is stuck out will not go back in.I advised she go to the ecc to be evaluated.¿ on (b)(6) 2013: ¿abdominal pain, lower abdomen.The patient states his [sic] has been present for a number of months.She feels as if something is catching at the lower part of her abdominal incision when she rises from a sitting or recumbent position.She has failed multiple attempts, 4, at herniorrhaphy with mesh.¿ ¿coordinate her surgery with dr.(b)(6) to excise the existing mesh, repair the hernia, and close the abdomen with component separation and the use of acellular dermal matrix.¿ explant preoperative complaints: on (b)(6) 2014: ¿comes to the emergency room via ambulance because of abdominal pain.She tells me that she has been feeling worse over the past couple of days with intense abdominal pain thought to be due to an abdominal hernia and unresponsive to treatment with oral hydrocodone.She states she had her last bowel movement approximately 6 hours ago, does not think that she is passing any flatus and vomited x 1 this morning.She is scheduled to have large abdominal wall surgery with a combined effort by dr.(b)(6) and dr.(b)(6).This is due to failure of her previous hernia repair (actually i believe she has had three prior abdominal hernia repairs).In (b)(6), i expressed my concern to the surgeons that she had very poorly controlled diabetes and was likely to not do well with a large abdominal procedure until her sugars were better controlled.¿ on (b)(6) 2014: discharge summary: ¿came to the emergency room, abdominal pain.This has been a chronic problem recently and has stimulated plans for repair of her ventral hernia.This will be the third operative repair and will be a major procedure combining forces from general surgery and plastic surgery.Her belly exam in __ [sic] itself was not terribly remarkable and her plain films did not support any suggestion of either ileus or bowel obstruction.However, due to the severity of her pain, which is requiring intravenous narcotics, i admitted her to observation status.Her abdominal pain improved considerably and then 12 hours before discharge, she did not receive any pain medication.¿ on (b)(6) 2014: ¿hernia, incisional/recurrent ventral.Has a symptomatic incisional hernia and would benefit from repair.After a full discussion of the risks, benefits and alternatives to laparoscopic incisional hernia repair with mesh placement, i believe that [the patient] fully understand [sic] the surgery as outlined and wishes to proceed.This hernia is recurrent several times over, and now i believe the best approach is component separation and mesh underlay.She has seen dr.(b)(6), in anticipation of a combined surgical effort to repair the hernia.He is in agreement.¿ explant procedure: exploratory laparotomy, lysis of adhesions, explant of mesh x2 by dr.(b)(6).Excisional debridement of the skin, subcutaneous tissue, and muscle of the anterior abdominal wall and excision of hernia sac.Reconstruction of the abdominal wall muscle defect with a left rectus muscle advancement flap.Repair of the hernia with 20 cm in length by 15 cm in width acellular porcine matrix biological mesh.Complex closure of 20 cm of the anterior abdominal wall skin and subcutaneous tissue from the defect created by the general surgeon during the lysis of adhesions by dr.(b)(6).Explant date: (b)(6) 2014.Dr.(b)(6): ¿a midline laparotomy incision was made with a 10-blade scalpel extending from the mid upper abdomen to several "fingerbreadths" above the pubic symphysis.This was carried down to the tissues using a combination of sharp dissection and bovie electrocautery.The fascia was encountered and carefully entered.The upper portion of the abdomen was entered just above the mesh placed.She had previously had two hernia repairs done via laparoscopic approach.She had a dual mesh.This was known prior to the procedure.Once entering the abdomen, any adhesions of the intestine to the anterior abdominal wall were taken down using metzenbaum scissors.Care was taken to not injure any bowel or make any serosal tears.The adhesions to the overlying mesh, the ventralight st, were minimal.The sorbafix spiral tacks that had been used to affix the ventralight st mesh to the anterior abdominal wall were removed using a kocher clamp and the mesh peeled away from the anterior abdominal wall.Beneath this, there was a dual mesh that had been affixed to the anterior abdominal wall using protack titanium spiral tacks.This was a bit more difficult to remove from the anterior abdominal wall and required excision of portion of the anterior abdominal wall fascia.The tacks were torn out of the fascia also using a kocher clamp.Each mesh was fully excised from the anterior abdominal wall.These were passed off the table as specimen.The anterior abdominal wall was palpated in its entirety, and one additional protack was found and removed.Good hemostasis was noted.Dr.(b)(6) scrubbed into the case as the second piece of mesh was being excised and assisted with this portion of the procedure.¿ dr.(b)(6): ¿i assisted her with removal of the existing mesh.The fascia and muscle edges of the rectus abdominis were noted to be quite scarred and adherent to the mesh.These fascial edges were excised with a curved mayo scissors in order to have a clean bleeding margin.After the hernia sac and mesh were removed, skin flaps were raised about the left rectus abdominis muscle laterally to the external oblique.The perforators to the skin were maintained as much as possible.The external oblique fascia was incised with a 15 blade scalpel, and the avascular layer between the external oblique and internal oblique was entered.I used a right-angle clamp to dissect cranially and caudally, and incised the external oblique in a step-wise fashion.Careful attention was paid not to enter or incise the internal oblique.Meticulous hemostasis was obtained with the bovie cautery.Once the external oblique was incised 5 cm superior to the incision and inferiorly to the inguinal ligament, i was able to mobilize the rectus abdominis sufficiently to close the wound without needing the release of the right external oblique.We then took a piece of 20 x 15 cm matrix acellular porcine dermis to reinforce our hernia repair as an underlay.We advanced the flaps to the midline and used interrupted 0 pds sutures to fashion the adm as an underlay.We protected the bowels with a sterile towel and a malleable retractor, and used the interrupted pds sutures 5cm in from the rectus abdominis muscle edges all the way around the perimeter of the adm.Once the biological mesh was sewn in, we advanced the flaps more into the midline and started to close the hernia defect and then centered the muscle flaps over the biological mesh.We used figure-of-8 interrupted 0 pds sutures for this.¿ ¿specimens: mesh explant: dualmesh and ventralight st.¿ conclusions: it should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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 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 04803391.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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