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H6: codes b21 / c20 - product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: ¿ 2/23/09: (b)(6) medical center.(b)(6), do.Operative report.Indications: ¿the patient is a 38-year-old female patient who presents with an incisional hernia at a midline incision from a previous ovarian cystectomy.The patient is morbidly obese with bmi of 43.2 and she desired repair of this since she finally delivered a healthy baby in november of 2008.The operation was deferred until she had recovered post-partum.Proper consent was obtained to proceed with laparoscopic repair.¿ implant procedure: laparoscopic incisional hernia repair with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp06/05889124, 18cm x 24cm x 1 mm thick] implant date: (b)(6), 2009 (hospitalization dates unknown) (b)(6) 2009: (b)(6) medical center.(b)(6), do.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: scant.Specimens: none.Findings: 6 x 15-cm total hernia are repaired utilizing 16 x 24-cm piece of dual mesh bio material and 16 transabdominal sutures.Procedure: ¿the patient was brought to the operating suite and prepped and draped in the usual sterile fashion.A large ioban dressing was placed over the entire abdomen.Initial access to the abdomen was obtained using an optical viewing trocar in the left lateral abdomen.Upon entry into the abdomen, the abdomen was insufflated to 15 mmhg.A thorough inspection of the abdomen was carried out.There was no other intra-abdominal pathology noted and no injury from placement of the trocar.Under direct visualization, we placed 2 additional 5-mm trocars along the left lateral abdomen.We began to perform meticulous and tedious sharp lysis of adhesions.There was noted to be some incarcerated omentum in a very superiorly located hernia as well as a more inferiorly located hernia.This was completely reduced and there was good hemostasis on the operative field.Once we assessed the anterior abdominal wall, there appeared to be a well circumscribed hernia at the superior aspect of the patient¿s old incision as well as complete weakness and hernia formation of the mid and lower aspect of the incision.Spinal needles were placed at the extreme edges of the hernia defect and using an intracorporeal umbilical tape held taut, the entire defect area was measured to be 6 cm horizontally x 15 vertically.When we chose an 18 x 24-cm piece of dual mesh bio material, cut it to 16 x 24 cm.A gore vc suture was placed at each edge of the mesh.The mesh was rolled like a scroll and after placing a 5-mm trocar in the right lateral abdomen and switching out for a 10-mm trocar in the left lateral abdomen, we dragged the mesh into the abdominal cavity and unrolled it completely.I retrieved the inferior transabdominal suture first by measuring a 5-cm overlap along previously marked y axis on the anterior abdominal wall and the transabdominal suture was retrieved.I then measured a 5-cm overlap from the right lateral spinal needle along the x axis and retrieved the right lateral suture.With these 2 sutures held taut but untied, the mesh was stretched taut superiorly using a spinal needle to mark along the y axis where the transabdominal suture would be retrieved, the suture was retrieved using the gore suture passer.With these 3 sutures in position, the mesh lay taut against the anterior abdominal wall.The 3 sutures where then tied.Additionally, the left lateral aspect of the mesh was stretched laterally towards the left aspect of the abdomen and a spinal needle was used to mark out the site of suture retrieval along the x axis on the left.This suture was then retrieved and the mesh lay in good position against the anterior abdominal wall.We then tacked the mesh circumferentially approximately every 2 cm around the entire circumference of the mesh.I then placed three #1 novofil sutures for additional suture fixation in each quadrant of the mesh for a total of 16 transabdominal sutures.At the conclusion, the mesh lay in good position against the anterior abdominal wall with more than adequate overlap circumferentially around the hernia defect area.There was hemostasis in the operative field.I then closed the 10-mm trocar site defect on the left lateral abdomen using #1 novofil suture on the suture passer using figure-of-eight technique.The abdomen was completely desufflated.The fascial suture was tied.The trocars were removed.The fascial suture was tied down and the skin was closed with 4-0 monocryl and dermabond skin glue.In essence, the mesh covered the entire previous incision.The patient tolerated the procedure well and was transferred to the recovery room in stable and satisfactory condition.¿ (b)(6) 2009: (b)(6) hospital system.Implant sticker.Implant: gore dualmesh®plus biomaterial.Ref/catalogue number: 1dlmcp06.Lot/batch code: 05889124.Manufacturer: w.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp06/05889124) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2013: regional surgical specialists.(b)(6), md.Office notes.Patient returns for evaluation of ventral hernia.Has had hernia for years now and has failed previous attempts at repair.Has lost weight from 345 to 317.Reports constipation and abdominal pain associated with the hernia.No evidence of bowel obstruction per history.Medical problems: cardiac murmur, morbid obesity, osteoarthritis, hypertension.Past surgical history: ventral hernia repair in 2009; caesarean section x 2 in 2000 and 2002; right oophorectomy 1991.Current every day smoker; ½ pack per day.Bmi 66.36.Exam: abdomen obese, soft, tender to palpate at midline hernia.Hernia is incarcerated and not able to be reduced.Plan: patient wishes to have hernia repair.At high risk for recurrence because of her body habitus.She acknowledges the need to continued weight loss.Will schedule hernia repair as laparoscopic possible open repair.Patient agrees.(b)(6) 2013 - [date of discharge unknown]: [facility ni; possibly (b)(6) regional].Inpatient hospitalization.(b)(6) 2013: [facility ni; possibly (b)(6) regional] (b)(6), md.Operative report.Indication: a 42-year-old female with previously fixed laparoscopic hernia, now with recurrence.The patient has had increasing pain of incarceration.Preprocedure diagnosis: incarcerated incisional hernia.Postoperative diagnosis: incarcerated incisional hernia.Procedure: laparoscopic incarcerated incisional hernia repair with lysis of adhesions.Lysis of adhesions was greater than 5 hours greater than 80% of the case.Assistant: (b)(6), do.Anesthesia: general.Specimens: omentum incarcerated.Procedure: ¿a 42-year-old female was brought to the operating room, prepped and draped in normal sterile manner.Dr.(b)(6) was scrubbed and present throughout the entire case.Initially, a right upper quadrant 10 mm port was placed using the hasson technique under direct vision.This was placed in the abdomen, immediately encountered was a large number of dense adhesions.Initially, a right lower quadrant port was placed and was used to start dissecting free adhesions.There were dense adhesions from the omentum and the fat along the right side as well as the bowel that was obviously adherent to the midline area and structures.The prior mesh repair had adhesions to it over the entire abdomen.Bowel adhering to most of the middle abdominal previous tacks placed.In taking down the right-sided omentum, a bleeder was encountered.Clips were placed and then finally through using harmonic bleeding was controlled.Next, taking down the dense adhesions, we placed a left-sided ___ port.Long tedious dissection was done to get the dense adhesions of the bowel down from the previous tacks problems.This was done with sharp dissection using scissors.Numerous transitions and changing of vantage point was done to optimize the lysis of adhesions.Harmonic was used then to take down lot of omentum that was adherent all along the right side of midline of the patient.Once this was done, the hernia defect was seen to be over the top of the previous prior mesh.A large quantity of omentum was removed out of there.The entire abdomen was rinsed and irrigated several times and no bleeding was seen to be active.After this, a 20 x 25 cm piece of bard mesh was used with the cephalad caudad dimension being 20 cm.Two gore-tex sutures were placed anterior and cephalad and caudad and two lateral 1-0 proline were placed.Mesh was rolled and placed into the abdomen.Suture passer was used to bring these up after stab incisions.A total of 4 prolene were used then in evenly spaced quadrants for a total of 8 stitches to be brought up.Once this was done, the securestrap was used to place the mesh against the abdominal wall.This was only successful on the anterior half as the posterior inferior half where the prior mesh was, the securestrap was not placed through, so we had use a protack to gain purchase into the tissue.Once this was done, this mesh also covered up out hasson port and 5 mm port.Abdomen was inspected again, irrigated and found to have no bleeding.The entire abdomen at that time was inspected again.No injury was seen.The hasson port was then closed.Another figure-of-eight 0 vicryl stitch was placed to gain excellent closure.All ports were removed under direct vision.No bleeding was seen and the skin incisions were all closed with staples.The patient went to pacu in good stable condition.¿ (b)(6) 2013: (b)(6) regional.(b)(6), md.Pathology.Diagnosis: incarcerated omentum, excision: fibroadipose tissue with vascular congestion.Clinical history: preoperative diagnosis: ventral hernia.Postoperative diagnosis: same.Specimen(s): incarcerated omentum, incisional hernia, excision.Gross description: received ¿incarcerated omentum, incisional hernia¿ is 20 x 8 x 1 cm aggregate of multiple yellow lobulated omentum tissues with focal tan-red congested area.No adherent frbromembranous tissue is grossly identified.(b)(6) 2013: (b)(6) regional.(b)(6), md.Discharge summary.Discharge diagnosis: incisional ventral hernia, recurrence, status post repair.Respiratory insufficiency, resolved.Discourse: status post hernia repair.Diet was advanced over few days.At time of discharge she was tolerating regular diet and ambulating some.The patient at times unwilling to ambulate and get out of bed.Pain was well controlled on pain medications by mouth.Had some respiratory insufficiency, schedule breathing treatments, respiratory required to help with pulmonary toilet.Leukocytosis resolved by discharge.Patient will be going home.Okay to shower.Encourage ambulate more.No lifting greater than 5 pounds for 6 weeks.Follow up with dr.(b)(6) in 1 week.Explant procedure: [ni; not indicated].Explant date: [ni].It should be noted that the current 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.¿ 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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"the investigation has been completed.Based upon the totality of the information received over the course of the investigation 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 current 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.¿ the devices were not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for these devices, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as valid lot numbers were 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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