|
Model Number 1DLMCP03 |
Device Problems
Use of Device Problem (1670); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Adhesion(s) (1695); Discharge (2225); Hernia (2240)
|
Event Date 08/22/2011 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material¿.¿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¿.
|
|
Event Description
|
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2006 whereby a gore dualmesh® plus biomaterial was implanted.It was reported the patient also underwent open repair of an incisional hernia on (b)(6) 2006 whereby a second gore dualmesh® plus biomaterial was implanted.The complaint alleges that two explant procedures were performed on (b)(6) 2011 and (b)(6) 2012.It was reported the patient alleges the following injuries: hernia recurrence, adhesions, mesh removal, draining sinus tract, and mesh infection.Additional event specific information and medical records have been requested.
|
|
Manufacturer Narrative
|
Added date of birth.Updated manufacturing and sterilization evaluation results code.Conclusion code remains unchanged.
|
|
Manufacturer Narrative
|
Corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2006 indicate the patient underwent: ¿1.Laparoscopic transabdominal repair of recurrent incarcerated incisional hernia with mesh.2.Extensive laparoscopic lysis of adhesions.¿ postoperative diagnosis states: ¿incarcerated recurrent incisional hernia, symptomatic.¿ records prior to 2006 were not provided to gore.Findings from the (b)(6) 2006 procedure state: ¿there was a quite large recurrent incarcerated incisional hernia just to the right of the midline along the cesarean section scar.This was on the edge of the previous mesh which was identified.A 10 x 15 cm piece of dual gore-tex mesh was then placed transversely.There were dense adhesions including omentum and small intestine which were incarcerated within the hernia sac itself.The hernia was quite larger than anticipated.¿ the (b)(6) 2006 procedure notes state: ¿using a combination of blunt dissection, cautery and harmonic scalpel, all adhesions including omentum and small intestine were taken off of the intraabdominal wall until the chronically incarcerated component of the incisional hernia was visualized fully and this contained the small intestine.This was meticulously dissected free from the hernia sac using the harmonic scalpel with some of the dissection being preperitoneal.This was eventually reduced and approximately over one hour was spent lysing adhesions and taking down all adhesions including omentum and small intestinal adhesions so as to fully visualize the fascial defect which was eventually visualized and on the inferior and right lateral aspect did contain some old mesh.The hernia itself was quite larger than anticipated.It was felt that it would be a 3 cm hernia and it turned out to be more of approximately 7 cm.¿ the (b)(6) 2006 records state: ¿once some dissection was carried out a 10 x 15 cm right angular piece of dual gore-tex mesh was chosen, oriented with a marking pen and a 2-0 vicryl suture placed in the middle of the mesh.The mesh was then placed intraperitoneally and positioned transversely across the fascial defect in the right lower quadrant along the cesarean section scar.An endoclose was placed through the middle of the fascial defect and the 2-0 vicryl within the mesh grasped and pulled up so as to oppose the hernia to the anterior abdominal wall, and this was secured using multiple endo-tacks.Once the surgeon was satisfied there was good and complete coverage of the fascial defect, all instruments were removed and pneumoperitoneum evacuated.Prior to this the bowel was inspected and there was no evidence of bowel injury.¿ the records indicate a gore dualmesh® plus biomaterial (1dlmcp03/0380313) was used during the procedure.Operative records dated (b)(6) 2006 indicate the patient underwent repair of a chronically incarcerated symptomatic umbilical hernia.Findings from the procedure state: ¿the hernia sac was quite large but the fascial defect only measured approximately 1.5 cm in size.¿ the (b)(6) 2006 operative report states: ¿with the patient prepped and draped in the usual sterile fashion, curvilinear incision was made on the inferior aspect of the umbilicus and deepened down to the hernia sac.This was skeletonized almost circumferentially down to the fascial defect.The superior aspect of the hernia sac was extremely densely adherent to the umbilical skin and on attempting to dissect the sac, a button hole was made in the umbilical skin deep within the umbilicus.This was repaired using figure-of-eight 3-0 vicryl suture for the dermis.The decision was therefore made to leave part of the hernia sac in situ which was adherent to the umbilical skin.The remainder of the sac was excised down to fascia and submitted to pathology.The fascial layers were dissected and cauterized circumferentially and fascial defect only admitted the surgeon¿s index finger.Given the button hole in the umbilical skin and given the small size of the hernia, we elected not to place mesh.The fascial defect was repaired transversely using several interrupted 0 ethibond sutures.Palpation revealed good repair following placing the sutures.The deepest aspect of the umbilicus was then tacked to the fascia with a single 3-0 vicryl suture and subcutaneous tissues also closed with interrupted 3-0 vicryl sutures followed by skin staples and sterile dressings.This completed the procedure.The patient was taken back to the recovery room in stable condition.No complications were noted.There was no mention of infection or device removal and no mention of the gore device in the records.Operative records dated (b)(6) 2006 indicate the patient underwent open repair of a recurrent lower midline incarcerated incisional hernia.Findings from the procedure state: ¿her fascial defect along the previous c-section scar measured 5 x 5 cm.¿ the (b)(6) 2006 records state: ¿with the patient prepped and draped in the usual sterile fashion, a transverse incision was made over the palpable mass and on the previous c-section scar.This was deepened down to the hernia sac which was circumferentially dissected and skeletonized down to the fascial defect.The sac was then excised and submitted to pathology.The fascial edges were cauterized.The recurrent hernia was on the left lateral edge of the previously placed laparoscopic mesh and the fascial defect measured 5 x 5 cm.Once the circumferential edges of the fascia were dissected and identified, the 8 x 10 piece of dual gore-tex mesh was then trimmed to fit so as to obtain excellent circumferential overlap and this was secured circumferentially to normal fascial edges using a running #1 gore-tex sutures.There was good repair by palpation following the repair.Subcutaneous tissues were closed with running 2-0 vicryl sutures after the wound was irrigated with saline.Skin was closed with staples and subcutaneous tissues infiltrated with 0.5% sensorcaine.Sterile dressings were applied.This completed the procedure.The patient was then taken back to the recovery room in good condition.There were no complications and she tolerated the procedure well.¿ the records indicate a gore dualmesh® plus biomaterial (1dlmcp02/04518356) was used during the procedure.There was no mention of infection and no mention of removal of the previously placed gore mesh.Records between 12/11/2006 and 5/29/2008 were not provided.Operative records dated (b)(6) 2008 indicate the patient underwent hysteroscopy and dilatation and curettage for diagnoses of menorrhagia and morbid obesity.There was no mention of the gore devices in the records.Records between 5/29/2008 and 8/22/2011 were not provided.Operative records dated (b)(6) 2011 indicate the patient underwent repair of an umbilical hernia with mesh, repair of an incisional hernia with mesh, and removal of old mesh.Postoperative diagnoses state: ¿recurrent incisional hernia and recurrent umbilical hernia.¿ the (b)(6) 2011 records state: ¿attention was first directed to the umbilical area.There was an incarcerated recurrent umbilical hernia present which had previously been repaired.A curved incision was made around the umbilicus inferiorly after injecting with local anesthetic.Dissection was taken down to the hernia sac.This was gently peeled away from the surrounding structures.The scar was lysed and dissection was taken down to the fascia neck.The sac was then opened.The adhesed incarcerated omental fat was then lysed and taken down.The sac was excised at the neck of the fascia.Adhesions were taken down underneath to free up the undersurface of the abdominal wall to prepare for mesh placement.Once this was accomplished a 6 cm circular ventralex double-sided mesh [non-gore device] was placed through the defect and pulled up against the abdominal wall.The inner aspect against the bowel was the gore-tex layer and the upper mesh against the abdominal wall was the polypropylene mesh.The fascia was then closed transversely with figure-of-eight 0 pds suture with the central sutures going through the polypropylene mesh in the top of the ventralex patch to ensure stability and fixation against the abdominal wall.Once this was completed, the umbilical skin was tacked down to the fascia with 3-0 vicryl and the wound was closed loosely with subcutaneous vicryl sutures.The skin was then closed with staples.¿ records for the implant of a polypropylene mesh were not provided to gore.The (b)(6) 2011 records continue: ¿attention was then directed to the lower abdominal ventral incisional hernia.Again, local anesthetic was infiltrated.The old pfannenstiel scar was re-incised and dissection was carried down through the fat to expose the hernia sac.This was gently dissected free circumferentially taking down the old scar tissue until the fascial margins were identified.The sac was then opened and lysis of the incarcerated contents was performed.The omental fat and bowel was released from attachments in and around the neck of the sac area.Wide margins were developed underneath for placement of the mesh.A 10 x 15 parietex coated mesh [non-gore device] was selected and marked.It was gently slipped into place.Interrupted #1 pds sutures were used to place the mesh margins widely out from the defect.This gave at least a 2 inch overlap on all sides.Once the mesh underlay was completed, the fascial margins were then closed transversely over this.The large rolled up mass of gore-tex on the right lateral margin of the hernia sac was excised prior to closure to allow approximation of good fascia.At the completion of the fascia closure, the subcu pocket was irrigated with saline.All hemostasis was secured with electrocautery.¿ there was no mention of infection involving the gore devices.Operative records dated (b)(6) 2012 indicate the patient underwent excision of wound sinus tract and removal of old infected mesh.Postoperative diagnosis is noted as: ¿nonhealing sinus tract of abdominal wound with underlying infected hernia mesh.¿ the (b)(6) 2012 operative report states: ¿the abdomen was prepped and draped in a sterile fashion.Local anesthetic was infiltrated around the sinus tract opening in the lower mid abdomen.An elliptical incision was made around this and the soft tissues were cored out down along the tract to remove the tract down to the fascia level.Once this was excised cultures were performed on the fluid that was draining through the fascial opening.There was a small window that showed the subfascial hernia pocket where the prior mesh had been placed.There was some loose free-floating mesh in the pocket.This was grasped and pulled out through the opening.Basically all of the old gore-tex and polypropylene mesh was trimmed out through this opening.A jp drain was then placed through a separate stab incision and passed through the fascial pocket into that subfascial space.The fascia was reclosed with a figure-of-eight #1 pds suture and the skin was closed with staples after irrigation of the subcu space.Patient tolerated the procedure well.¿ operative records dated (b)(6) 2013 indicate the patient underwent repair of a recurrent incisional hernia with mesh.The records state: ¿this 51-year-old white female presents for her 5th hernia operation that resulted from the original c-section scar herniation.She has had several episodes of the mesh which had become infected and removed.She presents with a recurrent hernia and arrangements are made for tissue graft permacol given the history of infection.¿ the (b)(6) 2013 records state: ¿a low transverse abdominal incision was made.A wide oval was made around the old scar tissue to take out the skin, fat and area around the hernia sac.Dissection was taken down to the fascia and then around encircling the neck of the sac.The sac was opened and the redundant hernia sac was taken off at the fascial margin circumferentially taking care to protect and preserve the bowel beneath this.There was some old mesh present which was stripped away.Adhesions underneath the surface of the anterior abdominal wall were taken down circumferentially.A 15 x 20 cm permacol [non-gore device] was brought up to cover the approximately 10 x 12 defect.A ridge of doubled over permacol was stapled on the distal 3rd and several #1 prolene sutures were drilled through the pubic bone and attached across the surface of the pubic bone and tied down to the ridge of permacol to lock it into position on the pubis.¿ the (b)(6) 2013 records continue: ¿the distal 3rd flap was left down under the pubic bone top of the bladder to prevent any herniation underneath this.The larger two thirds flap anteriorly was brought up to the undersurface of the abdominal wall.It was sutured with interrupted #1 pds sutures across the undersurface at approximately the umbilical level to fix this apron in place.Several interrupted stitches were taken around the periphery the ridge of permacol was then sutured with a running double stranded #1 pds suture along the pubic surface taking big bites through the fascia and periosteum overlying the pubis all the way across to further locked this into position.Once this was completed, the overlying thinned loose fascia was then brought down and sutured with running double stranded #1 pds to closed back over the permacol.¿ 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® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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® plus biomaterial instructions for use also states: "cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect." 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.
|
|
Manufacturer Narrative
|
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: on (b)(6) 2006: (b)(6) medical center.(b)(6) , md.History and physical.Reason for admission: 44-year-old morbidly obese female referred for evaluation because of a three-week history of pain as well as a mass in the right very low abdomen at site of previous cesarean section.She was felt to have an incisional hernia and is therefore referred for my evaluation.Has some pain but nothing significant.Past medical history: right lower quadrant abdominal wall hernia by myself approximately 10 years ago.Cholecystectomy 1976.Cesarean section 1992.Medications: prednisone dose pack.(b)(6) 05 for allergies.Abdomen exam: obese with well-healed right lower quadrant incision.No evidence of recurrent hernia.She, however, has a 5 cm chronically incarcerated incisional hernia in the right lateral very low abdomen overlying the cesarean section scar.Partially reducible and nontender, but obviously contains bowel.Impression: right lower quadrant incisional hernia at cesarean section site.Plan: options including open repair versus possible laparoscopic repair were discussed with the patient.Given her body habitus and recent surgical literature recommending laparoscopic approach on obese patients, i have recommended we attempt laparoscopic repair of incision hernia with mesh.Possible complications including bleeding, infection, recurrence, seroma, bowel injury, bladder injury, etc., were all discussed.Possibility of conversion to open procedure explained.We will plan on placing the trocars in the left abdomen which is virgin.Surgery is scheduled at the patient's convenience.On (b)(6) 2006: (b)(6) medical center.(b)(6) , md.Pathology report.Specimen: (b)(6).Diagnosis: soft tissue, incisional: hernia sac with new and old hemorrhage consistent with history of incarceration.On (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.Chief complaint: recurrent incisional hernia.History: multiple hernias over the years.She has had 4 prior repairs, some with mesh.Currently has a baseball sized lump which is painful when bending over at work.Seems to be present all the time, slowly getting bigger.Abdomen exam: obese with overriding panniculus in lower abdomen/ suprapubic area.Has a 5 cm rounded bulge in center, with reducible hernia contents on compression.Assessment: unspecified ventral hernia without mention of obstruction or gangrene.Plan: ct abdomen/pelvis 07/26/11.Follow up 2 weeks.On (b)(6) 2011: [missing records: records for the ct abdomen/pelvis were not provided.] on (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.2 week follow up.Ct shows a large open fascial defect again, as well as a recurrent umbilical hernia.She desires repair.Plan: discussed repair with risks/benefits/alternatives for informed consent.She understands the increased risk of complications and problems healing with reoperative surgery.Will plan open repair mesh.Inpatient admission due to open lysis of adhesions and postop ileus.Follow up 3 weeks.On (b)(6) 2011: [missing records: a pathology report detailing analysis of the device removed during the (b)(6) 2011 procedure was not provided.] on (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.Drainage and pain around incision site.Postop incisional hernia repair.Had large gush of serous pink fluid over weekend, but has tapered off.No pus seen.Assessment: seroma, postoperative, non-infected.Sounds like she spontaneously drained.Keep dry dressing over wound and give some prophylactic antibiotics.Septra ds, oxycodone-ibuprofen and diflucan prescribed.Follow up one week.On (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.Post op.Feeling fine, still having some clear intermittent drainage from wound on right, but much less.Exam: wound port sites are clean, dry, intact and healing well, no surgical site infection, no hernia.Open wound lower abdomen incision healed well except for a pinhole opening right mid area with some clear yellow serous drainage.Iodoform placed into wound for better drainage.Assessment: incisional hernia.Seroma, postoperative, non-infected.Plan: wound redressed; instructions given.On (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.Follow up hernia.Has had much less drainage since last week.Exam: small pinhole is partially occluded with clear proteinaceous debris.Silver nitrate stick inserted and probed/painted into cavity.It tracts only about 1 cm deep and has no open pocket at base now.Assessment: seroma, postoperative, non-infected.Plan: treated with silver nitrate.Clearly improving.Cover with dry gauze.Follow up one week.On (b)(6) 2011: [facility ni].(b)(6) , md.Office notes.Follow up hernia repair.Had a gastrointestinal bug yesterday with vomiting and diarrhea.Started having more serous drainage from the incision after doing a lot of wretching [sic].Exam: wound the [sic] one small pinhole spot that she had before has reopened, and there is a small amount of serous drainage expressed.Plan: start cipro for presumed gastroenteritis.Follow up one week.On (b)(6) 2011: (b)(6) surgical associates.(b)(6) , md.Office notes.Drainage from hernia repair site.Still has some intermittent spotting from the one small open spot along incision in suprapubic scar.Exam: open wound 2-3 mm open wound with pale pink old granulation, no expressible fluid or pus, no erythema or induration.Ultrasound at bedside does not reveal any obvious fluid pockets under this area to suggest specific seroma or abscess.Hyper-echoic line at fascia level consistent with mesh, which appears intact in normal position.Assessment: seroma, postoperative, non-infected.Open sinus tract in wound, non-healing.Treatment: add prophylactic antibiotics.Dry dressing, daily cleansing, silver nitrate applied to proud flesh at opening.On (b)(6) 2012: (b)(6) surgical associates.(b)(6) , md.Office notes.Follow up ct, having drainage from abdominal wound.Comes in with ongoing drainage that is now purulent.She had a jp drain in the large suprapubic pocket left when the hernia sack was reduced, and had serous drainage from the tract after it was removed for 2-3 months.She had several rounds of antibiotics initially, although never had fever or chills, and the drainage was typically clear/serous.Once it tapered off, we thought we were healed, and then she didn't come back for further follow up.Apparently she began having more drainage over the holidays, but because of her husband¿s illness found it more convenient to return to see her gynecologist, who then treated her for several months with further antibiotics.She states that she had several cultures done, as the first of these showed mrsa and she was put on septra for a month.Subsequent cultures were clear.She still has the drainage and it is more like mucopurulent consistency.Wt.264 lbs.Abdomen exam: small pinhole in mid scar at pubis with skin lined tract.Assessment: infection and inflammatory reaction due to unspecified device, implant and graft.Plan: antibiotics for 2 weeks, then plan surgery to excise chronic skin lined tract and debride underlying tissue if needed.Second stage may be to remove infected mesh and place biomesh tissue patch to repair hernia.Follow up 2 weeks.On (b)(6) 2012: (b)(6) surgical associates.(b)(6) , md.Office notes.Not having much improvement, still draining purulent fluid from lower midline wound.Just finishing antibiotics.Plan: continue current antibiotics for another 2 weeks, then schedule for excision of tract and debridement of deeper infected tissue.Follow up 2 weeks.On (b)(6) 2012: (b)(6) surgical associates.(b)(6) , md.Office notes.Abdominal drainage.Continues to have thick sticky drainage from the pinhole in lower abdomen.No change in amount or quality after 2 weeks of antibiotics.She wants something else done, although is not keen on having major resection.Wt.270 lbs.Plan: discussed a number of options from a simple incision and drainage and packing, to open excision of mesh and abdominal wall reconstruction in stages.She once had a similar problem after gb [gallbladder] surgery with dr.Lemaire, and ultimately had the wound excised and closed primarily after packing for many months with no improvement.She desires to have simple tract excision and closure, and understands that this may re-occur and re-infect in spite of our best efforts.Follow up 3 weeks.On (b)(6) 2012: [missing records: a pathology report detailing analysis of the device removed during the (b)(6) 2012 procedure was not provided.] on (b)(6) 2012: (b)(6) surgical associates.(b)(6) , md.Office notes.2-week post op.Doing well, no complaints.Wound clean, dry, intact, healing well.Jp drain removed; staples removed.Wound looks good.Follow up 3 weeks.On (b)(6) 2012: [missing records: follow up records from dr.(b)(6) were not provided.] on (b)(6) 2013: [missing records: a pathology report detailing analysis of the device removed during the 02/27/13 procedure was not provided.] on (b)(6) 2013: [missing records: follow up records from dr.(b)(6) were not provided.] on (b)(6) 20: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: recurrent incisional ventral hernia.Procedure(s): description of procedure: repair incisional hernia with mesh.Anesthesia: anesthesia type: general.Blood loss: estimated blood loss: <50 ml.Specimen(s): specimen(s) removed: portion of hernia sac.Implant(s): implants in: other (xenmatrix biologic tissue patch).Drain type: jp [jackson-pratt].Complications: no.Findings: description of findings: the patient was brought into the operating room and had identification, timeout, careful positioning and padding, sterile prep and drape, as per operating room protocols.A modest transverse incision was made around the umbilicus as this seemed to be centered on the underlying bulge.There is a large complex multilobed hernia sac with numerous loops of bowel.Gentle gradual dissection was performed to reduce all of intestine and isolate and identify the deeper muscle/fascial borders.Dissection of adhesions to the anterior abdominal wall were taken down circumferentially to create a bare surface against the muscular wall on which to attach the biologic mesh.A 15 x 20 sheet of xenmatrix antibiotic-coated porcine-derived biologic collagen tissue patch was placed inside the abdominal cavity and sutured circumferentially with through and through 0 pds stitches.The edges of the fascial neck were trimmed back to healthy tissue and then closed with figure-of-eight 0 pds sutures as well, closing over the zenmatrix [sic] graft.A jp drain was placed in the subcutaneous pocket and brought out through a lateral stab incision.The incision was closed loosely with 3-0 vicryl sutures in the subcutaneous, and then staples completed the skin closure.The patient remained stable throughout the case.¿ post-op diagnosis: same as pre-op diagnosis.On (b)(6) 2015: [missing records: follow up records from dr.Rucker were not provided.] a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® plus biomaterial 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.¿ the gore® dualmesh® plus 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.
|
|
Manufacturer Narrative
|
H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.H6: additional conclusion codes: 4315.The investigation has been completed.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 (1695, 2225, 1930) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2006 through (b)(6) 2015 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6) 2006 through (b)(6) 2008; from (b)(6) 2008 through (b)(6) 2011 were not provided.Patient information: medical history: abdominal wall hernia.Obesity.(b)(6) 2012: 264 lbs; bmi 48.3.(b)(6) 2012: 272 lbs; bmi 49.7.Prior surgical procedures: 1976: cholecystectomy.1992: cesarean section.1996: repair of abdominal wall hernia.Implant #1 preoperative complaints: (b)(6) 2006: ¿44-year-old morbidly obese female referred for evaluation because of a three-week history of pain as well as a mass in the right very low abdomen at site of previous cesarean section.She was felt to have an incisional hernia and is therefore referred for my evaluation.Has some pain but nothing significant.¿ ¿obese with well-healed right lower quadrant incision.No evidence of recurrent hernia.She, however, has a 5 cm chronically incarcerated incisional hernia in the right lateral very low abdomen overlying the cesarean section scar.Partially reducible and nontender, but obviously contains bowel.¿ implant #1 procedure: laparoscopic transabdominal repair of recurrent incarcerated incisional hernia with mesh.Extensive laparoscopic lysis of adhesions.Implant: gore® dualmesh® plus (03860313/1dlmcp03) 10cm x 15cm.Implant #1 date: (b)(6) 2006 [hospitalization dates unknown].Description of hernia being treated: ¿pneumoperitoneum was created with continuous co2 insufflation with continuous co2 pressure monitoring so as to not exceed 15 mmhg throughout the case.Under direct vision, three additional 5 mm trocars were placed, one in the right upper quadrant, one in the right lower quadrant and one in the left lower quadrant.Using a combination of blunt dissection, cautery and harmonic scalpel, all adhesions including omentum and small intestine were taken off of the intraabdominal wall until the chronically incarcerated component of the incisional hernia was visualized fully and this contained the small intestine.This was meticulously dissected free from the hernia sac using the harmonic scalpel with some of the dissection being preperitoneal.This was eventually reduced and approximately over one hour was spent lysing adhesions and taking down all adhesions including omentum and small intestinal adhesions so as to fully visualize the fascial defect which was eventually visualized and on the inferior and right lateral aspect did contain some old mesh.The hernia itself was quite larger than anticipated.It was felt that it would be a 3 cm hernia and it turned out to be more of approximately 7 cm.¿ implant size and fixation: ¿once some dissection was carried out a 10 x 15 cm right angular piece of dual gore-tex mesh was chosen, oriented with a marking pen and a 2-0 vicryl suture placed in the middle of the mesh.The mesh was then placed intraperitoneally and positioned transversely across the fascial defect in the right lower quadrant along the cesarean section scar.An endoclose was placed through the middle of the fascial defect and the 2-0 vicryl within the mesh grasped and pulled up so as to oppose the hernia to the anterior abdominal wall, and this was secured using multiple endo-tacks.Once the surgeon was satisfied there was good and complete coverage of the fascial defect, all instruments were removed and pneumoperitoneum evacuated.Prior to this the bowel was inspected and there was no evidence of bowel injury.All incisions were closed with staples, infiltrated with sensorcaine.And dressed with benzoin, steri-strips and sterile dressings.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2006: repair of a chronically incarcerated symptomatic umbilical hernia. ¿the superior aspect of the hernia sac was extremely densely adherent to the umbilical skin and on attempting to dissect the sac, a button hole was made in the umbilical skin deep within the umbilicus.This was repaired using figure-of-eight 3-0 vicryl suture for the dermis.The decision was therefor made to leave part of the hernia sac in situ which was adherent to the umbilical skin.The remainder of the sac was excised down to the fascia and submitted to pathology.The fascial layers were dissected and cauterized circumferentially, and fascial defect only admitted the surgeon¿s index finger.Given the button hole in the umbilical skin and given the small size of the hernia, we elected not to place mesh.The fascial defect was repaired transversely using several interrupted 0 ethibond sutures.Palpation revealed good repair following placing the sutures.The deepest aspect of the umbilicus was then tacked to the fascia with a single 3-0 vicryl suture and subcutaneous tissues also closed with interrupted 3-0 vicryl sutures followed by skin staples and sterile dressings." implant #2 preoperative complaints: [none provided].Implant #2 procedure: open repair of a recurrent lower midline incarcerated incisional hernia.Implant: gore® dualmesh® plus biomaterial (04518356/1dlmcp02) 8cm x 12cm.Implant #2 date: (b)(6) 2006 [hospitalization dates unknown].Description of hernia being treated: ¿with the patient prepped and draped in the usual sterile fashion, a transverse incision was made over the palpable mass and on the previous c-section scar.This was deepened down to the hernia sac which was circumferentially dissected and skeletonized down to the fascial defect.The sac was then excised and submitted to pathology.The fascial edges were cauterized.The recurrent hernia was on the left lateral edge of the previously placed laparoscopic mesh and the fascial defect measured 5 x 5 cm.¿ implant size and fixation: "once the circumferential edges of the fascia were dissected and identified, the 8 x 10 piece of dual gore-tex mesh was then trimmed to fit so as to obtain excellent circumferential overlap and this was secured circumferentially to normal fascial edges using a running #1 gore-tex sutures.There was good repair by palpation following the repair.Subcutaneous tissues were closed with running 2-0 vicryl sutures after the wound was irrigated with saline.Skin was closed with staples and subcutaneous tissues infiltrated with 0.5% sensorcaine.Relevant medical information: (b)(6) 2011: ¿obese with overriding panniculus in lower abdomen/ suprapubic area.Has a 5 cm rounded bulge in center, with reducible hernia contents on compression.¿ explant #1 preoperative complaints: (b)(6) 2011: ¿ct shows a large open fascial defect again, as well as a recurrent umbilical hernia.She desires repair.¿ explant #1 procedure: repair of an umbilical hernia with mesh, repair of an incisional hernia with mesh, and removal of old mesh.Explant #1 date: (b)(6) 2011 [hospitalization dates unknown].¿attention was then directed to the lower abdominal ventral incisional hernia.Again, local anesthetic was infiltrated.The old pfannenstiel scar was re-incised and dissection was carried down through the fat to expose the hernia sac.This was gently dissected free circumferentially taking down the old scar tissue until the fascial margins were identified.The sac was then opened and lysis of the incarcerated contents was performed.The omental fat and bowel was released from attachments in and around the neck of the sac area.Wide margins were developed underneath for placement of the mesh.A 10 x 15 parietex coated mesh [non-gore device] was selected and marked.It was gently slipped into place.Interrupted #1 pds sutures were used to place the mesh margins widely out from the defect.This gave at least a 2 inch overlap on all sides.Once the mesh underlay was completed, the fascial margins were then closed transversely over this.The large rolled up mass of gore-tex on the right lateral margin of the hernia sac was excised prior to closure to allow approximation of good fascia.At the completion of the fascia closure, the subcu [subcutaneous] pocket was irrigated with saline.All hemostasis was secured with electrocautery.¿ records indicate a non-gore device was implanted during the 8/22/11 procedure.Relevant medical information: (b)(6) 2011: ¿seroma, postoperative, non-infected.Sounds like she spontaneously drained.Keep dry dressing over wound and give some prophylactic antibiotics.¿ (b)(6) 2011: ¿wound port sites are clean, dry, intact and healing well, no surgical site infection, no hernia.Open wound lower abdomen incision healed well except for a pinhole opening right mid area with some clear yellow serous drainage.Iodoform placed into wound for better drainage.¿ (b)(6) 2011: ¿small pinhole is partially occluded with clear proteinaceous debris.Silver nitrate stick inserted and probed/painted into cavity.It tracts only about 1 cm deep and has no open pocket at base now.¿ ¿(b)(6) 2011: ¿had a gastrointestinal bug yesterday with vomiting and diarrhea.Started having more serous drainage from the incision after doing a lot of wretching [sic].Exam: wound the [sic] one small pinhole spot that she had before has reopened, and there is a small amount of serous drainage expressed.¿ (b)(6) 2011: ¿open wound 2-3 mm open wound with pale pink old granulation, no expressible fluid or pus, no erythema or induration.Ultrasound at bedside does not reveal any obvious fluid pockets under this area to suggest specific seroma or abscess.Hyper-echoic line at fascia level consistent with mesh, which appears intact in normal position.¿ explant #2 preoperative complaints: (b)(6) 2012: ¿follow up ct, having drainage from abdominal wound.Comes in with ongoing drainage that is now purulent.She had a jp drain in the large suprapubic pocket left when the hernia sack was reduced, and had serous drainage from the tract after it was removed for 2-3 months.She had several rounds of antibiotics initially, although never had fever or chills, and the drainage was typically clear/serous.Once it tapered off, we thought we were healed, and then she didn't come back for further follow up.Apparently she began having more drainage over the holidays, but because of her husband¿s illness found it more convenient to return to see her gynecologist, who then treated her for several months with further antibiotics.She states that she had several cultures done, as the first of these showed mrsa [methicillin resistant staphylococcus aureus] and she was put on septra for a month.Subsequent cultures were clear.She still has the drainage and it is more like mucopurulent consistency.¿ (b)(6) 2012: ¿not having much improvement, still draining purulent fluid from lower midline wound.Just finishing antibiotics.Plan: continue current antibiotics for another 2 weeks, then schedule for excision of tract and debridement of deeper infected tissue.¿ (b)(6)2012: ¿continues to have thick sticky drainage from the pinhole in lower abdomen.No change in amount or quality after 2 weeks of antibiotics.She wants something else done, although is not keen on having major resection.¿ explant #2 procedure: excision of wound sinus tract and removal of old infected mesh.Explant #2 date: (b)(6) 2012 [hospitalization dates unknown].¿an elliptical incision was made around this and the soft tissues were cored out down along the tract to remove the tract down to the fascia level.Once this was excised, cultures were performed on the fluid that was draining through the fascial opening.There was a small window that showed the subfascial hernia pocket where the prior mesh had been placed.There was some loose free-floating mesh in the pocket.This was grasped and pulled out through the opening.Basically, all of the old gore-tex and polypropylene mesh was trimmed out through this opening.A jp drain was then placed through a separate slab incision and passed through the fascial pocket into that subfascial space.The fascia was reclosed with a figure-of-eight #1 pds suture and the skin was closed with staples after irrigation of the subcu space.¿ culture reports of the specimens collected during the (b)(6) 2012 procedure were not provided.Relevant medical information: (b)(6) 2012: ¿wound clean, dry, intact, healing well.Jp drain removed; staples removed.Wound looks good.Follow up 3 weeks.¿ conclusion: it should be noted that the gore® dualmesh® plus 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.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore ® dualmesh ® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the device.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.Staples or helical tacks (also known as helical coils) can be used as an alternative to sutures.Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation.¿ 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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 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.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 03860313.Additional manufacturer narrative: 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)].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.
|
|
Manufacturer Narrative
|
H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.H6: additional conclusion codes: 4315.The investigation has been completed.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 (1695, 2225, 1930) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span may 11, 2006 through july 1, 2015 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from december 11, 2006 through may 29, 2008; from may 29, 2008 through july 21, 2011 were not provided.Patient information: medical history: abdominal wall hernia.Obesity. (b)(6) 2012: 264 lbs; bmi 48.3. (b)(6) 2012: 272 lbs; bmi 49.7.Prior surgical procedures: 1976: cholecystectomy.1992: cesarean section.1996: repair of abdominal wall hernia.Implant #1 preoperative complaints: (b)(6) 2006: ¿44-year-old morbidly obese female referred for evaluation because of a three-week history of pain as well as a mass in the right very low abdomen at site of previous cesarean section.She was felt to have an incisional hernia and is therefore referred for my evaluation.Has some pain but nothing significant.¿ ¿obese with well-healed right lower quadrant incision.No evidence of recurrent hernia.She, however, has a 5 cm chronically incarcerated incisional hernia in the right lateral very low abdomen overlying the cesarean section scar.Partially reducible and nontender, but obviously contains bowel.¿.Implant #1 procedure: laparoscopic transabdominal repair of recurrent incarcerated incisional hernia with mesh.Extensive laparoscopic lysis of adhesions.Implant: gore® dualmesh® plus (03860313/1dlmcp03) 10cm x 15cm.Implant #1 date: (b)(6) 2006 [hospitalization dates unknown].Description of hernia being treated: ¿pneumoperitoneum was created with continuous co2 insufflation with continuous co2 pressure monitoring so as to not exceed 15 mmhg throughout the case.Under direct vision, three additional 5 mm trocars were placed, one in the right upper quadrant, one in the right lower quadrant and one in the left lower quadrant.Using a combination of blunt dissection, cautery and harmonic scalpel, all adhesions including omentum and small intestine were taken off of the intraabdominal wall until the chronically incarcerated component of the incisional hernia was visualized fully and this contained the small intestine.This was meticulously dissected free from the hernia sac using the harmonic scalpel with some of the dissection being preperitoneal.This was eventually reduced and approximately over one hour was spent lysing adhesions and taking down all adhesions including omentum and small intestinal adhesions so as to fully visualize the fascial defect which was eventually visualized and on the inferior and right lateral aspect did contain some old mesh.The hernia itself was quite larger than anticipated.It was felt that it would be a 3 cm hernia and it turned out to be more of approximately 7 cm.¿.Implant size and fixation: ¿once some dissection was carried out a 10 x 15 cm right angular piece of dual gore-tex mesh was chosen, oriented with a marking pen and a 2-0 vicryl suture placed in the middle of the mesh.The mesh was then placed intraperitoneally and positioned transversely across the fascial defect in the right lower quadrant along the cesarean section scar.An endoclose was placed through the middle of the fascial defect and the 2-0 vicryl within the mesh grasped and pulled up so as to oppose the hernia to the anterior abdominal wall, and this was secured using multiple endo-tacks.Once the surgeon was satisfied there was good and complete coverage of the fascial defect, all instruments were removed and pneumoperitoneum evacuated.Prior to this the bowel was inspected and there was no evidence of bowel injury.All incisions were closed with staples, infiltrated with sensorcaine.And dressed with benzoin, steri-strips and sterile dressings.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2006: repair of a chronically incarcerated symptomatic umbilical hernia ¿the superior aspect of the hernia sac was extremely densely adherent to the umbilical skin and on attempting to dissect the sac, a button hole was made in the umbilical skin deep within the umbilicus.This was repaired using figure-of-eight 3-0 vicryl suture for the dermis.The decision was therefor made to leave part of the hernia sac in situ which was adherent to the umbilical skin.The remainder of the sac was excised down to the fascia and submitted to pathology.The fascial layers were dissected and cauterized circumferentially, and fascial defect only admitted the surgeon¿s index finger.Given the button hole in the umbilical skin and given the small size of the hernia, we elected not to place mesh.The fascial defect was repaired transversely using several interrupted 0 ethibond sutures.Palpation revealed good repair following placing the sutures.The deepest aspect of the umbilicus was then tacked to the fascia with a single 3-0 vicryl suture and subcutaneous tissues also closed with interrupted 3-0 vicryl sutures followed by skin staples and sterile dressings." implant #2 preoperative complaints: [none provided].Implant #2 procedure: open repair of a recurrent lower midline incarcerated incisional hernia.Implant: gore® dualmesh® plus biomaterial (04518356/1dlmcp02) 8cm x 12cm.Implant #2 date: (b)(6) 2006 [hospitalization dates unknown].Description of hernia being treated: ¿with the patient prepped and draped in the usual sterile fashion, a transverse incision was made over the palpable mass and on the previous c-section scar.This was deepened down to the hernia sac which was circumferentially dissected and skeletonized down to the fascial defect.The sac was then excised and submitted to pathology.The fascial edges were cauterized.The recurrent hernia was on the left lateral edge of the previously placed laparoscopic mesh and the fascial defect measured 5 x 5 cm.¿.Implant size and fixation: "once the circumferential edges of the fascia were dissected and identified, the 8 x 10 piece of dual gore-tex mesh was then trimmed to fit so as to obtain excellent circumferential overlap and this was secured circumferentially to normal fascial edges using a running #1 gore-tex sutures.There was good repair by palpation following the repair.Subcutaneous tissues were closed with running 2-0 vicryl sutures after the wound was irrigated with saline.Skin was closed with staples and subcutaneous tissues infiltrated with 0.5% sensorcaine.Relevant medical information: (b)(6) 2011: ¿obese with overriding panniculus in lower abdomen/ suprapubic area.Has a 5 cm rounded bulge in center, with reducible hernia contents on compression.¿.Explant #1 preoperative complaints: (b)(6) 2011: ¿ct shows a large open fascial defect again, as well as a recurrent umbilical hernia.She desires repair.¿.Explant #1 procedure: repair of an umbilical hernia with mesh, repair of an incisional hernia with mesh, and removal of old mesh.Explant #1 date: (b)(6) 2011 [hospitalization dates unknown].¿attention was then directed to the lower abdominal ventral incisional hernia.Again, local anesthetic was infiltrated.The old pfannenstiel scar was re-incised and dissection was carried down through the fat to expose the hernia sac.This was gently dissected free circumferentially taking down the old scar tissue until the fascial margins were identified.The sac was then opened and lysis of the incarcerated contents was performed.The omental fat and bowel was released from attachments in and around the neck of the sac area.Wide margins were developed underneath for placement of the mesh.A 10 x 15 parietex coated mesh [non-gore device] was selected and marked.It was gently slipped into place.Interrupted #1 pds sutures were used to place the mesh margins widely out from the defect.This gave at least a 2 inch overlap on all sides.Once the mesh underlay was completed, the fascial margins were then closed transversely over this.The large rolled up mass of gore-tex on the right lateral margin of the hernia sac was excised prior to closure to allow approximation of good fascia.At the completion of the fascia closure, the subcu [subcutaneous] pocket was irrigated with saline.All hemostasis was secured with electrocautery.¿ records indicate a non-gore device was implanted during the (b)(6) 2011 procedure.Relevant medical information: (b)(6) 2011: ¿seroma, postoperative, non-infected.Sounds like she spontaneously drained.Keep dry dressing over wound and give some prophylactic antibiotics.¿.(b)(6) 2011: ¿wound port sites are clean, dry, intact and healing well, no surgical site infection, no hernia.Open wound lower abdomen incision healed well except for a pinhole opening right mid area with some clear yellow serous drainage.Iodoform placed into wound for better drainage.¿.(b)(6) 2011: ¿small pinhole is partially occluded with clear proteinaceous debris.Silver nitrate stick inserted and probed/painted into cavity.It tracts only about 1 cm deep and has no open pocket at base now.¿.(b)(6) 2011: ¿had a gastrointestinal bug yesterday with vomiting and diarrhea.Started having more serous drainage from the incision after doing a lot of wretching [sic].Exam: wound the [sic] one small pinhole spot that she had before has reopened, and there is a small amount of serous drainage expressed.¿.(b)(6) 2011: ¿open wound 2-3 mm open wound with pale pink old granulation, no expressible fluid or pus, no erythema or induration.Ultrasound at bedside does not reveal any obvious fluid pockets under this area to suggest specific seroma or abscess.Hyper-echoic line at fascia level consistent with mesh, which appears intact in normal position.¿ explant #2 preoperative complaints: (b)(6) 2012: ¿follow up ct, having drainage from abdominal wound.Comes in with ongoing drainage that is now purulent.She had a jp drain in the large suprapubic pocket left when the hernia sack was reduced, and had serous drainage from the tract after it was removed for 2-3 months.She had several rounds of antibiotics initially, although never had fever or chills, and the drainage was typically clear/serous.Once it tapered off, we thought we were healed, and then she didn't come back for further follow up.Apparently she began having more drainage over the holidays, but because of her husband¿s illness found it more convenient to return to see her gynecologist, who then treated her for several months with further antibiotics.She states that she had several cultures done, as the first of these showed mrsa [methicillin resistant staphylococcus aureus] and she was put on septra for a month.Subsequent cultures were clear.She still has the drainage and it is more like mucopurulent consistency.¿.(b)(6) 2012: ¿not having much improvement, still draining purulent fluid from lower midline wound.Just finishing antibiotics.Plan: continue current antibiotics for another 2 weeks, then schedule for excision of tract and debridement of deeper infected tissue.¿.(b)(6) 2012: ¿continues to have thick sticky drainage from the pinhole in lower abdomen.No change in amount or quality after 2 weeks of antibiotics.She wants something else done, although is not keen on having major resection.¿.Explant #2 procedure: excision of wound sinus tract and removal of old infected mesh explant #2 date: (b)(6) 2012 [hospitalization dates unknown].¿an elliptical incision was made around this and the soft tissues were cored out down along the tract to remove the tract down to the fascia level.Once this was excised, cultures were performed on the fluid that was draining through the fascial opening.There was a small window that showed the subfascial hernia pocket where the prior mesh had been placed.There was some loose free-floating mesh in the pocket.This was grasped and pulled out through the opening.Basically, all of the old gore-tex and polypropylene mesh was trimmed out through this opening.A jp drain was then placed through a separate slab incision and passed through the fascial pocket into that subfascial space.The fascia was reclosed with a figure-of-eight #1 pds suture and the skin was closed with staples after irrigation of the subcu space.¿ culture reports of the specimens collected during the (b)(6) 2012 procedure were not provided.Relevant medical information: (b)(6) 2012: ¿wound clean, dry, intact, healing well.Jp drain removed; staples removed.Wound looks good.Follow up 3 weeks.¿.Conclusion: it should be noted that the gore® dualmesh® plus 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.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore ® dualmesh ® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the device.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.Staples or helical tacks (also known as helical coils) can be used as an alternative to sutures.Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation.¿ 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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 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.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 03860313.Additional manufacturer narrative: 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)].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.
|
|
Search Alerts/Recalls
|
|
|