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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Catalog Number 1DLMCP06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Obstruction/Occlusion (2422)
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| Event Date 11/17/2006 |
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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.C1: 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)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: open ventral hernia repair with dual layer cortex mesh.[nurse reviewer note: type of mesh implanted not identified.Operative report for mesh explant does indicate the mesh that was implanted was gore-tex].Implant date: (b)(6) 2004 (hospitalization unknown).On (b)(6) 2004: (b)(6) medical center.(b)(6), surgical resident; (b)(6), md.Operative report.Preoperative diagnosis: large incisional/ventral hernia.Postoperative diagnosis: same.Resident assistant: dr.(b)(6).Anesthesia: general endotracheal anesthesia.Estimated blood loss: 150cc.Specimens: none.Findings: the patient had multiple large fascial defects and a midline incision from a previous gastric bypass surgery, as well as multiple defects in a right upper quadrant incision from a prior open cholecystectomy.A 9 by 15cm piece of dual layer mesh was cut in half and sutured to a single 24 by 18cm sheet of mesh for repair.Complications: none.Indications for procedure: the patient is a (b)(6)-year-old white male who had previously undergone an open gastric bypass procedure and had a prior ventral hernia repair as well.He also had a right upper quadrant incision for an open cholecystectomy in the distant past as well.The patient presented to the surgery clinic with a very large incisional hernia, as well as multiple smaller hernia defects.The patient was medically cleared and scheduled for surgery.Details of procedure: ¿after informed consent was obtained the patient was taken to the operating room where he was placed on the operating table in a supine position.General endotracheal anesthesia was administered and the patient was subsequently prepped and draped in the usual sterile fashion with betadine scrub and solution over the entire anterior surface of the abdominal wall.An ioban was employed in the draping process.A number 10-blade scalpel was then used to excise the large midline abdominal scar due to the patient¿s history of an open wound, which had granulated and healed by secondary intention.Once the skin and immediately underlying soft tissue were excised, the dissection was carried down with the bovie electrocautery to the fascia.Care was taken during this portion of the procedure to avoid injury to any hernia sacs, which potentially could contain bowel within them.During the course of this dissection, multiple small hernia sacs containing mostly preperitoneal fat and omentum, was well as some containing bowel were located in the upper abdomen along the midline incision.Additionally, around the umbilicus there was a very large hernia defect with a large amount of small intestine protruding through the hernia defect, being contained within a sac and subcutaneous tissue, primarily in the left lower quadrant, anterior to the abdominal musculature and fascia.This hernia sac was dissected out after the contents had been reduced into the peritoneal cavity.The midline was reopened with the bovie electrocautery, using blunt dissection techniques to assure protection of the bowel while opening the abdomen.Once the entire incision had been opened, cranially and caudally, care was taken to lyse some adhesions of the intra-abdominal contents to the anterior wall.The adhesions were taken down both with bovie electrocautery as well as with sharp dissection with metzenbaum scissors.At this point, after the adhesions had been taken down in the right upper quadrant, the right upper quadrant incision was palpated from an internal orientation, noting that there were multiple substantial defects in this incision.For this reason, it was decided to go ahead and open up the prior incision in the fascia without actually incising the skin.Large skin and subcutaneous flaps were raised laterally, as well as cranially and caudally, such that the mesh could be sutured in place 4 to 5cm away from the midline wound.By raising the subcutaneous flap in the right upper quadrant, the entire previous right upper quadrant fascial incision was reopened connecting the fascial defects.At this point the fascia was then closed from lateral to medial using number one pds suture in a running fashion.Once this fascia had been closed and the midline fascia freshened, it was determined that the large defect would require mesh for appropriate closure, which was expected.The larger available size of cortex dual layer mesh was 18 by 24 cm in width and length.This sheet of mesh was substantially too small for the defect, therefore, another mesh, size 19 by 15 cm was obtained and divided in half.This rounded piece of mesh was connected to the square.At this point dual layer mesh was sutured into place, placing the smooth brown side down toward the internal abdominal contents and the white sticky side up, towards the fascia.The fascia was then sutured into place, using 2-0 prolene suture in a running fashion, sewing over and over.In this fashion, the entire piece of mesh was sutured into place, with the edges of the mesh being located approximately 4 to 5cm outside of the fascial edges, all the way around.This also allowed closure of the fascia over the mesh from inferior to superior in a running fashion, using heavy pds suture.Once the mesh was in place and the fascia was re approximated, the subcutaneous tissues were then tacked down to the anterior fascia with a heavy vicryl suture in a simple interrupted fashion.Additionally, the mesh was sutured into place in the right upper quadrant superior and lateral to the edge of the incision, which was repaired in an attempt to also add mesh repair to the incision.Once the subcutaneous tissue of the internal abdominal wall was anchored into place, attention was turned toward closure of the skin.Multiple 2-0 and 3-0 vicryl sutures were used to re approximate the skin edges, placing the vicryl sutures in a deep dermal fashion.The skin was then closed using skin staples.The wound was subsequently cleaned with wet and dry sponges and a dressing was applied.The patient tolerated the procedure well and was subsequently extubated and transferred to the recovery room in stable condition.¿ explant procedure: excision of abdominal mesh, lysis of adhesions for approximately two hours, primary fascial closure of the abdomen.Explant date: (b)(6) 2006 (hospitalization unknown).On (b)(6) 2006: (b)(6).(b)(6), md.Operative report.First surgical assistant: (b)(6), md.Second/third surgical assistant: (b)(6), md.Anesthesia: general endotracheal anesthesia.Preoperative diagnosis (es): infected abdominal mesh.Postoperative diagnosis (es): infected abdominal mesh.Indication for procedure: the patient is a (b)(6)-year-old male who underwent a gastric bypass procedure approximately seven years ago.He subsequently developed a ventral incisional hernia which was repaired at an outside hospital about three years ago.The hernia appeared to be repaired using gore-tex mesh which had subsequently become infected.The patient reports purulent drainage for about two years which has been progressively worsening.Ct scan of the abdomen confirmed findings of an infected mesh and he desires elective removal.Operative findings: infected ventral abdominal mesh that was not incorporated with the surrounding tissues.Extensive adhesions between the omentum, some portions of the small bowel and the anterior abdominal wall.Description of procedure: ¿after obtaining informed consent, the patient was taken to the operating room and placed under general anesthesia.His anterior abdominal wall was prepped and draped in the usual sterile manner using betadine, and he received 2 grams of cefazolin preoperatively.There were two areas of excoriated skin with gross purulence coming through the abdominal wall.These were opened in the midline using electrocautery, thus exposing the underling mesh.The mesh was not incorporated to the surrounding tissue whatsoever, and the mesh was easily removed by excising the previously placed prolene sutures.Once the mesh was removed, the remaining cavity was examined.Sharp dissection was used to carefully enter the plane between the adherent omentum and the underlying surface of the abdominal wall fascia.This dissection and lysis of adhesions was continued circumferentially around the wound until the entire anterior abdominal wall fascia was freed from the abdominal contents for at least 8 cm circumferentially.As evidenced on preoperative ct scanning, there was a large ventral hernia in the patient¿s right mid abdomen.This was identified intra-abdominally and bowel and omentum were reduced from the hernia sac.The edges of this hernia were also freed from the surrounding bowel adhesions.The total lysis of adhesion took approximately two hours of operative time.The right mid abdominal hernia was then closed intra-abdominally using #1 prolene sutures in a figure-of-eight fashion.A total of four sutures was placed in this hernia to completely close the hernia opening.Attention was then turned towards closing the midline abdominal fascia defect, where the mesh had previously been located.By mobilizing the fascia and intra-abdominal contents, it was clear that this could be closed primarily without the need for placing an artificial mesh in this infected field.Flaps were made above the abdominal fascia.Between the fascia and the skin using electrocautery for a distance of approximately 8 cm.The midline fascia was then reapproximated without any tension using running #2 prolene sutures.Specifically, the fascia was approximated with two sutures beginning superiorly and one inferiorly and joining in the middle.The skin flaps and remaining abdominal wound were then copiously irrigated with irrigation containing kantrex.The wound was then packed using kerlix gauze.¿ specimen removed: infected abdominal mesh.Estimated blood loss: 100 ml.Intraoperative fluids: 2,900 ml of crystalloid.Sponge/instrument/needs counts: all sponges and needle counts were correct at the end of the case.Condition of discharge from operating room: the patient was extubated and stable and in good condition to the pacu.Urine output: approximately 50 ml.Relevant medical information: on (b)(6) 2019: (b)(6).Letter to consumer attorney record services.Here is the information i have found regarding the hernia mesh devices.There was no serial #, lot #, nor expiration for the hernia mesh.I was given the model # for both devices.1dlmcp04 size: 15cm x 19cm.1dlmcp06 size: 18cm x 24cm.Also, i was told the (b)(6) was not required to keep sticker information for joint commission because it was not tissue related.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® 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 open ventral/incisional hernia repair on (b)(6) 2004 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2006, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infected mesh, not adherent mesh, adhesions and bowel obstruction.Additional event specific information was not provided.
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Manufacturer Narrative
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Correcting date received, by manufacturer for the initial mdr: the information needed to determine reportability was received 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: open ventral hernia repair with dual layer cortex mesh.[product id provided by letter dated (b)(6) 2019, pid sticker nor implant log was provided] [implant: gore® dualmesh® plus biomaterial, 1dlmcp04/lot # not provided, 15cm x 19cm x 1mm thick, oval and gore® dualmesh® plus biomaterial, 1dlmcp06/lot # not provided, 18cm x 24cm x 1mm thick] (b)(6) 2019: (b)(6).Letter to consumer attorney record services.Here is the information i have found regarding the hernia mesh devices.There was no serial #, lot #, nor expiration for the hernia mesh.I was given the model # for both devices.1.1dlmcp04 size: 15cm x 19cm.2.1dlmcp06 size: 18cm x 24cm.Also, i was told the va was not required to keep sticker information for joint commission because it was not tissue related.Explant procedure: excision of abdominal mesh, lysis of adhesions for approximately two hours, primary fascial closure of the abdomen.Explant date: (b)(6) 2006 [hospitalization dates unknown].(b)(6) 2006: (b)(6) md.Pathology report.Diagnosis: ¿foreign body, abdomen, removal ¿ mesh (gross only).¿ specimen: ¿a.Abdominal mesh.¿ gross description: ¿this specimen is received fresh in a container labeled ¿(b)(6)¿ and ¿infected abdominal mesh.¿ it contains tan-green mesh, measuring 21.5 x 15 x 2 cm.No soft tissue attached to the mesh.¿ 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® 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: 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® 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.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.C1: 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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