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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/03/2017 |
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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.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: [medical records not provided].Implant procedure: [medical records not provided].Implant date: [alleged ¿2016¿].Relevant medical information: [not provided].Explant preoperative complaints: (b)(6) 2017: (b)(6) medical center.(b)(6), md.Preoperative diagnosis: ¿recurrent abdominal incisional herniation and pathological pannus.¿ explant procedure: repair of recurrent incarcerated incisional epigastric hernia and repair of recurrent incisional suprapubic hernia with onlay mesh.Functional panniculectomy.Closure by medial rotation of 2 fasciocutaneous flaps.Introduction of 2 on-q pain pump catheters.Explant date: (b)(6) 2017 [hospitalization dates (b)(6) 2017].(b)(6) 2017: (b)(6) medical center.(b)(6), md.(b)(6), md.Operative report.Pre- and postoperative diagnosis: recurrent abdominal incisional herniation and pathological pannus.Anesthesia: general.Estimated blood loss: 120 ml or less.Specimens removed: omentum.Panniculus.Recurrent epigastric incisional hernia.Umbilicus overlying recurrent suprapubic hernia.Gore-tex mesh recovered from previous repair of suprapubic hernia.Complications: none.Implants: parietex covidien mesh. procedure: ¿this procedure was done as a combined procedure with general surgery and plastic surgery to address the abdominal herniae, as well as the intraperitoneal component of this presentational procedure.Dr.(b)(6) accomplished the plastic surgery aspect of the procedure, and dr.(b)(6) addressed the intraperitoneal aspect.The procedures will be separately dictated by the 2 specialties.The patient was placed on the operating table in the supine position.The arms were abducted to 80 degrees and the palms were supinated.Kendall stockings were inflated prior to the induction of anesthesia.A foley catheter was placed in the patient's bladder.The abdomen was prepped and draped.The initial part of the procedure was performed by plastic surgery, and this involved the planning of the cutaneous incisions and the separation of the fasciocutaneous component from the muscular fascial component, so that these 2 components would move in different vectors in achieving a closure which would be much less likely to recur.This part of the procedure was to unite the rectus muscles in the midline and then reinforce the anterior rectus sheath with onlay mesh.This would drop the recurrence rate for the 2 herniae encountered from 60-67% down to less than i %.The separation of the 2 components would permit this advancement closure and create a plane, under which the onlay mesh could be placed.The initial part of the procedure was thus to separate the 2 components and to explore the recurrent herniae prior to the intraperitoneal part, which would be followed by the final repair of the anterior abdominal wall by reconstruction and closure by rotating the fasciocutaneous flaps at the same time as undertaking the panniculectomy.The planned incisions were midline to encompass the previous midline scars and the umbilicus and then to extend this down to the suprapubic region, where the second herniae were encountered and extend across the suprapubic region and to the mid lateral line with an extended pfannenstiel incision.All the incision lines were infiltrated in the subdermal plane with 0.5% xylocaine with 1:200,000 epinephrine, and the incisions were made after vasoconstriction had been achieved in order to minimize blood loss.The incisions were made down through the epidermis and dermis using a scalpel, and thereafter the dissection was done with cutting electrocautery.The 2 large fasciocutaneous flaps were raised at the level of the deep fascia, exposing the anterior rectus sheath and the conjoined tendons.These were then reflected cranially when the midline opening in the abdominal wall was undertaken.Below the umbilicus the dissection revealed a layer of gore-tex mesh, which had been placed between the rectus muscles and the anterior rectus sheath.This repair was giving way to permit the hernia to reoccur in the midline suprapubically.The gore-tex was dissected out completely and preserving both the muscle on the deep surface and the anterior rectus sheath on the superficial surface.Above the umbilicus the peritoneum was opened.There was essentially an epigastric recurrent hernia extending up towards the xiphisternum with multiple sutures from the previous repair.There was considerable omental adhesion to this hernia recurrence, and this would ultimately be resected by dr.(b)(6).The umbilicus was essentially part of the recurrent ventral hernia repair, and this was therefore removed along with the midline scar at this point.Dr.(b)(6) then took over the procedure, resecting the extensive adhesions in the left iliac fossa and those to the liver itself, removing the adherence of the omentum to the deep surface of the epigastric incisional hernia recurrence.All these tissues were carefully dissected by dr.(b)(6), and this will be separately dictated.The omentum was partially resected in order to reduce the intra-abdominal volume and permit the transverse colon to take a normal anatomical position.There was no adherence of the bladder or bowel to the lower suprapubic hernia recurrence.It was merely that the gore-tex mesh was no longer able to support the intra-abdominal contents at this level.When dr.(b)(6) had completed his part of the procedure and then intra-abdominal hemostasis had been completed, the peritoneum was to be closed.The peritoneum was closed with a single layer of 0 ethibond interlocked suture, uniting the peritoneum perfectly in the midline from the symphysis pubis up to the level of the xiphisternum.The rectus muscles were then brought into midline apposition with 2 layers of anterior rectus sheath interlocked 0 ethibond suture without tension or significant change in the peak inspiratory pressure, which was not increased by more than 3 cm of water throughout the procedure, and which ultimately returned to the baseline when the patient was put into the head-up position.The closure of the skin was permitted by rotation of the 2 fasciocutaneous flaps in a medial direction without any tension in the midline, and the panniculus was then defined as to the level of amputation by placing the patient in 30 degrees of head elevation.The skin was again reinjected in the subdermal plane with 0.5% xylocaine with 1:200,000 epinephrine so that the panniculectomy could be performed.The panniculus where this was rubbing against his lower abdominal and upper thigh skin was then resected and hemostasis was achieved using electrocautery.The entire wound was thoroughly lavaged with dilute hydrogen peroxide to demonstrate all possible bleeding points, and the flaps were then held in place with quilting sutures of 2-0 vicryl in multiple rows 2 inches apart.The wounds were closed over two #15 blake drains, and these were sewn into place on the lateral thighs with 2-0 silk.The final function was to introduce 2 on-q pain pump catheters into the wound for the hourly delivery of 4 ml of 0.25% plain marcaine to the wound each hour for the first 3 postoperative days.These were introduced through the epigastric skin and secured with 1/2-inch steri-strips and bioclusive dressings.The purpose of the on-q pain pump was to reduce the amount of opiates necessary in the postoperative period and therefore encourage mobilization at the same time as minimizing the risk of ileus.The wounds were closed with temporary 2-0 silk suture, and this was replaced with 2 layers of suture using 3-0 pds suture for the deep layer of dermis and the 3-0 nylon suture for interrupted cutaneous sutures with a 4-0 prolene continuous epidermal approximation suture, all of which was then covered with bioclusive dressing.The patient was stable throughout the procedure.The blood loss was thought to be less in its entirety than 200 ml.The patient was returned to the recovery room in a semi-fowler position in his own bed to be admitted to the hospital for 2 to 3 days because of the risk of ileus.The patient was to be under the care of general surgery and plastic surgery during this admission.(b)(6) 2017: (b)(6), md.Pathology report. ¿preoperative diagnosis: incisional hernia.Type of specimen: omentum.Panniculus.Recurrent epigastric incisional hernia.Umbilicus overlying recurrent suprapubic hernia.Goretex (sic) mesh recovered from previous repair of suprapubic hernia. final diagnosis: omentum, resection: mature adipose tissue.Abdominal panniculus, resection: skin and subcutaneous adipose tissue.Epigastric region: consistent with hernia.Umbilicus, resection: consistent with hernia.Goretex (sic) mesh: portion of mesh with adherent tissue showing focal dense.Fibrosis (clinically from previous repair of suprapubic hernia). gross description: specimen a is received in formalin in a container labeled with the patients name and number and "omentum".It consists of an apron of fibroadipose tissue measuring 27.5 x 21.2 x 2.8 cm.Sectioning reveals yellow, glistening cut surfaces with no discrete mass or lesion identified grossly.Representative sections are submitted in cassettes al a3.Specimen b is received in formalin in a container labeled with the patient¿s name and number and ¿panniculus¿.It consists of three fragments of tan hair bearing skin with underlying fibroadipose tissue and multiple fragments of yellow fibroadipose tissue together weighing 2.88 kilograms and measuring 45.1 x 26.5 x 6.0 cm in aggregate.There is an area of hypopigmentation measuring 2.8 x 2.0 cm of skin as well as multiple stretch marks.Sectioning reveals yellow glistening cut surfaces with diffuse white fibrous tissue.No discrete masses or lesions are identified.Representative sections are submitted as allows: bl skin with underlying subcutaneous tissue, including area of hypopigmentation; b21 b3 fibroadipose tissue.Part c is received in formalin in a container labeled "recurrent epigastric incisional hernia".It consists of multiple fragments of fibroadipose tissue each showing blue embedded sutures.The fragments measure inaggregate 6.5 x 4.2 x 1.3 cm.Representative sections are submitted in cassette c1.Part d is received in formalin in a container labeled "umbilicus overlying recurrent suprapubic hernia".It consists of a pale tan grossly unremarkable skin excision with an eccentric depression consistent with umbilicus which measures 26.0 x 3.5 cm and is excised to a maximum depth of 3.3 cm.Focally attached to the deep surface of the excision is a fragment of fibroadipose tissue which measures 13.5 x 2.8 x 1.5cm.Sectioning through the fibroadipose tissue reveals yellow glistening cut surfaces with diffuse pale-white fibrous tissue and no discrete masses of lesions grossly.Representative sections: full thickness section through central umbilicus.Full thickness section through focally attached fibroadipose tissue.Part e is received in formalin in a container labeled "gortex mesh recovered from previous repair of suprapubic hernia".It consists of three fragments of a medical mesh material with a minimal amount of attached tan to yellow soft tissue.The fragments measure in aggregate 10.5 x 6.0 x 0.3 cm.Representative soft tissue is submitted in cassette el. microscopic description: a: sections show mature adipose tissue with mild vascular congestion.There are no specific features or evidence of neoplasm.B: sections show skin with subcutaneous adipose tissues.There are no specific features.C: sections show fibromembranous tissue with surrounding adipose tissue.A small amount of skeletal muscle is also included with the specimen.D: sections show some dense fibromembranous tissue with surrounding adipose tissue and overlying skin.E: sections show some fibroadipose tissue with focal dense fibrosis.¿ 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-tex® soft tissue patch 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." 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Event Description
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It was reported to gore that the patient underwent an unknown suprapubic hernia repair on an unknown date in 2016 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: recurrence.Additional event specific information was not provided.
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Manufacturer Narrative
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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.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible complications with the use of any tissue deficiency prosthesis may include, but are not limited to, infection, seroma formation, adhesions, hematomas, inflammation, fistula formation and recurrence.¿ medical records that indicate mesh ¿movement¿ or that th e device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing records could not be performed as a valid lot number was not provided.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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