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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930); Pocket Erosion (2013); Seroma (2069)
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| Event Date 03/28/2012 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (ug/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (ug/cm3)].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) 2010: (b)(6) medical center ¿ (b)(6).Operative report.Preoperative and postoperative diagnosis: incarcerated incisional hernia x2.Procedure: multiple incarcerated incisional hernia repairs with proceed mesh.Anesthesia: general.Blood loss less than 50 ml.Specimens: hernia sac.Procedure: ¿a periumbilical incision was made overlying the 1st hernia which was carried down through the skin into the subcutaneous tissue.A large incarcerated hernia was noted with omentum closely adherent and quite stuck.This was reduced and noted to be viable.The superior hernia was then approached, again a large amount of omentum was incarcerated and this was circumferentially taken down.In taking this down, 3 other hernias along the left wall were also noted quite separate and discrete, and these were also taken down circumferentially and cleared of their impacted omentum.Lysis of adhesions was performed to widely clear the area.Due to the multiple defects in the fascia, mesh was cut to size and secured to the fascial edges using interrupted 0 prolene sutures and figure-of-eight in interrupted fashion.Lap and needle counts were correct.The subcutaneous tissue was on closed using interrupted vicryl sutures, and staples was used for the skin.¿ implant log.Proceed surgical mesh.Lot#: cag046.Manufacturer: j&j ethicon.Implant #1 preoperative complaints: no information.Implant #1 procedure: repair recurrent incisional hernia with gore-tex mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/06787486, 15cm x 19cm x 1mm].Implant #1 date: (b)(6) 2011 (hospitalization dates unknown) (b)(6) 2011: (b)(6) medical center ¿ (b)(6).Operative report.Preoperative and postoperative diagnosis: incarcerated recurrent incisional hernia.Anesthesia: general.Blood loss: minimal.Specimen: none.Procedure: ¿midline incision was reopened.Massive amounts of adhesions were noted.These were meticulously taken down.Once the abdomen was able to be entered, 5 separate small hernias were noted, one in the right upper quadrant, one in the left upper quadrant, one in the area of the umbilicus and one in the left lower quadrant in addition to the midline.These were all opened widely and reduced of the bowel and omentum.Hemostasis was ensured and then a 15 cm gore-tex mesh was placed within with interrupted 0 prolene sutures in a figure-of-8 fashion.Sequentially these were tied and the soft tissue was closed with interrupted vicryl sutures.Staples were used for the skin.The patient underwent epidural by anesthesia preoperatively.¿ (b)(6) 2011: (b)(6) medical center ¿ (b)(6).Implant log.Item: ¿mesh surg dual teflon plus 15x 19cm, 1mm.¿ lot number: 06787486.Manufacturer: w.L.Gore & associates.Expiration date: 4/30/2012.Relevant medical information: no information.Explant #1 preoperative complaints: (b)(6) 2012: (b)(6) hospital - (b)(6) medical center.(b)(6), md (b)(6).History: ¿the patient is a (b)(6)-year-old gentleman with a history of an attempted hernia repair who for some time has been managed for infected mesh.Upon evaluation in the outpatient setting, he was found to have 2 areas of mesh that eroded through the skin and obvious cellulitis and purulence from the wound.We counseled the patient extensively about the rationale for a component separation and removal of this mesh as well as possible biologic mesh as a wide underlay, should it be necessary.Informed consent was obtained prior operation.¿ explant #1 procedure: removal of infected hernia mesh.Lysis of adhesions.Bilateral component separation.Repair of recurrent ventral hernia.Insertion of a 16 x 20-cm strattice mesh.Wound vac placement.Explant #1 date: (b)(6) 2012 (hospitalization dates unknown).(b)(6) 2012: (b)(6) hospital - (b)(6) medical center.(b)(6), md (b)(6).Operative report.Assistant: dr.(b)(6).Preoperative and postoperative diagnoses: recurrent ventral hernia.Infected permanent mesh.Anesthesia: general.Estimated blood loss: 100 ml.Specimens: excised mesh and granulation tissue to pathology.Findings: ¿an infected piece of gore-tex mesh with extrusion through the skin and associated abscess cavity.A 10 x 8 cm recurrent ventral hernia.¿ procedure: ¿an elliptical incision was made to excise the skin, sinus tracts and infected mesh.The mesh was removed in its entirety revealing healthy viable fascial edges.This was sent to pathology and a small associated abscess was drained and the fluid from that was sent to microbiology for culture and sensitivity.Next, the fascia was identified, elevated and lysis of adhesions was performed for approximately 45 minutes to circumferentially free the bowel and omentum from the overlying anterior abdominal wall.Next, we raised wide suprafascial flaps circumferentially and performed a bilateral component separation by incising the external oblique fascia.We also took great care in releasing the internal oblique fascia from the external with good mobility of both the right and left myofascial flap.We took care to preserve identified perforating vessels.Next, a 16 x 20 cm piece of strattice was introduced onto the field.It was tacked as a wide underlay.We opted not to do a primary component separation repair because there were several "swiss cheese" defects lateral to the main ventral hernia.We opted to perform a wide underlay in this setting.The 16 x 20 mesh was secured with 0-pds interrupted sutures.The fascia was then closed in the midline with 0-pds sutures.Two 19- french round drains were placed.The subcutaneous tissue was reapproximated with intermittent vicryl sutures and a wound v ac was placed on the open skin wound.All drains were secured with 0-silk stitches.Sterile dressings were placed.The patient was awakened from general anesthesia and returned to pacu in stable condition after tolerating our procedure well.¿ (b)(6) 2012: (b)(6) hospital - (b)(6) medical center.Implant sticker.Stratticetm.Manufacturer: lifecell.Lot: s10919-094.Expiration: 2012-09.Size: 16x20.Firm.Ref: (b)(4).Relevant medical information: no information.Implant #2 preoperative complaints: (b)(6) 2013: (b)(6) hospital ¿ the medical center.(b)(6), md.Indications: ¿the patient is a (b)(6)-year-old male who has previously undergone an incisional hernia repair with mesh and developed an infection which required removal with an open abdomen and biological mesh repair which developed a recurrence.The multiple hernia defects were approximately 15 x 9 cm in diameter in the fascia and resulted in a moderate amount of herniated contents into his hernia sac with very dense adhesions.He was taken to the operating room for laparoscopic recurrent hernia repair with mesh with robotic assistance and extensive lysis of adhesions.He understood the risks of procedure including risk for bleeding, infection, injury to internal organs, and possible necessity of further procedures as well as recurrent mesh infection.¿ implant #2 procedure: laparoscopic recurrent incisional hernia repair with mesh with robotic assistance.Laparoscopic extensive lysis of adhesions with robotic assistance.Implant: gore® dualmesh® biomaterial [1dlmc06/11083974, 18cm x 24cm x 1mm].Implant #2 date: (b)(6) 2013 (hospitalization dates unknown).(b)(6) 2013: (b)(6) hospital ¿ the medical center.(b)(6) , md.Operative report.Assistant: dr.(b)(6).Preoperative diagnoses: recurrent incisional hernia (multiple hernia defects).Status post midline incisional hernia repair and prior open abdomen and wound infection.Postoperative diagnoses: same.Severe intra-abdominal adhesions.Anesthesia: general.Estimated blood loss: 40 ml.Procedure: ¿a 5-mm transverse incision made along the right subcostal margin under direct visualization.The abdominal cavity was inflated with co2 gas.Laparoscopic camera was inserted through trocar.Using laparoscopic visualization, a 12-mm port was placed in the right side of the abdomen and an 8-mm port was placed in the right lower quadrant.Laparoscopic instruments inserted through trocars.Attention was turned to the midline of the abdomen.There were extensive adhesions.Using slow tedious dissection with scissors and laparoscopy adhesions were taken down to allow docking of the da vinci robot to the patient, the da vinci robot was brought into surgical field and docked to the patient.Using robotic assistance, lysis of adhesions was continued to fully mobilize all the adhesions off the anterior abdominal wall and then fully prolapse the hernia contents back in the abdominal cavity.The adhesiolysis took approximately 75 minutes to fully take down all the adhesions and evaluate the abdominal wall.The hernia defects were mapped to the abdominal wall and a 14 x 24 mm oval piece of gore dualmesh was sized to the abdomen and mapped to the patient's abdomen with a marking pen.The mesh was placed in way to cover the prior removed mesh as well as the hernia defect with more than 5 cm of overlap circumferentially.The robot was undocked from the patient.The mesh was inserted into the abdomen with sutures of 0 gore-tex on it as well as an 0 vicryl suture to close the fascial defects.The robot was then redocked to the patient and the fascial edges reapproximated with robotic assistance using a running 2-0 vicryl suture.After the fascia was completely closed.The mesh was then sewn in place circumferentially using the landmarks of mapped to the abdominal wall, the mesh was sewn circumferentially with the roux 2 running 0 gore-tex sutures around the entire edge of the mesh into the posterior fascia of the abdomen.Upon completion of the place of the mesh it was found in good position with good overlap with no evidence of bleeding.Hemostasis was completely confirmed.The 12-mm trocar site had its fascia closed with 0 vicryl suture in carter-thomason needle trocars and instruments were removed from the abdominal cavity.The skin incisions were closed with 4-0 monocryl subcuticular sutures and the wounds were dressed with dermabond glue.¿ (b)(6) 2013: (b)(6) hospital ¿ the medical center.Implant log.Manufacturer: gore.Item: ¿dual mesh¿.Catalogue number: 1dlmc06.Lot#: 11083974.18cm x 24cm x 1mm.Quantity: 1.Expiration: 12/1/2017.Relevant medical information: no 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.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial and on (b)(6) 2013 gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh failure resulting in pain, limited range of motion, "an infected piece of gore-tex mesh with extrusion through the skin and associated abscess cavity".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® 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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H6: conclusion code remains unchanged.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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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.It should be noted that the gore® dualmesh® plus 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.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.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].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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