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| Model Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 11/03/2015 |
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Event Type
Injury
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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) 2014 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on november 3, 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: fistula, adhesions, infection, pain.Additional event specific information was not provided.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Manufacturer Narrative
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H6: updated health effect - impact code.Updated investigation findings code.Conclusion remains unchanged it should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2014: (b)(6), md.¿preoperative diagnosis: ventral hernia.¿ implant procedure: ventral hernia repair with mesh.[implant: gore® dualmesh® biomaterial, 1dlmc06/11148027, 18 cm x 24 cm x 1 mm thick] implant date: (b)(6) 2014 [hospitalization dates unknown].(b)(6) 2014: (b)(6), md.Preoperative diagnosis: ventral hernia.Postoperative diagnoses: multiple ventral hernias.Anesthesia: general.Estimated blood loss: approximately 100 ml.¿mesh used: gore-tex dual mesh 16 x 6 cm.¿ complications: specimens: hernia sac.¿ wound classification: ¿clean¿.¿ findings: [not provided].¿ procedure: ¿the patient was brought to the operating room and placed in supine position on the operating table.A time-out occurred identifying the patient and procedure to be performed.Prior exploratory laparotomy incision in the midline was opened, this was taken sharply to the fascia.The fascia was then evaluated.Multiple defects existed.Fascia then opened the length of the incision.Lysis of adhesions then occurred and once the fascial edges were clear, gore -tex mesh was brought onto the field.This was then placed and secured using multiple ethibond sutures in an interrupted fashion securing the mesh in a transfascial technique.The fascia was then reapproximated and secured using a 1 looped pds in a continuous manner.Following placement of the mesh and securing of the fascia, the defect was then repaired in its entirety, as well as being closed anteriorly by the rectus fascia at the midline.Following placement and closure, defect was then examined and appeared to be closed in its entirety.The incisional cavity was then copiously irrigated until the effluent was clear.Hemostasis had been obtained along the dissection planes.The subcutaneous tissues were then reapproximated with 2-0 vicryl in interrupted inverted fashion, the skin, was then reapproximated and secured with skin staples.Sterile dressing was then applied.The patient tolerated the procedure well.The patient was subsequently transferred to the recovery area for further recovery and admission to the inpatient service for postoperative management.¿ (b)(6) 2014: (b)(6).Implant report: ¿implants/ prosthesis/fixation: gore dualmesh 18 cm x 24 cm x 1 mm.Lot#: 11148027.Exp: 2018-01.¿ (b)(6) 2014: (b)(6).Implant sticker: ¿gore dualmesh® biomaterial.Ref catalogue number: 1dlmc06.Lot batch code: 11148027.W.L.Gore & associates.¿ (b)(6) 2014: (b)(6), md.Pathology report: ¿gross description: the specimen is labeled ¿ventral hernia sac¿.The specimen consists of two saccular portions of thick and fatty fibromembranous tissue aggregating 6.5 x 6.0 x 2.5 cm.Microscopic description: microscopic examination performed.Final diagnosis: soft tissue, ventral abdomen, hernia repair.Mesothelial lined fibroconnective tissue consistent with hernia sac.¿ relevant medical information: (b)(6) 2014: inpatient hospitalization [same day admission].(b)(6) 2014: (b)(6), md.Operative report.Procedure: vacuum -assisted closure change and washout.Pre-and postoperative diagnosis: open abdominal wound.Anesthesia: iv sedation.Blood loss: minimal.Specimens: none.Complications: none.¿ indications: [not provided].¿ wound classification: ¿contaminated¿.¿ procedure.¿the patient was brought to the operating room and placed in a supine position on the operating table.Time-out occurred identifying the patient and procedure.Previous vac sponge was removed.Abdomen was prepped and draped in sterile fashion.The incisional cavity was inspected.This was irrigated.There was no indication of infection, purulence, or necrotic tissue.New black vac sponge was placed in the incision and secured in the standard fashion.The patient was then transferred to the recovery area for further recovery and discharged home in good condition.Anticipate return to the operating room possibly thursday for secondary closure of this wound given its clean appearance and viable tissue.¿ (b)(6) 2014: inpatient hospitalization [same day admission].(b)(6) 2014: (b)(6), md.Operative report.Procedure: removal of wound vac.Delayed primary closure.Pre-and postoperative diagnosis: open abdominal wound with wound vacuum-assisted closure in place.Anesthesia: mac (monitored anesthesia care) with iv sedation and local.Estimated blood loss: minimal.Specimens: none.¿ indications: [not provided].¿ wound classification: ¿clean contaminated¿.¿ procedure: the patient was brought to the operating room and placed in supine position on the operating table.Time-out occurred identifying the patient and procedure.Vac sponge was removed.The abdomen was prepped and draped in sterile fashion.Sutures of 2-0 prolene were then used in horizontal mattress fashion to close the wound edges.The wound was inspected prior to closure and was pink and viable with positive granulation tissue.No evidence of infection or purulence a sterile dressing was then applied.The patient tolerated the procedure well.The patient was subsequently transferred to the recovery area for further recover and discharged home in good condition.¿ explant preoperative complaints: (b)(6) 2015: (b)(6).¿pathologists: archuletta, carpenter, wagner¿.Microbiology: ¿wound culture.Collection date: (b)(6) 2015.¿ ¿final release date: (b)(6) 2015.Isolate 1 (final): few staphylococcus aureus.Specimen source: fistula.¿ (b)(6) 2015: (b)(6), md.History and physical.¿history of present illness: 39-year-old male who is here for follow-up for a chronic abdominal wall abscess.The patient appears to have a fistula from the skin in the subcutaneous tissue in the midline wound which healed by secondary intention after undergoing hernia repair.The patient¿s operative report describes a cortex (sic) sheet placed intraperitoneal with the fascia closed over the gore-tex so hopefully this infection does not involve the cortex (sic) itself.The patient has now been on a week¿s worth of keflex with no significant improvement in the purulent material from the fistula tract.¿ ¿gastrointestinal inspection: abnormal ¿ within the midline abdominal scar, approximately 3 cm cranial to the umbilicus there is an open fistula tract draining purulent material.There is minimal surrounding erythema.¿ ¿assessment: 39-year-old male with chronic¿s (sic) abdominal wall fistula indicating a chronic abscess within his abdominal wall, likely within the deep subcutaneous tissue.By ct scant this does not appear to involve the muscular layer or the underlying cortex (sic) though the patient understands that there may be a fistula track all the way to the cortex (sic).I have proposed a limited surgical intervention where we excised the fistula tract to its base and remove any foreign material or any scar tissue and allow it to heal secondarily.The patient is growing staph aureus on culture which is pansensitive.Antibiotics alone have not resolved this infection.Plan: plan excisions of chronic abdominal wall abscess with healing by secondary intention.The patient will remain on keflex until the surgery and for 1 week postop.¿ (b)(6) 2015: (b)(6), md.Indications: ¿the patient is a 39 -year -old male who is status post several abdominal operations.The patient's most recent operation was repair of a midline incisional hernia with gore -tex placed deep to the fascia in an intraperitoneal location and then the fascia closed over the gore -tex.The patient's wound initially appeared to heal but he did develop a draining sinus.This showed chronic infection with staph aureus.By physical exam and by ct scan this did not appear to involve the underlying gore -tex, and exploration of his abdomen with excision of the sinus tract to its base is planned.Patient understands that this could possibly involve the underlying gore-tex.¿ explant procedure: abdominal wall exploration, removal of infected gore-tex, re-closure of abdominal wall.Explant date: (b)(6) 2015 [hospitalization dates (b)(6) 2015].(b)(6) 2015: (b)(6), md.Operative note.Preoperative diagnosis: chronic abdominal wall abscess.Postoperative diagnosis: chronic abdominal wall abscess with involved gore-tex.Anesthesia: general.¿specimens removed: scar + gortex.¿ wound classification: ¿infected/dirty¿.findings: ¿fistula through fascia to chronically involved gortex.¿ procedure: ¿under adequate general anesthesia, the patient was placed supine on the operating room table, and the abdomen was prepped and draped in the usual sterile manner.An elliptical incision was performed surrounding the clear-cut sinus tract.Incision was carried through the skin, subcutaneous tissue, and the midline abdominal fascia.The fascia consisted of extensive scar tissues.Dissection was then carried out along the fascia to try to get to the base of the fistula tract.Eventually what was exposed was a chronic sinus going through the entire layer of the fascia and down to the underlying gore -tex.The fascia was opened slightly more cranially and caudally and it became clear that there was a chronic cavity between the gore -tex and the overlying abdominal wall which was lined with chronic granulation tissue and some purulent material.Without excising this entire cavity which would involve excising the underlying gore-tex, this infection would not resolve.For this reason, the skin incision was extended caudally to the right of the umbilicus through the patient¿s old scar, and then slightly below the umbilicus.The fascial incision was then slowly and carefully also enlarged until the entire length of the gore -tex was exposed.The gore -tex was then separated from the abdominal wall, first on the right side.This was done carefully as there was extensive scar tissue.It was then separated cranially and then towards the left and finely (sic) caudally.The entire piece of gore -tex was removed.The gore -tex was held in place both with spiral tack pack and with braided blue suture.All of tacks and all of the blue suture were completely removed.This chronic scar tissue from either side of the open fascia was then debrided to try to get back to fresh fascia which was not involved in the chronic infection.Once all of the gore -tex and all of the suture and all of the tacks and all the chronic scar tissue was removed, the undersurface of the abdominal wall was cleared of adhesions in all directions for a distance of about 2.5 to 3 cm to allow adequate closure of the fascia.All of the underlying greater omentum and few of the exposed bowel loops were carefully inspected.None of the bowel loops had been involved in the chronic scarring to the gore -tex.The midline fascia was then reapproximated with a running stitch of # 1 pds.The skin was loosely reapproximated with surgical staples.Sponge and instrument count correct.The patient tolerated the procedure well without complication, was returned to the recovery room in stable condition.¿ (b)(6) 2015: (b)(6), md.Pathology report: ¿clinical history: chronic abdominal wall abscess.source of specimen: explanted goretex mesh and abdominal scar tissue gross description: the specimen is labeled "explanted gore -tex mesh and abdominal scar tissue." received is a 6.5 x 4.5 x 0.4 cm irregular segment of tan ribbed synthetic material, which is adhesed upon itself with attached 9.0 x 3.5 x 2.0 cm portion of pink-tan fibrous tissue.Several silver-colored metallic clips are noted on the mesh.Also submitted are three irregular segments of tan skin and soft tissue ranging from 5.0 cm to 8.1 cm in greatest dimension and aggregating 7.0 x 5.0 x 1.8 cm.The skin surfaces include a 0.9 x 0.7 cm irregular segment of tan skin with a micronodular surface.Another elliptical segment of tan skin is 4.1 x 1.0 cm.This surface displays a central depressed area with a 0.3 x 0.2 x 0.2 cm papule.This is 0.4 cm from the nearest margin.Sectioning reveals dense underlying fibrosis.microscopic description: microscopic examination performed.final diagnosis: abdominal scar tissue and explanted gore-tex mesh, excision of chronic abdominal wall abscess.¿ skin and attached soft tissue with chronic active inflammation, ulceration and fibrosis.¿ synthetic mesh for gross examination only¿.(b)(6) 2015: (b)(6).Microbiology: ¿mrsa screen: culture results (final): no methicillin resistant staphylococcus aureus isolated.Specimen source: nares.¿ (b)(6) 2015: (b)(6), md.Discharge summary: ¿hospital course: the patient is a 39-year-old male who was admitted to the hospital for a chronic abdominal wall infection overlying a midline incision with gore -tex in place.The patient underwent debridement of a chronic abscess, but the abscess distended below the level of the abdominal wall musculature and extensively involved the gore -tex patch was then placed in an intraperitoneal location.As the wound was opened further than originally it had been planned and the entire gore -tex patch was removed with debridement of the fascia on either side of the wound and fresh closure.The patient was kept overnight for pain control.The following day, his pain was controlled with oral pain medicine, and he was tolerating a regular diet.His wound was healing well.Discharge diagnosis: chronic abdominal wall infection with infected gore-tex.¿ relevant medical information: (b)(6) 2015: (b)(6).¿pathologist: archuletta, carpenter, wagner¿.Wound culture: ¿collection date: (b)(6) 2015.¿ ¿final release date: (b)(6) 2015.Culture results (final): few usual skin flora.Specimen source: abdominal wound.¿ (b)(6) 2015: (b)(6).¿pathologist: archuletta, carpenter, wagner¿.Wound culture: ¿collection date: (b)(6) 2015.¿ ¿final release date: (b)(6) 2015.Culture results (final): many usual skin flora consisting of diptheroids.Specimen source: abd [abdominal] wall abscess.¿ 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® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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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® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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