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W. L. GORE & ASSOCIATES, INC. GORE-TEX® SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 06/09/2009 |
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Event Type
Injury
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Manufacturer Narrative
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H6: codes b21 / c20 - 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: (b)(6) 2004: (b)(6) md.Indications: ¿this is a 40-year-old white female, who has a lower midline incision.Has previously had an attempted incisional hernia repair with mesh.She reports an enlarging mass in her hypogastric region that is painful.She occasionally has constipation and nausea and vomiting associated with possible intermittent and incarcerated small bowel.She has no overt abdominal pain and no fevers or chills consistent with strangulation.¿ implant procedure: laparoscopic reduction of incisional hernia.Laparoscopic repair of incisional hernia with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp08/03161050, 26cm x 36cm x 1mm thick, oval.Implant: gore-tex® suture] implant date: (b)(6) 2004 [hospitalization (b)(6) 2004 ¿ unknown discharge date].(b)(6) 2004: (b)(6) md.Operative report.Preoperative diagnosis: ____ recurrent incisional hernia (incarcerated).Postoperative diagnosis: incarcerated recurrent incisional hernia.Anesthesia: general.Estimated blood loss: 100 cc.Specimens: none.Implanted material: gore dual mesh plus.Size 28x 27 cm.Hernia defect size: 19.5 cm x 17 cm.Wound classification: not provided.Findings: a large incisional hernia with recurrence inferior to the implanted prolene mesh, which has contracted and convoluted onto itself.The small bowel and omentum have incarcerated itself into the abdominal wall proper primarily on the right side.After a complete reduction and inspection of the interior abdominal wall revealed no other hernias.Procedure: ¿the patient was brought to the operating theatre and placed on the operating table.He underwent general endotracheal anesthesia and antibiotics.He was prepped and draped in the usual duraprep.Sterile drape was applied.A left upper quadrant trocar was placed after exposing the fascia.The fascia was divided using the knife and the muscle-splitting technique was used to place the blunted trocar on the left upper quadrant.Pneumoperitoneum was gained and direct visualization.Two 5-mm trocars were inserted in the left lower quadrant in the left gutter after infusion of marcaine and transillumination.The adhesions were lysed using the sharp dissection with the scissors, and the harmonic scalpel.The harmonic scalpel was further utilized with gentle traction with an assisting grasper to mobilize the small bowel and omentum out of the hernia defect.Photos were obtained.Adhesiolysis and hernia reduction was complicated further by the involved mesh.The mesh had been convoluted and contracted upon itself in the superior aspect of the hernia defect.The extremely dense adhesions between the mesh and the incarcerated viscera complicated the dissection.The dissection took approximately an hour to adequately mobilize the adhesions and the incarcerated viscera.Once adequate mobilization of the abdominal viscera had been performed, further pictures were taken to document the involved mesh and the hernia defect.The spinal needle was used to sound the abdominal wall and mark the perimeter of the hernia defect, which was marked on the exterior abdominal wall using the pen.Pneumoperitoneum was released.Then 4 cm of overlap was then measured of the hernia defect.And mesh measurements were as above, taking into consideration and a piece of dual mesh plus was brought to the field.The corduroy side unit and the smooth side down.Appropriate markings were placed on the mesh.Gore cvo sutures were placed numbering 6 around the perimeter equidistant apart.This was rolled tightly and brought through the left upper quadrant port after placing a 5-mm port in the right gutter under direct visualization.The mesh was unrolled in the abdominal viscera with the smooth side down and the corduroy side up after the appropriate markings had been delineated.Using the ________ suture passer, the sutures were brought through the abdominal wall after sounding with the spinal needle.This was done for all 8 sutures and it was secured to the anterior abdominal wall.A protacker was used to secure the perimeter of the mesh to the anterior abdominal wall in the standard fashion.A spinal needle was used to sound the areas between the initially placed sutures.Place an additional 14 sutures was allowed between 1 to 2 cm distance between the cvo sutures.This was done on the entire circumference.Photos were taken after conclusion of the case.An excellent amount of hemostasis was observed.The abdominal viscera was thoroughly inspected and found to be free of any evidence of bleeding or injury.A 5 -mm trocar ports were removed and found to be hemostatic.Endoclose was used to close the 10-mm blunt tip trocar site without difficulty.Marcaine was infused in the skin, and the skin was closed with running monocryl.The patient tolerated the procedure well.Transferred to the recovery room in stable condition.¿ (b)(6) 2004: (b)(6).Implant sticker: dualmesh plus antimicrobial.Ref: 1dlmcp08; lot: 03161050, expiration: n/a; size: n/a.The records confirm a gore® dualmesh® plus biomaterial (ref: 1dlmcp08; lot: 03161050) was implanted during the procedure.Explant preoperative complaints: (b)(6) 2009: (b)(6) md.Clinical notes: ¿the patient is a 45-year-old lady who has had 2 previous incisional hernia repairs.The last time was done laparoscopically with implantation of gore-tex mesh.Since that time recently she has begun to have more and more abdominal pain and swelling and development of a red, indurated mass to the left of the midline.Ct scan revealed a collection around the gore-tex mesh and inflammation in the abdominal wall.She was brought to the operating room to have this repaired.Explant procedure: exploratory laparotomy, resection of infected and encapsulated mesh with drainage of abscess, debridement of abdominal wall, ventral hernia repair with strattice mesh 20 x 20 cm with component separation.Explant date: (b)(6) 2009 [hospitalization: (b)(6) 2009 ¿ discharge unknown] (b)(6) 2009: (b)(6) md.Operative report.Pre- and postoperative diagnosis: infected gore-tex mesh.Anesthesia: general.Estimated blood loss: n/a.Specimens: n/a.Findings: the mesh was encompassed and encapsulated with about 500 ml of purulent material.Cultures were obtained.There was residual prolene in the abdominal wall.Most of the collection around the gore-tex was on the peritoneal side of it and one of the gore sutures tracked up to the infection along the left side of the abdominal wall.We resected all of the infection in the capsule and tried to get out all of the mesh and sutures and previously placed pack and then we did component separation and replaced the mesh with strattice biomaterial.Procedure: ¿with the patient on the operating table in the dorsal supine position the abdomen was prepped with chlorhexidine, draped with sterile towels and sheets in the standard manner.Midline incision was made and carried down below and above the inflammatory mass and we were able to separate the viscera from the mass inferiorly and then opened up over the gore-tex material and the infection was draining around it and so we cultured that and then we opened the mesh and drained the large collection beneath it an cultured that again and we gradually were able to separate the mesh from the abdominal wall, removing the gore sutures and tacks.I resected the portion of the capsule that was adherent to the omentum as well.There was further prolene mesh and prolene suture in the abdominal wall and i tried to resect all of that.I then raised the skin and subcutaneous flaps laterally, superiorly, inferiorly and medially well out to the flank and made curvilinear incisions through the superficial fascia so that the abdominal wall could be mobilized to the midline.I then obtained a 20 x 20 cm portion of strattice biomaterial and placed 0 gore sutures through it at the four corners and then five equally spaced down each side.We introduced this into the abdomen and then passed those sutures through the musculofascial abdominal wall with the stork suture passer and then tied those circumferentially and then the edges were further tacked to the anterior abdominal wall with the helical tacker and reinforced with other gore 0 sutures.In the process of doing the component separation we encountered the tract on the left side and we cleaned all that out and divided it and removed the suture that was in it and divided the midline fascia where the prolene and polypropylene mesh was.We then closed the midline fascia with interrupted 0 pds sutures.A leg drain was placed through a stab wound to lie beneath the cutaneous flaps and this was sutured to the skin with nylon suture.The infected tract laterally was packed with iodoform gauze.It should be mentioned that when we encountered the nature of the collection around the mesh the patient received a gram of vancomycin iv intraoperatively, as well as her preop ancef.Subcutaneous tissue was approximated with vicryl.Sponge, needle and instrument counts were all reported correct.Skin edges were approximated with clips.Sterile dressings were applied.The patient tolerated the procedure well and returned to the recovery room in satisfactory condition.¿ (b)(6) 2009: st.Mary's medical center (knoxville, tn).Implant information: stratticetm 20 x 20 cm firm, lot 810543.Ref: (b)(4).Lifecell corp.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® suture 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-tex® suture 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 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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The following information was obtained from medical records.Implant #1 and #2 procedure: laparoscopic reduction of incisional hernia.Laparoscopic repair of incisional hernia with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp08/03161050, 26cm x 36cm x 1mm thick, oval.Implant: gore-tex® suture] implant #1 and #2 date: (b)(6) 2004.Explant #1 and #2 procedure: exploratory laparotomy, resection of infected and encapsulated mesh with drainage of abscess, debridement of abdominal wall, ventral hernia repair with strattice mesh 20 x 20 cm with component separation.Explant #1 and #2 date: (b)(6) 2009.Implant #1: (b)(6).Implant #2: (b)(6).It was initially reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2004 whereby a gore® dualmesh® plus 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: mesh removal, infected mesh, inflammatory mass, infection, seroma, resection, additional surgery, pain & suffering.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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization 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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