|
Model Number 1DLMCP07 |
Device Problems
Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682); Insufficient Information (3190)
|
Patient Problems
Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Sepsis (2067)
|
Event Date 07/29/2010 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿.
|
|
Event Description
|
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2010 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure was performed whereby the gore device was explanted.It was reported the patient alleges the following injuries: abdominal wall abscess, adhesions, necrotic tissue, panniculitis, draining sinus tract, mesh infection, mesh removal.Additional event specific information and medical records have been requested.
|
|
Manufacturer Narrative
|
Corrected date.Updated results code for the sterilization evaluation.Conclusion code remains unchanged.
|
|
Manufacturer Narrative
|
Corrected brand name.
|
|
Manufacturer Narrative
|
Corrected date.Updated results code.The sterilization evaluation is still in progress.Conclusion code remains unchanged.
|
|
Manufacturer Narrative
|
Additional/revised details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: history and physical records dated (b)(6) 2010 state: ¿i first saw her in november last year and did not appreciate a ventral hernia, but the patient is quite corpulent.Her history is that she had an ovarian cancer resected back early in 2009 and began to have abdominal pain.It was done approximately a year ago in (b)(6).She did not have any adjunctive chemotherapy or radiation therapy, indicating that it must have been an early stage tumor, and the postoperative pain she has developed maintains some degree of mild abdominal discomfort, and at one point was having drainage from the umbilicus.She lives here locally, and although she was scheduled to have a hernia repair by dr.Tate in charlotte, she would like to have it done here, and dr.Teresa romzick sent her to see me.On my last admission, i noted that she did have a very significant 4 to 5 cm umbilical hernia that was palpable and reducible.I thus counseled her on 2 occasions, on 02/09/08 and 02/10 on a large ventral hernia to be done laparoscopically.¿ weight is noted as 284 lbs, height is 5¿.¿she has a very corpulent abdomen; does have a reducible ___ [sic].¿ ¿impression: ventral hernia.¿ operative records dated (b)(6) 2010 state the patient underwent ¿laparoscopic ventral hernia repair.The procedure was approximately 3-1/2 hours long with approximately 2-1/2, 3 hours of taking down adhesions.¿ the records state the patient ¿¿had a previous abdominal surgery and a previous ventral hernia repair which has failed.She is very corpulent, so we were unable to determine how big her ventral hernia was.We knew that she had a significant umbilical-type hernia.We thus elected to bring her to the operating room for laparoscopic repair, which turned out to be fortuitous.¿ records for the noted previous ventral hernia repair were not provided to gore.Discharge summary dated (b)(6) 2010 indicates: ¿she underwent left ventral hernia repair with an extensive 3-1/2-hour dissection of her intestines to take down adhesions and place in a large piece of mesh.Postop, she has done extremely well.We are going to restrict her activities to just walking, keep her on a stool softener, percocet for pain and discharge home.She has done extremely well in the postop period.She is eating a regular diet, ambulatory and stooling.Discharge diagnosis: large ventral hernia with laparoscopic ventral hernia repair.¿ an abdominal ultrasound report dated (b)(6) 2010 states: ¿gray scale evaluation was performed of the umbilical region.Within the subcutaneous tissues is a fluid collection measuring 3.6 x 5.3 x 6.5 cm.Echogenic material is also identified within this region, compatible with packing material and possibly abdominal wall mesh material.Impression: 3.5 x 5.3 x 6.5 cm subcutaneous fluid collection within the umbilical region, compatible with abscess or seroma.¿ history and physical records dated (b)(6) 2010 state: ¿¿patient with a large ventral hernia who i received from dr.Romzick's.She underwent a laparoscopic ventral hernia repair by me, a 3 hour operation, using a 20 x 30 piece of mesh.We had to take a good deal of tissue out of the hernia sac.In the postop period, unfortunately, the patient necrosed her umbilicus and has begun to drain.Initially, i thought this was very superficial, but she began to drain free pus from this area, and i am worried that it is in contact with the mesh.I tried to obtain a sonogram today, but i obtained an ultrasound of the area from radiologty [sic] that shows a 3-4 cm area in contact with the umbilicus abscess.I thus used retractors and probed the area and have drained more pus out.I cannot see mesh in the bottom of the wound, i only see granulation tissue.¿ history and physical records dated (b)(6) 2010 continues: ¿i am going to try to continue to ride this out with packing at the present time.I am very concerned that this is an infected mesh, and we may eventually have to remove it.The patient's main complaint is that of pain.We will increase her to 7.5 percocet.I will see her back in 1 week to reassess the situation.If, indeed, this is a problem with infection, we will probably have to go back in, remove the mesh, and consider component separation.The patient is very obese and this could be a difficult procedure.¿ pre emergency room records dated (b)(6) 2010 indicate: ¿ s/p ventral hernia repair & wound abcess [sic] recurrent abcess [sic] renal failure anemia r/o sepsis.¿ admission records dated (b)(6) 2010 indicate: ¿[the patient] is a 60-year-old obese african-american female who underwent a laparoscopic incisional hernia repair by dr.Skudlarick in may.She developed a perioperative infection of the umbilicus and has been treated with open packing of the wound since that time.She has been seeing dr.Skudlarick every other week to manage the wound.Earlier today, the patient noticed some swelling in the left midabdomen and spontaneously ruptured through the skin and began to drain a large amount of purulent material with a foul smell.She came to the emergency department for further care and was found to have a significant elevated white blood cell count, acute renal insufficiency, and evidence of significant anemia as well as hypotension.The patient is being admitted to the hospital for management of what appears to be an apparent sepsis syndrome in the face of an intraabdominal infection, probably infected mesh.¿ the (b)(6) 2010 admission records state: ¿abdominal exam reveals well healed incisions except at the umbilicus where she has a fair amount of purulent material coming out through the umbilicus and also a left lower quadrant area thats quite indurated and has a 1 cm diameter skin defect with a fair amount of foul smelling white purulent material coming out of it as well.There is surrounding edema and erythema extending out for approximately 10 cm in the area.¿ ¿cbc shows a white count of 17,600, hemoglobin is 7.7, platelet count 486,000.¿ the (b)(6) 2010 admission records continue: ¿impression: 1.Intraabdominal abscess probably representing an infected mesh from a recent ventral hernia repair.2.Acute anemia with hypotension.3.Possible sepsis syndrome with hypotension.4.Acute renal insufficiency possibly secondary to the sepsis syndrome versus dehydration.¿ the (b)(6) 2010 admission records state: ¿plan: well plan to proceed with admission to the hospital and aggressively rehydrate the patient, including transfusion of a couple of units of packed red blood cells, anticipating further dilution after rehydration.In addition, this is as a result of her hypotension.A culture of the abscess has been performed in the emergency department as well as blood cultures drawn, and zosyn was delivered iv.I believe this is a relatively appropriate antibiotic although it does not have adequate staph coverage, but until we get a proper identification of the bacteria growing from this abscess, zosyn should suffice in addition of vancomycin should she show evidence of further septic complications.Once we are able to get her stabilized overnight with fluids and antibiotics, dr.Skudlarick will be around to reevaluate the patient and consider surgical exploration with control of the septic source.¿ history and physical records dated (b)(6) 2010 state: ¿[the patient¿s] history is that she had a laparoscopic ventral hernia done several months ago, and unfortunately necrosed a small area within her umbilicus that led to a direct contact with her gore-tex mesh, and she's developed a wound infection and gradually developed an abscess cavity that has progressed to draining purulent material.I have tried to persuade her in the office to come into the hospital and have this operatively resected, but she's resisted.We had ordered for her a wound vac, but it took a week or longer to receive the wound vac and she never had it applied.She came back into the hospital last night with draining pus through umbilicus and then a secondary phlegmon in the left lateral abdomen, and of course, my feeling is that she should have this mesh removed immediately.We are thus going to prepare her.She's very anemic.We are going to prepare here with transfusions and hydration, bowel prep.Her bun is 37 and creatinine is 2.1.She is diabetic and grossly obese.This will be a very difficult procedure.We may only be able to close her skin over the top of this wound owing to the amount of infection.Impression: infected gore-tex mesh.Plan: removal.¿ operative report dated (b)(6) 2010 indicates the patient underwent resection of mesh, closure of fascia, and debridement of multiple abscesses.A postoperative diagnosis states: ¿infected mesh with multiple subcutaneous abscesses.¿ postoperative diagnoses noted on records for placement of a central line on (b)(6) 2010 state: ¿septic mesh, infected mesh for abdominal exploration, venous access a necessity.¿ a progress note dated (b)(6) 2010 states: ¿[the patient] is following up after her mesh infection with excision of the mesh and vac dressing.She is feeling much better than when i saw her in the emergency room.She is tolerating a diet, she is up and ambulatory, and she is afebrile.Exam: the wound is healing well with granulation tissue being apparent underneath the vac sponge.Cultures have grown an enterococcus that is sensitive to both ampicillin and vancomycin.¿ a progress note dated (b)(6) 2010 state: ¿her wound is healing well.There is minimal drainage.¿ surgical pathology report dated (b)(6) 2010 regarding a specimen collected 7/29/2010 states: ¿clinical diagnosis: infected mesh and abdominal tissue.Tissue submitted: mesh and abdominal tissue.Gross:¿received is a container labeled with the patient¿s name and also labeled ¿infected abdominal tissue and mesh.¿ the specimen consists of 560 grams in aggregate of tissue.An ellipse of black skin measuring 8 x 2 cm is present on the largest portion of tissue.Apparent fibrino-purulent exudate is present on the surfaces of the tissue in areas.¿ ¿a portion of mesh measuring 24 x 12 mm is also present.Microscopic: sections show skin and subcutaneous tissue.Masses of neutrophils are present in the subcutaneous tissue.Brown-hopps stain for bacteria and gms stain for fungi are negative.¿ diagnosis for the specimen states: ¿mesh and infected abdominal tissue, debridement-skin and subcutaneous tissue with acute inflammation and abscess formation.¿ discharge summary dated (b)(6) 2010 states: ¿[the patient] is a lady who had a laparoscopic ventral hernia repair and began draining pus from her umbilicus.I had initially wanted to bring her back to the operating room and debride this but she balked at that initially but finally came to the hospital with pus draining from the lateral aspect of her wound.Essentially what had happened is that the pus was initially draining from the center of her umbilical area and the mesh was infected and she began draining out one of the suture holes that was holding the mesh in.I went back in surgically and was able to easily debride all of the mesh.I came out quite easily since it was infected.Took out the sutures.Surprisingly, the patient developed a good deal of scarring and she didn't have much of a ventral hernia.¿ discharge summary dated (b)(6) 2010 continues: ¿i was able to repair the fascial defect (that is the hernia) with surgilon and i placed a drain in between the fascia and the omentum.The omentum had sealed itself off to form a pseudo-peritoneal cavity.We placed a wound vac.In the postop period, we've changed the wound vac twice and her wound looks excellent, granulating nicely, no sign of pus.It is draining a good deal of fluid from this large wound and i think it's safe for her to go home with her home wound vac, continue care, and follow up with me.Home health will help her with her wound vac and daily living and she will see me back in 1 week.She did grow out enterococcus and we've kept her on ampicillin for a week now.I'm going to discontinue the ampicillin since we are essentially treating the wound open and i don't want to develop any further resistant organisms.She does not have any evidence of systemic infection at the present time.Discharge diagnosis: infected mesh.Operation: debridement of the mesh, closure of hernia, and wound vac, wound care.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ 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.
|
|
Manufacturer Narrative
|
Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2010 state the patient ¿¿had a previous abdominal surgery and a previous ventral hernia repair which has failed.She is very corpulent, so we were unable to determine how big her ventral hernia was.We knew that she had a significant umbilical-type hernia.We thus elected to bring her to the operating room for laparoscopic repair, which turned out to be fortuitous.¿ records for the noted previous ventral hernia repair were not provided to gore.The (b)(6) 2010 records state: ¿i initially placed a trocar in the left upper quadrant of the abdomen and unfortunately she had adhesions throughout her abdomen.We did really not have a clear view area to start any dissection.I finally made a rent in the falciform ligament and found an area in the right upper quadrant that looked like it was relatively free and placed a 2nd trocar in this area and worked back and forth until i had a space in the upper abdomen to work with.To make a long story short, we ended up with 5 trocars, 2 in the left side, 3 in the right side.She was very corpulent and we had to use large trocars.We finally dissected free all of the adhesions.She had extensive adhesions throughout the abdomen.She had an approximately 10-12 cm in diameter hernia in the abdomen, and after the adhesions were taken down we also found a small right inguinal hernia.The patient was very protuberant.She had a very large panniculus.I was not sure how well we could get sutures through the lower abdomen to secure the mesh so i elected to go ahead and use a much larger piece of mesh than we actually needed.¿ the (b)(6) 2010 records continue: ¿i used a 20 x 30 piece of mesh and think probably to cover the area we only needed about a 15 x18 piece of mesh, but i thought by doing this i would have a larger ingrowth area and less tension on the mesh overall.So we took an oblong piece of 20 x 30 mesh, put sutures in the top, bottom and the 2 sides, marked cross hairs on the abdominal wall to the center of the mesh, measured internally at least 5 cm from the edge of the hernia to be sure that we had the mesh centered, slid the mesh in through a 12 mm port, unrolled the mesh, and then placed the tacking sutures just above the pubis inferiorly, about 8-9 cm above the upper edge of the hernia superiorly and laterally pulled the mesh out taut.I then went about stapling the mesh circumferentially to the anterior abdominal wall until we had the mesh completely outlined and had it taut as a trampoline all the way around the abdomen, then i put a 2nd layer of staples inside the outer layer and felt that we had secured it satisfactorily.I then went about the abdomen being sure that we had all bleeding stopped.We did have some bleeding from the falciform ligament which we attended to.We viewed the abdomen; we did not see any evidence of any bowel injury; in fact, i thought we had done a very tedious, good job of bowel dissection during the procedure.¿ ¿the procedure was approximately 3-1/2 hours long with approximately 2-1/2, 3 hours of taking down adhesions.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp07/06425877) was used during the procedure.Operative report dated (b)(6) 2010 indicates the patient underwent resection of mesh, closure of fascia, and debridement of multiple abscesses.A postoperative diagnosis states: ¿infected mesh with multiple subcutaneous abscesses.¿ the (b)(6) 2010 records state: ¿patient with an infected draining mesh, an abscess on her abdominal wall, panniculitis.Brought to the operating room¿¿ ¿i began the operation after prepping the abdomen by excising through her umbilicus, which i told the patient i would.She began draining through her umbilicus, and my thoughts were that the umbilicus had necrosed and communicated with the hernia sac below and caused infection in the mesh, but as i dissected down to the abscess cavity in the abdomen, i began to change my mind.It did not appear that the deep umbilicus, which was approximately 5 inches deep, was actually necrotic; it was just a draining sinus.When i reached the fascia edge, there was a hole in the fascia about the size of my thumb and i saw the mesh within it.I used a kocher clamp and was able to eviscerate the mesh, which was swimming in old blood and pus, and was able to pull the mesh out.The mesh had been sewn in with 4 sutures and essentially stapled in; we had not used any other stay sutures.So all the clips or spiral tackers came out with the mesh and i eviscerated the mesh.The (b)(6) 2010 records continue: ¿then underneath the fascia, i could put my finger in the fascia, the fascia appeared to be strong and scarred and well-healed, and i swept out this abscess cavity which essentially contained old blood.I began to think that possibly the patient had developed a large hematoma between the mesh and the abdominal wall and then it drained itself through the umbilicus.Now, where the lateral gore-tex suture was, was where she had begun to drain again up through the fatty tissue of the very large panniculus.I resected all this tissue along with the gore-tek [sic] suture that was holding the mesh in place.There was quite a putrid abscess in this area of the panniculus.I resected all the soft tissue, which was obviously lipomatous fat, from the panniculus, all of which was dead or infected.I resected back to normal-appearing fat.¿ the (b)(6) 2010 records state: ¿i then had to make a decision as to how to handle the deep abscess cavity.This abscess cavity seemed to be walled-off well with a layer of omentum.Putting my finger through it, it appeared that the omentum was adherent all the way circumferentially around this pocket where the abscess had formed.Since we had no foreign body in there, but did have an empty apace, i went ahead and took a jp flat drain, cut part of it off, inserted the drain down through the fascial defect.I then closed with the fascial defect with double layers of no.1 pds, left the drain to hopefully drain all liquid material between the fascia and the omentum up into the subcutaneous tissue.I then, after being sure that we had all the dead tissue out and a dry field, placed a large wound vac sponge in the field just on top of the drain that i mentioned and applied the wound vac.Hopefully with the wound vac and the drain we will help drain all areas of the body and cavities that need to be drained and allow this to heal secondarily.The patient was awakened and returned to the recovery room.¿ surgical pathology report dated (b)(6) 2010 regarding a specimen collected (b)(6) 2010 states: ¿clinical diagnosis: infected mesh and abdominal tissue.Tissue submitted: mesh and abdominal tissue.¿ diagnosis for the specimen states: ¿mesh and infected abdominal tissue, debridement-skin and subcutaneous tissue with acute inflammation and abscess formation.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ 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.
|
|
Manufacturer Narrative
|
Previous patient code/codes (1690, 1695, 1971, 2225, 3191 used for ¿panniculitis.¿) was/were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been complete.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span may 18, 2010 through august 3, 2010 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Patient information: medical history: diabetes, 2009: ovarian cancer resected, asthma with occasional steroid use, 5/18/10: obesity, weight 284 lbs., height 60 inches., bmi 55.5, hypercholesterolemia.Prior surgical procedures: n/a.Relevant medical information: implant preoperative complaints: on (b)(6) 2010: ¿i first saw her in november last year and did not appreciate a ventral hernia, but the patient is quite corpulent.Her history is that she had an ovarian cancer resected back early in 2009 and began to have abdominal pain.It was done approximately a year ago in june.She did not have any adjunctive chemotherapy or radiation therapy, indicating that it must have been an early stage tumor, and the postoperative pain she has developed maintains some degree of mild abdominal discomfort, and at one point was having drainage from the umbilicus.She lives here locally, and although she was scheduled to have a hernia repair by dr.(b)(6) in (b)(6) , she would like to have it done here, and dr.(b)(6) sent her to see me.On my last admission, i noted that she did have a very significant 4 to 5 cm umbilical hernia that was palpable and reducible.I thus counseled her on 2 occasions, on (b)(6) 2008 and (b)(6) on a large ventral hernia to be done laparoscopically.¿ weight is noted as 284 lbs, height is 5¿.¿she has a very corpulent abdomen; does have a reducible [sic].¿ ¿impression: ventral hernia.¿ implant procedure: laparoscopic ventral hernia repair [gore® dualmesh® plus biomaterial, 1dlmcp07/06425877, 20cm x 30cm].Implant date: (b)(6) 2010.Description of hernia being treated: ¿the procedure was approximately 3-1/2 hours long with approximately 2-1/2, 3 hours of taking down adhesions.¿ ¿¿had a previous abdominal surgery and a previous ventral hernia repair which has failed.She is very corpulent, so we were unable to determine how big her ventral hernia was.We knew that she had a significant umbilical-type hernia.We thus elected to bring her to the operating room for laparoscopic repair, which turned out to be fortuitous.¿ ¿i initially placed a trocar in the left upper quadrant of the abdomen and unfortunately she had adhesions throughout her abdomen.We did really not have a clear view area to start any dissection.I finally made a rent in the falciform ligament and found an area in the right upper quadrant that looked like it was relatively free and placed a 2nd trocar in this area and worked back and forth until i had a space in the upper abdomen to work with.To make a long story short, we ended up with 5 trocars, 2 in the left side, 3 in the right side.She was very corpulent and we had to use large trocars.We finally dissected free all of the adhesions.She had extensive adhesions throughout the abdomen.She had an approximately 10-12 cm in diameter hernia in the abdomen, and after the adhesions were taken down we also found a small right inguinal hernia.The patient was very protuberant.She had a very large panniculus.I was not sure how well we could get sutures through the lower abdomen to secure the mesh so i elected to go ahead and use a much larger piece of mesh than we actually needed.¿ implant size and fixation: ¿i used a 20 x 30 piece of mesh and think probably to cover the area we only needed about a 15 x18 piece of mesh, but i thought by doing this i would have a larger ingrowth area and less tension on the mesh overall.So we took an oblong piece of 20 x 30 mesh, put sutures in the top, bottom and the 2 sides, marked cross hairs on the abdominal wall to the center of the mesh, measured internally at least 5 cm from the edge of the hernia to be sure that we had the mesh centered, slid the mesh in through a 12 mm port, unrolled the mesh, and then placed the tacking sutures just above the pubis inferiorly, about 8-9 cm above the upper edge of the hernia superiorly and laterally pulled the mesh out taut.I then went about stapling the mesh circumferentially to the anterior abdominal wall until we had the mesh completely outlined and had it taut as a trampoline all the way around the abdomen, then i put a 2nd layer of staples inside the outer layer and felt that we had secured it satisfactorily.I then went about the abdomen being sure that we had all bleeding stopped.We did have some bleeding from the falciform ligament which we attended to.We viewed the abdomen; we did not see any evidence of any bowel injury; in fact, i thought we had done a very tedious, good job of bowel dissection during the procedure.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp07/06425877) was used during the procedure.Post-operative period [three days]: on (b)(6) 2010: discharge summary: ¿she underwent left ventral hernia repair with an extensive 3-1/2-hour dissection of her intestines to take down adhesions and place in a large piece of mesh.Postop, she has done extremely well.We are going to restrict her activities to just walking, keep her on a stool softener, percocet for pain and discharge home.¿ relevant medical information: on (b)(6) 2010: abdominal ultrasound: ¿¿umbilical region.Within the subcutaneous tissues is a fluid collection measuring 3.6 x 5.3 x 6.5 cm.Echogenic material is also identified within this region, compatible with packing material and possibly abdominal wall mesh material.Impression: 3.5 x 5.3 x 6.5 cm subcutaneous fluid collection within the umbilical region, compatible with abscess or seroma.¿ on (b)(6) 2010: history and physical: ¿¿patient with a large ventral hernia who i received from dr.(b)(6).She underwent a laparoscopic ventral hernia repair by me, a 3 hour operation, using a 20 x 30 piece of mesh.We had to take a good deal of tissue out of the hernia sac.In the postop period, unfortunately, the patient necrosed her umbilicus and has begun to drain.Initially, i thought this was very superficial, but she began to drain free pus from this area, and i am worried that it is in contact with the mesh.I tried to obtain a sonogram today, but i obtained an ultrasound of the area from radiologty [sic] that shows a 3-4 cm area in contact with the umbilicus abscess.I thus used retractors and probed the area and have drained more pus out.I cannot see mesh in the bottom of the wound, i only see granulation tissue.¿ ¿i am going to try to continue to ride this out with packing at the present time.I am very concerned that this is an infected mesh, and we may eventually have to remove it.The patient's main complaint is that of pain.We will increase her to 7.5 percocet.I will see her back in 1 week to reassess the situation.If, indeed, this is a problem with infection, we will probably have to go back in, remove the mesh, and consider component separation.The patient is very obese and this could be a difficult procedure.¿ on (b)(6) 2010: pre emergency room: ¿s/p ventral hernia repair & wound abcess [sic] recurrent abcess [sic] renal failure anemia r/o sepsis.¿ on (b)(6) 2010: hospitalization on (b)(6) 2010: admission: ¿[the patient] is a 60-year-old obese african-american female who underwent a laparoscopic incisional hernia repair by dr.(b)(6) in may.She developed a perioperative infection of the umbilicus and has been treated with open packing of the wound since that time.She has been seeing dr.(b)(6) every other week to manage the wound.Earlier today, the patient noticed some swelling in the left midabdomen and spontaneously ruptured through the skin and began to drain a large amount of purulent material with a foul smell.She came to the emergency department for further care and was found to have a significant elevated white blood cell count, acute renal insufficiency, and evidence of significant anemia as well as hypotension.The patient is being admitted to the hospital for management of what appears to be an apparent sepsis syndrome in the face of an intraabdominal infection, probably infected mesh.¿ ¿abdominal exam reveals well healed incisions except at the umbilicus where she has a fair amount of purulent material coming out through the umbilicus and also a left lower quadrant area thats quite indurated and has a 1 cm diameter skin defect with a fair amount of foul smelling white purulent material coming out of it as well.There is surrounding edema and erythema extending out for approximately 10 cm in the area.¿ ¿cbc shows a white count of 17,600, hemoglobin is 7.7, platelet count 486,000.¿ ¿impression: 1.Intraabdominal abscess probably representing an infected mesh from a recent ventral hernia repair.2.Acute anemia with hypotension.3.Possible sepsis syndrome with hypotension.4.Acute renal insufficiency possibly secondary to the sepsis syndrome versus dehydration.¿ ¿plan: well plan to proceed with admission to the hospital and aggressively rehydrate the patient, including transfusion of a couple of units of packed red blood cells, anticipating further dilution after rehydration.In addition, this is as a result of her hypotension.A culture of the abscess has been performed in the emergency department as well as blood cultures drawn, and zosyn was delivered iv.I believe this is a relatively appropriate antibiotic although it does not have adequate staph coverage, but until we get a proper identification of the bacteria growing from this abscess, zosyn should suffice in addition of vancomycin should she show evidence of further septic complications.Once we are able to get her stabilized overnight with fluids and antibiotics, dr.(b)(6) will be around to reevaluate the patient and consider surgical exploration with control of the septic source.¿ explant date:(b)(6) 2010 explant preoperative complaints: on (b)(6) 2010: ¿[the patient¿s] history is that she had a laparoscopic ventral hernia done several months ago, and unfortunately necrosed a small area within her umbilicus that led to a direct contact with her gore-tex mesh, and she's developed a wound infection and gradually developed an abscess cavity that has progressed to draining purulent material.I have tried to persuade her in the office to come into the hospital and have this operatively resected, but she's resisted.We had ordered for her a wound vac, but it took a week or longer to receive the wound vac and she never had it applied.She came back into the hospital last night with draining pus through umbilicus and then a secondary phlegmon in the left lateral abdomen, and of course, my feeling is that she should have this mesh removed immediately.We are thus going to prepare her.She's very anemic.We are going to prepare here with transfusions and hydration, bowel prep.Her bun is 37 and creatinine is 2.1.She is diabetic and grossly obese.This will be a very difficult procedure.We may only be able to close her skin over the top of this wound owing to the amount of infection.Impression: infected gore-tex mesh.Plan: removal.¿ on (b)(6) 2010: ¿infected mesh with multiple subcutaneous abscesses.¿ ¿septic mesh, infected mesh for abdominal exploration, venous access a necessity.¿ explant procedure: resection of mesh, closure of fascia, and debridement of multiple abscesses.¿patient with an infected draining mesh, an abscess on her abdominal wall, panniculitis.Brought to the operating room¿¿ ¿i began the operation after prepping the abdomen by excising through her umbilicus, which i told the patient i would.She began draining through her umbilicus, and my thoughts were that the umbilicus had necrosed and communicated with the hernia sac below and caused infection in the mesh, but as i dissected down to the abscess cavity in the abdomen, i began to change my mind.It did not appear that the deep umbilicus, which was approximately 5 inches deep, was actually necrotic; it was just a draining sinus.When i reached the fascia edge, there was a hole in the fascia about the size of my thumb and i saw the mesh within it.I used a kocher clamp and was able to eviscerate the mesh, which was swimming in old blood and pus, and was able to pull the mesh out.The mesh had been sewn in with 4 sutures and essentially stapled in; we had not used any other stay sutures.So all the clips or spiral tackers came out with the mesh and i eviscerated the mesh.Then underneath the fascia, i could put my finger in the fascia, the fascia appeared to be strong and scarred and well-healed, and i swept out this abscess cavity which essentially contained old blood.I began to think that possibly the patient had developed a large hematoma between the mesh and the abdominal wall and then it drained itself through the umbilicus.Now, where the lateral gore-tex suture was, was where she had begun to drain again up through the fatty tissue of the very large panniculus.I resected all this tissue along with the gore-tek [sic] suture that was holding the mesh in place.There was quite a putrid abscess in this area of the panniculus.I resected all the soft tissue, which was obviously lipomatous fat, from the panniculus, all of which was dead or infected.I resected back to normal-appearing fat.¿ ¿i then had to make a decision as to how to handle the deep abscess cavity.This abscess cavity seemed to be walled-off well with a layer of omentum.Putting my finger through it, it appeared that the omentum was adherent all the way circumferentially around this pocket where the abscess had formed.Since we had no foreign body in there, but did have an empty apace, i went ahead and took a jp flat drain, cut part of it off, inserted the drain down through the fascial defect.I then closed with the fascial defect with double layers of no.1 pds, left the drain to hopefully drain all liquid material between the fascia and the omentum up into the subcutaneous tissue.I then, after being sure that we had all the dead tissue out and a dry field, placed a large wound vac sponge in the field just on top of the drain that i mentioned and applied the wound vac.Hopefully with the wound vac and the drain we will help drain all areas of the body and cavities that need to be drained and allow this to heal secondarily.The patient was awakened and returned to the recovery room.¿ relevant medical information: on (b)(6) 2010: ¿[the patient] is following up after her mesh infection with excision of the mesh and vac dressing.She is feeling much better than when i saw her in the emergency room.She is tolerating a diet, she is up and ambulatory, and she is afebrile.Exam: the wound is healing well with granulation tissue being apparent underneath the vac sponge.Cultures have grown an enterococcus that is sensitive to both ampicillin and vancomycin.¿ on (b)(6) 2010: ¿her wound is healing well.There is minimal drainage.¿ on (b)(6) 2010: surgical pathology report/ specimen collected (b)(6) 2010: ¿clinical diagnosis: infected mesh and abdominal tissue.Tissue submitted: mesh and abdominal tissue.Gross: ¿ received is a container labeled with the patient¿s name and also labeled ¿infected abdominal tissue and mesh.¿ the specimen consists of 560 grams in aggregate of tissue.An ellipse of black skin measuring 8 x 2 cm is present on the largest portion of tissue.Apparent fibrino-purulent exudate is present on the surfaces of the tissue in areas.¿ ¿a portion of mesh measuring 24 x 12 mm [sic] is also present.Microscopic: sections show skin and subcutaneous tissue.Masses of neutrophils are present in the subcutaneous tissue.Brown-hopps stain for bacteria and gms stain for fungi are negative.¿ diagnosis for the specimen states: ¿mesh and infected abdominal tissue, debridement-skin and subcutaneous tissue with acute inflammation and abscess formation.¿ on (b)(6) 2010: discharge summary: ¿[the patient] is a lady who had a laparoscopic ventral hernia repair and began draining pus from her umbilicus.I had initially wanted to bring her back to the operating room and debride this but she balked at that initially but finally came to the hospital with pus draining from the lateral aspect of her wound.Essentially what had happened is that the pus was initially draining from the center of her umbilical area and the mesh was infected and she began draining out one of the suture holes that was holding the mesh in.I went back in surgically and was able to easily debride all of the mesh.I came out quite easily since it was infected.Took out the sutures.Surprisingly, the patient developed a good deal of scarring and she didn't have much of a ventral hernia.¿ ¿i was able to repair the fascial defect (that is the hernia) with surgilon and i placed a drain in between the fascia and the omentum.The omentum had sealed itself off to form a pseudo-peritoneal cavity.We placed a wound vac.In the postop period, we've changed the wound vac twice and her wound looks excellent, granulating nicely, no sign of pus.It is draining a good deal of fluid from this large wound and i think it's safe for her to go home with her home wound vac, continue care, and follow up with me.Home health will help her with her wound vac and daily living and she will see me back in 1 week.She did grow out enterococcus and we've kept her on ampicillin for a week now.I'm going to discontinue the ampicillin since we are essentially treating the wound open and i don't want to develop any further resistant organisms.She does not have any evidence of systemic infection at the present time.Discharge diagnosis: infected mesh.Operation: debridement of the mesh, closure of hernia, and wound vac, wound care.¿ 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 gore® dualmesh® plus biomaterial is provided sterile.Procedure and specific patient factors may contribute to or cause infection, leading to contamination or infection of the mesh material.The instructions for use further states: ¿any postoperative infection should be aggressively treated at the earliest possible time.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 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: 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.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 records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number 06425877 additional manufacturer narrative: 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.
|
|
Search Alerts/Recalls
|
|
|