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| Model Number 1DLMC05 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Fistula (1862); Unspecified Infection (1930)
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| Event Date 12/10/2009 |
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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 incisional hernia repair on (b)(6) 2003 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, explant.Fistula.Dense adhesions.Additional event specific information was not provided.
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Manufacturer Narrative
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G3/g4: correcting date received by manufacturer for the initial mdr: the information needed to determine reportability was received on 4/22/21, not on 3/30/21.
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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: repair of incisional ventral hernia, right lower quadrant with dual mesh.Implant: gore® dualmesh® biomaterial [1dlmc05/(b)(6) , 7.5 x 10 cm] implant date: (b)(6) 2003 (hospitalization [ni]) on (b)(6) 2003: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: right lower quadrant incisional ventral hernia.Postoperative diagnosis: right lower quadrant incisional ventral hernia.Assistant: lisa turner.Anesthesia: general.Anesthesiologist: dr.(b)(6).Ebl: minimal.Complications: nil.Drains: nil.Indications: the patient is a 46-year-old caucasian female who presented with history of pain and swelling in the right lower quadrant for the last few months increasing and becoming more uncomfortable over the last three to four weeks.She has no history of incarceration episodes or nausea, vomiting, or distention.On exam, she did have a reducible right lower quadrant incisional hernia.Therefore, a plan was made to proceed with repair of the same with gore-tex patch or dual mesh.All risks, benefits, complications, including infection, bleeding, dvt, anesthesia risks were thoroughly explained to the patient and informed consent was signed.Procedure: ¿after correct identification of patient, the patient was prepped and draped in sterile fashion under general anesthesia in a supine position.A right lower quadrant transverse incision was made and incision depended [sic] with the bovie cautery down to the subcutaneous fat and scarpa fascia.The sac was completely isolated from the surrounding rectus sheath and musculature and excised completely.The incision was carried down to healthy areas of fascia of previous gore-tex patches.A dual mesh 7.5 x 10 cm was then chosen and anchored to healthy fascial edges, all surrounding patches of other gore-tex from previous repair with a running stitch of 0 gore-tex.After completion of repair, irrigation was used and suctioned out.Hemostasis was thoroughly checked and secured.Deep layers were closed with 3-0 vicryl and after infiltration of 10 cc of 0.4% marcaine and 1% lidocaine for local anesthesia, staples were used to close the skin.Compression dressings applied.The patient was extubated in the operating room and transferred to the recovery room in a stable condition after all counts were confirmed to be correct.¿ on (b)(6) 2003 [assigned]: [facility ni].Implant sticker.Dualmesh biomaterial.Lot: (b)(6).Item: 1dlmc05.The records confirm a gore® dualmesh® biomaterial (1dlmc05/(b)(6) ) was implanted during the procedure.Explant procedure: exploration of abdominal wall.Resection of infected gore-tex mesh.Lysis of adhesions.Small bowel resection with stapled functional end-to-end anastomosis.Repair of abdominal wall with stratice mesh.Explant date: (b)(6) 2009 (hospitalization [ni]).On (b)(6) 2009: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: chronic abdominal wall drainage following recurrent incisional hernia repairs with mesh.Postoperative diagnosis: prosthetic mesh infection.Intraabdominal adhesions.Assistant: lisa turner.Anesthesia: general endotracheal.Anesthesiologist: suzanne lontor, crna.Estimated blood loss: 100 ml.Drains: a 19-french blake x2.Indications: the patient is a 52-year-old female.She is overweight.She in the past has undergone multiple incisional hernia repairs.The last such repair occurred in 2003.The defect encountered at that time was repaired using apparently gore-tex dual mesh.Soon postoperatively, the patient began experiencing discharge from her operative area.This has been persistent.Medical care was either not sought or provided previously because of insurance concerns.However with the time, the situation has not only been persistent but intensifying.At times, the patient has had bloody drainage.At other times it has been serousy.She also experiences discomfort which is accentuated by activity.There has been no strong associated gastrointestinal symptomatology.The patient was last admitted to (b)(6) on (b)(6) 2009.This was for upper abdominal pain.At that time, she was evaluated by gastroenterology.An egd was performed, which revealed hemorrhagic gastritis and a superficial antral ulcer.Medical therapy was initiated.During that admission, i was introduced to the patient.At that time, a sinus of the inferior portion of the vertical midline incision was appreciated.It was at that time that concern was raised about mesh infection.The patient recently was again seen in my office with accentuating symptomatology.Following discussions with the patient, surgical treatment was offered and scheduled.She was informed that the exact etiology of her difficulties was not entirely clear.Whether this was merely representative of a condition such as suture granulomata versus a more complicated problem such as mesh infection was discussed.She was offered and agreed upon exploration of the abdominal wall with possible removal of the infected mesh (should this be found to be the case) and replacement of this infected mesh with a new biologic material.The patient was informed preoperatively of the operative risks of such a surgical intervention including but not limited to bleeding, infection, recurrence of her incisional hernia, and recurrent mesh infection.The patient presents to (b)(6) on (b)(6) 2009, for the proposed surgical intervention.Procedure: ¿following her re-identification in (b)(6) prep and holding area and administration of broad-spectrum parenteral antibiotic, the patient was transported to (b)(6) major operating room.She was positioned supine on the operating table.A general endotracheal anesthetic was then administered without incident.The area of the sinus tract drainage in the lower third of her vertical midline incision was re-identified.The area of this abnormality was prepped.The tract was cannulated and methylene blue was injected into the tract.This was so as to hopefully assist in identifying the pathology.Of note, the tract was difficult to cannulate even utilizing a lacrimal duct probe.Subsequently, the intraabdominal wall was again prepped and draped in sterile fashion.A vertically oriented ellipse of skin centered about this sinus tract was then created.This incision was deepened down through the subcutaneous tissue using bovie electrocautery as necessary.During dissection, no pocket of purulent material was encountered.Upon inspection of the anterior abdominal wall, however, a minute in diameter tract which did proceed posterior to the anterior abdominal wall and communicated with an underlying gore-tex mesh was appreciated.The tract opening was enlarged.Granulation tissue as well as mucoid/purulent materials were encountered.Cultures were obtained and submitted to the microbiology department.The abnormality was further unroofed.It was at this point that it became recognized that significant involvement of the gore-tex dual mesh likely was the case.The abdominal wall was sharply incised from the underlying prosthetic material.During this, innumerable prolene sutures as well as gore-tex sutures were encountered.These were removed during the operative procedure.Eventually, enter into the true peritoneal cavity was able to be accomplished.Rather dense adhesions to the undersurface of the anterior abdominal wall were encountered.These adhesions affected no only the greater omentum but also the small bowel.During the mobilization, a rather severely affected loop of small bowel did become traumatized.A full thickness disruption without associated enteric leakage ensued.The mobilization did continue.At this point, this injured loop of small bowel was able to be delivered into the operative wound.Lysis of adhesions from the undersurface of the anterior abdominal wall followed.Eventually, a significant length of small bowel was able to be delivered into the operative area.Resectional therapy was selected.Using gia staplers, the points of proximal and distal transection of the small bowel were selected.During this maneuver, approximately 8 to 10 cm of small bowel was resected.Subsequently, a functional end-to-end anastomosis between the remaining loops of healthy small bowel was created.This functional end-to-end anastomosis was completed using yet another gia stapler as well as ta stapler.The mesenteric defect created during the resection was closed using interrupted 3-0 silk sutures.Additional lysis of adhesions now followed.Eventually, the entire undersurface of the anterior abdominal wall was cleared of these adhesions.All foreign body was at this point sharply and bluntly removed and submitted to the pathology department for further evaluation.At this point, an obvious sizable defect of the anterior abdominal wall remained.Because of the chronic infection of the operative area as well as now the inadvertent entry into the gi tract, only biologic-type material was suitable in repair of the abdominal wall.A strattice mesh was selected.This was sutured in an interrupted fashion using 0 pds suture to the undersurface of the anterior abdominal wall in a circumferential fashion.This did result in a seemingly satisfactory repair of the anterior abdominal wall.The mesh and abdominal wounds were irrigated with bacitracin containing solution.Hemostasis was secured.The subcutaneous tissues were closed in layers using interrupted 2-0 vicryl suture.This was after via separate stab wounds in the right mid abdominal wall, two 19-french blake drain had been passed and placed in a subcutaneous/preperitoneal location.The drains were secured to the skin of the anterior abdominal wall using interrupted 2-0 nylon sutures.The skin edges were reapproximated using stainless steel skin clips.The incision as well as the drains was dressed independently using bio-occlusive dressings.The operative procedure was well tolerated by the patient.Intraoperatively, because of the necessary small bowel resection and the extensive lysis of adhesions, nasogastric tube decompression was initiated.Subsequent to completion of the procedure, her bladder was catheterized with a foley catheter.She was able to be extubated in the operating room and transported to the recovery room.She will subsequently be admitted to a surgical floor bed for postoperative care including ongoing antibiotic therapy.¿ relevant medical information: on (b)(6) 2009: (b)(6).Intraoperative nursing record.Asa: 3.Hypertension, smoker, increased bmi.Implant sticker.Strattice 20x20 cm firm.Abdomen.On (b)(6) 2009: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: bile peritonitis, anastomotic leak.Postoperative diagnosis: bile peritonitis, anastomotic leak.Procedure: exploratory laparotomy, small bowel resection with hand-sewn end-to-end anastomosis, peritoneal irrigation.Assistant: (b)(6) md.Anesthesia: general endotracheal.Anesthesiologist: (b)(6) md.Estimated blood loss: estimated blood loss of 100 ml.Transfusions: two units of packed red blood cells.Drains: a 19-french blake times 2.History: the patient is a 62-year-old female with history of systemic lupus erythematosus/remote disease.She has a past surgical history of multiple incisional hernia repairs.Her last hernia repair occurred in 2003.The hernia encountered was repaired using a gore-tex dual mesh.Apparently soon postoperatively, the patient began experiencing intermittent, but persistent drainage associated with the utilized abdominal wound.Over the ensuring [sic] years, this drainage has been persistent and with it she has experienced discomfort.Recently the situation has become almost disabling.On (b)(6) 2009, she was admitted to (b)(6) following an outpatient evaluation by myself.At that time under general anesthetic, her abdominal wall explored.She was unfortunately found to have infection associated with the gore-tex mesh.There were dense adhesions of both the greater omentum and small bowel to the undersurface of the mesh.At that time, the gore-tex dual mesh was removed.A small bowel resection was required.A functional/stapled end-to-end anastomosis ensued.Subsequently, the abdominal wall defect was repaired using a strattice mesh.Initially postoperatively, the patient did well.Several days ago, however, she had mental status changes associated with apparent dehydration and rising bun/creatinine.The situation was progressive and on (b)(6) 2009, transfer to the intensive care unit was required.Since that time, she has had persistence of her renal insufficiency associated with tachycardia and large fluid requirement.Last evening she had fever, which was significant.In addition for the first time, output from the blake drains placed in the area of her prosthetic mesh was noted to be enteric.At this point, it was suspected that she had leakage from her small bowel anastomotic site.The situation was discussed at length with the patient¿s family.The need for surgical intervention was recognized.On the afternoon of (b)(6) 2009, when operating time became available, the patient was transferred from her intensive care unit bed to the operating room for surgical treatment.Description of procedure: on the afternoon of (b)(6) 2009, the patient was transported to the operating room.At this point, she did have a persistent tachycardia.She however was normotensive without inotropic support.During her transport, an element of hypoxemia despite ventilatory support was appreciated.Following positioning on the operating room table, a general anesthetic was administered via the preexisting endotracheal tube.Intraoperatively, the anesthesia department did proceed on with not only upsizing of her endotracheal tube, but also placement of an arterial catheter.The skin staples utilized during her recent prior operative intervention were removed as were the blake drains productive of bilious fluids.The abdomen was vigorously prepped and draped in sterile fashion.The skin edges were bluntly reopened and the subcutaneous tissues entered.Quite rapidly, it became apparent that there was a large amount of bilious fluid retained within the peritoneal cavity.The strattice mesh recently placed was visualized.It remained in place.The sutures utilized in securing the strattice mesh were intact.The mesh recently placed was visualized.It remained in place.The sutures utilized in securing the strattice mesh were intact.The mesh was somewhat discolored from the bile.The mesh was incised vertically allowing entry into the peritoneal cavity.A large volume of intraperitoneal bilious fluid was encountered.It was aspirated using suction.Vigorous irrigation of the abdominal and pelvic cavities ensued.At this point, the viscera was able to be delivered out into the operative arena through the incision in the strattice mesh.The patient was at this point recognized as having a disruption of the stapled functional end-to-end anastomosis.Venous congestion and perhaps even thrombosis was appreciated.The exact etiology of the anastomotic disruption is not entirely clear.Whether her autoimmune diseases and the postoperative dehydration previously described contributed is hypothesized.In any event, the need for resection of the area of leakage was recognized.Points of proximal and distal transection in the small bowel were selected.Kocher clamps were applied and the bowel was sharply incised.Subsequently, the mesentery to this new area of small bowel resection was transected.Silk ties were applied for hemostatic purposes on the cut mesenteric surfaces.At this point, repeat irrigation of the abdominopelvic cavities utilizing a pulse irrigation device ensued.Copious irrigation was utilized.This was performed until not only the effluent from the abdominopelvic cavities returned clear, but also the staining of the strattice mesh had been largely rectified.A hand-sewn end-to-end anastomosis between remaining adequately perfused segments of small bowel was at this point undertaken.Interrupted 3-0 silk sutures were utilized in this anastomosis.The mesenteric defect created during this repeat resection was closed using interrupted 3-0 silk sutures.The newly created anastomosis was wrapped with a lip of greater omentum, which was mobilized intraoperatively.At this point, new drapes and gloves were applied.Closure of the abdominal wall was initiated.The strattice mesh, which had been vertically incised, was closed using a combination of running looped and interrupted pds sutures.Vigorous skin and subcutaneous tissue irrigation again using the pulse irrigator device ensued.The subcutaneous tissues were reapproximated using interrupted 2-0 vicryl sutures.Of note prior to subcutaneous tissue re-approximation, two #19-french blake drains were positioned over the strattice mesh.These drains were secured to the skin of the anterior abdominal wall using 3 0 nylon sutures.Skin edges were reapproximated using skin clips.A bioclusive dressing was applied.The operative procedure was well tolerated by the patient.At no point during procedure was there excessive blood loss.She continued to be productive of urine throughout the operative intervention.She was able to be transported from the operating room back to her critical care unit bed still requiring ventilatory support and high inspired oxygen concentrations.Her family members were informed immediately postoperatively of the operative interventions completed and the patient¿s critical condition.¿ on (b)(6) 2009: (b)(6).Intraoperative nursing record.Emergent.Wound class: infected.Asa: 4e.Blood: 2 units.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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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.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: ¿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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