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| Model Number 1DLMC200 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/04/2015 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® 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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Event Description
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It was reported to gore that the patient underwent open ventral/incisional hernia repair on (b)(6) 2001 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: recurrence, infected mesh, draining sinus.Additional event specific information was not provided.
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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 procedure: ventral herniorrhaphy with mesh using gortex composite mesh.Lysis of adhesions and takedown jejunostomy.Implant: gore® dualmesh® biomaterial [1dlmc200/00978197].Implant date: (b)(6) 2001 (hospitalization [ni]).On (b)(6) 2001: (b)(6) cancer center.(b)(6) , md.Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia.Anesthesia: general endotracheal.Indications for procedure: a 57-year-old man status post ivor lewis esophagectomy approximately eight months ago, now with a large ventral incisional hernia.Findings: a large ventral incisional hernia with no evidence of incarceration.Tension free repair using composite mesh undertaken.Details of procedure: ¿informed consent was obtained prior to the procedure.He was counseled as to the risks and benefits.He was brought to the operating room and he was placed on the table in a supine position where general endotracheal anesthesia was administered.The abdomen was then shaved, prepped and draped in a sterile fashion.An elliptical incision was made around the previous upper midline wound to include the previous hypertrophic scar.The incision was carried down to the fascia with a knife.The skin was then excised sharply.The hernia sac was identified and entered.We then circumferentially dissected around the hernia sac down to the edges of the fascia which measured approximately 10 centimeters x 12 centimeters.We did a takedown jejunostomy, the previous esophagectomy procedure, sharply.There were a few adhesions of the small bowel to the anterior abdominal wall and these were taken down sharply as well.The sac was excised.The fascial edges were freed of overlying scar tissue.A composite gortex mesh was then placed in the wound deep to the fascial edges and then sewn to the fascial with interrupted horizontal mattress sutures using 0 prolene.There was a nice tension-free closure at the completion.Two 19 blake drains were placed in the subcutaneous space.The wound was irrigated.The subcutaneous was closed with running 2-0 vicryl.The skin was closed with running 4-0 vicryl.The wounds were cleaned and dressings applied.The patient was then awakened, extubated and then to recovery room in stable condition.¿ complications: none.Estimated blood loss: less 100; replacement crystalloid.Drains: two size 19 blake drains.Dr.(b)(6) was present for the entire procedure.On (b)(6) 2001: (b)(6) cancer center.Implant sticker.Gore-tex dualmesh biomaterial.Item #: 1dlmc200.Lot #: 00978197.The records confirm a gore® dualmesh® biomaterial (1dlmc200/00978197) was implanted during the procedure.Explant procedure: removal of infected mesh.Laparoscopic repair of incisional hernia using biologic mesh.Lysis of adhesions.Explant date: (b)(6) 2015 (hospitalization [ni]).On (b)(6) 2015: (b)(6) hospital.(b)(6) , md.Operative report.Preoperative diagnosis: infected mesh.Incisional hernia.Postoperative diagnosis: infected mesh.Incisional hernia.Assistant: gregory sweet.Anesthesia: general.Estimated blood loss: minimal.Fluids: see anesthesia note.Complications: none.Findings: infected mesh.Specimen: mesh.Indication: the patient with prior incisional hernia repair presents with draining sinus from abdominal wound consistent with infected mesh.Operative summary: ¿the patient was taken to the operating theater and underwent general anesthesia.Abdomen was prepped and draped in the usual fashion.A 5 mm optical trocar was placed in the right upper quadrant.Other ports were placed under direct camera visualization.Lysis of adhesion was required to gain adequate access.The area of the draining sinus is overlying the mesh, which was in the superior aspect.The patient was noted to have 2 pieces of mesh, one superiorly and one inferiorly.The superior mesh was obviously infected and this was circumferentially dissected and removed.The lower mesh was well incorporated without any signs of infection.After this, a biologic piece was introduced in the abdominal cavity and using protack, was circumferentially secured.The drain was left in the area of the cavity created by the infected mesh.The drain was secured using nylon.Other ports were closed using monocryl followed by dermabond.The patient tolerated the procedure well.¿ relevant medical information: on (b)(6) 2015: [facility ni].(b)(6) , md.Pathology.Anatomic pathology diagnosis: mesh, removal: mesh identified (gross only).Material: mesh.History: seventy-one-year-old male with incisional hernia.Gross: received in formalin labeled ¿mesh¿ are two irregular pieces of synthetic material aggregating 10.0 x 5.5 x 1.0 cm consistent with mesh.One piece contains multiple blue sutures and both pieces metallic springs, 0.3 cm in diameter.There is minimal attached soft tissue.The specimen is submitted for gross identification only.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 results code.Conclusion code 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: relevant medical information: (b)(6) 2007: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6), md.1.Laparoscopic repair of recurrent incisional hernia.2.Open repair of recurrent bilateral inguinal hernias.[implant: prolene mesh.] preoperative diagnoses: 1.Recurrent bilateral inguinal hernias.2.Recurrent incisional ventral hernia.Postoperative diagnoses: 1.Recurrent bilateral inguinal hernias.2.Recurrent incisional ventral hernia.Anesthesia: general.Estimated blood loss: minimal.Specimens: none.Complications: none.Indications: ¿the patient is a 64-year-old male who presents with pain and increasing in size of incisional hernia, which he has had repaired in the past as well as bilateral inguinal hernias which he has had repaired in the past, all are reducible.These had been causing significant amount of pain and discomfort and increasing in size.¿ wound classification: ¿ii, clean contaminated wound¿.Findings: ¿recurrent bilateral inguinal hernias and recurrent incisional hernia.¿ procedure: ¿the patient was taken to operating theater under general anesthesia.Abdomen and groin were prepped and draped in usual sterile fashion.Initially, an incision was made from the right pubic tubercle towards the right anterosuperior iliac spine overlying a previous incision.Dissection was carried down and during this time, spermatic cord was identified.There was no closure of the external oblique fascia that i could identify.A significant amount of scar tissue was noted.The spermatic cord was dissected free from the surrounding tissue, and the anatomy was significantly distorted but the shelving edge was identified given the chronicity of the hernia, it was difficult to discern this as well as bladder or a chronically thickened inguinal hernia; therefore, the hernia sac was reduced.The prolene inguinal hernia system was introduced through the defect then secured inferiorly from the onlay to the pubic tubercle, laterally to the shelving edge, medially to the conjoint tendon.The internal inguinal ring was recreated by treading a slit in the onlay.The inguinal ring was fingertip tight.The overlying subcutaneous tissue was reapproximated.The incision on the left side was made in a similar fashion from the pubic tubercle towards the left anterosuperior iliac spine down to where the external oblique fascia was not encountered and the spermatic cord was identified, circumferentially dissected from the surrounding tissue.The defect was noted to be in the floor of the inguinal canal.The ilioinguinal nerve was identified and retracted for safety.The prolene hernia system was introduced through the hernia defect by previously reducing the hernia sac along with its contents into the abdominal cavity.Then the onlay was secured to the pubic tubercle inferiorly, shelving as laterally, the conjoint tendon medially, and the internal inguinal canal was recreated by creating a slit in the onlay, also noted to be fingertip tight.The overlying subcutaneous tissue was then approximated using interrupted vicryl sutures.Next, intraabdominal cavity was made through a stab incision in the left upper quadrant using a 5-mm optical trocar.After anesthetizing the skin with marcaine, insufflation was initiated.Next, a 5-mm port was placed on the left side of the abdomen under direct camera visualization.A defect was noted to be inferior to mesh overlying a prior incisional repair.Therefore, the left upper quadrant incision was enlarged to an 11-mm trocar.The mesh was sized measuring 4 inches x 6 inches, was introduced into the abdominal cavity through the 11-mm trocar.A stab incision was made overlying the incisional hernia.By using #2 ethibond, the fascia was approximated using endo close device.Next, a stay suture had been placed in the middle of the mesh and this was brought up to the middle of the incisional hernia using endo close device and the mesh was tacked into place using a tacker.Meticulous hemostasis had been obtained.The 10-mm port was removed under camera visualization.The fascia was closed using ethibond sutures.Insufflatian was then evacuated.The 5-mm port was removed.All the incisions were closed using 4-0 monocryl.The anterior iliac spine area was anesthetized with marcaine for local anesthesia to the groin.The patient tolerated the procedure well, was extubated, and transferred to the pacu in stable condition.¿ relevant medical information: (b)(6) 2015: (b)(6).[physician name was not provided.] microbiology report.Source: incision.Site: abdominal incision.Gram stain: rare wbc¿s.No organisms seen.Final (b)(6) 2015.Aerobic culture: organism 1: alpha strep, not pneumococcus.Final (b)(6) 2015.(b)(6) 2015: the methodist hospital system.[physician name was not provided.] microbiology report.Source: incision.Site: abdominal incision.Anaerobic culture: no anaerobic organisms isolated.Final (b)(6) 2015.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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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: ¿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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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