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| Catalog Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 03/26/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.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 laparoscopic ventral hernia repair on (b)(6) 2011 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions; adhesions (dense); infection; mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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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.Always include: 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: implant procedure: laparoscopic repair of ventral incisional hernias with gore-tex dual mesh 16 x 24 x 1.Implant: gore® dualmesh® plus biomaterial [1dlmc06/8588836, 16 x 24 x 1].Implant date: (b)(6), 2011 (hospitalization [ni]) on (b)(6) 2011: (b)(6) md.Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: multiple ventral incisional hernias.Assistant: dr.(b)(6).Anesthesia: general endotracheal.Indications: this is a very pleasant 46-year-old african-american woman sent to me in consultation by dr.(b)(6) for an evaluation of an umbilical incisional hernia.She noted the acute onset of a hernia following hysterectomy for benign tumor, surgery done in (b)(6) 2010.She had a progressive increase in size of the bulge at the level of the umbilicus.She was desirous of repair via the laparoscopic approach.Intraoperative findings: large hernial defects in the suprapubic and umbilical sites, additional swiss cheese-type defects between the two hernia defects.Blood loss was minimal.Description of procedure in detail: ¿the patient was identified as (b)(6) taken to the operating room, placed in the supine position.Sequential compression hose were placed in bilateral lower extremities.Following induction of adequate general endotracheal anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion with chloraprep and a clear plastic bandage over the skin.The patient was provided intravenous antibiotics and 025% marcaine with epinephrine was instilled in the left upper subcostal position medially.Dissection continued posteriorly through anterior fascia and muscle, posterior fascial muscle and into the peritoneal cavity.The applied medical balloon hasson trocars were placed in the peritoneal cavity, its balloon inflated with c02 insufflation to a level of 15 mmhg ensued.The patient was placed in slight trendelenburg position, hernia defects were identified and photographed.The inferior defect was just in the suprapubic position, and therefore the peritoneum and bladder were taken down using scissors and electrocautery only on small bleeding points.This allowed for identification of symphysis pubis and bilateral cooper's ligaments.Once this had been performed the measurement for desired piece of mesh was made and 18 x 24 x 1 piece of mesh and cut to a 16 x 24 x 1 size marked in the corners, sutures put at the 12, 3, 6 and 9 o'clock position with gore cvo suture.The mesh roll was placed in the peritoneal cavity, unrolled and sutures were brought out with suture passing device at the 12, 3, 6 and 9 o'clock positions and the sutures tied down, tacks with the protack device were placed 1-2 centimeters along the periphery of the mesh.Additional sutures were then placed between the previously placed sutures at about the 1:30, 4:30, 7:30 and 10:30 positions.Mesh was placed and broadly covered the hernia defects.Photographs were taken of the mesh in position.The peritoneum and bladder were then brought anteriorly back over the inferior aspect of the mesh and tacked in position with interrupted protack, taking care to tack only in peritoneum and not bladder.The remaining local anesthetic was placed around trocar sites.Trocars were removed under direct visualization.There was no evidence of bleeding from trocar sites.The abdomen was desufflated through the subcostal ports which were then removed.The subcostal fascial incision was closed with interrupted 2-0 vicryl to deep fascia, interrupted 0-vicryl in the anterior fascia.Skin incisions were approximated with 4-0 monocryl subcuticular sutures.Dressing was completed with mastisol and half-inch brown steri-strips, sterile towel and abdominal binder.The patient tolerated the procedure well without apparent complication.Sponge, needle and instrument counts were correct at the end of the case.¿ on (b)(6) 2011: (b)(6).Implant sticker.Gore® dualmesh® biomaterial.Ref catalogue number: (b)(4).Lot batch code: 8588836.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc06/8588836) was implanted during the procedure.Relevant medical information: on (b)(6) 2019: (b)(6) md.Pathology.Clinical history: intra-abdominal fluid collection, ascites.Final diagnosis: intra-abdominal fluid, paracentesis: concentration preparation: scattered inflammatory cells and numerous bacteria are present.Negative for malignant cells.Cell block: numerous bacteria and rare inflammatory cells are present in a background of fibrinoid material.Explant procedure: robot-assisted lysis of adhesions excision of 16 x 24 cm gore dual mesh.Explant date: (b)(6), 2019 (hospitalization [ni]).On (b)(6) 2019: (b)(6) md.Operative report.Preoperative diagnosis: infected prosthetic mesh of abdominal wall.Postoperative diagnosis: infected prosthetic mesh of abdominal wall.Anesthesia: geta.Assistant: (b)(6).Estimated blood loss (ml): 30.Pathology: other (multiple specimens for culture; mesh and surround rind for specimen).Operative findings: the patient had extensive filmy edematous adhesions to the anterior abdominal wall and the mesh.The 24 x 16 cm gore dualmesh was in place.The radiologically placed right lower quadrant drain was removed in its cavity there was noted to be some purulent fluid.Therefore, entire mesh removal was performed which included purulent fluid associated with the mesh and a large thick rind of infected appearing brown tissue.Procedure in detail: ¿the patient was taken to the operating room and placed in supine position.General endotracheal anesthesia was induced.The abdomen was prepped and draped in usual sterile fashion and a surgical timeout was performed to verify correct patient procedure and site.Local anesthetic was injected in the skin and subcutaneous tissue 5 mm optiview trocar placed in the left upper abdomen with the laparoscope in place.The abdomen was insufflated to 15 mmhg with c02 gas which the patient tolerated well.A 5 mm port was placed in the left mid abdomen.There were extensive adhesions throughout the abdomen to the anterior abdominal wall.Some upper abdominal adhesions were taken down sharply and then a 12 mm port placed in the epigastrium.An 8 mm robotic port was then placed in the right upper abdomen.The patient was placed in slight trendelenburg position the da vinci robot was docked.The progress was placed in arm 1 and the monopolar scissors in arm 2.There were extensive adhesions of omentum to the anterior abdominal wall and the previously placed mesh.The adhesions were primarily filmy and took about 45 minutes to remove from the anterior abdominal wall using blunt dissection and cautery.The adhesions were edematous.At this point attention was turned to the right lower abdomen where the previously placed radiologic pigtail drain was.This was going anterior to the mesh and in this cavity, there appeared to be some purulent fluid.The drain was removed.Due to this purulence and after suctioning the cavity the mesh was floppy and abnormal appearing, i opted to continue with mesh excision.Using blunt dissection and the shears proceeded to excise the entire 16 x 24 cm mesh including associated metal pro-tacks.There is an associated very thick rind with thick brown necrotic debris associated with it which was also fully removed, entire mass was removed which was down to level of the pubis.There was purulent fluid associated with a significant portion of the mesh.Some of the fluid was sent for culture.The 12 mm port was changed to a 15 mm port and the 15 mm endo catch bag placed.The mesh, tacks, and thick rind were all placed into the 15 mm endo catch bag and brought up through the incision.The fascia was slightly enlarged as well as the skin and the mesh and rind taken out.The rind was taken out in pieces.A portion of the rind was also sent for culture.The abdominal cavity was irrigated with 5 l of normal saline.The last 2 l had 2 g of ancef in it.A 19 french round blake drain was placed to the left lower incision and secured with 3-0 nylon.It was placed in the lower abdomen.A piece of seprafilm was placed through the 15 mm port and laparoscopically positioned.The anterior abdominal wall did feel attenuated especially at the umbilicus.However, due to the extensive contamination and really no obvious fascial defect of concern for incarceration in the near future, i did not primarily close any defects.All trochars were now removed and the fascia at the 15 mm site closed with multiple 0 vicryl sutures.Skin was closed with subcuticular 4-0 monocryl and dermabond.The patient tolerated procedure well was extubated and taken to pacu in stable condition.¿ relevant medical information: on (b)(6) 2019: (b)(6), md.Pathology.Clinical history: intra-abdominal fluid collection.Tissue: infected mesh.Gross description: nine pliable tan white portions of mesh material with surface areas that vary from 3.0 to 1.5 cm to 25 x 14.5 cm.Focally adherent to the portions of mesh material is friable tan brown material.The largest portion at one end has a 12.5 x 6.5 cm thickened tan white area measuring up to 0.7 cm in thickness.The remainder of the portions average 0.1 cm in thickness.Rss 3.A-b-thickened area, c- adherent friable material.Final diagnosis: soft tissue and mesh, intrabdominal, excision: densely collagenized fibroconnective tissue and adipose tissue with adherent fibrin and granulation tissue with abundant neutrophils and hemosiderin-laden macrophages.Mesh material (gross diagnosis only).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.".
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Manufacturer Narrative
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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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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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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