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| Catalog Number 1MYM09 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 04/28/2015 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® mycromesh® 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® mycromesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.
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Event Description
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It was reported to gore that the patient underwent open inguinal hernia repair on (b)(6) 2015 whereby a gore® mycromesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2015 and (b)(6) 2015, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infection, surgery to remove mesh, severe and chronic pain/discomfort.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.D4: added serial #, catalog #, expiration date, udi#.H4: added device manufacture date.H6: updated type of investigation code and investigation findings code.Conclusion code remains the same.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: relevant medical information: on (b)(6) 2010: [facility ni (not indicated)].(b)(6), md.Office notes.Has barrett¿s esophagitis and schatzki¿s ring, chronic gastroesophageal reflux disease symptoms that bother her a lot; wants fixed and a nissen fundoplication would be reasonable.On (b)(6) 2010: [facility ni]: (b)(6), md.Office notes.Approximately a week out from laparoscopic converted to open nissen fundoplication; converted because of adhesions.In the process of getting the adhesions done there was a bowel duct injury.On (b)(6) 2011: [facility ni]: (b)(6), md.Office notes.Small hernia at roughly the level of the umbilicus.Talked about repair; she is thinking some time in fall or early winter.On (b)(6) 2011: [facility ni]: (b)(6), md.Office notes.Height: 65 inches, weight 152 pounds.Wants incisional hernia repaired, located to the right of the umbilicus.History of alcoholism; recently in emergency room because of crash with blood alcohol 290.She does smoke.I think laparoscopic repair in general for her situation would be better way to go, because of her dense intraabdominal adhesions.I think we will try to fix this from outside first, even though that may have a slightly higher recurrence rate.On (b)(6) 2011: [facility ni]: (b)(6), md.Office notes.Follow up hernia surgery.Doing pretty well without and complaints.Wounds healing.On (b)(6) 2012: [facility ni]: (b)(6), md.Office notes.She is worried she may have a little recurrence of a hernia from previous hernia repair; it was just a small open procedure without mesh.I'm not convinced a hernia is there, but if it is it will certainly get worse and she could come back and see us at that time.On (b)(6) 2012: [facility ni]: (b)(6), do.Office notes.Past history: asthma, open cholecystectomy in 1975, incisional herniorrhaphy.Quit smoking 2012.On (b)(6) 2012: [facility ni]: (b)(6), do.Office notes.Recently spent 3 months in jail for driving under influence.Follow up chronic obstructive pulmonary disease; back to smoking quarter pack of cigarettes a day.Long history alcoholism; been through numerous rehabs.She¿s had incisional herniorrhaphies and is concerned for a recurrence.Weight 156 lbs.Impression: chronic obstructive pulmonary disease, depression, anxiety, tobacco abuse.On (b)(6) 2013: [facility ni]: (b)(6), do.Office notes.Ct done on (b)(6) 2013 showed mass in liver and multiple anterior abdominal wall hernias containing fat and a small hiatal hernia.Does have occasional pain from hernias but has not had any gastrointestinal symptoms, nausea, vomiting or constipation.On (b)(6) 2014: [facility ni]: (b)(6), do.Office notes.Follow up rectal bleeding.Height 65¿, weight 149.Impression/plan: rectal bleeding: recommend colonoscopy.Alcoholism: recommend long term rehab; she states she is not ready at this time.On (b)(6) 2015: (b)(6), md.Anesthesia record.Height: 66.0 inches.Weight: 155 lbs.Bmi: 25.Active problems: chronic obstructive lung disease, hernia, pancreatitis.Procedure history: 3 abdominal surgeries, intestines removed, cholecystectomy, incisional herniorrhaphy, exploratory laparotomy for fundoplication, pancreatic pseudocyst with duodenal perforation and repair.Social history: alcohol: 1-2 times per week.Substance abuse: heroin, methamphetamines ¿ stopped in 2010.Tobacco: use per day: 8 cigarettes.Asa class: iii.Implant procedure: right inguinal hernia repair, open with mesh.Implant: gore® mycromesh® (1mym09/13372056; 1 mm thick x 6 cm width x 12 cm length).Implant date: on (b)(6) 2015 (same day surgery).On (b)(6) 2015: (b)(6), md.Operative report.Preoperative diagnosis: right inguinal hernia.Postoperative diagnosis: right inguinal hernia, direct.Anesthesia: general endotracheal intubation [blank].Estimated blood loss: minimal.Description of procedure: ¿the patient was taken to the operating room, laid supine, draped and prepped in sterile fashion, given general anesthetic.An incision was now made overlying the hernia sac and taking this down through the subcutaneous tissues and scarpa's with cautery to reach external oblique aponeurosis.Aponeurosis cleaned up using sharp dissection with metzenbaum scissors.Then opened with a #15 blade scalpel length of the external ring.We dissected bluntly around the round ligament.This was clamped and divided.She had an indirect hernia coming down, so pushed back into the internal ring.We placed a mesh right over the internal ring of gore-tex micromesh.This was sutured just above the pubic tubercle, one arm up with double-armed 3-0 prolene, one arm was run up along the inguinal ligament, and the shelving edge was along the conjoint tendon [blank] internal ring and tied the sutures down.This provided a good tension-free repair the detect.I then went ahead and closed the external oblique aponeurosis with a running 2-0 vicryl, closed scarpa's with interrupted 2-0 vicryl, and closed skin with 5-0 vicryl subcuticular.She tolerated the procedure well and was taken to recovery in stable condition, to be discharged home the same day.¿ on (b)(6) 2015: (b)(6) center.Implant log.Device type: hernia repair mesh.Implant item: mesh, surgical fixation tissues soft 1 mm thick x 6 cm width x 12 cm length sterile expanded polytetrafluoroethylene micromesh.Implant supplied by facility: yes.Lot number: 13372056.Catalog#: 1mym09.Implant site: groin, right.Quantity: 1.Serial number: na.Manufacturer: wl gore & associates.Expiration date: 11/01/2019.The records confirm a gore® mycromesh® (1mym09/13372056) was implanted during the procedure.Relevant medical information: on (b)(6) 2015: (b)(6), md.Operative report.Preoperative diagnosis: right groin abscess after hernia repair.Postoperative diagnosis: right groin abscess after hernia repair.Procedure: i and d [incision and drainage] right groin abscess.Estimated blood loss: minimal.Complications: none.Specimens: cultures sent.Description of procedure: ¿procedure was explained in detail including a detailed explanation of the risks and benefits.The patient freely consented.Her area was prepped sterilely with betadine, local anesthetic was used to anesthetize the skin and subcutaneous tissues at her previous incision.Previous incision was then opened up and entering into a moderate size fluid collection somewhat murky-looking fluid, not definitively pus.Cultures were taken for anaerobic and aerobic.Specimens: [blank] finger was placed into the cavity broke down all loculations and was packed with saline soaked gauze.The patient tolerated the procedure.We will continue wound care and antibiotics, wait for cultures.¿ on (b)(6) 2015: (b)(6) center.Microbiology report.Source: abscess, abdomen.Final report: light growth staphylococcus aureus.Gram stain: rare white blood cells.No organisms seen.On (b)(6) 2015: (b)(6), md.Anesthesia record ¿ preanesthesia evaluation.Asa class: iii, infected mesh.Explant procedure: explantation of infected right groin mesh, right inguinal hernia repair with biologic mesh.This was acell mesh.Explant date: on (b)(6) 2015 (hospitalization on (b)(6) 2015).On (b)(6) 2015: (b)(6), md.Operative report.Anesthesia: general.Description of procedure: ¿the patient was taken to the operating room.She had previous incision and drainage by my partner but the mesh was really infected and underneath was abscessed.I went ahead and lengthened the incision through the previous incision, took this down to the fascial repair.There [blank]a lot of fluid here, but as i opened up the external oblique aponeurosis fascia, a fair amount of fluid was obtained.This was not purulent appearing, as a lot of it was just blood-tinged seroma but the impression was that this was almost severely infected.Mesh was now easily visible.This was grasped with a kocher clamp, suture was cut and it was removed.I now irrigated the wound out with bacitracin irrigation and a 5 ply acell mesh was hydrated and then cut to fit.I sutured this with an interrupted 2-0 vicryl, coming up the conjoined tendon as well as the shelving edge of inguinal ligament.After suture [blank] pubic tubercle, came up over the internal ring, sutured in here as well.At this point, i went ahead now and closed the external oblique aponeurosis back over it partially.I then placed a drain in the subcutaneous tissues, placed this drain down on top of the mesh, and then closed the skin with staples.She tolerated the procedure well and was taken to recovery in stable condition, admitted to the floor for iv antibiotics.Final diagnosis: infected mesh, right groin.She underwent and explantation of this mesh and repair of right inguinal hernia with acell biologic mesh.¿ on (b)(6) 2015: (b)(6) center.Operative record.Wound class: 4- dirty ¿ infected.On (b)(6) 2015: (b)(6) center.Implant log.Implant item: matri-stem surgical matrix plus.Implant site: groin, right.Manufacturer: acell matristem.Relevant medical information: on (b)(6) 2015: (b)(6), md.Emergency room visit.Smoking history: former smoker.Height: 167.64 cm, weight 65.77 kg, bmi 23.4.Impression: chronic obstructive pulmonary disease, anxiety.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® mycromesh® 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® mycromesh® 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: (b)(6) 2015: (b)(6) medical center.Emergency department.(b)(6).Consultation.The patient is a 57-year-old female, who is out few weeks from an open right inguinal hernia repair with mesh.She came to the emergency room complaining of increased purulent -looking drainage and pain and swelling.She did see dr.Murray last week and had a little swelling, but they were going to watch it.She has had some mild subjective chills.No fevers.Extremities: on the right groin there is some erythematous changes and opened up purulent-looking drainage from the incision of her previous hernia repair.Assessment and plan: probably right groin wound infection with abscess formation.At this point, we will do an i and d and cultures.She understands if this infection extends down to the ____ [blank] great chance she may have the mesh removed.At this point, we will get cultures ____[blank] wound and treat accordingly and see how she responds clinically.She understands the risks of bleeding, complications, chronic pain or numbness in the area, inadequate drainage requiring further drainage.Procedures were explained to the consents.We will proceed forward.(b)(6) 2015: (b)(6) medical center.(b)(6).Imaging ¿ ct abdomen/pelvis w/contrast.History: evaluate for pelvic abscess, prior hernia repair (b)(6) 2015.Findings: ct abdomen: a 4 x 6 mm noncalcified pulmonary nodule is present on axial image 5 in the base of the right middle lobe more likely benign.Based on the fleischner society criteria consider followup ct in 12 months.Remaining lungs are clear.A lesion is present in the posterior segment right lobe liver centered on axial image 23 which has low density in the center and some peripheral enhancement an [sic] measures 23 x 28 mm.Probably this is a benign homangioma but it this is unknown followup three phase ct liver may be helpful [sic] no true lateral confirmation this is a hemangioma and not a lesion of other origin.Alternatively followup ct could be done in 3 to 6 months.The gallbladder has been removed.The spleen come [sic] adrenal glands and kidneys are normal.The common bile duct is dilated to 15 mm which may well be from prior cholecystectomy.Underlying stricture or occult lesion or stone are difficult to exclude.Is [sic] correlate with lab values.The aorta tapers normally.A fat containing midline ventral hernia seen in the upper abdomen level of the liver [sic] the greatest transverse diameter opening of 3.7 cm.No bowel is seen in this hernia.A midline ventral hernia is present more inferior just above the emboli chest with herniation of colon into the hernia with greatest transverse to opening of some 0.6 cm.The hernia measures 3.2 cm in ap dimension.There is no evidence of strangulation or bowel obstruction.Ct pelvis: the bladder is normal.Uterus is intact.A cystic collection is seen [sic] the right groin region just anterior to some apparent stricture [sic] the suture from a prior inguinal hernia repair.The fluid collection measures approximately 7 cm transversely x 4 cm ap dimension x 6.5 cm craniocaudal dimension and has a greatest oblique dimension of 8 cm.This could be a postsurgical seroma or abscess in the correct clinical setting.This is accessible to ct guided drainage if desired.Impression: a loculated fluid collection is seen in the right groin region just anterior to the musculature in the subcutaneous tissues which abuts the anterior edge of the mesh probably from prior hernia repair.This could be a postsurgical seroma or an abscess.This measures in greatest dimension 8 cm.Midline supraumbilical ventral hernia is present with herniation of colon into the hernia but no evidence of strangulation or obstruction.A second fat containing smaller midline ventral hernia seen superiorly at the level of the liver.Lesion is seen posterior segment right lobe liver 28 mm probably a hemangioma.If this is unknown followup three-phase ct liver without and with iv contrast with delayed imaging to the liver could be done to confirm this suspicion or followup ct 3 to 6 months could be done.A 6 mm noncalcified pulmonary nodule is present in the base of the right middle lobe more likely benign but consider followup ct in 12 months.The common bile duct is dilated to 15 mm probably from prior cholecystectomy but please correlate clinically.(b)(6) 2015: (b)(6) medical center.(b)(6).Subjective: c/o pain.Plan: adjust pain meds.Cont [continue] iv abx [antibiotics]and wound care.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Subjective: still with significant pain at abscess site.Plan abscess rlq at surgical site s/p i and d.Mssa in wound.Cont [sic] with ancef.Defer further intervention to surgery.Copd stable rt protocol.Dvt prophylaxis.Dispo: await further recommendations from surgery if any other surgery is needed.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Subjective r [right] groin infection with infected mesh.Assessment: infected mesh.Plan: explantation of mesh, puls [sic] lavage and implant biologic mesh in am.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Right groin abcess [sic] due to infected inguinal mesh.Wound culture grew mssa.Continue ancef.Mesh explantation today.Home after if ok w/surgery.Copd.No exacerbation, rt protocol dvt prophylaxis: start lovenox.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® mycromesh® 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® mycromesh® 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 results code.Conclusion code remains unchanged.It should be noted that the gore® mycromesh® 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® mycromesh® 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® mycromesh® 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: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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