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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP02 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 12/15/2010 |
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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 (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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 hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infected mesh, removal of mesh, abdominal wall reconstruction, adhesions, and pain and suffering.Additional event specific information was not provided.
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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: relevant medical information: [ni].Implant procedure: [ni].Implant: gore® dualmesh® plus biomaterial [1dlmcp02/04106037].Implant date: (b)(6) 2006 [per implant log] (hospitalization ni) (b)(6) 2006: [ni].Implant records.Implant: mesh dual #1dlmcp02 8 cm x 12 cm *wl gore* or-1dlmcp02 * 04106037.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp02/04106037) was implanted during the procedure.Relevant medical information: [ni] explant procedure: laparoscopic removal of her adjustable gastric band and port.Removal of infected gore-tex mesh through separate incision and procedure.Abdominal wall reconstruction with repair of hernia, component separation reconstruction, bilateral rectus muscle flaps and alloderm 20 x 16 cm onlay graft.Explant date: (b)(6) 2010 (hospitalization (b)(6) 2010) (b)(6) 2010: (b)(6) md.Operative report.Preoperative diagnosis: infected mesh from previous ventral hernia repair elsewhere.Previous adjustable gastric banding and port placement currently adjacent to the infected mesh.Postoperative diagnosis: infected mesh from previous ventral hernia repair elsewhere.Previous adjustable gastric banding and port placement currently adjacent to the infected mesh.Procedure performed: laparoscopic removal of her adjustable gastric band and port.Removal of infected gore-tex mesh through separate incision and procedure.Indication: patient was admitted to dr.Eggl with infected mesh from previous ventral hernia repair.She also has an adjustable gastric band with subcutaneous port place.The port was in proximity to the area of infected mesh.Because the plans were for removal of infected mesh with subsequent repair of her hernia using component separation technique, and because this repair would necessarily expose and contaminate the port, it was elected to remove the adjustable gastric band and port.Consideration was given to internalizing the port tubing in the hopes of replacing a port and connecting it to the tubing at a later date.However, the tubing was adherent to the undersurface of the mesh intra-abdominally and there was concern that the remainder of the adjustable band and components would subsequently become infected, seated from the current mesh infection and would have to removed.That removal, however, would be made much more difficult by the extensive nature of her abdominal reconstruction planned today.Findings: the patient had adhesions throughout the abdomen especially in the midline structure.The superior aspect of her infected mesh was visualized inside the abdomen with the tubing from her band adherent to it.We were able to gain exposure by placement of three 5-mm trocars in the left upper quadrant in an area where were able to take down enough adhesions to obtain that exposure.An allergan lap-band presumably standard ap was identified, dissected free from its encasement around the stomach, unbuckled, and removed.The patient had two separate sheets of gore-tex mesh that were grossly infected.These two pieced were sutured together.There was a large amount of pus associated with the mesh.There was a fairly dense rind of tissue on the undersurface of the mesh.They contained numerous gore-tex sutures as well as numerous fixation wires.There were all removed surgically.Description of procedure: ¿the patient was taken to the operating room and placed in the supine position.After satisfactory genera endotracheal anesthesia, the abdomen was prepped and draped sterilely.A 5-mm transverse incision was made just inferior and slightly medial to the palpated port.A veress needles was inserted, but initial attempt to obtain a pneumoperitoneum were unsuccessful, as pressures appeared to be too high indicative of the veress needle not finding the actual peritoneal cavity.A second incision was made in the right upper quadrant also 5 mm and well away from her surgical scars as well.Again, a veress needle was inserted and attempts were made to obtain pneumoperitoneum with the same results, that is we were unable.Veress needle was returned to the left upper quadrant incision and a second attempt made.Firmly on the third attempt, the veress needle appeared to find the actual peritoneal cavity and pneumoperitoneum could be established.A 5-mm bladeless trocar was placed under direct vision and did enter the peritoneal cavity.There was no evidence of visceral injury and there was adherent bowel in this area.There was omental and other filmy adhesions.A second 5-mm bladeless trocar was placed more laterally in the right upper quadrant under direct vision.Using these two port sides, adhesions were taken down with primarily blunt dissection.A third 5-mm bladeless trocar was placed also in the right upper quadrant between the first two.Utilizing these three ports, the tubing was identified and dissected down to the adjustable band around the stomach.Anterior encapsulation was divided sharply and with the harmonic.This freed up the band.The band was unbuckled and removed from around the stomach.The tubing of the band was cut and the band and tubing brought out through the 5 mm trocar just medial to the port site.Pneumoperitoneum was released and the trocars removed.Incision was extended laterally from the most medial port site and dissection was carried down to the port.The port itself was dissected free from the abdominal wall and the port and tubing were removed.The band was likewise removed through the 5-mm port site by extending the fascial opening just enough to extract the band through it.Closure of this facial defect will be incorporated with the closure of the main hernia itself.Trocars were all removed and the laparoscopic equipment put away.Vertical midline incision was made through a previous surgical scar over the area of suspected mesh infection and the area of most induration.Very indurated tissue was encountered and dissection was carried down through this and ultimately through the overlying fascia into an abscess encompassing the gore-tex mesh patch.It was rather contracted.It was gradually dissected free from the anterior and posterior tissues with primarily blunt dissection.Gore-tex sutures and wire tacks were removed dissecting circumferentially around the mesh.The mesh was eventually removed from the abdominal field.There was a very fairly dense rind of omental tissue behind this.Good hemostasis was noted.Dr.De la torre and his team men assumed control of the procedure and component separation and reconstruction of the abdominal wall, which is dictated separately.I was present and participated fully in all aspects of the operation.¿ (b)(6) 2010: (b)(6) , md.Operative report.Assistant: (b)(6) , md.Procedure performed: abdominal wall reconstruction with repair of hernia, component separation reconstruction, bilateral rectus muscle flaps and alloderm 20 x 16 cm onlay graft.Anesthesia: general.Estimated blood loss: 200 ml.Complications: none.Specimen: none.Brief history: this is a 60-year-old female who had a history of ventral hernia in the past.She has a hernia repair with prosthetic mesh and no now has developed abscess around the material.She was admitted to the hospital by the gi service for management.They are planning on removing her infected mesh as well as a port for gastric band and she will require abdominal wall reconstruction.We have discussed this with her team and gone over the risks and benefits with the patient including seroma, hematoma, need for revision procedures, wound healing problems, and hernia recurrence.She understands and wishes to proceed.Technical details: ¿the patient was taken to the operating room by (b)(6), dr.(b)(6) and their team and underwent their portion of the procedure.They dictated a separate operative report for that portion.Once they had removed the mesh and port we were called in.Through the midline incision and fascial opening we were able to evaluate intra-abdominally and there was a significant amount of inflammatory reaction to the infected mesh.We were able to advance the hernia margins together and approximate them using 0 prolene simple interrupted suture.We then dissected laterally on either side to beyond the lateral border of the rectus sheath.Once the rectus sheath on each side was defined an incision was made through the external oblique fascia on each side so that the rectus muscles were advanced to the midline.They were advanced and approximated using 0 vicryl simple interrupted sutures and then a looped #1 nylon continuous running suture to inset them.The wound was irrigated and checked for hemostasis.A segment of alloderm 20 x 16 cm was hydrated and irrigated.It was the inset using several 0 vicryl sutures to set first longitudinal tension and then the horizontal tension offloading some of the tension at the rectus muscle inset.There are also some redundancy laterally that we tacked out as far as we could across the external oblique fascial defect.However we did not put them under any physiologic tension.Some quilting sutures were also placed over the rectus sheath.The wound was irrigated again, checked for hemostasis.Two drains were brought out inferiorly, 19 blake drains which were secured with 3-0 nylon.The midline incision was then closed with 0 vicryl for the deep layer and superficial fascial layer.The deep dermal layer was closed with 2-0 vicryl and the skin with 3-0 monocryl.The port incision was also closed in similar fashion.Xeroform and light dressing, and an abdominal binder were placed.The patient tolerated the procedure well and went to recovery room in stable condition following surgery.I spoke with her family and was present for and supervised the entire operation.¿ relevant medical information: (b)(6) 2010: (b)(6) md.Pathology.Clinical information: the patient is a 60-year-old white female with infected abdominal wall mesh.Gross description: part a is received in a container labeled with the patient¿s name, medical record number, and designated ¿mesh.¿ the specimen consists of a fragment of surgical mesh material which measures 15.0 x 11.0 x 1.8 cm.The mesh material is tan with red streaks on it.There are staples at the edges of the mesh.The specimen is for gross examination only.Part b is received in a container labeled with the patient¿s name, medical record number, and designated ¿periprosthetic capsular line.¿ the specimen consists of a fragment of soft tissue which measures 9.5 x 7.0 x 2.8 cm.The tissue is pink, fibrotic, and somewhat hemorrhagic.There is a small amount of golden yellow fats associated with the specimen.The specimen s serially sectioned revealing a glistering fibrotic cut surface.Block summary: a.Gross only.B1.Represenative section of periprosthetic capsular line.Microscopic description: a.Microscopic examination has been performed.Diagnosis: abdominal wall, ¿mesh,¿ removal: surgical mesh (gross examination only).Soft tissue, ¿periprosthetic capsular lining,¿ excision: fibroconnective tissue with focal abscess formation and xanthomatous macrophages.(b)(6) 2010: (b)(6) md.Discharge summary.Services: plastic surgery services.Admission diagnosis: status post ventral hernia repair with infected mesh with possible feeding from gastric band.Ct scan (b)(6) 2010 showing peripheral enhancing fluid collections consistent with abscess associated with intraabdominal mesh.Hospital course: ms.(b)(6)is a 60-year-old white female with history of ventral hernia repair in 2005 and 2006 secondary to colectomy for colorectal cancer in 2005.In (b)(6) 2010, she underwent exploratory laparotomy for a ruptured spleen and later had a ct scan the revealed anterior and posterior fluid collection around her midline abdominal mesh.She was admitted to the emergency department to the gi service for continued symptoms of fevers and chill and the ct scan was performed showing intraabdominal abscess associated with her mesh.She was initially admitted to the gi surgery service, and she was treated with intravenous antibiotics and prepared for surgery.On (b)(6) 2010, she was taken to the operating room.Her postoperative cultures grew methicillin-resistant staphylococcus aureus which was sensitive to bactrim and after prolonged period of intravenous vancomycin, she was then switched over to oral bactrim with continued decrease in her white count.Her postoperative course was uneventful and she was tolerating her regular diet at the time of discharge with normal bowel function.Her white count had returned to a near normal level with a white count of 12, no fevers, and her vital signs were stable.She did have abdominal drain.She was instructed on how to report daily output.She will follow up in clinic in approximately one week and was given a number to call for any fever greater than 101.5, increasing pain, or bleeding, or any other concerns.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 results code and component code.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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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) 2005: (b)(6).(b)(6).Discharge summary.Admitting diagnosis : incisional ventral hernia.Postoperative diagnosis: same.Procedure performed: laparoscopic incisional ventral herniorrhaphy.54 year old presents status post lower anterior resection of a 3 m focus of adenocarcinoma in the upper rectum.He developed an incisional ventral in the midline in suprapubic position.The risks, benefits and options were discussed with the patient in detail.She wished to proceed with laparoscopic ventral herniorrhaphy.On (b)(6) 2005, the patient underwent a laparoscopic ventral herniorrhaphy.She progressed very well in her postoperative course.She has remained afebrile and has tolerated her diet.Her incision is intact.She had her foley catheter removed and she is voiding satisfactory.She is ambulatory and will be discharged home on oral analgesic, with follow up in our office in one week.(b)(6) 2006: (b)(6).(b)(6).History and physical.Recurrent incisional ventral hernia.Preoperative diagnosis: recurrent incisional ventral hernia.Planned procedure: laparoscopic ventral hernia repair.Patient is a 55 year old who is status post anterior resection in 2005.She had a herniation in the lower midline.She underwent a laparoscopic ventral herniorrhaphy in(b)(6) of last year.There is a small lower midline recurrence.She continues to wear a binder.This is confirmed via ct scan.She has a reducible hernia in the lower midline¿ impression: recurrent incisional ventral hernia.In review of her ct scan, this is inferior to her previously placed mesh and is essentially suprapubic in location of her hernia.We discussed with the patient and plan to approach this laparoscopically.This is a difficulty site to fix for a ventral hernia and may require an open repair.The risks, benefits and options discussed with the patient in detail and she wishes to proceed.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.H6: corrected health effect - impact code.
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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.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 device.¿ 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.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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