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| Model Number 1DLMC04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Obstruction/Occlusion (2422)
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| Event Date 09/08/2021 |
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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 laparoscopic ventral incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2019, (b)(6) 2020, and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh failure and erosion, infection, inflammation, adhesions and bowel obstruction, producing chronic 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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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) 2008: (b)(6) hospital.(b)(6).Radiology¿small bowel follow-through.Indication: small bowel obstruction.Impression: mild partial small bowel obstruction.(b)(6) 2008: (b)(6) hospital.Operative record.Procedure: exploratory laparotomy, ventral hernia repair with mesh.Preoperative/postoperative diagnosis: abdominal pain.Asa class: 2.Wound class: clean.Implant procedure: exploratory laparotomy, ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial] [1dlmc04/ (b)(6) , 15cm x 19cm x 1.0cm] implant date: (b)(6) 2008 (hospitalization [ni] [not indicated]).(b)(6) 2008: [operative report for mesh implant was not provided.].(b)(6) 2008: (b)(6) hospital.Implant record.Description: dual mesh biomaterial.Quantity: 1.Catalog no.: 1dlmc04.Serial/lot number: (b)(6).Size: 15cm x 19cm x 1.0 cm.Implant site: abdomen.Manufacturer: gore.Expiration date: 2/17/2009.The records confirm a gore® dualmesh® biomaterial (1dlmc04/(b)(6)) was implanted during the procedure.Explant #1 procedure: laparoscopic converted to open lysis of adhesions, small bowel resection, abdominal mesh resection, bilateral transverse abdominis plane block, and prevena wound vac closure.Explant #1 date: (b)(6) 2019 (hospitalization [ni]).(b)(6) 2019: (b)(6) hospital.(b)(6) md.Operative report.Assistant: none.Preoperative diagnosis: adhesive small-bowel obstruction.Postoperative diagnosis: adhesive small-bowel obstruction with bowel ingrowth into abdominal wall mesh.Indications: the patient is a 62-year-old woman with a significant past medical history including a nephrectomy, which was robotic, and open hysterectomy with postoperative hernia repair with mesh.She presented with a small-bowel obstruction by ct and previous history of 2 bowel obstructions.Overnight, she produced over a liter of ng output and continued to have pain.We discussed options, including continued observation and a contrast study or surgery.I recommended laparoscopic, possible open possible bowel resection.The patient agreed.Description of procedure: ¿she was taken to the operating room.Dr.(b)(6) induced general endotracheal anesthesia.She received iv ancef.Her abdomen was prepped and draped, and a time-out was conducted.A veress needle was inserted in the left upper quadrant.Pneumoperitoneum was created.Three trocars were placed on the left side of the abdomen.Extensive lysis of adhesions was carried out.This continued until the small bowel in the right lower quadrant was seen clearly adherent to the previously placed mesh.At this time, we elected to convert to open procedure.The instruments were counted.A 10 blade was used to make a midline incision around the umbilicus.It was carried down to the area of previous dissection.The small bowel was carefully dissected off the mesh.In one area, there was an enterotomy, and due to the atrophic nature of the bowel and the mesh in the right lower quadrant, we elected to do a bowel resection.The remaining adhesions in the right lower quadrant were lysed.The mesentery proximally and distally to the damaged bowel was opened with a ligasure device.Endo gia staples were used to transect the bowel proximally and distally.This was an approximately 1 foot section of chronically obstructed and damaged bowel.The intervening mesentery was taken with the ligasure.Matching enterotomies were made, and a side-to-side functional end-to-end anastomosis was carried out.The enterotomy was closed with running maxon suture.The intervening mesenteric defect was closed with 2-0 polysorb suture.At this point, the remaining bowel was examined.There were no other areas of injury.It was returned to the abdomen.The abdomen was irrigated.The area of mesh that had the bowel ingrowth was also debrided.Bilateral tap block was carried out with local anesthesia.The wound was closed with running looped #1 maxon, and the skin was loosely stapled.The trocar sites were stapled and the wound covered with a large 20 cm prevena wound vac.The patient tolerated the procedure well.Ebl was approximately 100 ml.The patient will be continued with bowel rest and antibiotics until she has return of bowel function.Her sister was updated at the conclusion of the procedure.¿ relevant medical information: (b)(6) 2020: (b)(6) hospital.(b)(6) md.History and physical.Chief complaint: open wound abdomen status post-surgery (b)(6) 2019.Does not smoke.Still with pain mid-incision, mild drainage inferior incision.Positive nausea, abdominal pain.Medical history: diabetes mellitus, history of rheumatoid arthritis, open wound abdomen, renal cancer.Surgical history: (b)(6) 2019: release of small intestine/small bowel obstruction, (b)(6) 2019: lumbar facet injection.(b)(6) 2016: colonoscopy.(b)(6) 2015: laparoscopic partial nephrectomy.(b)(6) 2010: colonoscopy/polypectomy.(b)(6) 2008: incisional hernia repair with graft or prosthesis.(b)(6) 2008: subtotal abdominal hysterectomy.(b)(6) 2007: colonoscopy/polypectomy.(b)(6) 2007: abdominal hysterectomy.(b)(6) 1993: cholecystectomy.Exam: midline abdominal wound with opening and drainage inferiorly.Impression/plan: poorly healing abdominal wound.May have a stitch abscess or mesh infection.Discussed options.Recommend abdominal wound exploration and possible wound vac placement.Agrees, wishes to proceed.Recent ct reviewed.Explant #2 procedure: abdominal wound debridement, small wound vac placement.Explant #2 date: (b)(6) 2020 (hospitalization, same day surgery).¿ 3/16/20: (b)(6) hospital.(b)(6) md.Operative report.Admission diagnosis(es): non healing wound.Discharge diagnosis(es): same, due to mesh in base of wound.Assistant: none.Anesthesia: gen lma.Anesthesiologist: (b)(6) do.Technique: ¿the patient was met in pre-op hold and the inferior abdominal wound was marked.The patient was taken to the or and dr.(b)(6) induced general lma anesthesia.Her abdomen was prepped and draped, and a surgical time-out was conducted.Local anesthesia was injected.The inferior aspect of the wound was opened.Cultures were taken.The granulation tissue was debrided.There was unincorporated goretex mesh that was debrided.Mesh remains but would require abdominal wall reconstruction to remove.We elected to place a via wound vac in the wound, and try conservative management first.This was discussed with her sister maria at the conclusion of the case.¿ indication for surgery: non-healing wound after bowel resection.Findings: mesh at base of wound.Specimen(s): portion of mesh, cultures.Estimated blood loss: 5 ml.Complications: none.Date of admission: (b)(6) 2020 05:36.Date of discharge: (b)(6) 2020.Condition on discharge: stable.Discharge disposition: home, office visit tomorrow.Information provided to patient and family: no followup entered.Follow-up instructions: office visit tomorrow.Primary care physician: (b)(6) md.Relevant medical information: (b)(6) 2020: (b)(6) md.Office notes.Phone-to prevent risk of covid-19.Discuss ct.Ct shows defect in explanted area of mesh.As of chronic infection, wound continues to drain and has expanded.Problem list: rheumatoid arthritis: onset (b)(6) 2010.Was treated with methotrexate and plaquenil between 2006 and 2008.Hypertension, fibromyalgia/myalgia.Medications: metformin.Positive abdominal pain.Impression: abdominal wall abscess at site of surgical wound.Neck mesh infection, open draining wound.Slightly worse findings by ct.Discussed options; recommend exploratory laparotomy, explant of mesh, wound vac.Follow-up (b)(6) 2020.(b)(6) 2020: (b)(6) hospital.(b)(6) md.History and physical.Phone appointment.Impression: abdominal wall abscess at site of surgical wound.Chronic mesh infection, open draining wound, slightly worse by ct.Plan: exploratory laparotomy, explant of mesh, wound vac; will plan on biologic mesh.Explant #3 procedure: abdominal wound exploration, removal of mesh and wound vac placement.Explant #3 date: (b)(6) 2020 (hospitalization (b)(6) 2020).¿ (b)(6) md.Operative report.Preoperative diagnosis: chronic wound infection.Postoperative diagnosis: chronic wound infection due to infected mesh.Indications: the patient is a 63-year-old woman.She has had a series of bowel obstructions, ultimately resulting in an exploratory laparotomy and bowel resection in (b)(6) of 2019.She was found to have loops of bowel adherent to mesh with near fistula formation.That section of mesh was removed.Postoperatively, she developed chronic drainage and after an additional wound exploration we planned to remove the entire piece of mesh.Today she was met in the preoperative hold.Her covid test was negative.Description of procedure: ¿we took her to the operating room.Dr.(b)(6) induced general endotracheal anesthesia.Her abdomen was prepped and draped and a time-out was conducted.The lower portion of her wound was excised.This revealed a chronic fistula to a large piece of unincorporated gore-tex mesh.The gore-tex mesh was held in place by a prolene suture, but the rest of it was unincorporated.We carefully removed the entirety of the mesh by cutting the gore-tex suture.Irrisept was placed into the wound.It appeared as if the mesh was in a retro rectus or preperitoneal space.There was no obvious underlying fascial defect and there was a large fibrous reaction, so we elected not to close the overlying fascia and decided to just place a wound vac.A medium-sized silver sponge wound vac was placed into the wound and secured and attached to the suction device.The patient tolerated the procedure well.Ebl was approximately 10 ml.Surgeon was myself, dr.(b)(6).There were no complications.The patient will be kept in-house for 48 hours for her 1st wound vac change and outpatient wound vac therapy will be ordered.¿ relevant medical information: ¿ (b)(6) 2020: (b)(6) md.Discharge summary.Discharge diagnosis: chronically infected abdominal wall mesh, status post explant and wound vacuum-assisted closure placement.Hospital course: 63-year-old woman with a series of procedures, including a hernia repair, complicated by bowel obstruction involving the mesh requiring bowel resection.After that surgery, developed a chronic fistula and upon wound exploration, was noted to need excision of the mass [sic].She ultimately was taken to the operating room on (b)(6); had a large piece of gore-tex mesh excised and wound treated with wound vac.In-house, she had 1 wound vac change prior to discharge and then returned to office for an outpatient wound vac change.Currently having wound vac changes by home health.Otherwise without complication.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 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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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: on (b)(6) 2008: (b)(6) (medical center) (b)(6), m.D.Indications: the patient is a 51-year-old black woman who has been readmitted to the hospital one week after hysterectomy for small-bowel obstruction.The small-bowel obstruction has partially resolved, but cat scan revealed an incisional hernia with possibly evisceration of bowel through the rectus sheath, as well as, the patient having pain in this area and severe tenderness.The risks, benefits, alternatives and complications, as well as bowel resection, vertical incisions and use of mesh have been discussed with the patient and her family and the patient desires for urgent surgery.On (b)(6) 2008: (b)(6) (medical center) (b)(6), m.D.Assistant (b)(6), m.D.Anesthesia: general endotracheal anesthesia and 60ml of 0.25% marcaine with epinephrine locally, as well as 400ml of 0.5% plain via the pump.Estimated blood loss: less than 100ml.Specimens: none.Complications: none.Condition: improved.Pre-operative diagnosis: 1.Ventral incisional hernia/evisceration.2.Status post bowel obstruction.3.Status post hysterectomy.4.Arthritis.5.Anemia.Post-operative diagnosis: 1.Ventral incisional hernia/evisceration 2.Status post bowel obstruction.3.Status post hysterectomy.4.Arthritis.5.Anemia.Procedures performed: 1.Limited exploratory laparotomy.2.Implantation of mesh with ventral incisional herniorrhaphy.3.Implantation of pain pump.Findings: 1.There was a small, not infected seroma in the lower pfannenstiel incision.2.One-third of the left rectus medial muscle was torn just at the umbilicus.3.There were protruding loops of bowel in this area and in lower separated area times two.4.There was approximately 3 cm of a torsed omentum adherent to the small bowel.5.Dense fibrous adhesions and scar.6.All bowel was viable in decompressed and no enterotomies were noted.Procedure: ¿preoperatively, the patient received one gram of ancef iv and her lovenox was stopped.She was taken to operating room four and after adequate general endotracheal anesthesia was attained, compression stockings were placed and she was prepped and draped in the usual fashion with chloraprep.After appropriate time out, the previous pfannenstiel incision was incised and the thompson retractor was placed on the left side of the bed.There was a small seroma that was not infected in the lower portion of the wound and the wound edges were well adherent.Electrocautery was used to extend this incision down through the minimal scar to the fascia.Once the rectus fascia was identified, the previous incision was opened using electrocautery, as there was dense, thickened scar tissue there.Once this was done, the fascia peeled easily off the rectus sheath in the lower portion of the abdomen all the way up to the umbilicus.It was at this time that the lower third of the rectus sheath was noted to be adherent, but the upper two-thirds was separated with two portions of bowel protruding through.The bowel was viable and carefully freed up using electrocautery and sharp scissors and blue dissection.Additionally, the medial third of the rectus muscle on the left at the level just 2 cm below the umbilicus and slightly lateral to the midline was torn and had old scar tissue present.There was a 3-cm ball of torsed omentum in this area that was viable.After freeing up the bowel and the omentum, the omentum was transected in the area where it was torsed.That small portion of fatty tissue was discarded.The bowel was freed up and was decompressed and had no evidence of enterotomies and was returned to the abdominal cavity.With the patient in trendelenburg position, the lower third of the wound and the left side had densely adherent bowel and i was unable to free up this bowel through this incision in order to place a mesh deep to the rectus muscle.There was no posterior fascia in this area and the peritoneum could not be readily identified.Since the bowel returned to the abdominal cavity once it was freed from the adhesions and a fibrous band that was knuckling the bowel was divided with electrocautery, hemostasis was again checked and attained.After considering options at this point since the patient needed to have her hernia reduced and this had been accomplished in order to prevent recurrent hernia, i was not able to approximate the rectus muscle.Therefore, a dual mesh gore-tex biomesh was placed and cut to size, being approximately 14 cm long x 9 cm wide.The item was 1dlmc04 and the lot number was 02927349.The mesh was secured multiple times along the medial borders of the rectus with 2-0 interrupted vicryl sutures and a second row of sutures through the mesh to the muscle was placed midway between the center of the mesh and the edges of mesh.Finally, the entire mush was secured along its periphery with two separate running 2-0 prolene sutures.Hemostasis was excellent.This was done under direct vision and the wound was copiously irrigated.The lower fascial edge was freed up and under direct vision, the fascia and skin and subcutaneous tissues were anesthetized with the local marcaine.Under direct vision and palpitation, the pain pumps were put in an inverted v crisscross fashion in the subcutaneous tissue just along the fascia.Lastly, the fascia was closed using running #1 pds sutures.The subcutaneous tissue was irrigated and the skin closed using running intracuticular 4-0 monocryl sutures and demrabond.The pain pumps were then threaded and secured with mastisol, dermabone and opsite.The patient tolerated the procedure well and preliminary and final sponge, instrument and needle counts were reported correct.Prior to closing, my individual examination of the wound and abdomen revealed no evidence of retained instruments or sponges.After surgery, the patient had a foley catheter placed, which returned 350ml of urine and this will be discontinued in the recovery room.The patient was taken to the recovery room in improved condition and will be followed by me.I discussed the results with her sister and dr.Maresh.¿ explant #1 date: (b)(6), 2019 (hospitalization dates (b)(6), 2019) on (b)(6) 2019: (b)(6) medical center.(b)(6), m.D.Discharge diagnosis: 1.Small bowel obstruction s/p bowel resection, loa [lysis of adhesions] and wound vac placement.With post operative ileus.2.Leukocytosis, resolved.3.History of renal cell cancer status post left nephrectomy 4.Hypertension 5.Chronic pain syndrome.Hospital course: 62 years old with history of renal cancer and left nephrectomy, with history of small bowel obstruction she comes in with abdominal pain and found to have small bowel obstructions.Patient was admitted to medical floor, kept nothing by mouth, ng was placed that [sic], pain medication was provided.The patient then because of significant pain and not getting better or she has to go for surgery with adhesion lysis converted to open, small bowel resection, abdominal mesh resection, bilateral tap block, prevene wound vac closure.Her recovery of surgery was very slow due to her development of ileus.Her bowel movement has slowly come back and patient start on clear liquid and this was advanced as tolerated.With improvement of her bowel movement, abdominal pain, her oral intake patient will be discharged home and follow up with dr.(b)(6) on (b)(6) 2019.On (b)(6) 2020: (b)(6) medical center lab.Procedure: culture wound aer/ana with gram stain: body site: abdominal wound.Final reports (b)(6) 2020: light streptococcus anginosus.Many white blood cells.No epithelia cells, no organisms seen.On (b)(6) 2020: (b)(6) hospital, (b)(6), m.D.Pathology report: gross description: x 2.9 x 2.1 cm.On [sic] section are fatty to fibrous cut surfaces consistent with scar.There is possible focal necrosis and ulceration.Rs ¿ 1.B.Received in zinc-supplemented 10% neutral buffered formalin in a container with appropriate demographic identification labeled ¿gore-tex mesh¿ is an irregular fragment of pink-tan rubbery mesh material.It measures up to 15.5 cm in greatest dimension by 0.1 thick.No secretions submitted.Gross only.Microscopic description: a.One block, one level, one original h&e slide.See below.B.N/a.Diagnosis: a.Skin and subcutaneous tissue, abdomen excision: - abscess with granulation tissue, foreign body reaction and fibrosis.B.Foreign body, abdomen, removal: gore-tex mesh.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.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: 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: (b)(6) 2019: (b)(6) medical center.Md.(b)(6) pathology report: gross description: ¿the specimen is submitted as ¿distal small bowel.¿ received in zinc-supplemented 10% neutral buffered formalin in a container with appropriate demographic identification labeled ¿distal small bowel¿ is an unopened segment of small bowel closed at both ends with staples.It measures 44.0 cm in length and up to 3.5 cm in diameter.The serosa is pink-tan and smooth to irregular with multiple adhesions and what appears to be a sutures defect which is inked.The defect is 11.0 cm from the closest resection margin.Upon opening, the mucosa is pink-tan and the lumen contains pink-tan mucoid material.There is focal narrowing at the level of serosal adhesions but no complete obstruction.There are no lesions including the site of perforation.¿.Cassette summary: ¿a1 mucosal margins, a2-a3 area of disruption, a4-a5 additional representative sections of mucosa with serosal adhesion.¿.Diagnosis: ¿small bowel, distal, partial resection: benign small bowel with with [sic] marked serosal adhesions (negative for malignancy ).¿.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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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: relevant medical information: ¿ (b)(6) 2015: (b)(6) medical center new.(b)(6), md.Operative report.Assistant: (b)(6), md.Procedure: left robotic-assisted laparoscopic partial nephrectomy.Preoperative diagnosis: left renal mass.Postoperative diagnosis: left renal mass.Anesthesia: general.Estimated blood loss: 20 ml.Specimen(s): left renal mass.Complications: none.Indications: ¿58-year-old female with a history of a complex renal cysts which is increased from 1 cm to 4 cm in size.The patient now elects to proceed with robotic-assisted laparoscopic partial nephrectomy.¿ wound classification: not provided findings: left renal mass.Procedure: ¿following proper identification, the patient was brought to the operating room.Anesthesia was present and administered general anesthesia.The patient was then placed in the lateral decubitus position with the left flank elevated.All of her pressure points were padded adequately.An axillary roll was placed.The positioning was secured with adhesive tape across the hips.Adhesive tape was also placed across the shoulders.After adequate positioning, her abdomen was prepped and draped in the standard surgical fashion.Attention was drawn lateral to the umbilicus where a varies [sic] needle was placed and a pneumoperitoneum was established.We then proceeded to place a [sic] 8 mm trocar just lateral to the umbilicus.We examined the intra-abdominal contents which were normal.Another three, 8 mm robotic ports and 12 mm assistant port were placed under direct vision.The da vinci robotic system was then docked.The procedure was initiated at the console.The colon was identified and reflected medially giving rise to the retroperitoneum.We then proceeded to identify the ureter overlying the psoas muscle.The ureter was elevated and traced to the renal hilum where the renal vasculature was identified and skeletonized.Anesthesia administered 12.5 mg of mannitol.We then released the kidney and drew attention to gerota's fascia.Gerota's fascia was removed exposing the capsule of the kidney.Lntraoperative ultrasound was then used to identify the above described renal mass.Lntraoperative ultrasound was used to demarcate the surgical margins.The margins were then scored with monopolar cautery.Attention was subsequently drawn to the renal hilum where 2 bulldog clamps were placed on the renal artery.Attention was drawn back to the tumor which was excised with cold shears in his entirety.The surgical margins visually appeared negative.The tumor was placed off to the side for later extraction.Attention was drawn to the tumor bed where the renal repair was performed.3-0 vicryl was used to repair the collecting system and obtain adequate hemostasis.Suture of 0 prolene was subsequently used to reapproximate the renal capsule.After renal repair, attention was drawn to the renal hilum where the bulldog clamps were removed.Our total warm ischemia time was 20 minutes.Attention was drawn to the renal repair where excellent hemostasis was visualized.The kidney had excellent perfusion.Surgi-flo was placed over the renal defect.A 7 mm jackson-pratt drain was placed in the vicinity of the kidney.The specimen was placed in an endo catch bag.The da vinci robotic system was undocked and the specimen was extracted throughout 12 mm camera port site.This extraction site was reapproximated using interrupted 0 vicryl.The remaining 12 mm port sites were closed with interrupted 0 vicryl and the remaining port sites were closed with 4-0 monocryl.At the end of the case all sponge, needle, instrument counts were correct.The patient was awakened from anesthesia and taken back to recovery in stable condition.¿ 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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Additional codes.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding 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.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® 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 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.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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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Search Alerts/Recalls
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