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| Model Number 1DLMC02 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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| Event Date 03/04/2015 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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 ventral hernia repair on (b)(6) 2013 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, dense adhesions, lysis of adhesions, hernia recurrence, and revision surgery.Additional event specific information was not provided.
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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: rrecords regarding the patient¿s surgical history of caesarean section and laparoscopic hysterectomy were not provided.12/09/97: (b)(6) health system.(b)(6), md.Operative report.¿this patient came in with a one month history of cholecystitis and an ultrasound showed cholelithiasis and cholecystitis with question of air in the wall of the gallbladder.At surgery the area was very scarred down and the common duct was sucked up toward the gallbladder so we nicked the common duct and after removing the gallbladder we had to go back and do a laparotomy and put a t tube in the common duct.¿ procedure: ¿under general anesthesia the patient was prepped and draped in the usual manner.The area above the umbilicus was infiltrated with.25% marcaine.A stab wound was made and the insufflating needle was inserted and 4.4 liters co2 was put in the peritoneal cavity.The wound was extended and the 1 cm trocar was inserted through a visiport under direct vision and 1 cm trocar was inserted in the epigastrium and two 5 mm trocars laterally.The patient was placed in semi-fowler¿s and turned to the left.The gallbladder was grasped at the fundus with a forceps and the adhesions were lysed off the gallbladder.The ampulla was grasped.She had a large stone and a lot of scarring at the ampulla.The cystic duct was isolated and was triplely clamped and transected.In trying to free up the scarring at this area we inadvertently nicked the common duct so we continued with the procedure and triplely clamped the cystic artery and transected it and dissected the gallbladder off the bed with cautery.The gallbladder was removed through the umbilical port.We then made a subcostal incision on the right and put a #10 t tube in the common duct and closed the common duct with interrupted sutures of 4-0 silk and the t tube was draining well uphill so there was good tight closure of the common duct.The t tube was brought out through a stab wound.A one inch penrose drain was left in the area and this was brought out through the lateral edge of the wound.The peritoneum was closed with a running suture of #1 vicryl.The deep fascia was closed with a running suture of #1 vicryl.The subcu was irrigated with normal saline.The skin was closed with clips as were the other wounds.The t tube was sutured in place with 4-0 silk.Dry sterile pressure dressing was applied.The patient left the operating room in good condition.Blood loss was approximately 200 cc.¿ 07/07/98: (b)(6) health system.(b)(6), md.H&p.Admitted w/ probable appendicitis.Exam: abdomen non-distended, soft, no signs of generalized peritonitis.Hypertrophic right subcostal incision in upper quadrant; no signs of herniation or infection.Several trocar sites; no signs of herniation.Well healed lower midline incision from previous c-section; no problems.No inguinal adenopathy.Assessment/plan: probable early appendicitis.Discussed need of exploration; given complicated surgeries in past, will likely defer laparoscopic approach and proceed with open approach.07/07/98: (b)(6) health system.(b)(6), md.Operative report.Pre/postop dx: appendicitis.Procedure: appendectomy.Description: ¿the patient was taken to the operating room and placed on the stable in supine position.The abdomen was prepped with betadine scrub and draped in sterile fashion.Peritoneum was entered through a right lower quadrant rocky davis muscle splitting incision.Once inside, there were some omental adhesions which were cleared.The omentum was not grossly inflamed.The cecum was able to be grasped and brought up in to the field.The appendix was inflamed over the serosa but there was no sign of any abscess formation or perforation.A window was developed in the mesoappendix near the appendiceal base and the appendix was divided between hemostats.Mesoappendix was also taken down between hemostats.2-0 vicryl ties were used to ligate the mesoappendix followed by suture ligature of the appendiceal stump with 2-0 vicryl.The mucosa was then cauterized on the stump.Everything was hemostatic.The small bowel was run back for several feet and there was no sign of any meckel¿s diverticulum.There was no purulent fluid within the belly.The incision was then closed in layers using running 2-0 vicryl followed by irrigation and wound closure.The skin was closed with subcuticular 4-0 dexon.Benzoin, steri strips and sterile dressing were applied.Overall she tolerated the procedure well and there were no known complications.Estimated blood loss was minimal.She was taken to the recovery room in stable condition.¿ 09/02/99: (b)(6) health system.(b)(6), md.Office note.Hpi: c/o abdominal pain, persistent since open cholecystectomy approx.6 months ago.Pain worse w/ coughing in hard manner, when stretches stomach.Dr.Ciresi, her surgeon, does not feel there¿s an intra-abdominal process for abdominal pain.Ct abdomen essentially unremarkable.Psh: appendectomy, cholecystectomy, c-section.Social: smoker, nondrinker.Exam: 160 lb.Abdomen; well healed appendectomy scar rlq.On palpation, does have tenderness in ruq along upper rectus abdominis muscle on right, also tenderness on left.No rebounding or guarding, active bowel sounds.Assessment: abdominal pain, probably muscular in origin.Plan: trigger point injections and pt for rehabilitation of abdominal musculature.[missing records: records for ct abdomen ¿essentially unremarkable¿ were not provided.] 09/07/99: (b)(6) health system.(b)(6), pt.Physical therapy evaluation.Dx: abdominal pain.Hpi: reports problem w/ abdomen since shortly after having gallbladder surgery (b)(6)1997.Since that time having problems w/ apparent cramping, knotting up of stomach.Has problem w/ stretching, valsalva maneuver and coughing.Typically, does not have tender to touch.Injection last week at pain clinic; has not noticed improvement.Beyond injections no active treatment.Does admit to having weak abdominal muscles secondary to multiple surgical problems.Unusual type of condition; doubt any treatment in pt going to be of any assist.Has weak abdominal muscles; needs to work on strengthening.Records between 1999 and 2004 were not provided.06/28/04: [facility ni].(b)(6), md.H&p.Hpi: referred for colonoscopy.Has chronic lower abdominal pain associated w/bowel movements, worse in the last several months.Has pain in lower quadrant, sometimes on left, but almost exclusively on the right.Persists slightly before, during, and shortly after bowel movements.Has chronic back problems, muscular pain; not certain these are at all related.Has been receiving cortisone injections.Psh: appendectomy, open cholecystectomy w/ common bile duct injury leading to t-tube placement.Tahbso.Exam: abdomen shows multiple scars, appear herniated, no masses.Some pain w/deep palpation over the iliac fascia on both sides consistent w/ muscle pain.A/p: endoscopic evaluation.01/19/05: (b)(6) health system.(b)(6), md.Radiology-ct abd/pelvis.No suspicious pelvic mass or fluid collection seen.Conclusion: unremarkable postop study.01/25/05: (b)(6) clinic.(b)(6), md.H&p.Continuing problems with abdominal pain.Has extremely long course with this; pain present for last 6 years, has increased slightly in frequency and intensity.Occurs in right lower quadrant just below umbilicus about the mid clavicular line over an area measuring several inches.Psh: open cholecystectomy, c-section through midline incision, appendectomy through right lower quadrant incision.Pain tends to be quite sharp; from once a day to once a week.Never febrile or nauseated w/ this; feels pressure relieved somewhat, by passing gas or having a bm.Had recent abd/pelvic ct; unremarkable.Exam: abdomen mildly obese w/well healed incisions without evidence of herniation; questionable small hernia right at umbilicus and c-section scar does extend above this, but with having her stain multiple times, i was unable to demonstrate actual hernia.Only a suggestion that there may be one there; probably would not be responsible for symptoms.No masses.Assessment/plan: chronic right lower quadrant pain; desiring surgery.Upfront with her that i thought i had little to offer her, that surgery performed for pain alone often unsuccessful, no guarantee would have improvement in symptoms.Explained high likelihood i would be unsuccessful doing this laparoscopically given numerous surgeries and probable adhesions; likely have to do open approach.Understands she would be in all likelihood producing more adhesions postoperative.Will proceed with exploratory laparotomy w/probably lysis of adhesions.Pmh: reflux, muscle spasms.02/04/05: (b)(6) health system.(b)(6), md.Operative report.Preop diagnosis: chronic abdominal pain with suspicion of adhesions.Postop diagnosis: chronic abdominal pain with adhesions.Procedure: exploratory laparotomy with lysis of adhesions.Procedure: ¿the patient was taken to the operating room and placed on the table in the supine position with plexipulse in place.After induction of general anesthesia the abdomen was prepped with a betadine scrub and draped in a sterile fashion.Her peritoneal cavity was entered through a small midline incision revealing surprisingly little in the way of adhesions in the midline.With the incision extended exploration was underway and the omentum was found to be adherent to the abdominal wall in the vicinity of where she had preoperatively localized the pain.These were all taken down using electrocautery and there were one or two bands across the right colon.These were divided.She did have some omentum stuck to the underside of her previous cholecystectomy incision but this showed no evidence of any internal defects and was left intact.This was far removed from the sight of her pain.Exploration of her abdomen was then undertaken.The pelvis showed the uterus and ovaries to be surgically absent.The bladder was soft and pliable.Rectum was palpably normal and there were no appreciable masses present within the colon.The small bowel was run from the terminal ileum to the ligament of treitz and showed no evidence of meckel¿s diverticulum or diverticulosis.The mesentery was soft and pliable.There was no adenopathy noted.The right lobe of the liver was palpably normal as it was able to be reached laterally around the gallbladder adhesions.Palpation of the stomach and spleen was well as right lobe of the liver were also normal.Without any other abnormalities noted the procedure was terminated.I should mention that there were no palpable defects in the abdominal wall consistent with herniation.The fascia was then closed with a looped 0 pds followed by irrigation of the incision and closure of the skin with clips.Overall she tolerated the procedure well and there were no known complications.Estimated blood loss was minimal.She will be taken to the recovery room in stable condition where she will be an a.M.Admission.¿ 02/05/05: (b)(6) health system.(b)(6), md.Discharge summary.50-year-old woman admitted for exploratory laparotomy for evaluation of chronic right sided abdominal pain.Had fairly extensive workup; felt this probably represented adhesive disease.Hospital course: (b)(6) 2005 underwent exploratory laparotomy.Did have adhesive disease in area of pain, which was taken down as well as two moderately tight bands across right colon.No significant abnormalities were noted.Tolerated procedure well, had benign postoperative course and by first postoperative day was afebrile w/ stable vs and tolerating regular diet.Discharged home.Discharge dx: intraabdominal adhesive disease now s/p adhesion lysis, exploratory laparotomy.Follow up 1 week for staple removal.No lifting in interim.Records between 2005 and 2011, including the origin of the incisional hernia mentioned in the 4/25/2011 records, were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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Corrected results code.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2011, including the origin of the incisional hernia mentioned in the (b)(6) 2011 records, were not provided.Additionally, records regarding the patient¿s surgical history of cholecystectomy, caesarean section, laparoscopic hysterectomy, and appendectomy mentioned in the (b)(6) 2015 records were not provided.Operative records dated (b)(6) 2011 indicate the patient underwent mesh repair of an incisional hernia.The records state: ¿the site had been previously marked and was just to the right of the umbilicus.Her previous incision was opened and carried down through the subcutaneous tissue until the hernia sac was encountered.This was sharply dissected using electrocautery and a knife until the fascia was encountered and circumferential dissection revealed ultimately a fascial defect measuring 2 x 4 cm.The sac was opened and much of the incarcerated fat on the inside was simply transected.This allowed access to the bowel and there were multiple adhesions to the underside of the fascia which were cleared using electrocautery.This allowed a piece of mesh to be cut.Surgipro mesh was used and was cut so that there was an inlay of 2 cm on all sides.This was tacked in place using mattress sutures at the cardinal points followed by interrupted sutures to tack up the comers underneath the fascia.Following this, the edge of the fascia was then sewn to the mesh using a running 3-0 prolene in a circumferential fashion.¿ the records indicate a non-gore device was used during the procedure.Records between 2011 and 2013 were not provided.Records dated (b)(6) 2013 indicate the patient underwent ventral herniorrhaphy with mesh for treatment of a recurrent incarcerated ventral hernia.The records state: ¿patient was taken to the operating room after preoperatively identifying the area of her hernia defect which was essentially by the umbilicus.She had had multiple previous surgeries including a previous mesh repair at that site.She was placed on the table in the supine position with plexipulse in place and appropriate padding.After induction of general anesthesia, the abdomen was prepped with chloraprep and draped in a sterile fashion.A skin incision was made over the previous scar and defect area.This is carried down into the subcutaneous tissue with identification of fairly significant scarring and blurring of the normal tissue planes.¿ the (b)(6) 2013 operative report continues: ¿eventually we entered what appeared to be a portion of the hernia sac as evidenced by visualization of what appeared to be omental tissue.A small plane was developed around this and this was used to gain access into a multiloculated scarred in hernia sac that came up just beneath the umbilical skin.In clearing the sac, a small defect was made in the umbilical skin on the left side of the incision.The hernia sac was then identified circumferentially and dissected down to the level of the fascia.There were dense adhesions circumferentially and access was eventually gained into the peritoneal cavity.Finger was able to be inserted and we were able to in this fashion develop a small window and then gently work around the fascial defect freeing up the underlying omental tissue as well as some of the accompanying small intestine.The largest hernia defect was identified, however, as the tissue was taken down on the peritoneal surface.Two smaller defects on the left side of the larger defect were identified.The defect was simply enlarged to incorporate all of the defects into 1 single opening.The adhesions were taken down circumferentially until full finger length was freed up circumferentially.¿ the (b)(6) 2013 records state: ¿at this point the defect was measured and it was found to be 4 x 5 cm.Given the fact that we were inside the abdominal cavity, dual-sided gore-tex mesh was then used.It was then cut to size and marked appropriately to center it and that we would have 2.5 cm of overlap circumferentially.Next, interrupted mattress sutures of 0 ethibond were then placed circumferentially to secure the mesh in place.It was then inserted into the peritoneal cavity and the sutures were then drawn up.I should indicate that during placement of the sutures, careful attention was paid to protecting the small bowel present in the bottom of the incision.With the mesh then in place, the sutures were then secured and no gaps were felt in between the sutures.Next, the edge of the fascia was then tacked down to the mesh with a running 3-0 prolene.The wound was then irrigated and a total of 12 ml of marcaine were injected into the repair and subcutaneous tissues.The subcutaneous li88ues were then reapproximated with a running 3-0 vicryl followed by closure of the skin incision with subcuticular 4--0 undyed vicryl.The small umbilical skin defect was closed in a similar fashion.¿ the records confirm a gore dualmesh® biomaterial (1dlmc02/7853811) was implanted during the procedure.Records between 2013 and 2015 were not provided.Operative records dated (b)(6) 2015 state the patient underwent laparoscopic repair of a recurrent incisional hernia.Intraoperative records from the 3/4/2015 procedure indicate the following surgical history: cholecystectomy, caesarean section, laparoscopic hysterectomy, appendectomy, umbilical hernia repair.The records state: ¿skin incision was made transversely just 2 fingerbreadths below the left costal margin, transversely, and we dissected down to the anterior fascia which was incised and retracted exposing the peritoneum.Peritoneum was carefully incised.A finger sweep revealed no adhesions.The balloon hasson trocar was placed, and the pneumoperitoneum was established.The laparoscope was introduced.There were extensive adhesions all along the midline from the round ligament to just below the umbilicus.Both lower quadrants were free of adhesions.There was also extensive adhesions in the right upper quadrant from her previous open cholecystectomy.We ended up placing five 5mm bladeless trocars, 1 in the left lower quadrant, 1 in the low midline, 1 in the right lower quadrant and 1 in the right upper quadrant.¿ the (b)(6) 2015 records continue: ¿through these ports, we took down the adhesions in the midline mostly using sharp dissection with the endo shears.The adhesions were carefully taken down.There were dense adhesions between the transverse colon, and the previous mesh repair.We also took down the adhesions in the right upper quadrant from the previous cholecystectomy, but some of them were left intact.We just took down enough so that we could place our right upper quadrant trocar.We did not have to take down the round ligament.We next defined the extent of the recurrent hernia.There were several pockets with hernia sacs each having fascial defects approximately 2cm, and then there was a larger generalized weakness in the area, so we used a spinal needle passed through the abdominal wall to determine the size of mesh that would allow for at least 5 cm of overlap all way around, and we ended up needing a 15 cm x 20 cm oval physiomesh.We oriented it transversely.¿ the (b)(6) 2015 records state: ¿the mesh was then introduced into the abdominal cavity through the hasson trocar.It was unrolled, and then we used the suture passer and stab incisions to place through and through 2-0 ethibond stitches, 1st at the 12, 3, 6 and 9 o'clock , and then we placed stitches at 1 :30, 4:30, 7:30 and 10:30 on the clock.These sutures were placed to anchor the mesh circumferentially without any undue tension or laxity.All the sutures were tied with the pneumoperitoneum diminished to 8 mm hg.We then used the secure strap tacker to secure the mesh circumferentially around the edges as well as a ring of tacks around the inner aspect of the mesh.These tacks were placed approximately every centimeter around the edge and wider on the interior portion of the mesh.A total of 60 tacks were used using 2 guns.We made sure we had good hemostasis.Then we used the suture passer to place a 2-0 vicryl fascial stitch at the hasson trocar site.We then removed.Each 5 mm trocar under direct vision, and made sure there was no bleeding from any of these sites.¿ ¿a total of 2-1/2 hours were used to lyse the adhesions carefully, and there was no sign of any serosal tears to the colon or small bowel during our dissection to lysed the adhesions.¿ the records indicate a non-gore device was used during the procedure.There was no mention of infection and no mention of gore device removal.Discharge records dated (b)(6) 2015 state: ¿is a 60-year-old female who is status post umbilical hernia repair times 2, who presented with a recurrent hernia.It was felt that she would benefit from a laparoscopic approach.¿ ¿lntraoperative findings did include extensive adhesions requiring prolonged adhesiolysis.¿ records also state: ¿present at the time of admission and unchanged at discharge: 1.Restless leg syndrome.2.Tobacco abuse.3.Hypercholesterolemia.4.Gastroesophageal reflux disease.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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: 12/08/97: (b)(4) cc: upper abdominal pains.Hpi: pain through the months or years; has increased to everyday, worse after eating.Known gallstones on us last summer.Wt 165 lbs.Impression: by clinical hx, fits best w/cholecystitis, low grade or dysfunctional gallbladder.Plan: ultrasound.12/??/97: (b)(4) hpi: abdominal pain for at least a month; especially bad after she eats.Us today revealed cholelithiasis, stone in cystic duct near common duct, but common duct does not appear to have any stones in it.Ros: [included] abdominal pain w/nausea, no vomiting.Occasional diarrhea, no constipation.Exam: abdomen; soft, no masses; tenderness ruq.Impression: acute and chronic cholecystitis and cholelithiasis, s/p c-section years ago.Instructed on procedure.12/??/97: (b)(4) discharge summary.Dx: acute and chronic cholecystitis and cholelithiasis.Had lap chole; common duct was adhered up to the ampulla of gallbladder, so it was nicked.Had to do an open procedure to put t-tube in common duct.Did well postoperatively except a lot of drainage because we also had a penrose drain to drain off the bile.Discharged on the following monday, told to come back tuesday for dressing change.Dr.Scammell did a t-tube cholangiogram; showed dye going both ways but there was a lot of leakage.Came back and saw me on thursday; drain was removed.Discharged on cipro and flagyl.04/21/98: (b)(4) cc: abdominal wall pains.Hpi: gets burning, brief knife-like feeling across upper chest.Occurred since surgery in january.Increased in weight since that time.Some soreness to touch on one spot, no emesis or nausea, no change in bowel habits.Exam: abdomen; well healed abd scar; most tender for burning feeling just below scar on right.No current tenderness in that region to palpation.Somewhat more medially, slightly tender to palpation.Impression: s/p cholecystectomy, muscle wall pains or nerve pains on the surface, more likely neuritis type pain on surface of abd.Plan: reassurance this will likely disappear during next 2 months.10/06/98: (b)(4) intermittent ruq pain; soreness now but noted when lying down feeling of something moving.No injury.Impression: ruq discomfort; suspect may be due to residual chole scar.Talked about possibility of adhesions causing some movement sensation in abdomen.Not toxic, nothing surgical going on here.Plan: advised observation regarding abd pain.If gets worse or persistent vomiting, should be checked.06/25/99: (b)(4) abdominal wall pain.Impression: muscle wall pain, poss.Small hernia near site of chole scar.Plan: have dr.Scammell review above condition in coming weeks.07/12/99: (b)(4) hpi: rt sided abd pain.Apparently has been more musculoskeletal; resting usually makes attacks resolve.Concern is she may have hernia in one of her precious incision scars; had open cholecystectomy w/t-tube several yrs ago and had an appendectomy.Incisions appear to be well healed; do not detect any herniations.Pain appears located to very lateral aspect of chole scar.No fascial defect appreciated, but possibility does exist there could be such a small hernia that it is undetectable clinically.At this point i think it is musculoskeletal or possibly scar pain; recommended nonsteroidal meds.If no improvement next 1 to 2 weeks, would consider referral to pain clinic, try abd wall injection; utilizing surgical exploration as last resort.07/19/99: (b)(4) telephone call.Talked about continued abdominal pains and opinion w/dr.Scammell that this is likely related to muscular pain or scar region pain next to cholecystectomy site.Still having some spasms; still worries her.Interested in second opinion, realizing she may need to be injected either with surgeon or anesthesia pain clinic in that area in order to determine source of pain.Set up time w/general surgeons at midelfort clinic for second opinion.08/06/99: (b)(4) office note.Cc: abdominal pain, poss.Hernia.Hpi: referred for second opinion regarding incisional pain.Impression: probable incisional pain, r/o small incisional hernia.Plan: ct abd/pelvis to assure no hernia.Assuming there is not; agree pain clinic would be useful.Clearly does sound to be musculoskeletal, not gastrointestinal in etiology.08/13/99: (b)(4) radiology-ct abd/pelvis.Hx: abdominal pain; s/p cholecystectomy, r/o hernia.Impression: essentially normal post-operative scan of abdomen.No complications in surgical bed identified.No hernias identified to account for pain.Does demonstrate thick-walled right adnexal cyst; unlikely to account for discomfort.08/27/99: (b)(4) office note.Cc: f/u incisional pain.I agree this is musculoskeletal in nature; referral to pain clinic would be in order.Plan: referral to pain clinic for possible focal trigger point injections.10/21/99: (b)(4) radiology-pelvic us.Impression: physiologic type cyst of left ovary, otherwise negative study.11/05/99: office note.Hpi: still having abd pain, 1-2 x/week; severe in low right abdomen.Indicates she cannot stand it; thinks something needs to be done to relieve the pain.Impression: scar region pain unclear cause.It was aggravated w/injection of the tissue so she will not receive further anesthesia pain clinic treatments.Discussed w/ her that i would see if there is another level of steps or consultant dr.Ciresi would recommend.11/24/99: (b)(4) office note.I talked to dr.(b)(4) earlier this month; felt this area of localized pain near the scar should not be surgically removed, that surgery in same area would cause pain to worsen.Will take sometimes several years for a trapped nerve end to release.He thought only major option was injection through anesthesia pain clinic.I know this has not met w/marjorie¿s current desires.06/08/00: (b)(4) office note.Hpi: presents for evaluation of abdominal pain; states pain all over the lower abdomen.Hurts w/walking, worse w/menses.Wt 161 lb.Return 2 weeks for f/u.07/25/00: (b)(4) steve folz, md.Radiology-pelvic us.Hx: s/p laparoscopic hysterectomy w/decreasing hgb and hypotension.Impression: free fluid in upper abdomen.Images show no abnormality but are compromised by bowel gas.08/23/00: (b)(4) telephone call.Increased cramps in abdomen.Had some of it before hysterectomy but increased after.Dr.Weber mentioned possibly irritable bowel syndrome medicine.Does mention her tendencies towards diarrhea; acceleration of amount of cramps, pain and diarrhea since hysterectomy.01/25/02: (b)(4) office note.Hpi: painful swelling in abdomen; especially noticeable when straining.Tender to touch, has increased; probably been there a few years, but more definite and tender to touch than it had been.Problem w/cramps over several years; occur if sneezes or coughs, causes intense pain in right lateral to anterior abdomen area.Had workup for this in past w/dr.Scammell; no clear reason found.Exam: abdomen; no deformity visible; to palpation she has deformity or bulging present in the epigastrium that is especially present if she is bearing down at all.Seems to be about 5-10 cm in width and height, tender to palpation.Seems to be at corner of chole scar.Lower abd without masses, mildly tender.Impression: abd wall hernia; seems to be incisional vs.Ventral hernia or both.Right abdomen pain going on for several years.If any way this could be evaluated or explored in work-up of this abd pain or in conjunction w/repair, it may be to her advantage.Plan: f/u w/surgeon.01/28/02: (b)(4) office note.Cc: referred for possibility of incisional vs.Epigastric hernia by dr.Rich.Hpi: c/o soreness epigastric region when she presses w/her fingers; notes had this chronically over last several years since open gallbladder procedure.Thinks there may be a hernia; told by dr.Rich he thought there was hernia at gallbladder scar.Impression: likely abd muscle strain; no evidence of incisional hernia; advised no hernia palpated.Plan: f/u prn basis.If hernia there, it will enlarge over time until it can be palpated; at this time do no suspect hernia present.02/28/02: (b)(4) office note.Cc: apparently referred by phone from dr.Rich for surgical consultation for right lower quadrant abdominal pain.Of note from pmh, has had some type of pain syndromes, possibly fibromyalgia, although i do not think she actually carries this dx.Has had pain clinic visits in past for back and upper abd pain.Last had trigger point injections of myofascial abd pain in upper abd in 1999.States she thinks this pain is different from that.Exam: abdomen; no distress, although, does note she is currently having abd pain; indicates rlq w/her hand.Abd soft, mildly obese, non-distended, normoactive bowel sounds.Multiple well healed surgical scars including infra-abdominal midline scar, ruq subcostal scar.No palpable hernias, masses or hepatosplenomegaly appreciated in inguinal regions or in abd along any of incisions.Moderate degree of tenderness to palpation in rlq, no peritoneal signs.Impression: sharp rlq abd pain, seems most likely r/t abdominal muscular strain.Symptoms seem most r/t movement.Without any evidence of gi type symptoms, other constitutional symptoms, i doubt very much this is significant intraabdominal process.I do not palpate any abd wall hernias.Recommendation is rest w/limited use of abd musculature including lifting less than 10 to 15 lbs.Rx naprosyn.06/26/02: (b)(6) office note.Hpi: lower abd pain still bothers her similar as earlier this year.Has not noticed any definite bulging in this area, no hernia found.Impression: lower abdominal wall pain thought to be muscle wall pain.Still most logical conclusion for this lower abdominal pain.07/12/02: (b)(6)radiology-upper gi.Impression: no hiatus hernia.Small amount of gerd.(b)(6) 02: midelfort clinic.John foss, md.Office note.Hpi: [included] c/o knotting of stomach located just below cholecystectomy scar; states scar began shortly after surgery for gallbladder.Had a tear in bile duct and had a g-tube for a period of time.Pain is worse when she moves and lift things heavy.Wt 179 lb.Impression: [included] abd pain certainly sounds musculoskeletal, but given her concern, a ct scan of abd to look at abdominal wall and common bile duct would be helpful.Will schedule for upper endoscopy.07/25/02: (b)(6) health system.(b)(6) radiology-ct abd/pelvis w/contrast.Hx: abdominal wall cyst, dilated common duct.Impression: s/p cholecystectomy and hysterectomy.Diverticulosis without evidence of diverticulitis.No other significant abnormality seen.(b)(6) 04: (b)(6) office notes.Hpi: rt pelvis pain, sometimes hurting 4 times during day, sometimes skipping a day; present at least a few months, worse at time of bowel movements.Has had multiple abdominal/pelvic surgeries through the years.Exam: abdomen; tender to light touch along rt pelvis area; seems to be in muscle layers, cannot palpate any definite hernia.Impression: lower rt abd pain in recent months, most likely musculoskeletal.(b)(6) 05: (b)(6) office note.Cc: rt mid abdomen pain.Plan: talk to dr.Scammell about re-evaluation or referral source for abd wall pain, poss.Occult hernia.(b)(6) 05: (b)(6) office note.Hpi: seen 9 days postop exploratory laparotomy for lysis of adhesions.States doing well; has not had recurrence or persistence of preoperative pain, only some mild incisional tenderness.Incisions appears to be healing well, no signs of infection; staples removed today w/steri-strips applied.Impression/plan: apparently improved at this point.Work excuse for additional 2 weeks.Rx darvocet prn.F/u 2 weeks.(b)(6) /05: (b)(6) office note.Hpi: 24 days postop exploratory laparotomy.Doing well; incision appears to be healing well, no signs of any problems.Basically, back to normal activity.Can return to light duty meaning 25 lbs as of march 7 with unrestricted duty after march 21.Should be noted she has had no recurrence of preoperative pain thus far.(b)(6) 2009: (b)(6) radiology-ct urogram.History: gross hematuria.Impression: [included] 1 cm fat-containing non-specific lesion within spleen, most likely hemangioma.Colonic diverticulosis.Ventral abdominal wall hernia containing only fat.Postoperative change in pelvis.08/25/10: mayo clinic.(b)(6) office note.Cc: problem w/swallowing and coughing on food, food getting stuck.Ros: has had old right sided pain evaluated over the years; thought to be muscular when re-evaluated through surgeons.Has been the same over last 10 years or more.Exam: abdomen; mild to moderate obesity.Mildly tender in epigastric area.Very tender along the right abdomen and muscles when moving up and down from lying position.(b)(6) 2011: mayo clinic.(b)(6) office note.Cc: abdomen lumps; tender, painful, worsening over 2-3 months.Smoker; encouraged to quit.Exam: abdomen; obese w/well healed scars.When standing, lying, and doing shoulder raise there is increased signs of bulging to the right of umbilicus, a 3 cm area that bulges, is tender and more epigastric area medial to a cholecystectomy scar there is a bulging area that is a few cm in size, tender and firm when she does valsalva or maneuvers her trunk.Impression: abdominal hernias likely cause of current symptoms.Obesity; encouraged to lose weight; would help overall hernia symptoms.Plan: f/u w/general surgeon.May need to consider surgery within coming weeks or months d/t insurance coverages.(b)(6) 2011: (b)(6) office note.Hpi: know from previous surgeries, although have not seen her in several years.Referred by dr.Rich; has been experiencing abd pain consistent w/hernia.Now developed painful area at medial side of cholecystectomy incision, painful mass by umbilicus.Examination limited primarily to having her sitting on the table doing sit ups while palpation of these areas undertaken.Incisions themselves seem well healed; appreciate a bulge to right of umbilicus.Not so certain i can feel a bulge at the medial aspect of subcostal incision.She would appear to be high risk for incisional hernias.Explained sometimes these can be multifocal; proceed w/ct first to delineate the extent of hernia disease, possibly discuss laparoscopic repair in another facility if this would appear to be a better choice.Otherwise, has 2 separate incisional hernias far removed, each requiring open repair; will discuss that once we know results of ct.(b)(6) 2011: (b)(6) radiology-ct abd/pelvis w/contrast.Hx: evaluate for abd wall hernias-particularly umbilicus and epigastric at medial chole scar.Impression: colonic diverticulosis.Stable benign fatty lesion in central spleen.Ventral abd wall fat containing hernia, just to right of umbilicus; approx.4 cm neck.No evidence of hernia in right upper quadrant adjacent to small amount of scar tissue from cholecystectomy.(b)(6) 2011: (b)(6) office note.Hpi: returns for preop scheduling regarding umbilical hernia; actually, an incisional hernia at umbilical site.Exam: abdomen; mildly obese w/palpable incarcerated hernia just right of the umbilicus consistent with ct.Impression/plan: incarcerated, not strangulated incisional hernia at level of umbilicus.Mesh repair has been discussed; understands we will be using the same incision, reducing the hernia, placing mesh.(b)(6) 2011: (b)(6) operative nursing data.Implants: type; mesh.Pathology sent to lab: specimens; umbilical hernia sac and contents.(b)(6) 2011: (b)(6) office note.Hpi: returns 1 week after repair of incisional hernia w/mesh.Overall, doing quite well.Still slightly sore laterally from the incision consistent w/placement of sutures in surrounding fascia.No sign of seroma, hematoma or infection.Repair appears to be intact to having her push against it lightly.Continue current lifting restrictions for the full 6 weeks as the tissue was noted to be somewhat weak.Understands she is at high risk for recurrence given poor nature of the tissue from multiple surgeries at the site.(b)(6) 2012: (b)(6) office note.Cc: abdominal wall hernia recurrence.Hpi: she reminded me of past abdominal wall surgeries w/dr.Scammell including mesh implantation about a year ago.She had a sharp tearing feeling when she had emesis and diarrhea in november.Since then, will get tenderness to right of upper abdomen area similar to past areas of pain.Retired in last year.Exam: abdomen; multiple scars.Tender in several areas; seems to have likely abdominal wall hernia to right of midline mid upper abdomen.Impression/plan: abdominal wall hernia; tolerating it well enough, intermittent.Won¿t go for re-evaluation w/surgeon but knows she could.She has a way of reducing it by standing and stretching out.(b)(6) 2013 : (b)(6) office note.Cc: abdominal wall pain, low back pain.Hpi: worried she is having recurrence of hernias.If she stands or lies down, she can decrease pain, but has fairly intense pain w/prolonged sitting.Happens 2-3 x /week.Feels as if everything twists or gets painful or tight; if she stands it will improve.Exam: abdomen; multiple old scars.Very tender on several areas above and below umbilicus near surgical scars.Can point them out easily; they seem tender, seems to be slight bulging in at least 2 areas.Inguinal area no definite hernias.Impression/plan: abd wall pain, progressed from last year.Opinion from surgeon appears indicated, whether to re-check ct scan, evaluations for abd wall hernias.Past mesh placement in this area.Reports she hay have dx of adhesions in past, which may be a factor in intermittent pain.Plan: see dr.Scammell.(b)(6) 2013 : office note.Hpi: comes today because she is concerned she has recurrence of ventral hernias.States she feels she may have a hernia at medial aspect of cholecystectomy scar.Same complaints in 2011, however, ct scan only revealed hernia at the umbilicus, which was fixed.States she had the flu this past winter, and that is when she felt the tear when she was heaving w/vomiting.Looking at her weights between time of hernia repair, her weight is back down, but she gained as much as 10 kg in intervening several years.Exam: abdomen; remains somewhat obese.Multiple well-healed scars.When lies down or strains, it does appear she has recurrence near umbilicus and it does feel as though there is a fascial defect at the umbilicus.Unable to appreciate an actual mass at the upper epigastric area near the medial aspect of cholecystectomy scar, but given abdominal girth, it would be easy to miss a hernia.Plan: ct abdomen to evaluate for presence of possible multiple abd wall hernias.Will get back in regard to fixing these, based on those results.(b)(6) 2013 : (b)(6) radiology-ct abd/pelvis w/contrast.History: evaluate for ventral hernia.Comparison: 04/12/11.Impression: supraumbilical ventral hernia w/fat herniation, the transverse colon extends to the deep margin of the ventral hernia but does not extend into the hernia defect; no wall thickening or colon obstruction.Slightly more distortion than on ct 04/11 but little additional change.Surgical absence of uterus and gallbladder.Colon diverticulosis.Benign fat containing splenic lesion.Remainder of ct negative.(b)(6) 2013 : mayo clinic health system-red cedar.[illegible signature].Discharge instructions.Hernia repair w/mesh for reinforcement.Do not lift more than 0 pounds for 2 weeks or until first post-op visit; doctor will discuss further weight restrictions at that time.F/u 11/11/13 with dr.Scammell.(b)(6) 2013 : (b)(6) office note.Hpi: seen a week after repair of fairly complex ventral hernia.Other than being sore, reports no specific problems.No nausea/vomiting, fevers or signs of infection.States she did notice a lump to the left lateral side of incision.Exam: appears she has a hematoma.Does not impulse w/valsalva.No sign of infection or bleeding.The repair actually feels intact when i have her valsalva in the supine position.At this point, continue all restrictions; see back the week of december 16th.(b)(6) 2013 : mayo clinic.(b)(6) office note.Hpi: 6-week check after repair of ventral hernia.Incision well healed; in upright position w/valsalva, can appreciate no evidence of recurrence of persistence of her hernia.Mild tenderness to left side; likely traction from some of the sutures, but no evidence of any problem.She can gradually resume normal activity, but still avoid any excessive straining for next several months.F/u as needed.(b)(6) 2015 : (b)(6) office note.Hpi: past hernia repairs; 11/2013 mesh placed.There is an area that is tender, bulging, right lateral to area where she had surgery; gradual since surgery.Has also had a lump below the xiphoid; present in recent years, slightly tender to touch.Exam: abdomen; on palpation, has several scars.Tender just to the right of 1 of her scars near umbilicus; probably bulging several centimeters when she bears down in that region, also epigastric bulge, tender.Inguinal region without tenderness or bulge.Impression/plan: hernias; review w/dr.Scammell.Tobacco use; encouraged to quit.Obesity; discussed weight loss/exercise.(b)(6) 2015: mayo clinic.(b)(6) office note.Hpi: has recurrence of umbilical hernia that has been fixed twice in past w/mesh.Last was approximately a year and a half ago.Ct in september 2013; showed supraumbilical hernia containing fat.Since that time, has complained of pain at the medial aspect of pervious cholecystectomy incision; a ct at that time did not show any evidence of hernia at the site.States still having pain there and occasionally feels a bulge.Exam: does have recurrence on the right side of her umbilicus.No incarceration.Cannot appreciate any type of herniation at the right or medial aspect of cholecystectomy incision.Impression/plan: recurrent umbilical hernia.Good candidate for laparoscopic repair.Contact eau claire regarding surgeons currently doing laparoscopic repair.(b)(6) 2015: (b)(6) office note.Hpi: seen regarding recurrent umbilical hernia.Has had umbilical hernia repaired 2 times, at least once w/mesh; last repair november 2013, gore-tex dual mesh was used, using an open technique.Recently saw dr.Scammell because of pain and bulge along right side of umbilical region.He felt there was recurrence of hernia and she was candidate for laparoscopic repair since she had recurrences from open repairs.C/o pain and bulge along right side of pervious hernia repair.Thinks bulge has been there perhaps a month or 2.No change in bowel habits, no difficulty emptying bladder, no chronic cough/bronchitis.Social: smokes 1ppd of cigarettes, no alcohol.Exam: abdomen; obese/soft.Well-healed low midline incision.Well-healed incision in the umbilical area, oriented transversely.Well-healed right subcostal scar.Examined her both supine and standing.There is somewhat of a bulge along right side of periumbilical area; does not seem to reduce, do not feel definite fascial defect here.Also says she has some pain and bulge in the subxiphoid area; i do not feel anything to suggest hernia there, but she does seem tender; do not feel mass there.Impression/plan: pain/bulging at previous recurrent umbilical hernia repair site; could represent scar tissue, some neuropathy type pain r/t previous mesh repair.Recommend ct scan of abdomen.Do not think this is at risk for incarceration or strangulation.In regards to pain/lump in subxiphoid area, could not feel lump there; possible she has small hernia there.Presumably, she has had maybe a trocar site there, not too far from subcostal incision, maybe r/t that.Understands if we do find significant recurrence of ventral hernia, we would recommend surgical repair.If she does have recurrent hernia, we ought to consider laparoscopic hernia repair since open repairs in past failed; talked about use of mesh for repair.(b)(6) 2015 : me red cedar clinic.(b)(6) radiology-ct abd/pelvis w/contrast.History: recurrent incisional hernia.Impression: midline anterior abdominal wall incisional hernia.Centered in the region of the umbilicus; measures approx.7.5 cm x 7.5 cm in greatest dimension.Appears to be some mesh material anteriorly.Incisional hernia has increased in size when compared to 09/13/13, now contains the midportion of the sigmoid colon.No evidence of incarceration, strangulation or obstruction.Colonic diverticulosis.(b)(6) 2015 : mayo clinic.(b)(6) office note.Called marjorie w/results of ct scan of abdomen to evaluate recurrent incisional hernia.Shows incisional hernia containing sigmoid colon; no sign of incarceration or obstruction.Fascial defect estimated at approx.7.5 cm in diameter.Explained we recommend elective repair of hernia and laparoscopic mesh repair would be our recommendation.Plan: scheduled for laparoscopic incisional hernia repair on march 4th as outpatient.Will take things 1 day at a time postop to decide how long she will stay based on ability to tolerate oral diet, control pain.Talked about possibility of having to convert to open procedure if adhesions are too dense to allow for laparoscopic mobilization and visualization of the hernia defect.(b)(6) 2015 : mayo clinic.(b)(6) office note.Cc: first appt.Postop laparoscopic recurrent ventral hernia repair.Hpi: only complaint is small area of superficial burning pain in the skin surrounding left upper quadrant trocar site; burning intermittent, exacerbated by any type of movement.Attempted to use percocet and flexeril; have not helped at all in managing this pain.Distressed about it; rates pain 8/10.The generalized abd pain from the surgical repair resolved.Has not noted bulging or hernia recurrence.No fevers, nausea or vomiting.Eating/drinking well.Continues to smoke cigarettes.Exam: abdomen; soft, obese, nontender, nondistended.At present, not experiencing the burning pain, nor was i able to elicit any type of pain w/palpation.Bowel sounds normoactive.All surgical incisions healing well/well approximated.No surrounding erythema/drainage.Still remains some scabbing on left upper quadrant trocar incision.Impression/plan: satisfactory postop check.Abdominal cutaneous nerve injury.Discussed it is not uncommon to have cutaneous nerve disruption at trocar site; typically allow this to resolve over time, should resolve in approx.3 months.Unlikely oral meds would help this pain, but others have had relief w/lidoderm patch; wishes to try the patch.Reminded 10-pound lifting restriction in effect for additional 4 weeks.F/u 3-4 weeks.(b)(6) 2015 : mayo clinic.(b)(6) office note.Hpi: returns 5 weeks after lap recurrent ventral hernia repair w/mesh.Doing well; decreased abd pain, pain left upper quadrant trocar site improving; only painful w/coughing, twisting or bending.Looser stools since surgery.Exam: abdomen; soft, without distention or tenderness.All lap incisions well healed.Examined both standing and supine w/valsalva maneuvers; do not detect any hernia bulge at original recurrent hernia site just above the umbilicus, nor feel any hernia bulging at any trocar sites.Particular attention paid to left upper quadrant trocar site which was hassan trocar site; tender to palpation but no hernia bulge seen.Impression/plan: no sign of recurrent hernia.Resume activity as tolerated.Would expect tenderness at hassan trocar site in luq to gradually subside.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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Manufacturer Narrative
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Previous patient codes (1695, 1994, 2240) were reported based on the original complaint and are no longer applicable and/or not reportable 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.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 1997 through (b)(6) 2015 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Records from (b)(6) 2013 through (b)(6) 2015 were not provided.Patient information: medical history: obesity: (b)(6) 2002: 179lbs; bmi 31.7. (b)(6) 2005: 182lbs; bmi 32.2. (b)(6) 2010: 195lbs; bmi 34.Smoker: (b)(6) 2005: 1-2 pack/day x 35 years. (b)(6) 2010: 1 pack/day.Hypercholesterolemia.Gastroesophageal reflux disease.Abdominal wall hernia.Diverticulosis.Hiatal hernia.Chronic abdominal pain.Intraabdominal adhesive disease.Prior surgical procedures: (b)(6) 1987: cesarean section with tubal ligation.(b)(6) 1997: cholecystectomy.(b)(6) 1998: appendectomy.(b)(6) 2000: hysterectomy with bilateral salpingo-oophorectomy.(b)(6) 2005: exploratory laparotomy, lysis of adhesions, no evidence of defects or hernia.Implant preoperative complaints: (b)(6) 2013: ¿worried she is having recurrence of hernias.If she stands or lies down, she can decrease pain, but has fairly intense pain w/prolonged sitting.Happens 2-3 x /week.Feels as if everything twists or gets painful or tight; if she stands it will improve.Exam: abdomen; multiple old scars.Very tender on several areas above and below umbilicus near surgical scars.Can point them out easily; they seem tender, seems to be slight bulging in at least 2 areas.Inguinal area no definite hernias.¿ (b)(6) 2013: ¿comes today because she is concerned she has recurrence of ventral hernias.States she feels she may have a hernia at medial aspect of cholecystectomy scar.Same complaints in 2011, however, ct scan only revealed hernia at the umbilicus, which was fixed.States she had the flu this past winter, and that is when she felt the tear when she was heaving w/vomiting.Looking at her weights between time of hernia repair, her weight is back down, but she gained as much as 10 kg in intervening several years.Exam: abdomen; remains somewhat obese.Multiple well-healed scars.When lies down or strains, it does appear she has recurrence near umbilicus and it does feel as though there is a fascial defect at the umbilicus.Unable to appreciate an actual mass at the upper epigastric area near the medial aspect of cholecystectomy scar, but given abdominal girth, it would be easy to miss a hernia.¿ (b)(6) 2013: ct abdomen/pelvis: ¿supraumbilical ventral hernia w/fat herniation, the transverse colon extends to the deep margin of the ventral hernia but does not extend into the hernia defect; no wall thickening or colon obstruction.Slightly more distortion than on ct (b)(6) but little additional change.Surgical absence of uterus and gallbladder.Colon diverticulosis.Benign fat containing splenic lesion.¿ implant procedure: ventral herniorrhaphy with mesh for the treatment of a recurrent incarcerated ventral hernia.Implant: gore® dualmesh® biomaterial (7853811/1dlmc02) 8 cm x 12cm.Implant date: (b)(6) 2013 [hospitalization dates unknown] description of hernia being treated: ¿patient was taken to the operating room after preoperatively identifying the area of her hernia defect which was essentially by the umbilicus.¿ ¿a skin incision was made over the previous scar and defect area.This is carried down into the subcutaneous tissue with identification of fairly significant scarring and blurring of the normal tissue planes.Eventually we entered what appeared to be a portion of the hernia sac as evidenced by visualization of what appeared to be omental tissue.A small plane was developed around this and this was used to gain access into a multiloculated scarred in hernia sac that came up just beneath the umbilical skin.In clearing the sac, a small defect was made in the umbilical skin on the left side of the incision.The hernia sac was then identified circumferentially and dissected down to the level of the fascia.There were dense adhesions circumferentially and access was eventually gained into the peritoneal cavity.Finger was able to be inserted and we were able to in this fashion develop a small window and then gently work around the fascial defect freeing up the underlying omental tissue as well as some of the accompanying small intestine.The largest hernia defect was identified, however, as the tissue was taken down on the peritoneal surface.Two smaller defects on the left side of the larger defect were identified.The defect was simply enlarged to incorporate all of the defects into 1 single opening.The adhesions were taken down circumferentially until full finger length was freed up circumferentially.At this point the defect was measured and it was found to be 4 x 5 cm.¿ implant size and fixation: ¿given the fact that we were inside the abdominal cavity, dual-sided gore-tex mesh was then used.It was then cut to size and marked appropriately to center it and that we would have 2.5cm of overlap circumferentially.Next, interrupted mattress sutures of 0 ethibond were then placed circumferentially to secure the mesh in place.It was then inserted into the peritoneal cavity and the sutures were then drawn up.I should indicate that during placement of the sutures, careful attention was paid to protecting the small bowel present in the bottom of the incision.With the mesh then in place, the sutures were then secured and no gaps were felt in between the sutures.Next, the edge of the fascia was then tacked down to the mesh with a running 3-0 prolene.The wound was then irrigated and a total of 12 ml of marcaine were injected into the repair and subcutaneous tissues.The subcutaneous tissues were then reapproximated with a running 3-0 vicryl followed by closure of the skin incision with subcuticular 4--0 undyed vicryl.¿ post-operative period: [same day] (b)(6) 2013: discharge instructions: ¿do not lift more than 0 pounds for 2 weeks or until first post-op visit; doctor will discuss further weight restrictions at that time.¿ relevant medical information: (b)(6) 2013: ¿seen a week after repair of fairly complex ventral hernia.Other than being sore, reports no specific problems.No nausea/vomiting, fevers or signs of infection.States she did notice a lump to the left lateral side of incision.Exam: appears she has a hematoma.Does not impulse w/valsalva.No sign of infection or bleeding.The repair actually feels intact when i have her valsalva in the supine position.¿ (b)(6) 2013: ¿6-week check after repair of ventral hernia.Incision well healed; in upright position w/valsalva, can appreciate no evidence of recurrence of persistence of her hernia.Mild tenderness to left side; likely traction from some of the sutures, but no evidence of any problem.¿ (b)(6) 2015: ¿past hernia repairs; (b)(6) 2013 mesh placed.There is an area that is tender, bulging, right lateral to area where she had surgery; gradual since surgery.Has also had a lump below the xiphoid; present in recent years, slightly tender to touch.Exam: abdomen; on palpation, has several scars.Tender just to the right of 1 of her scars near umbilicus; probably bulging several centimeters when she bears down in that region, also epigastric bulge, tender.Inguinal region without tenderness or bulge.¿ (b)(6) 2015: ¿has recurrence of umbilical hernia that has been fixed twice in past w/mesh.Last was approximately a year and a half ago.Ct in (b)(6) 2013; showed supraumbilical hernia containing fat.Since that time, has complained of pain at the medial aspect of pervious cholecystectomy incision; a ct at that time did not show any evidence of hernia at the site.States still having pain there and occasionally feels a bulge.¿ (b)(6) 2015: ¿has had umbilical hernia repaired 2 times, at least once w/mesh; last repair (b)(6) 2013, gore-tex dual mesh was used, using an open technique.Recently saw dr.(b)(6) because of pain and bulge along right side of umbilical region.He felt there was recurrence of hernia and she was candidate for laparoscopic repair since she had recurrences from open repairs.C/o pain and bulge along right side of pervious hernia repair.Thinks bulge has been there perhaps a month or 2.No change in bowel habits, no difficulty emptying bladder, no chronic cough/bronchitis.¿ ¿examined her both supine and standing.There is somewhat of a bulge along right side of periumbilical area; does not seem to reduce, do not feel definite fascial defect here.Also says she has some pain and bulge in the subxiphoid area; i do not feel anything to suggest hernia there, but she does seem tender; do not feel mass there.¿ (b)(6) 2015: ct abdomen/pelvis: ¿midline anterior abdominal wall incisional hernia.Centered in the region of the umbilicus; measures approx.7.5 cm x 7.5 cm in greatest dimension.Appears to be some mesh material anteriorly.Incisional hernia has increased in size when compared to (b)(6) 2013, now contains the midportion of the sigmoid colon.No evidence of incarceration, strangulation or obstruction.Colonic diverticulosis.¿ (b)(6) 2015: laparoscopic repair of a recurrent incisional hernia ¿skin incision was made transversely just 2 fingerbreadths below the left costal margin, transversely, and we dissected down to the anterior fascia which was incised and retracted exposing the peritoneum.Peritoneum was carefully incised.A finger sweep revealed no adhesions.The balloon hasson trocar was placed, and the pneumoperitoneum was established.The laparoscope was introduced.There were extensive adhesions all along the midline from the round ligament to just below the umbilicus.Both lower quadrants were free of adhesions.There was also extensive adhesions in the right upper quadrant from her previous open cholecystectomy.We ended up placing five 5mm bladeless trocars, 1 in the left lower quadrant, 1 in the low midline, 1 in the right lower quadrant and 1 in the right upper quadrant.Through these ports, we took down the adhesions in the midline mostly using sharp dissection with the endo shears.The adhesions were carefully taken down.There were dense adhesions between the transverse colon, and the previous mesh repair.We also took down the adhesions in the right upper quadrant from the previous cholecystectomy, but some of them were left intact.We just took down enough so that we could place our right upper quadrant trocar.We did not have to take down the round ligament.We next defined the extent of the recurrent hernia.There were several pockets with hernia sacs each having fascial defects approximately 2cm, and then there was a larger generalized weakness in the area, so we used a spinal needle passed through the abdominal wall to determine the size of mesh that would allow for at least 5 cm of overlap all way around, and we ended up needing a 15 cm x 20 cm oval physiomesh.We oriented it transversely.The mesh was then introduced into the abdominal cavity through the hasson trocar.It was unrolled, and then we used the suture passer and stab incisions to place through and through 2-0 ethibond stitches, 1st at the 12, 3, 6 and 9 o'clock , and then we placed stitches at 1:30, 4:30, 7:30 and 10:30 on the clock.These sutures were placed to anchor the mesh circumferentially without any undue tension or laxity.All the sutures were tied with the pneumoperitoneum diminished to 8 mm hg.We then used the secure strap tacker to secure the mesh circumferentially around the edges as well as a ring of tacks around the inner aspect of the mesh.These tacks were placed approximately every centimeter around the edge and wider on the interior portion of the mesh.A total of 60 tacks were used using 2 guns.We made sure we had good hemostasis.Then we used the suture passer to place a 2-0 vicryl fasciai stitch at the hasson trocar site.We then removed each 5 mm trocar under direct vision, and made sure there was no bleeding from any of these sites.¿ (b)(6) 2015: ¿only complaint is small area of superficial burning pain in the skin surrounding left upper quadrant trocar site; burning intermittent, exacerbated by any type of movement.Attempted to use percocet and flexeril; have not helped at all in managing this pain.Distressed about it; rates pain 8/10.The generalized and pain from the surgical repair resolved.Has not noted bulging or hernia recurrence.No fevers, nausea or vomiting.Eating/drinking well.Continues to smoke cigarettes.¿ ¿abdomen; soft, obese, nontender, nondistended.At present, not experiencing the burning pain, nor was i able to elicit any type of pain w/palpation.Bowel sounds normoactive.All surgical incisions healing well/well approximated.No surrounding erythema/drainage.¿ ¿abdominal cutaneous nerve injury.Discussed it is not uncommon to have cutaneous nerve disruption at trocar site; typically allow this to resolve over time, should resolve in approx.3 months.¿ (b)(6) 2015: ¿returns 5 weeks after lap recurrent ventral hernia repair w/mesh.Doing well; decreased and pain, pain left upper quadrant trocar site improving; only painful w/coughing, twisting or bending.Looser stools since surgery.¿ ¿no sign of recurrent hernia.Resume activity as tolerated.Would expect tenderness at hassan trocar site in luq to gradually subside.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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