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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Model Number 1DLMCPH04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 01/24/2005 |
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Event Type
Injury
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Manufacturer Narrative
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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)].It should be noted that the gore® dualmesh® plus biomaterial with holes 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® plus biomaterial with holes 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 open ventral hernia repair on (b)(6) 2004 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2005, (b)(6) 2005, (b)(6) 2006, and (b)(6) 2008 additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, infection, mesh removal, recurrence, revision, bilateral component separation, debridement of scar tissue and fibrosis, drainage of purulent material, reopening of wound, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: ¿ (b)(6) 2004: (b)(6) hospital.(b)(6), md.History and physical.Chief complaint: ¿ventral hernia.¿ history of present illness: ¿mrs.(b)(6) is a 51-year-old woman who underwent ventral hernia repair three years ago initially with good results.She developed the acute onset of pain and bulging on the ieft side of her previous hernia repair approximately a week ago.Since then, she has had significant ongoing pain to the point she is unable to function.She presents now for repair of recurrent hernia.¿ abdomen: ¿quite full but soft.There is a well-healed midline abdominal incision.To the left and cephalad aspect of this incision there is an obvious bulge which is somewhat uncomfortable.This is easily reducible.There are no other palpable masses or hernias.¿ impression: ¿recurrent ventral hernia.¿ plan: ¿due to the symptomatic nature of this hernia and the fact that it is occurring adjacent to a previously placed polypropylene mesh, will proceed with recurrent hernia repair.In addition.I discussed plans for weight loss with mrs.(b)(6) to ultimately result in long term remission from her hernia.I discussed all of this at length with mrs.(b)(6) including the real risk of recurrent herniation despite repair.She wishes to proceed.¿ implant procedure: ventral hernia repair with placement of intraabdominal dual mesh.[implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph04/02114484, 15cm x 19cm x 1.5mm thick.] implant date: (b)(6), 2004 [hospitalization dates (b)(6), 2004] ¿ (b)(6) 2004: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: incarcerated ventral hernia.Postoperative diagnosis: same.Anesthesia: general.Complications: none.¿ wound classification: ¿cl¿ [clean ] ¿ findings: ¿the patient has a very large hernia sac with 4 x 5 cm hernia defect.This was closed by resection of the hernia sac, reduction of the intra-abdominal contents, and placement of gore-tex dual mesh in the intraabdominal location.The fascia was then closed anteriorly over the mesh.Drains were left anterior to the repair in the subcutaneous space.The patient tolerated the procedure well.¿ ¿ procedure: ¿the patient was brought to the operating room and placed supine on the operating room table.General anesthesia was administered.The patient's abdomen was prepped and draped in the usual sterile fashion.The previous incision was excised and incision was carried down through the subcutaneous tissues into the underlying hernia sac which was very close to the overlying skin.The hernia was dissected circumferentially as well as possible to the left side of the defect.This was taken all the way to the fascia.At this point the finger could be passed through using the hernia sac to feel the hernia defect.The hernia defect was quite deep and was small.There was very dense scarring in the cephalad region and on the right side of the patient due to previous repair.The fascial defect, however, was quite discrete underneath this.Because of the dense scarring from the previous repair, the hernia sac could not be dissected free from the scarring.In addition.The hernia sac was quite redundant.It was felt that the best way to obtain a satisfactory repair was to resect the entire hernia sac.The hernia sac was dissected circumferentially back to viable fascia from within the sac.At this point the fascial rim was identified circumferentially and was found to be viable and satisfactory.There were no other palpable hernia defects with probing of the defect up along the anterior abdominal wall.All adhesions were taken down so that the abdominal wall was completely free.A segment of gore-tex dual mesh was trimmed to the appropriate size to overlap the hernia defect by approximately 3 cm circumferentially.This was then tacked through and through with u sutures to the anterior abdominal wall fascia at 2 cm intervals circumferentially.These were placed in the anterior abdominal fascia so that the mesh lay perfectly flat.At this point all of the intraabdominal contents were reduced satisfactorily back into the abdominal cavity and the mesh was pulled up tight to the anterior abdominal wall so that the grooved face of the mesh was against the anterior abdominal wall musculature.All the sutures were tied down.At this point the fascia was then closed in a transverse fashion with interrupted sutures of no.1 prolene incorporating the mesh in the posterior aspect of the repair.The wound was then copiously irrigated with warm sterile saline.Meticulous hemostasis was obtained in a spot-like fashion.Two no.10 flat jackson-pratt drains were placed into the prefascial space and placed to bulb suction.Skin was closed with staples.The drains were sutured in place with sutures of 3-0 nylon.Bulky sterile dressing was applied.The patient was awakened from general anesthesia and taken to the recovery room in stable and satisfactory condition.Sponge and needle count were correct following the procedure.¿ ¿ (b)(6) 2004: (b)(6).Implant record.¿mesh dual plus 15cm x 19.¿ site: abd [abdomen].Cat #: 1dlmcph04.Lot #: 02114484.Size: 15 x 19.Expiration date: 4/8/05.Manufacturer: ¿gore.¿ ¿ (b)(6) 2004: (b)(6).(b)(6), md.Discharge summary.Activity: ¿light.¿ diet: ¿as tolerated.¿ follow up: ¿in my office in one week.The patient is to care for her wound and her drains.She was drained [sic] on this prior to discharge.¿ hospital course: ¿the patient was admitted through same day surgery [sds] and taken to the or [operating room] where she underwent ventral hernia repair with preperitoneal placement of vortex [sic] mesh.She tolerated the procedure well and was transferred postop to the floor.The following day on postop day 1 the patient had mild abdominal distention and poor po intake.She had no bowel function.She was kept in the hospital an additional night.The following day she had a bowel movement and was receiving regular diet.She was ambulating in the hall without assistance.She has two drains left in place within the surgical wound and was trained on drain care prior to discharge.She will follow up with me in one week.She was discharged home with disposition and followup as previously dictated.¿ partial explant preoperative complaints: ¿ (b)(6) 2005: (b)(6).(b)(6), md.History and physical.Chief complaint: ¿infected abdominal wall mesh.¿ history: ¿ms.(b)(6) is a 52 year old woman who has had two separate abdominal wall hernias.Most recently she underwent repair in (b)(6) of last year.She initially did very well, however, she returned approximately three weeks ago with induration and mass on the anterior abdominal wall.This was drained of significant amount of purulent material.With dressing changes and oral antibiotics this has improved but has not healed.The track still is quite deep.It tracks all the way to the underlying abdominal wall and underlying mesh.¿ abdomen: ¿full but soft.There is a draining sinus in the mid abdomen.There is some surrounding induration, no fluctuance.No other palpable masses, no hernias.¿ impression: ¿previous ventral hernia repair with infected abdominal wall mesh.¿ plan: ¿proceed with open removal of mesh and primary repair of underlying abdominal fascia.I have discussed this in depth with ms.(b)(6) and she wishes to proceed.¿ partial explant procedure: i & d of abdominal wall abscess.Partial explant date: (b)(6), 2005 [hospitalization dates (b)(6), 2005] ¿ (b)(6) 2005: (b)(6).(b)(6), md.Operative note.Preoperative diagnosis: infected abdominal wall mesh.Postoperative diagnosis: abdominal wall abscess without involvement of underlying mesh.Anesthesia: general.Complications: none.¿ wound classification: ¿cc¿ [clean contaminated ] ¿ findings: ¿the tract was widely opened.This was probed to the base.Several loculated collections of purulent material were entered and drained.All of the chronically indurated tissue and ioculated fluid collections were removed.One tiny corner of the mesh was exposed after vigorous dissection and this was excised.There was no other additional exposed mesh.The wound was copiously irrigated with betadine and sterile saline and packed open with iodoform gauze.¿ ¿ procedure: ¿the patient was brought to the operating room and placed supine on the operating room table.General anesthesia was administered.The patient's abdomen was prepped and draped in the usual sterile fashion.The wound tract was probed up along its entire length.The entire tract was coated with thickened scar and fibrinous material.This was dissected free from the surrounding normal subcutaneous fat circumferentially.Dissection continued inferiorly until a walled off area of purulent material was entered.This was cultured and aspirated free.This entire cavity was then excised from the surrounding normal fatty tissue.Dissection then continued inferiorly and toward the midline.Two additional sections of walled off infection were entered that indirectly communicated to the initial component.Eventually the entire walled off area was completely excised.One corner of the mesh was exposed in the base of the wound.The remainder of the mesh was firmly adherent and well incorporated.The plane of the mesh was not easily dissectable.The corner of the mesh which was infected was excised with mayo scissors.At this point there was no further exposed mesh and all surrounding tissue appeared normal.The wound was then copiously irrigated with betadine and subsequently with sterile saline.This was repeated ten times.At this point, the wound was packed open with iodoform gauze and bulky sterile dressing was applied.The patient was awakened from anesthesia and taken to the recovery room in stable and satisfactory condition.¿ ¿ [pathology report was not provided.] ¿ (b)(6) 2005: (b)(6).(b)(6), md.Discharge summary.Course: ¿the patient was admitted through sds and taken to the or where she underwent radical debridement of the wound and exploration.The mesh was not found to be exposed or infected.The wound was packed and she was treated with iv [intravenous] antibiotic therapy.For the next 24 hours the patient received pulse lavage therapy and meticulous dressing care.She had significant pain with her first dressing change and required intravenous narcotics for pain control.She subsequently developed ileus secondary to narcotic pain medication associated with her surgery.This was treated with suppositories and fleets enemas.She had a normal bowel movement and was discharged home at this time.¿ explant preoperative complaints: ¿ (b)(6) 2005: (b)(6).(b)(6), md.Indications.¿ms.(b)(6) [sic] is a 62 year old woman who has had a chronically draining wound following ventral hernia repair and placement of ptfe [polytetrafluoroethylene] mesh.She is brought to the operating room at this time for wound exploration and possible removal of mesh.¿ explant procedure: removal of same [infected abdominal wall mesh.] explant date: (b)(6), 2005 [hospitalization dates not provided] ¿ (b)(6) 2005: (b)(6).(b)(6), md.Operative note.Preoperative diagnosis: infected abdominal wall mesh.Postoperative diagnosis: same.Anesthesia: general.Complications: none.¿ wound classification: ¿d¿ [dirty ] ¿ findings: ¿the patient¿s wound tracked all the way to the abdominal cavity.Mesh was obviously infected with fluid between the mesh and the abdominal wall.The mesh was removed, and the wound was packed open with iodoform gauze.The patient tolerated the procedure well.¿ ¿ procedure: ¿the patient was brought to the operating room and placed supine on the operating table.General anesthesia was administered, and the patient's abdomen was prepped and draped in the usual sterile fashion.The patient had two sinus tracts adjacent to each other.Both of these were excised.The larger was dissected down to the underlying abdominal wall and then the cavity was entered.The cavity was traced through a small opening to the preperitoneal space.The space entered into fluid collection bordered anteriorly by the abdominal wall musculature and posteriorly by the ptfe mesh.The mesh was brought up into the field and each suture of polypropylene was snipped circumferentially and the mesh was brought up into the field.This was quite tedious as the mesh and surrounding tissue was densely scarred.Ultimately the mesh was brought all the way up through the wound and passed off the operative field and sent for pathologic evaluation.At this point the upper tract was completed excised in separate incision.All the dense scar tissue was excised back to normal subcutaneous fat.There was a very small detect without a true functional hernia due to dense scarring.The wound was copiously irrigated with warm sterile saline until the irrigant returned as clear.Both wounds were then packed with iodoform gauze.Bulky dressing was applied.The patient was awakened from general anesthesia and taken to the recovery room in stable and satisfactory condition.¿ ¿ [pathology reports were not provided.] relevant medical information ¿ (b)(6) 2006: (b)(6).(b)(6), md.Operative report.Procedure: excision of retained prolene sutures, abdominal wall.Preoperative diagnosis: retained foreign body, abdominal wall.Postoperative diagnosis: retained prolene sutures, abdominal wall.Anesthesia: monitored anesthesia care.Complications: none. indications: ¿the patient is a 53-year-old woman who underwent ventral hernia repair with polytetrafluoroethylene mesh.She developed infection of the mesh and required mesh removal.Her wound had been healed but recently reopened.This failed to heal and she is brought back to the operating room for suspected retained foreign body.¿ wound classification: ¿cl¿ [clean ] - findings: ¿the patient had two large prolene sutures found in the base of her wound incorporated in vigorous scar tissue.These were excised and the wound was packed with iodoform gauze.The patient tolerated the procedure well.¿ procedure: ¿the patient was brought to the operating room and placed supine on upon [sic] the operating table.Under the patient's supervision, the area had been marked in the preoperative holding area.Intravenous sedation was administered.The patient's abdomen was prepped and draped in the usual sterile fashion.The skin was anesthetized with 0.5% marcaine as well as the subcutaneous tissue.The draining sinus was opened widely and tracked to its base.Two separate prolene sutures were identified within the wound and densely incorporated in the associated cicatrix and scarring.Both of these were excised and significant portion of the cicatrix was removed back to more pliable tissue.The entire area was definitely exposed and no additional foreign body could be identified.The wound was copiously irrigated with warm sterile saline.Meticulous hemostasis was obtained in spot-like fashion with electrocautery.The wound was packed with iodoform gauze and bulky sterile dressing was applied.The patient was awakened from sedation and taken to the recovery room in stable and satisfactory condition.¿ [pathology report was not provided.] ¿ (b)(6) 2008: university of (b)(6) hospitals (b)(6).(b)(6), md.Office note.History of present illness: ¿ms.(b)(6) is a 55-year-old female who developed what appeared to be an umbilical hernia in 2001 and underwent primary repair of that.Subsequently she has had five hernia operations associated with it over the ensuing years in about 2002.She had a mesh repair which became infected.This actually was operated on again and removed in (b)(6) 2005.I do not have these records but she once again underwent a hernia repair with mesh replacement because of persistent drainage.This was subsequently removed and subsequently developed a recurrent hernia in her epigastrium now and is here to discuss the potential surgical intervention.The hernia itself is becoming increasingly large on her and is seeking to have this repaired.It is not causing the obstructive symptoms.¿ assessment and plan: ¿persistent incisional hernia after removal of infected mesh x2, although her wound is healed now.I think that she has a risk for developing a secondary wound infection if a prosthetic is placed.Because of her symptoms she would like to have a hernia repair performed.I discussed with her participating in our postoperative ileus hernia study and she was agreed to do so after further discussing this with our research nurses.I discussed with her performing component separation repair of this.She is aware of the potential for infection and the need to remain hospitalized for approximately five days.Preop workup was performed.Anticipation for surgery date on (b)(6) 2008.¿ ¿ (b)(6) 2008:(b)(6).Inpatient hospitalization.- (b)(6) 2008: (b)(6), md.Operative report.Assistants: (b)(6), md, (b)(6), md.Procedure: repair of incarcerated hernia with bilateral component separation, as well as flex hd mesh, fascial debridement.[implant: flex hd mesh.] preoperative diagnosis: recurrent incarcerated incisional hernia.Postoperative diagnosis: recurrent incarcerated incisional hernia.Anesthesia: general.Estimated blood loss: approximately 200 ml¿s.Specimens: a portion of the fascial debridement.Complications: none.- wound classification: ¿clean ¿ - findings: ¿there was approximately a 10 x 15 cm fascial defect in the patient¿s periumbilical area.The hernia itself contained primarily omentum, as well as transverse colon that was incarcerated within it.This was able to be reduced.There was also some retained old mesh from her previous hernia repair, as well as a chronic pocket of granulation tissue and fibrosis associated with the previous repair.These areas were debrided, as well as the residual mesh was removed.The fascial defect was closed primarily after bilateral component separation, as well as freeing up of the posterior rectus sheath beneath the rectus muscle.¿ - procedure: ¿after adequate induction of general endotracheal anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion.We initially made a midline incision through the patient's midline scar, beginning in the mid epigastrium and extending down into the suprapubic area.We continued the dissection down to the subcutaneous fat until we were able to enter the hernia sac.This was at about the level of the umbilicus.After we opened the hernia sac, we encountered incarcerated omentum and transverse colon.This was eventually able to be reduced from the hernia sac and replaced into the abdominal cavity with a combination of traction, as well as suture scissor dissection.We extended the incision from the subcutaneous fat into the suprapubic area.The bowel and hernia contents as i said were reduced into the abdominal cavity.We then encountered some mesh at the most superior portion of the incision.This was excised.Similarly, there was a fair amount of scar tissue and fibrosis in the mid portion of the incision in the subcutaneous fat.Within this area was also some chronic granulation tissue in a small pocket.This entire area was debrided down to viable fascia, as well as viable subcutaneous fat.Similarly, the fascia throughout the length of the incision was debrided of attenuated fascia.We then proceeded to skeletonize the subcutaneous fat from the anterior fascia throughout the entire extent of the incision basically from the subcostal area to the anterosuperior iliac spine and the lateral dissection continued to the anterior axillary line.Once this was completed on both sides, we performed a component separation by incising the anterior rectus sheath at the junction with the rectus muscle throughout the entire length of the exposure.This gave us several centimeters of latitude of laxity in order to appose [sic] the fascia in the midline.Because it seemed to be a little bit tight, i performed another relaxing incision through the mid portion of the posterior rectus sheath throughout the entire length of the incision.After doing so, we had enough laxity to close the defect primarily, which was done with interrupted #1 pds suture.The operative field was irrigated as it had been throughout the operation.We then took two pieces of flex hd mesh and originally a piece was 12 x 20 cm's and we cut this in half and this flex hd mesh was secured to the component separation fascial defect in the lateral abdominal wall.This was done by using short running 11 prolene suture, as i said, suturing this to the periphery of the defect created by the component separation.It was done on both the right and left sides.Once this was complete, we left the jackson-pratt drains in the subcutaneous tissue.One was left in the abdominal cavity to keep the [sic] drain the pelvis.We then reapproximated the subcutaneous tissue and fat with interrupted 2-0 vicryl sutures and then once this was complete, skin clips closed the skin.The patient tolerated this procedure well.¿ - (b)(6) 2008: (b)(6).Implant record.¿graft flex hd 12 x 20 ultra thick.¿ - [pathology report was not provided.] - (b)(6) 2008: (b)(6) health care.(b)(6), md.Discharge summary.Hospital course: ¿ms.(b)(6) was admitted s/p [status post] ventral hernia repair with component separation.She had an uncomplicated hospital course with return of bowel function and pain well controlled on po [by mouth] medication.¿ ¿she is being discharged with her drains due to high serous output and these will be removed on return to clinic.¿ discharge instructions: ¿1.Continue drain care as advised.2.May shower.3.Wear abdominal binder at all times.4.If fever > [greater than] 101.5 f [fahrenheit], increased abdominal pain, increased nausea or vomiting, redness or warmth at incisions, change in drain output color or consistency, call md.Return to: dr.(b)(6) clinic in 2 weeks or next available appointment.Activity: as tolerated: no heavy lifting > 10 lbs.[pounds ].¿ ¿ (b)(6) 2008: (b)(6).(b)(6), md.Office note.¿ms.(b)(6) is a 55-year-old female who returns for followup after undergoing a component separation repair of a recurrent incisional hernia on (b)(6).She had an uneventful postoperative today.She was part of the postoperative ileus study and had no sequelae.Today she brought her as she had 3 drains in place, straining between 11 and 38 ml per day.These were removed.We moved [sic] her staples also.She is complaining of a bulge in her left flank that was present immediately after surgery and was able to palpate today.I do not think it is a recurrent hernia but we will keep an eye on it.¿ assessment and plan: ¿stable postoperative course.We will have her return in a month to 6 weeks for a wound check.¿ ¿ (b)(6) 2008: (b)(6).(b)(6), md.Office note.History of present illness: ¿ms.(b)(6) is a 55-year-old woman who underwent ventral hernia repair with mesh approximately 2 months ago by dr.(b)(6).She notified our office today that she was having increasing abdominal pain and difficulty using the bathroom.She reports that she has been constipated now for multiple weeks and has to strain fairly excessively for a bowel movement.She is taking minimal stool softeners at this point, using only one colace per day.She states that her pain started over the weekend, and is predominantly in the upper abdomen, but does extended [sic] lower abdomen.She says it is removed from her midline incision, and she states that she can feel small lumps in these areas.She denies fever, chills, nausea or vomiting.¿ physical examination: abdomen: ¿moderately obese.Her midline incision is essentially healed over with about 0.5 cm area with granulation tissue and no signs of infection.Approximately 8-10 cm around the incision, and an oval pattern, she has tenderness to palpation and what feels like a scar tissue around the entire area.She has tenderness to palpation in these regions.This area coincides with the edges of the mesh that is noted in the operative report.Her abdomen is otherwise nondistended and nontender.¿ assessment: ¿abdominal pain along the edges of previous hernia repair/mesh placement.Constipation.¿ plan: ¿it seems that her abdominal pain has been exacerbated recently by her constipation issues.I think that first item would be necessary for her is to get her bowels working appropriately, to see if this abdominal decompression assists with her pain.We have given her instructions for obtaining fleet's phospho-soda and she is to take this once she gets home.I have also instructed to call our clinic tomorrow or the next day to update as on her progress and see if this helps with her abdominal pain.¿ ¿ (b)(6) 2008: (b)(6).(b)(6), md.Office note.¿she has not recovered from a surgery ¿ even though her incision has healed.She states that she continues to be chronically constipated and has swollen abdominal wall on the right and left of her incisional repair.¿ 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 gore® dualmesh® plus biomaterial with holes 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® plus biomaterial with holes 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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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial with holes 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® plus biomaterial with holes 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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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.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.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® plus biomaterial with holes 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." 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 device." the instructions for use further warn: "when using this device as a permanent implant and unintentional exposure occurs.Treat to avoid contamination.Or device removal may be necessary." 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.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, 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.C1: 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.
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