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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 1998: (b)(6) hospital.Surgeon: dr.(b)(6).Laparoscopic cholecystectomy.Anesthesia record.Weight 257 pounds.Preoperative comments: ¿pt is very obese.¿ [operative report not provided.] implant preoperative complaints: (b)(6) 2005: (b)(6) surgical associates.(b)(6), md.Admission history & physical.Chief complain: lower abdominal incisional hernia.History of present illness: ¿self-referral.Two previous cesarean sections.She has developed an incisional hernia.This is growing in size, not getting any smaller.She is having more and more pain.She wants to have surgery for this to have it fixed so she does not have any risk of bowel injury.She drinks socially.Medications: lotrel, multivitamin and tylenol.Short of breath due to her weight.Review of systems.Cardiovascular: ¿she says she is short of breath because of her weight.¿ physical exam: abdomen: ¿obese, she has a midline incision from her umbilicus to her symphysis pubis.She has a soft ball sized subumbilical mass which is palpable.It is not easily reducible.She has a minimal amount of pain.She has no peritoneal signs.¿ impression: 1.Incisional hernia.2.Mild obesity.Plan: we will proceed with laparoscopic, possibly open hernia repair with mesh.¿ (b)(6) 2005: (b)(6) hospital.(b)(6), md.Clinical history:¿ patient is a 43-year-old female who saw me in my office two weeks ago complaining of a large incisional hernia.This (sic) says this is more and more painful but she denied any nausea, vomiting, fever, or chills.She says the fullness is just below her umbilicus.Because it is becoming more symptomatic she wanted to have this repaired.¿ (b)(6) 2005: (b)(6) hospital.(b)(6), rn.Admission assessment: weight 267 pounds.Implant procedure: laparoscopic incisional hernia repair with gore dual mesh plus which measured 10 cm by 19 cm.Implant: gore® dualmesh® plus biomaterial, 1dlmcp03/03684422, 10cm x 15cm x 1mm thick, oval) implant date: (b)(6) 2005 (hospitalization (b)(6) 2005).(b)(6) 2005: (b)(6) hospital.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: minimal.Wound classification: ¿clean¿.Procedure: ¿following signing of consent and induction of general endotracheal anesthesia, foley catheter and scds were placed.A 5 mm trocar in the left upper quadrant was placed.Pneumoperitoneum to 15 mmhg was achieved without difficulty.A 12 mm bladed trocar was placed in the epigastrium and another 5 mm trocar was placed in the left midaxillary line and another is in the right midaxillary line, approximately lateral to the umbilicus.There were several adhesions to the incisional hernia.These were taken down sharply.There was no evidence of injury to the bowel.Then a 19 x 10 cm piece of dualmesh was placed intra-abdominally after placing two prolene sutures and opposing the ends and six other #0 gore-tex sutures.The two prolene sutures were brought up through separate stab wounds opposite ends of the incision, north to south orientation.The mesh was then unrolled.The other sutures were pulled up in a clockwise fashion equal distance from the center.These were tied as the abdomen was being deflated.Laparoscopic tacker was used to help secure the mesh around its periphery.Pneumoperitoneum was released under direct visualization.#4-0 monocryl in a subcuticular fashion and was used to close the skin.The patient tolerated the procedure well and was extubated on the table.¿ (b)(6) 2005: (b)(6) hospital.Implant sticker: ¿gore dualmesh® plus biomaterial.¿ ref catalogue number: 1dlmcp03.Lot batch code: 03684422.Manufacturer: w.L.Gore & associates.Ah1382-ml1.(b)(6) 2005: (b)(6) hospital.(b)(6), md.Discharge summary.Primary diagnoses: incisional hernia, mild obesity, and hypertension.Hospital course: ¿the patient was admitted to the hospital on (b)(6) 2005.She underwent laparoscopic assisted incisional hernia repair.For specifics on the procedure please see the dictation from (b)(6) 2005.Postoperatively she has done exceedingly well.She has had minimal nausea.On the first day we advanced her diet to full liquids.We hep-locked her iv.We started her on oral medications.Her foley catheter was removed.She was encouraged to ambulate.However, that night she developed some mild nausea and some flushing.Her pain medication was changed over to vicodin.She has done very well with this pain medication.Her bowels have been a little bit slow but she took some prune juice and these have worked.Her diet was advanced to soft diet on (b)(6) 2005 and she has been tolerating diet ever since that time.Incisions are clean, dry, intact.Patient is to follow-up with me in two weeks.Medications include allegra-d, vicodin, and toradol.She is to call for any nausea, vomiting, fevers, chills, worsening abdominal pain, redness, or swelling.¿ relevant medical information: (b)(6) 2005: (b)(6) surgical associates.(b)(6), md.Office visit.¿(b)(6) comes in today complaining of pain just below her umbilicus.During the winter she was pulling down a garage door and she felt a pop and all of the sudden pain just below her belly button.She had had a previous laparoscopic ventral hernia repair.She is concerned that she has reherniated through this area.¿ objective: ¿there is no evidence of ecchymosis.There is a small seroma which has hardened which was there previously but just inferior to this there is a tender small gum ball sized lump.This is not reducible.¿ ¿impression: possible recurrence of hernia.Plan: because of her size it is difficult to determine whether this is seroma or whether that is a part of the mesh that pulled free.Therefore we will do an ultrasound of the abdominal wall to evaluate for recurrent hernia.If this shows hernia then we will schedule her for repeat hernia repair.If this is negligible then we would plan to do a ct scan of her abdomen to rule out hernia.¿ (b)(6) 2005: avera-sacred heart health services.(b)(6).Radiology.Ct abdomen and pelvis with contrast.¿history: umbilical pain/evaluation for hernia.Impression: abdomen: evidence of prior midline hernia repair in the mid lower abdomen.Midline herniation of a loop of bowel at the level of the pelvis.Pelvis: negative exam minimal diverticulosis.¿ (b)(6) 2005: avera-sacred heart health services.Frank messner.Radiology.Ultrasound abdominal wall.¿history: umbilical pain/evaluation for hernia.Impression: 4 cm midline herniation projecting 4 cm below the umbilicus.¿ (b)(6) 2005: yankton surgical associates.(b)(6), md.History and physical.¿chief complaint: recent recurrence of infraumbilical pain.History of present illness: 3 months ago underwent laparoscopic incisional hernia repair.She has done very well with this.However she was shoveling some snow and pulling down a garage door during this last snow storm and she felt a tugging and a pulling and then a modest amount of pain.She says this feels similar to the previous hernia she has had but just in a different location.¿ ¿physical exam: abdomen: soft.She does have a fullness infraumbilically.She has multiple previous scars from previous laparoscopic surgery.She also has a fullness infraumbilically which is mildly tender.This is not reducible.There is no erythema.Ultrasound was performed which showed a 4.5 cm mass showing strong shadows.Ct scan of the abdomen and pelvis shows incisional hernia.No other intrabdominal pathology is noted.Impression: new ventral hernia.Plan: proceed with laparoscopic assisted hernia repair.¿ (b)(6) 2006 ¿ (b)(6) 2006: admission to (b)(6) hospital.(b)(6) 2006: (b)(6), md.Clinical history: ¿patient is a 43-year-old female who in (b)(6) underwent laparoscopic incisional hernia.She said during the snowstorm in the middle of november she was shoveling snow and she reached up to close the garage and she felt a tug of pull and all sudden a mass appeared at her lower umbilicus.This is below where her previous hernia had been prior.On ultrasound did not show any signs of hernia; however ct scan showed questionable bowel loops above the fascia.This was not reducible but her pain was well controlled.Therefore we elected to proceed with repeat laparoscopic, possible open incisional hernia repair with mesh.¿ wound classification: ¿#1 [clean]¿.(b)(6) 2006: (b)(6), md.Operative report.Lysis of adhesions, exploration of the abdominal wall, and primary repair of incisional hernia.Laparoscopic converted to open hernia repair.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: small recurrent incisional hernia.Evidence of intramuscular hematoma.No injury to the bowel when converted to open.¿we began to take down adhesions off the anterior abdominal wall.The scissors were placed in the epigastric port.There was a momentary loss of control of the scissors and the tips went into the peritoneal cavity.We were unable to see if there was injury.Therefore at that time we elected to convert to an open to rule out any bowel injury.A vertical midline incision from just above her umbilicus to her xiphoid process was made.We dissected down into the abdomen.The colon was brought out.We could see a small expanding hematoma approximately a centimeter from the colon in the mid transverse.This had stopped with a mild amount of compression.The small bowel was eviscerated through the defect.We ran the small bowel proximally and distally.We did see a meckel's diverticulum approximately 2 feet from the terminal ileum; however there was no injury to the bowel.There was no evidence of expanding hematomas of the retroperitoneum.No evidence of bile leakage.We irrigated with a liter of fluids, still no evidence of any further disastrous injury.The bowel was replaced back in the abdomen.We continued to irrigate.Still no evidence of any leakage of bile or stool.The hematoma had become quiet.The colon was placed back in the abdomen.On further examination of the anterior abdominal wall the nodule that the patient felt was probably a hematoma when one of the sutures broke.The mesh was in place.This had been pulled up into the previous hernia.We then decided instead of putting more mesh in, as we had anticipated doing, below the umbilicus because there was no defect and because of the concern of contamination of the intraperitoneal cavity we primary closed the defect with running #1 pds.Staples were placed on the skin.#0 vicryl on a ur-6 needle was used to close the fascia at the 10 mm trocar sire.Staples were placed on the skin.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.¿ (b)(6) 2006: (b)(6) hospital.(b)(6), md.Discharge summary.¿hospital course: postoperatively the patient had a modest amount of pain.She also had low urine output.Her white blood cell count climbed to 14,500.She was started on antibiotics.She was treated with iv and oral pain medications.She was started on liquids and did not tolerate this very well on the first postoperative day.The second postoperative day she started passing flatus, did not pass any stool.Her symptoms gradually improved.During her hospital course she has had no significant untoward events so she has had no significant setbacks.Yesterday she was started on liquids.She was continued on full liquids and advanced to soft diet yesterday.She has been switched over to oral pain medications.She was started on some nebulizer treatments for persistent chest pain.Her chest x-ray did not show any signs for pneumonia.¿ medications: vicodin, toradol, lotrel.Follow-up for staple removal.¿ explant preoperative complaints: (b)(6) 2006: (b)(6) hospital.(b)(6), md.History and physical.¿chief complaint: infraumbilical pain and reducible right flank mass.Medications: lotrel, multivitamins and tylenol.She drinks socially, does not smoke.History of present illness: patient is a 44 -year -old female who is well known to me who has had multiple hernia surgeries in the past.She states that just a month ago she started developing a reducible right sided golf ball sized mass.She says that this is minimally uncomfortable, however more importantly she has developed an infraumbilical painful bulge.She says it is exquisitely tender.She did get nauseated and she vomited once this morning.She says it hurts down into the groins bilaterally.She says that it does reduce on its own.She says there is a significant amount of tugging and pulling.She has had hernias to this area.We did do surgery on her in (b)(6), however there was no hernia through this area.She says that these symptoms are new since then.¿ ¿physical exam: abdomen: mildly obese.She has a vertical midline incision from her xiphoid down to her umbilicus.She has an old scar with a painful bulge from her umbilicus down to her symphysis pubis.She also has a fullness in the right paramedian area just lateral to the umbilicus.These are not reducible and they are tender.¿ ¿impression: 1.Probable recurrent incisional hernias through the midline incision and subumbilically.2.Possible spigelian hernia.3.Obesity.4.Hypertension.5.Mild anxiety.Plan: would proceed with open incisional hernia, possible hernia repair with mesh.We have been through the surgeries before.She realizes there is potential risk for infection, recurrence, pain control issues, dvts, urinary tract infections, pneumonias.The patient understands the potential risks and wants to proceed.¿ (b)(6) 2006: (b)(6) hospital.(b)(6), md.Clinical history: ¿patient is a 44-year-old female who is well known to me who had two previous incisional hernias.These have repaired.Patient came to the office today complaining of severe subumbilical pain.She had experienced this the last four days.The pain was so excruciating she vomited earlier today.She denied any blood in her stool.She has been constipated as well.On examination she was found to have a hard nodule subumbilically which was the size of her tenderness.Therefore we elected to proceed with excision with exploration and hernia repair.¿ explant procedure: incisional herniorrhaphy with removal of two old pieces of mesh and placement of two new pieces of mesh via open procedure.Implant: bard x2.Explant date: (b)(6) 2006 (hospitalization (b)(6) 2006 through (b)(6) 2006).(b)(6) 2006: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: incarcerated incisional hernia.Postoperative diagnosis: incarcerated incisional hernia.Recurrent incisional hernia.Anesthesia: general.Estimated blood loss: minimal.Procedure: ¿following signing of consent and induction of general endotracheal anesthesia the abdomen was prepped and draped in the routine sterile supine position after foley catheter and scds had been placed.The abdomen was prepped and draped in a routine sterile supine position.Ioban was placed over the top.Vertical midline incision was made directly over the site of the hard nodule.We dissected down to the nodule.We opened this delicately.This was incarcerated but not strangulated, mesh adherent to omentum.This was carefully removed and resected.We then opened the fascia from the umbilicus to just above the symphysis pubis and entered the peritoneal cavity.We were able to identify another piece of mesh which was loosely adherent to the abdominal wall.There was a hernia lateral to this area.This old mesh was removed without significant difficulty and we carefully palpated the rest of the midline.Through the midline we were able to find several other defects in the midline.We dissected and removed the mesh.Two more pieces of mesh which measured 11 cm by 14 cm were placed and secured using #0 prolenes.These two were sutured together in the midline and secured from just above the bladder flap to just below the xiphoid process.A total of 12 sutures were used to adhere all these pieces of mesh.#1 pds was used to close the fascia.Staples were placed on the skin.The patient tolerated the procedure well, was extubated on the table and transferred to the recovery room in stable condition.¿ (b)(6) 2006: (b)(6) hospital.Implant sticker: bard® composix® kugel® hernia patch x2.(b)(6) 2006: (b)(6) hospital.(b)(6), md.Discharge summary.¿reason for admission: patient is a 44-year -old female who is well known to me who came to the office complaining of a severe subumbilical pain and reducible right flank mass.Findings: patient was found to have an incarcerated subumbilical hernia which included an older piece of mesh and she had recurrent right spigelian hernia.Hospital course: patient was admitted to the hospital on (b)(6) 2006.She was taken to the operating room.For specifics on this procedure please see the dictation from (b)(6) 2006.During surgery she was found to have two old pieces of mesh removed and two new pieces were placed.These older pieces had been placed laparoscopically.On postoperative day #1 patient was sitting up in bed.She had a mild amount of pain.Her lungs were clear to auscultation.She was given ice chips.She was given iv pain medications and encouraged voldyne.She was kept on oxygen overnight.She did have a temperature to 99.2 the following day.She had started passing flatus the following day.We started her on a full liquid diet on postoperative day #2.We encouraged her to ambulate.She said the pain was quite severe later in the afternoon on postoperative day #2.By postoperative day #3 her pain was much better.Her temperature was coming down to 97.6.We advanced her diet and advanced her activity.We encouraged her to shower.We started her on milk of magnesia and prune juice.She continued to pass flatus, continued to take in moderate amount of food.On postoperative day #4 her pain was well controlled enough that she could be taking p0 medications.Last night she was finally able to have a bowel movement after taking milk of magnesia and prune juice.¿ her incision is clean, dry, and intact.No signs of drainage.Patient is going to be discharged home.She is to follow-up with me on monday for staple removal.Medications include toradol, keflex, vicodin and lotrel.She is to call for any fevers, chills, nausea or vomiting, worsening abdominal pain, or incisional drainage.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore the following conclusions have been reached.All pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® suture instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions associated with the use of any suture include, but are not limited to, tissue dehiscence, infection, localized inflammatory reaction, and transitory local irritation.Broken needles or damaged thread may result in extended or additional surgery or retained foreign bodies.¿ product identification information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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