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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].Other relevant history: medical record.Adverse event problem health effect.Investigation finding.Investigation conclusions.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) 2003: (b)(6) hospital.Dr.(b)(6), md.Operative report.Assistant: nurse (b)(6), np.Procedure: laparotomy.Distal left salpingectomy with ovarian cystectomy.Preoperative diagnosis: left adnexal mass.Postoperative diagnosis: benign left ovarian cyst.Anesthesia: general.Procedure: ¿the patient was taken to the operating room and placed on the operating table in supine position.General endotracheal anesthesia was introduced.The patient was sterilely prepped and draped in the usual fashion for laparotomy.Patient is morbidly obese and we had attempted laparoscopic removal of her left adnexal mass, but were unable to do so because of inability to place the trocars within the abdominal cavity secondary to abdominal wall obesity.Patient therefore had a laparotomy.An approximately 8 cm midline vertical skin incision had been made from the synthesis pubis, close to the umbilicus.This incision was extended downward through the subcutaneous and fascial layers until peritoneal cavity was opened.The l4 retractor was placed.Bowel was packed out of the operative field.Uterus and right adnexa are normal.Left fallopian tube in the distal segment was adherent to benign-appearing cyst arising from the left ovary.Cyst was approximately 4 cm in diameter.Kelly clamps were used to clamp across the base of the cyst, removing the distal portion of the left fallopian tube and a small portion of the ovary itself in addition to the ovarian cyst.Specimen was excised.Pedicles were secured using 0 vicryl stitch.Another figure-of-eight suture was placed into the surface of the ovary at this area of excision of the ovarian cyst for hemostasis.Good hemostasis was then noted.Packings and retractor were all removed.Parietal peritoneum was closed with a running 3-0 polysorb running suture.Fascia was repaired with two separate running sutures of 0 pds.Subcutaneous tissue was reapproximated with a running 3-0 polysorb suture.Skin was reapproximated with staples.Patient tolerated all of this quite well.She was taken to the recovery room in good condition.There were no immediate problems.Urine continued to drain clear at the end of the operation.¿.(b)(6) 2005: (b)(6) medical center.Dr (b)(6), md.Radiology.Pelvic ultrasound, transabdominal and endovaginal.History: pelvic cramping pain for 2 months.Impression: 2 cm transmural fibroid in the anterior wall of the uterus.(b)(6) 2005: (b)(6) hospital.Dr (b)(6), pac/dr (b)(6), md.Emergency department visit for chief complaint of a painful lump in the lower mid abdomen.History of left ovarian cystectomy.Was informed she has a hernia in this location one month ago.She was advised to have it surgically corrected.Physical exam: an obese female who does appear to have an upper incisional hernia.When she raises her head up, the tender area does protrude; but when she relaxes, it is easily reducible.Impression: incisional hernia, urinary tract infection, status post left ovarian cystectomy in 2003.Plan: levaquin, pyridium, follow up with dr.(b)(6).(b)(6) 2005: (b)(6) hospital.Dr (b)(6), md.Operative report.Procedure: laparoscopic adhesiolysis and laparoscopic repair of incisional hernia.Preoperative and postoperative diagnosis: incisional hernia.Procedure: ¿under general anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion, and trocars were appropriately placed for a laparoscopic procedure.Dense adhesions were taken down extensively.This took approximately 45 minutes.That having been performed, a large piece of mesh [product id not provided] was placed into the peritoneal cavity and pexed to the abdominal wall, obliterating the hernial defect.Hemostasis was established.No other abnormalities were noted and the trocars were removed.The patient tolerated the procedure well and left the operating room in stable condition¿.(b)(6) 2005: (b)(6) hospital.Dr (b)(6), md.Emergency department visit for chief complaint of abdominal pain in the right lower quadrant for 48 hours.Prior surgery on (b)(6) 2005 for hernia repair.Physical exam: abdomen: obese.There is tenderness to palpation in the right pelvic area without peritoneal signs.Ct abdomen and pelvis showed an 8 x 9 x 8 cm fluid density between the abdominal wall and the mesh that appeared to indicate a seroma.It did not appear to indicate abscess.There was also a right ovarian cyst measuring 5x3 cm and a small amount of free air.Diagnoses: abdominal pain of unclear etiology.Ovarian cyst.Abdominal wall seroma.Discharge instructions: naproxen, tylenol, follow up with operating surgeon for seroma, and follow up with primary care for ovarian cyst.Discharged to home in improved condition.(b)(6) 2005: radiology.Dr (b)(6), md.Ct abdomen/pelvis with contrast.Impression: 1.Probable large physiologic cyst of the right ovary.Recommend sonographic follow up in approximately 6 weeks to assure regression and help exclude the unlikely possibility of an endometrioma, paraovarian cyst, or cystic neoplasm among other possibilities.This probably relates to the cul-de-sac fluid.2.Oblong fluid collection lying anterior to the mesh with a smaller portion herniating into the subcutaneous fat of the anterior abdomen.No additional findings two suggests that this collection is infected and i suspect this represents a postoperative seroma.(b)(6) 2006: (b)(6) medical center, dr (b)(6), md: ct abdomen/pelvis with contrast.History: previous hernia repair, fluid collection lower abdomen/pelvis.Findings: there is evidence of low abdominal/pelvic ventral hernia repair with mesh present.Anterior to this mesh is a somewhat irregularly-shaped fluid collection extending into the subcutaneous fat.This has maximum transverse dimension of 10 cm x approximately 3.6 cm.This could represent a post surgical fluid collection or seroma.There is no gas density seen within this to suggest abscess, however, this could not be completely excluded.Impression: ¿irregularly shaped fluid collection located anterior to ventral hernia mesh extending into the subcutaneous fat anteriorly¿.(b)(6) 2007: (b)(6) medical center.Dr (b)(6), md.Operative report.Assistant: dr.(b)(6).Preoperative diagnosis: a 28-year-old with symptomatic leiomyoma.Postoperative diagnosis: symptomatic leiomyoma plus significant bowel adhesions and anterior wall hernia.Procedure: total laparoscopic hysterectomy, bilateral salpingo-oophorectomy with enterolysis and cystoscopy.Findings: 1.Cystoscopy was normal at the end of the case with normal ureteral peristalsis and intact bladder.2.Anterior wall hernia site with mesh covering significant omental and bowel adhesions taken down there.3.Small bowel adhesions and colonic adhesions to the posterior uterus and left adnexa.Procedure: ¿the patient taken to the operating room and general anesthetic was undertaken.The patient was prepped and draped in the usual fashion for vaginal and abdominal surgery.Surgeons scrubbed and gowned.A long tip medium cup rumi placed after cervical dilatation per routine.Gloves were then changed.Umbilical 1 cm incision made through the punctum of the uterus while tenting the abdominal wall up and opening up the rather deep umbilicus with kocher.Optiview trocar then attempted to be placed intracorporeally in the typical fashion tenting the abdominal wall up with towel clamps.Had to use the extra long 10-12 mm trocar.Able to get to a level that i thought were through the fascia but it was unclear if we were in a pocket of adhesions or in the posterior fascia pocket unable to exit through the umbilicus succeed in getting an intracorporeal visualization.This was then abandoned.Oral gastric tube placed midclavicular line left upper quadrant two fingers below the costal margin.We then placed a 10-12 mm trocar site while tenting the abdominal wall up with towel clamps.Able now to visualize intracorporeally and insufflation gas held.She had a mesh placement with metal tacks.Able to visualize about half of it.The rest of it was involved with dense adhesions around the umbilicus and lower abdomen.Able to place a right mid abdomen trocar and left lower quadrant trocar.5 mm long ports under direct visualization and over the next 25 minutes took down anterior wall adhesions giving us a clear view down to the pelvis now.Due to the size of her pannus and body habitus, i actually operated through the left upper quadrant port the entire case, never finished the umbilical incision because that would require also going through the hernia mesh.There was a small hernia to the left of midline with rectal diastasis above the level of the bladder site was noted but not significant.Placed a trocar 5 mm through that avoiding the dome of the bladder.Adhesions of the colon to the posterior uterus, small bowel to the posterior uterus were now taken down sharply without cautery and skeletonized the left infundibulopelvic ligament.Put down the right ligament and eventually able to take adhesions off the left ovary.This took probably 30 minutes or more.The rest of the majority of the case was actually time wise spent trying to get normal anatomy before the hysterectomy began.Once all the adhesions were done i was able to visualize the cul-de-sac adequately.Bipolar crossed both infundibulopelvic and subsequently round ligaments and then separating the sheaths of the broad ligament in a typical fashion at all times with vigorous medial and cephalad retraction to get down to the uterine vessels without further difficulty.Bipolar crossed the uterine vessels bilaterally, anterior bladder flap taken down.She had two previous c-sections.This was carefully taken down.I was able to visualize the pubocervical fascia without difficulty.Anterior colpotomy then made and bipolars were used to cross the vessels once again.Circumferential monopolar crossed the plastic colptomizer ring performed and the uterus was then removed through the vagina.Six interrupted stitches of 0 pds placed laparoscopically through the cuff.Copious irrigation performed.No further issues being noted.Very difficult visualizing the ureter and impossible on the left hand side, challenging on the right, plus all the adhesions, we did cystoscopy after the end of the case.The gas removed, instruments removed, trocars removed once assuring good integrity and good hemostasis.The left upper quadrant 10-12 was closed with a carter thompson after switching to a 5 camera.The skin closed with 2-0 monocryl subcuticular bupivacaine injection.Cystoscopy was performed.We had given her indigo carmine during the cuff closure.150 ml of water injected in the bladder through the foley.The foley was removed.5 mm 0 degree laparoscope then used to cystoscopically evaluate the bladder.The bladder was intact, normal ureteral peristalsis with indigo carmine from both ureteral orifices.The patient to the recovery room having tolerated the procedure well¿.(b)(6) 2007: dr (b)(6), md.Pathology.Uterus, tubes, and ovaries.Microscopic description: ¿the uterine cervix shows moderate inflammation with squamous metaplasia.There is no dysplasia.The leiomyoma is moderately cellular with prominent areas of cystic degenerative changes.The mitotic index is low and there is no significant cellular atypia.The endometrium is proliferative without atypia, sections taken through both ovaries reveal bilateral follicular cysts.The fallopian tubes are unremarkable.¿ implant #1 preoperative complaints: (b)(6) 2008: (b)(6) medical center, dr (b)(4), md.Radiology.Ct abdomen/pelvis with contrast.Clinical history: possible incisional hernia, abdominal pain.Findings: patient is status post repair of an anterior abdominal wall hernia.Anterior mesh extends approximately 4 cm above and 6 cm caudal to the umbilicus.Inferior to the mesh, an additional anterior abdominal wall hernia is demonstrated on today's study, measuring 7 cm in craniocaudal dimension, 5 cm in ap dimension, and approximately 10 cm in transverse dimension.Hernia sac contains a small bowel loop.There is no small bowel obstruction, however.Small bowel caliber is normal throughout the abdomen.There is no colonic dilatation.Impression: anterior abdominal wall hernia below the level of the previous mesh repair.There is a small bowel loop within the hernia sac, no small bowel dilatation is present to suggest obstruction.Implant #1 procedure: repair of recurrent incisional hernia.Implant: gore® dualmesh® plus biomaterial [1dlmcpo6/(b)(4) 18cm x 24cm x 1mm, rectangle.Handwritten notes: ¿20 x12 cm dual mesh placed¿.Implant #1 date: (b)(6) 2008 [hospitalization dates unknown].(b)(6) 2008: (b)(6) medical center.Dr (b)(4), md.Operative report.Preoperative and postoperative diagnosis: recurrent incisional hernia.Anesthesia: general.Procedure: ¿the patient was brought to the operating room and placed supine on the operating table.Following the establishment of general anesthesia, the abdomen was prepped with duraprep and draped in a sterile fashion.A midline abdominal incision was made from just above the umbilicus to the symphysis pubis reopening an old surgical incision.Dissection was carried down through the subcutaneous tissue to the fascial level.Bleeding areas were controlled with electrocautery.The scarred linea alba was then incised.A hernia sac was encountered initially superiorly below the umbilicus.This was entered in dissected.Eventually the incision in the fascia was extended from slightly above the umbilicus through the symphysis pubis under direct vision.There was a segment of mesh present in the abdomen from a previous repair period this appeared to have pulled away along the left side and was surrounded by peritoneal sac.There were multiple spiral tackers noted about this edge of the mesh.The hernia seemed to extend all the way from the umbilicus to the symphysis pubis.It was apparent this old mesh needed to be excised.Gradually with some difficulty, we were able to excise all the old mesh including most of the tackers.Once this was done, the fascial defect could be defined.This extended really for most of the midline from the umbilicus to the symphysis pubis.Rectus muscles had also slid laterally in this very obese patient.The peritoneum was then debrided, and decision was made to place a large piece of gore dualmesh.The size of the mesh required was about 20 x 10-12cm.This was cut to an appropriate size.This mesh was interposed in this defect and secured there with interrupted 0 ethibond sutures.The ethibond sutures were placed through the fascia, through and through the mesh and back through the fascia.All sutures were placed in tide at completion, taking care to prevent any entrapment of bowel loops.This seemed to provide an adequate closure of this defects.Following this, the area was checked for hemostasis in this appeared satisfactory.A 15 round jackson-pratt catheter was placed in the wound and brought out through a separate stab wound to the right side of the incision.Incision was then closed with 3-0 vicryl suture on the subcutaneous tissue in subcuticular vicryl suture on skin.Sterile dressing was applied.¿ (b)(6) 2008: (b)(6) medical center.Implant sticker.¿gore dualmesh® plus¿.Ref catalogue number: 1dlmcpo6.Lot batch code: (b)(4).Expiration: 5/2010.W.L.Gore & associates.Relevant medical information: on (b)(6) 2010: (b)(6) medical center, (b)(6).Ct abdomen/pelvis with contrast.History: abdominal pain and ventral hernia repair.Findings: ¿there is a mesh repair of the lower abdominal wall which has been revised.Old healed midline infraumbilical incision is present.The ventral hernia inferior to the mesh repair is increased in size.It extends to the left of midline inferior to the pubic symphysis and contains fat as well as small bowel loops which are opacified with contrast.Superiorly it is contiguous with the mesh repair.Hernia sac measures approximately 20 cm in length x 6 cm in ap dimension.Along the anterior margin of the hernia sac there is a fluid collection measuring approximately 6 cm x 2 cm with some adjacent stranding of the soft tissues.There is no evidence of bowel obstruction.Impression: 1.Revised ventral hernia repair with recurrent inferior ventral abdominal wall hernia containing fat and small bowel without obstruction.2.Status post hysterectomy.Revision #1, implant #2 preoperative complaints: (b)(6) 2010: (b)(6) medical center.Dr (b)(6), md.Indications: a 32-year-old woman who suffers from morbid obesity.She has had a previous open hysterectomy.She has undergone 2 ventral hernia repairs in the past, both of which have failed.She now presents with a painful recurrent ventral hernia.Revision #1, implant #2 procedure: laparoscopic lysis of adhesions.Open ventral hernia repair.Implant: gore® dualmesh® plus biomaterial [product identification not provided].Revision #1, implant #2 date: (b)(6), 2010 [hospitalization dates unknown].(b)(6) 2010: (b)(6) medical center.Dr (b)(6), md.Operative report.Assistant: dr.(b)(6).Preoperative and postoperative diagnosis: recurrent ventral hernia.Anesthesia: general.Estimated blood loss: 100 ml.Procedure: ¿after informed consent was obtained, the patient was brought to the operating room and placed in supine position.General endotracheal anesthesia was attained.The patient's abdomen was prepped and draped in the usual sterile fashion.Timeout was performed.A small transverse incision was made in the left upper quadrant.Using a 5 mm scope and the optiview device, the abdomen was entered.The abdomen was insufflated to 15 mmhg with carbon dioxide gas.There were extensive adhesions to the previously placed mesh in the lower abdomen.A 12 mm left-sided port was placed, as well as a 5 mm port.Careful sharp dissection was then performed to lyse the small bowel, as well as omentum that were adhesed up to the anterior abdominal wall.A 12 mm right-sided port as well as a 5 mm right-sided port were also used to assist with this.Once the lysis of adhesions was complete, it was evident that there was a very large hernia sac inferiorly off to the left where the mesh had pulled away.This is very close to the bladder, and with the patient's large body habitus this to be not going to be able to be done laparoscopically, therefore a lower midline incision was created and carried down through the subcutaneous tissues.The previous mesh was incised.The fascial edges were identified circumferentially.The left rectus abdominis muscle had retracted laterally quite a bit.Flaps were raised.I was able to get a rim of fascia inferiorly.A 19 x 15 cm piece of dualmesh plus was then brought into the field.It was sewn in an underlay fashion using #0 prolene sutures.At the end, the mesh was tautly approximated.The fascial edges were approximated with a running #1 vicryl suture.Two 19-french blake drains were placed, secured to the skin with 3-0 nylon suture.Subcutaneous tissues were approximated with running 2-0 vicryl suture.The skin was closed with staples.Sterile dressings were applied.The patient awoke from anesthesia and transferred to the recovery room.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, 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® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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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