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| Model Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Hernia (2240)
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| Event Date 05/27/2008 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use 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." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2003 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2008 and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: resection of gore mesh, extensive adhesiolysis of greater than 45 minutes, repair of recurrent ventral hernia with new mesh, explant of gore mesh due to infection and unincorporated mesh, incision and drainage of abscess, wound vac placed.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged it should be noted that the gore® dualmesh® biomaterial instructions for use 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.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2003: (b)(6) , md.History and physical.Ultrasound consistent with fibroids, right ovarian 7 cm cyst.Surgical history: had been admitted to hospital with abdominal pain, and in hospital for 10 days before she went to the operating room for exploratory laparotomy; revealed diverticulitis which was fairly close to rupture and underwent partial colectomy.Social: smokes two packs/week.Weight: 265 [lbs.] plan: total abdominal hysterectomy and bilateral salpingo-oophorectomy; will use same vertical incision as used during colectomy.Understands that due to morbid obesity and possibly scarring from previous surgery, this could be very difficult.Also understands that due to partial colectomy, she may have dense adhesions and may require a general surgeon to take these down.On (b)(6) 2003: (b)(6) , md.Operative report.Preoperative diagnosis: menometrorrhagia.7 cm right ovarian cyst.Postoperative diagnosis: menometrorrhagia.Small right ovarian cyst.Operation: supracervical hysterectomy.Right salpingo-oophorectomy with lysis of dense pelvic adhesions.Complications: none.On (b)(6) 2003: (b)(6), md.History and physical.Seen in office on (b)(6) 2003 for evaluation of incisional hernia at superior aspect of midline incision.Patient had a low abdominal hysterectomy in may.Noted a bulge with a cough which has now gotten progressively bigger.Social: smokes ½ pack of cigarettes a day.Alcohol rarely.Review of systems positive for chronic cough, abdominal pain, diverticulosis and heartburn.Abdomen: lower abdominal scar.Large incisional hernia approximately 4-5 cm at the umbilicus, easily reducible.No palpable intraabdominal masses.Impression: symptomatic and enlarging incisional hernia.Plan: laparoscopic incisional hernia repair.On (b)(6) 2003: [signature illegible].Pre-anesthesia record.Weight: 266 lbs., bmi: [48.6].Medical history: asthma, smoker, hypertension, morbid obesity, gastroesophageal reflux disease, anemia, cigarettes less than 1 pack/day.On (b)(6) 2003: [signature illegible].Anesthesia record.Asa class: iii.Implant #1 procedure: laparoscopic incisional hernia repair with mesh.Implant: gore® dualmesh® biomaterial [1dlmc06/02004805, 14 x 14 cm].Implant #1 date: (b)(6) 2003 (hospitalization [ni] [not indicated]).On (b)(6) 2003: (b)(6), md.Operative report.Preoperative diagnosis: symptomatic incisional hernia.Postoperative diagnosis: symptomatic incisional hernia.Anesthesia: general.Indications: the patient is a 43-year-old female who developed a large incisional hernia at the level of the umbilicus following a recent gyn procedure.The hernia was symptomatic causing pain and repair was recommended and accepted.Prior to surgery the risks of procedure including risk of anesthesia and possible need for open repair were discussed with the patient who voiced an understanding and agreed to proceed.Description of procedure: ¿after receiving preoperative antibiotics and with venous compression boots in place the patient was taken to the operating room and placed in the supine position.After induction of general endotracheal anesthesia og tube and foley catheter were placed and the abdomen was prepped and draped in a sterile fashion.The patient has had a midline incision as well as a sigmoid colon resection, therefore the peritoneal cavity was entered through an open technique through a right lateral incision.This was difficult entering the peritoneal cavity because of the patient¿s large body habitus.She had several inches of subcutaneous tissue.The s-retractors were used initially.These were not deep enough.The appendiceal retractors were then obtained and these were not deep enough in order to directly visualize the fascia and finally deaver retractors were required in order to expose the fascia.The incision had to be enlarged to accommodate this.Stay sutures were placed and the peritoneal cavity was entered allowing insufflation of pneumoperitoneum.The camera was inserted.The patient had a large amount of adhesions to the anterior abdominal wall and within the hernia sac.Under direct visualization a 10 mm right upper quadrant port was placed to lyse the adhesions.This was fairly slow going until enough of the anterior abdominal wall could be cleaned off to safely permit the placement of the second 10 mm trocar with which to facilitate the adhesiolysis by pulling down on the bowel loops and lysing them.All adhesions were lysed with sharp dissection, no cautery under direct visualization.As the contents were adherent within the hernia sac and because of a larger number of adhesions this took at least 60 minutes of time.Once this was accomplished the hernia defect was measured and a piece of dual mesh measuring 14 x 14 cm was cut.Stay sutures of 0 prolene were placed at 3, 6, 9 and 12 o¿clock and the mesh was passed into the abdominal cavity.With stab incisions with an 11 blade at 12, 3, 6, and 9 o¿clock the prolene sutures were brought through the abdominal wall and secured.Following the protek stapler was used to tack the hernia to the anterior abdominal wall.Laterally there was good coverage and the mesh was flat and was the far side away from the trocars.The protek stapler was utilized fairly easily with good stapling and coverage.Medially because of the difficulty of the exposure and the patient¿s large size and the placement of the protek sutures visualization of them was extremely difficult.The camera position was switched several times.Both the 30 degree scope and the 10 mm scope were utilized to facilitate this.An additional one or two prolene sutures were placed on the medial aspect to try to suture the area better rather than tack it in order to ensure that the defect was completely covered.This was eventually accomplished successfully although the procedure took approximately three and a half to four hours due to the density of the adhesions, the large body size and the difficulty with exposure because of the large body size and the large size of the hernia.At the conclusion it was felt that there was good coverage of the defect.The trocars were removed.Steri-strips were placed over the stab incision.The fascial defect at initial entry into the peritoneal cavity was closed with 0 vicryl sutures and the skin was closed with staples.Dressings were placed.The patient tolerated the procedure well and was taken to the recovery room in stable condition.¿ on (b)(6) 2003: implant sticker.Dualmesh biomaterial.Lot: 02004805.Item: 1dlmc06.[handwritten] expiration date: (b)(6) 2008.The records confirm a gore® dualmesh® biomaterial (1dlmc06/02004805) was implanted during the procedure.Relevant medical information: on (b)(6) 2004: (b)(6) , md.History and physical.44-year-old status post hysterectomy with lysis of dense adhesions on (b)(6) 2003; had severe pelvic adhesions.Has continued to have pain and has a large complex cystic mass 10.6 x 7.1 x 9.5 cm.Admitted at this time for resection of the bilateral ovaries and the septic mass.Abdomen soft, obese, nontender.Well-healed incision without herniation.Impression: complex cystic adnexal mass status post hysterectomy without bilateral salpingo-oophorectomy.Plan: exploratory laparoscopy, bilateral salpingo-oophorectomy.On (b)(6) 2004: (b)(6) , md.Operative report.Preoperative diagnosis: left adnexal mass.Postoperative diagnosis: multiloculated pelvic cyst of the left ovary.Massive pelvic adhesions.Operative procedures: exploratory laparotomy.Lysis of adhesions.Left oophorectomy.Removal of the pelvic left cyst and ovary.Assistant: (b)(6), arnp.Anesthesia: dr.Heller.Description of procedure: ¿the patient was brought to the operating room after induction of excellent general anesthesia with a full preoperative mechanical and chemical bowel prep, preoperative deep venous thrombosis prophylaxis with compression hose, subcutaneous heparin, and preoperative intravenous antibiotics.She was positioned in the supine position for abdominopelvic surgery.A low transvers pfannenstiel incision was made, extended to a cherny¿s type incision.Due to the anterior previous placement of mesh, we felt that a pfannenstiel incision was an appropriate way to access this patient¿s abdomen, avoiding the mesh and minimizing the risk of recurrent hernia.Transverse pfannenstiel incision was carried down through the skin, subcutaneous tissue, scarpa¿s, and fascia.Subfascial tissues were dissected down.The peritoneum was densely adherent to omentum, and it was difficult to find a dissection plane.Careful dissection with metzenbaum scissors was done to enter the peritoneal cavity, and then multiple adhesions were lysed.About an hour of manual dissection with both blunt and sharp dissection was done, carrying out to gain access to the pelvic cavity.A buchwalter retractor was placed over the patient and positioned, and then using most lap tapes, the bowels were gently packed away as lysis was continued, freeing up the sigmoid colon, and the bowels and upper abdominal area.Omentum was densely adherent to the left pelvic sidewall and left ovarian mass.There was a multiloculated, clear, fluid-filled cystic mass occupying the pelvis, and extending out to the left adnexa.This was carefully dissected out with meticulous and tedious dissection with sharp metzenbaum scissors using countertraction with gently placed retractors using the buchwalter retractor to obtain visualization.Once this cyst and ovary were resected, free ties of 3-0 vicryl and 4-0 silk were used to obtain hemostasis.The ovary was removed.The area was irrigated and inspected, good hemostasis was noted.As a precaution, because of the extensive adhesiolysis, i felt that a jackson-pratt drain was indicated, and due to the patient¿s morbid obese condition.We set a jackson-pratt drain through a separate stab incision on the right side for the subcutaneous tissues, and on the left side through the fascia and down into the pelvis to obtain drainage through both into the intraabdominal pelvic cavity and through the subfascial space.These were 10 mm jackson-pratt drains.Once the jackson-pratt drain was placed, a correct instrument, sponge, and needle count was obtained.The fascia was closed with a #2 nylon in a running fashion.The subcutaneous tissues were irrigated and inspected, and a jackson-pratt drain was placed at the level of the fascia, and then the skin was closed with surgical steel clips.Two jackson-pratt drains were anchored with 0-silk at the site of the skin penetrations.Instrument counts: correct instrument, sponge, and needle counts.Estimated blood loss: 350 cc.The operation was completed.The patient was brought to the recovery room in satisfactory condition.¿ on (b)(6) 2008: (b)(6) surgical group.(b)(6), md.Office notes.Referred by dr.(b)(6) because of a large ventral hernia.She is obese, has had a ventral hernia repaired once before with mesh.She has had a recurrence.She was seen by a local surgeon, dr.(b)(6) who states that she is too high risk and difficult to repair.She has had this incarcerated in the past.It has been reduced but now it is persistently protruding, causing her significant abdominal pain, intermittent abdominal cramps, suggestive of partial bowel obstruction and now she can¿t function because of persistent pain.Medical history: cesarean section, hypertension.Social: currently smoking.No alcohol abuse.Abdomen: obese, soft, palpable large ventral defect, with probable omentum and bile nonreducible.Tender to palpation.Impression: incarcerated ventral hernia, recurrent.Plan: wishes surgical repair.Explained to her with her large size and this being done a second time, she does have higher incidence of recurrence, wound infection and graft infection.Understands these risks and is willing to proceed.Can schedule for martin memorial north in the next week or two for a ventral hernia repair with mesh, an all indicated procedures.On (b)(6) 2008: [signature illegible].Pre-anesthesia record.Weight: 290 lbs.Positive smoker; cigarettes, less than 1 pack/day.Morbid obesity.Surgical history: colon resection (b)(6) 2001, incisional hernia 2003, hysterectomy (b)(6).On (b)(6) 2008: [signature illegible].Anesthesia record.Asa 3.Implant #2/explant #1 procedure: resection of old ventral mesh.Extensive adhesiolysis of greater than 45 minutes.Repair of ventral defect with gore-tex mesh.Implant: gore® dualmesh® biomaterial [ni/05530182, 10 x 15 cm].Implant #2/explant #1 date: (b)(6) 2008 (hospitalization (b)(6) 2008).On (b)(6) 2008: (b)(6), md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Assistant: (b)(6), p.A.-c.Anesthesia: general.Details of procedure: ¿after prepping and draping the abdomen, a midline incision was made down through the previous incision site.Dissection was carried down through subcutaneous tissue and the hernia sac was immediately encountered.Cephalad dissection demonstrated a totally disrupted old gore-tex mesh.This was identified, grasped and then we dissected all adhesions from this circumferentially very meticulously to avoid injury to the bowel.This was carried on for quite an extensive period of time until it was completely circumferentially freed.It had been endo-tacked in position and these tacks were removed and the mesh was finally resected.There was a very large hernia sac with multiple loculated adhesions with large bowel and omentum.These were dissected out extensively and the combination of adhesial lysis was greater than 45 minutes.Once this was all freed up and we identified all fascial edges, the hernia sac was resected and sent for pathological exam.The viscera was then placed back in its normal anatomical position.Taking a mycellated dual mesh of gore-tex, we tailored it to the appropriate length and shape and then tacked it circumferentially with u-shaped stitches of 0 prolene.This was all done with the assistance of (b)(6).Once this was completed, we irrigated the wound.Two jackson-pratt drains were placed in the empty pocket for the previous sac and once this was completed, we then secured the jackson-pratt drains with 2-0 silk.The skin was closed with staples.A surgical dressing was applied.The patient tolerated the procedure well without complications and taken to recovery room in satisfactory condition, hemodynamically stable.¿ on (b)(6) 2008 [assigned]: (b)(6).Implant record.Stock #: 0002209.Description: mesh dual 10cm x 15 cm.Lot #: 05530182.Serial #: [ni].Quantity: 1.Vendor: gore.Site: ventral hernia.Expiration date: 11/04/2012.The records confirm a gore® dualmesh® biomaterial ([ni]/05530182) was implanted during the procedure.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore 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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® 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.The instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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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