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| Model Number 1DLMCP03 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Discharge (2225)
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| Event Date 08/03/2016 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.(b)(4).
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2016 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, sinus tract draining purulence, open draining wound, 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: 05/11/16: [missing records: record for operative report for ¿hernia repair, incisional¿ was not provided].05/11/16: anmed health.Implant record.Item number: 89819.Body site: abdomen.Expiration date: 9/30/2016.Quantity: 1.Wasted: 0.Date used: 10:08.Device description: mesh dual plus 10.0 x 15.0 x 1.0 1dlmcp03.Body side: not applicable.Manufacturer: w.L.Gore & associates inc.Manufacturer catalogue: 1dlmcp03.Serial number: 14702879.Physician: dr.Peter cook.Device: implant.Procedure: hernia repair, incisional.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/14702879) was implanted during the procedure.Records span (b)(6) 2016 to (b)(6) 2016.It should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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B7: added medical history.H6: updated results code.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) 2016: anmed health.(b)(6), jr.Md.Indication: ¿the patient has developed a very large symptomatic incisional hernia below the umbilicus.She is now admitted for repair.I have explained the indications, risks, and alternatives.She clearly understands.¿ implant procedure: exploratory laparoscopy with lysis of adhesions.Repair of a 10 x 12 incisional hernia with dual gore-tex mesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp03/14702879, 10cm x 15cm x 1mm).Implant date: may 11, 2016 (hospitalization dates unknown) (b)(6) 2016: anmed health.(b)(6).Md.Operative report.Preoperative and postoperative diagnosis: a 12 x 10 centimeter incisional hernia.Anesthesia: general.Procedure: ¿with informed consent, the patient was taken to the operating room.She was placed in supine position and given general endotracheal anesthesia.The abdomen in its entirety was prepped and draped in standard fashion.After appropriate time-out, the incisional hernia was below the umbilicus where i had taken her colon out in the past.I made an incision.The incision was pretty much the full length of the previous incision.The hernia sac was fairly large.It was dissected from the undersurface of the surrounding fat and skin.It was opened.The fascial edges were defined after adhesions were taken down.There was no evidence of any enterotomy or bleeding.At this point we elected to do a closure with a dual mesh plus, which is 10 cm x 15.I sutured this circumferentially with o prolene.I was very careful not to do any back stitches in the bowel, and i checked this multiple times.At this point, after appropriate irrigation, i closed the hernia sac over the mesh with 2-0 vicryl.I closed the skin with 2-0 vicryl and skin clips.She tolerated the procedure well.Minimal blood loss.There was no specimen.All sponge and needle counts were correct.¿ (b)(6) 2016: anmed health.Implant record.Item number: 89819.Body site: abdomen.Expiration date: 9/30/2018.Quantity: 1.Wasted: 0.Date used: 10:08.Device description: mesh dual plus 10.0 x 15.0 x 1.0 1dlmcp03.Body side: not applicable.Manufacturer: w.L.Gore & associates inc.Manufacturer catalogue#: 1dlmcp03.Serial number: (b)(6).Physician: dr.Peter cook.Device: implant.Procedure: hernia repair, incisional.Explant preoperative complaints: (b)(6) 2016: anmed health.(b)(6), md.Indications: ¿the patient had surgery for an incisional hernia repair back in may 11th.She had developed some purulent drainage through a sinus tract.We have been treating this fairly conservatively with antibiotics, packing through the sinus tract and it hasn't improved.She has never really since experienced any systemic complications, such as systemic toxicity, fever, chills or malaise from this.It has just been a chronic draining purulent sinus tract.Obviously this has been an infected mesh and after failed medical therapy, it is to be removed.¿ explant procedure: laparotomy, mesh explant.Explant date: (b)(6) 2016 (hospitalization dates unknown).(b)(6) 2016: anmed health.(b)(6), md.Operative report.Anesthesia: general.Preoperative diagnosis: infected gore-tex mesh 2-1/2 months status post incisional hernia repair with a 10 x 15 cm.Dual gore-tex mesh.Procedure: ¿after lengthy discussion with the patient about the indications, risks and the alternatives for surgery, we took her to the operating room and placed in a supine position.She was given general endotracheal anesthesia.The abdomen was prepped and draped in the standard fashion.After appropriate time-out, the incision which went above the umbilicus and down between the umbilicus and the pubis was carried down.At this point, the mesh was easily exposed and interestingly, the pus was coming from underneath the mesh.Basically the mesh was floating between a good solid bed of granulation tissue which obviously was over the bowel and the mesh.The sutures were cut.The mesh was easily removed.This culture was done of the mesh and the pus.Interesting, it left pretty good bed of granulation tissue which meant that we do not need to cover this in any way and subsequently she is probably going to have a hernia there, as expected that she is going to have to live with.After copious irrigation, the subcutaneous scar was approximated with 2-0 vicryl and skin loosely approximated on the superior and inferior edges with 2-0 vicryl and packed with telfa wick(?).Basically all the infection was removed.There was no evidence of tissue involvement i.E.Cellulitis, etc.So basically otherwise i was a little concerned and basically that is felt very confident this was a very appropriate operation done well.At this point, a dressing was placed.She tolerated the procedure well.Minimal blood loss.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial.Instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Added medical history.Conclusion code remains unchanged.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) 2016: anmed health, surgical consultants.(b)(6) , md.History and physical.Seen in consultation for hernia.History of present illness: ¿many years ago patient underwent sigmoid colectomy.Over the years she has matured weight wise and has gained weight and developed a symptomatic incisional hernia below the umbilicus.¿ medical history: coronary artery disease, chest pain, diabetes mellitus, type 2, dyslipidemia, hypertension, hypothyroidism, and status post angioplasty.She does smoke.She has a lot of pain and discomfort around her lower abdomen which is interfering with her lifestyle.Height 5¿7¿, weight 200 lbs., bmi 31.34.Abdominal exam: non-tender, no masses.Assessment: ventral incisional hernia.¿very symptomatic incisional hernia interfering with her lifestyle.Length discussion with her the pathophysiology of hernias the indications, risks and alternatives to have this fixed.I told her essentially she could live with this she can tolerate this is so large.It is bothering her to the point of interfering with her lifestyle.The risk of surgery include bleeding infection bowel perforation.¿ plan: ¿you need to quit smoking.¿ schedule outpatient surgery.Implant date: (b)(6) 2016 (hospitalization (b)(6) 2016) (b)(6) 2016: anmed health.(b)(6) md.Discharge summary.Hospital course: ¿she was taken to the operating room.An incision was made below the umbilicus and a moderate-sized incisional hernia was repaired fairly easily with dual gore-tex mesh.Her postop course was unremarkable.We observed her through the night.She had no fever, tachycardia, nausea or vomiting.She ate.She was doing well.She was a little sore.Her dressings were dry.At this point, i have carefully given her wound and activity instructions and some pain medicines.I will see in the office in about 5 days.¿ explant preoperative complaints: (b)(6) 2016: anmed health, surgical consultants.(b)(6) md.History and physical.Reason for visit: recheck wound.History of present illness: ¿the patient is 2 months status post incisional hernia with 2 pproline mesh.She still draining some peerless [sic] but certainly no systemic problems.¿ current every day smoker.Physical exam: ¿she has purulence coming out there is a moderate amount.¿ assessment: wound infection.Plan: start augmentin.Recheck in 2 weeks.Explant date: (b)(6) 2016 (hospitalization (b)(6) 2016) (b)(6) 2016: anmed health.(b)(6) md.Discharge summary.¿this lady is well known to me.She had a very symptomatic incisional hernia from a colon resection years ago.I fixed this in may made with gore-tex mesh.She did very well.Several weeks later she developed a sinus tract draining purulence.We treated this with packing and p.O.Antibiotics multiple times with multiple regimens.She was given an adequate medical and certainly failed.She was draining a lot of purulence and she is now admitted to the hospital for removal.¿ hospital course: ¿her postop course was unremarkable.Blood sugars were under good control~ she really was not having any pain and the dressings were dry with wicks.I told her she can take the dressings off and take a shower p.R.N., other than that if she wants to leave the dressing on until she sees me in the office in four days she is wil1ing to do that too, but an:v-w-ay she was discharged on the usual medicines with no antibiotics and she has got a prescription £or pain medicines.I will see her in the office in about four or five days.She knows to call if there are any problems.¿ relevant medical information: (b)(6) 2019: [facility not identified] (b)(6) md.Office visit.History and physical.Referred for concern for inverted appendix.¿she underwent colonoscopy and was found to have a masslike inversion of the appendix.She has had some minor abdominal pain but she also has recurrent ventral incisional hernias.Her past surgical history is significant for undergoing a low anterior resection and repair of colovaginal fistula in 2011.She then developed a ventral hernia and underwent ventral hernia repair with placement of a 10 by 12 centimeter gore dual mesh.3 months later she required reexploration and removal of the mesh.Since then she has developed recurrent ventral incisional hernia.¿ she underwent ct scan and it does show a mass in the base of the cecum at the appendiceal orifice.It also shows a large ventral hernia containing bowel.Current every day smoker, ½ pack daily.Followed for monoclonal gammopathy [rare blood disorder].Past abdominal surgeries: cesarean section, colectomy, hernia repair, mesh later removed for infection, and partial hysterectomy.Abdominal exam: abdomen is soft and nondistended.There is a hernia present.She has 2 ventral hernias one just above the umbilicus and one in the left lower quadrant both reducible and nontender.Assessment: mass at the appendiceal orifice.This could represent a benign adenoma or possibly carcinoma.Recommend right hemicolectomy.She will also require ventral hernia repair just to gain access to the abdomen.Mesh will not be used since bowel resection to be performed.Surgery scheduled for (b)(6) 2019.Diagnoses: mass of appendix, recurrent ventral incisional hernia.(b)(6) 2019: anmed health.Inpatient admission.O (b)(6) 2019: (b)(6) , md.Operative report.Preoperative diagnosis: abnormal mass at the appendiceal orifice seen on colonoscopy and confirmed by ct scan, recurrent ventral incisional hernia.Postoperative diagnosis: same, extensive intra- abdominal adhesions.Procedure: extensive lysis of adhesions, partial cecectomy with appendectomy, repair of recurrent ventral incisional hernia.? findings: ¿chronically obstructed appendix from large stool ball.¿ ? procedure: ¿anesthesia placed a tap block.Next, the abdomen is prepped and draped in standard fashion.The abdomen was entered through the previous midline incision.The small bowel was stuck to the anterior abdominal wall and tedious dissection was carried out just to get to where we could extend our fascial incision.We then spent the next 45 minutes doing lysis of adhesions as the bowel was stuck to the abdominal wall.There was adhesions down in the pelvis.The bowel was up into these multiple ventral hernia defects.We were able to get all the adhesions down.No enterotomy were made.At this point, we placed a wound protector and set up the bookwalter.We identified the appendix and it appeared to be enlarged and very long.There was still adhesions down the pelvis that had to be released so that we could mobilize the right colon.We actually had to follow the appendix down all the way to the deep pelvic region where it was then freed up from the pelvic sidewall.The right ureter was identified and kept out of harm's way.We did place a large clip at the distal extent of where we divided and released the tip of the appendix.We then mobilized the right colon and then palpated and the mass appeared to be a little bit removed from the appendiceal orifice where previously on imaging and colonoscopy it was right at the appendiceal orifice.The appendix clearly appeared to be chronically obstructed and firm.I was able to actually excise what was felt to be a tumor and the appendix by partial cecectomy and appendectomy using the ta 60 stapler.We took care to make sure we did not impinge on the terminal ileum as it entered into the cecum.I took the specimen down myself to pathology.We opened up the specimen and there was no tumor, but there was a large stool ball that appeared to have been chronically obstructing the appendix.The appendix itself was firm.We opened this and it was packed full of stool throughout.Finding no malignancy or tumor.I did not feel that right hemicolectomy was needed.I returned to the operating room, and reinforced my ta 60 staple line with interrupted 3-0 silk.We made sure there was good hemostasis.We irrigated the abdomen and pelvis, and then we repaired the ventral incisional hernia.Because this was a bowel case, i did not feel mesh was indicated.We closed the fascia to include the hernia fascial defect with a running #1 maxon and then closed the skin with staples.¿ o (b)(6) 2019: (b)(6) , md.Discharge summary.Discharge diagnosis: chronically obstructed appendix from large fecalith, recurrent ventral incisional hernia, severe intra-abdominal adhesions.Hospital course: ¿postoperatively, she has done very well.She has had minimal pain.She was started on clear liquids on post op day one, and on post op day two, advanced to full liquids.She is tolerating full liquids, having no nausea or vomiting.Some flatus, but not yet about movement.Her abdomen is soft with bowel sounds.Her incision is clean.She is considered stable for discharge home and will be discharged homeless plans to follow up me in my office in two weeks.¿ o (b)(6) 2019: (b)(6) md.Pathology.Diagnosis: appendix, clinically portion of cecum, excision.Benign veriform appendix and portion of cecum.Appendiceal lumen dilated by thick and viscous fluid and debris with partial calcification, consistent with partially calcified fecalith.No significant dysplasia or evidence of malignancy identified.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 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 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.H6: updated investigation finding.H6: updated investigation conclusions.H6: health effect impact code: f1903: device explantation.H6: medical device component: g04088: membrane.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® plus 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.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 14702879.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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