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| Model Number 1DLMC08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/02/2019 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® 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® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) , 2008 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) , 2019, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: chronically infected mesh and abscess which required surgery and follow up surgery due to an open wound.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopic incisional hernia repair with mesh.Implant: gore® dualmesh® biomaterial [1dlmc08/04797633, 1 mm x 26 cm x 34 cm] implant date: (b)(6) 2008 (hospitalization [ni]) ¿ (b)(6) 2008: carolinas healthcare system.Kent w.Kercher, md.Operative report.Preoperative diagnosis: recurrent ventral/incisional hernia.Postoperative diagnoses: recurrent ventral/incisional hernia ¿ multiple epigastric incisional hernias with massive lower abdominal (suprapubic) ventral hernia.Resident: dr.Hannah.Fellow: dr.Dolce.Anesthesia: general endotracheal.Estimated blood loss: 100 ml.Indications for procedure: the patient is a 61-year-old female who has undergone multiple previous abdominal operations, including 2 colon resections, for diverticulitis, as well as an open cholecystectomy and now presents with a recurrent incisional hernia after a previous primary repair.She has developed an increasingly symptomatic area of herniation in the epigastrium, and also appears to have a fairly large suprapubic defect on ct scan.Following preoperative mechanical bowel prep, she was taken to the operating room for laparoscopic incisional hernia repair with mesh.She is on coumadin and her medication has been held for 1 week preoperatively.Inr is 1.1 prior to surgery.Description of procedure: ¿the patient was identified in the operating room, placed in the supine position on the operating table.General endotracheal anesthesia was induced.Preoperative intravenous antibiotics were delivered and then redosed 3 hours into the procedure.Scds were placed on both legs.A nasogastric tube was inserted.Three-way foley catheter was placed.The arms were padded and tucked.The lower abdomen was then clipped and the entire abdomen widely prepped and draped in the usual sterile fashion from the breast down to well below the pubis and out to the arms bilaterally.The peritoneal cavity was entered at the left costal margin with a veress needle without difficulty.Insufflation was obtained and then a lateral 11-mm port was placed using the optiview trocar.The peritoneal cavity was entered without problems and the site of the verses needle inspected.There was no injury.The veress needle was removed and then 2 additional 5-mm ports were placed in the left lateral abdomen under direct laparoscopic vision.Survey of the abdominal cavity revealed extensive adhesions involving the entire abdomen from the xiphoid down to the pubis.Multiple loops of small bowel were adherent to the anterior abdominal wall along with the colon, as well as the omentum.A meticulous adhesiolysis was undertaken for the next 3 hours to lyse all of the adhesions between the bowel and the anterior abdominal wall.Care was taken to visualize all loops of bowel as the adhesiolysis was carried out.Essentially no electrocautery was used and only a few clips were required for control of small bleeding points on the omentum.No enterotomies occurred and the bowel again was carefully protected during the course of the procedure.One or two very small superficial serosal injuries on the bowel were carefully inspected and irrigated.All bowel was then evaluated at the conclusion of the adhesiolysis and again at the end of the procedure.There was no evidence of any injury.It should be noted that in the lower abdomen, there was a massive excisional hernia with bowel adherent along the entire hernia down to the pubis.All adhesions were taken down and ultimately the bladder identified.The bladder was filled with 350 ml of saline and then mobilized inferiorly away from cooper¿s ligament.The cooper¿s ligament and the pubic tubercle were exposed completely.Once the adhesiolysis was completed, the hernia defect was measured.The defect measured 25-cm in cranial caudal length and 15-cm transversely.The defect extended to within approximately 5-cm of the pubis and within approximately 5-cm of the xiphoid process.A 26 x 34-cm sheet of ptfe mesh was chosen for repair of the defect.The mesh was measured and then marked appropriately with 4 cardinal sutures placed on each edge using cv0 gore-tex suture.The mesh was then taken into the abdomen and unrolled.The suprapubic suture was brought out first, followed by the additional sutures, taking care to stretch the mesh tightly.All sutures were brought out with wide overlap of greater than 5 to 6-cm in all directions beyond the hernia defect.Sutures were tied down in the subcutaneous tissues.The mesh was then tacked circumferentially with spiral tacks on the edge of the mesh.Interrupted #1 prolene sutures were then brought through the abdominal wall and through the mesh for transfascial fixation at 3 points in each quadrant.Care was taken to avoid placing sutures or tacks below the iliopubic tract or along the iliac vessels in each of the lower quadrants.The mesh was fixed to the pubic tubercle with spiral tacks and 2 additional prolene sutures.It should be noted that one of the fixation sutures on the left did result in some bleeding of the epigastric vessels and this was controlled with a figure-of-eight prolene suture using the suture passer.Once the mesh was secured, we confirmed that the defect had been covered widely in all directions.There was no bleeding.The bowel was again inspected.Ports were removed under direct vision following closure of the 11-mm port site with a figure-of-eight #1 ethibond suture using a suture passer.Pneumoperitoneum was released.The skin incisions were closed with 4-0 monocryl and dermabond.The patient tolerated the procedure well, was x-rayed in the operating room and transferred to the recovery room in stable condition postoperatively.Sponge and needle counts were reported as correct x2.¿ ¿ 8/15/08: carolinas medical center.Implant record.Mesh dual 1 mm x 26 cm x 34 cm oval.Gore.1dlmc08.04797633.Incisional hernia.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc08/04797633) was implanted during the procedure.Relevant medical information: ¿ 1/09/19: carolinas medical center.Lab.Glucose 244 h (74-118).Wbc 15.9 h (4.1-10.7).¿ 1/29/19: carolinas healthcare system laboratory.Microbiology.Culture anaerobic aspirate.Source: intra-abdominal fluid.Culture: no anaerobes isolated.Culture gram stain.Source: intra-abdominal fluid.Gram smear: 1+ pmn.1+ gram-negative rods.Culture: moderate growth proteus vulgaris group.Culture anaerobic fluid.Source: subcutaneous abscess like.Culture: no anaerobes isolated.Culture gram stain.Source: subcutaneous abscess like.Gram smear: 1+ pmn.1+ gram-negative rods.Culture: light growth proteus vulgaris group.Explant procedure: exploratory laparotomy with extensive adhesiolysis.Drainage of intrabdominal abscess.Removal of infected ptfe mesh.Excisional debridement of abdominal wall (5 x 4 x 2 cm).Subcutaneous wound vac placement.Explant date: may 2, 2019 (hospitalization [ni]) ¿ 5/02/19: [facility ni].Kent william kercher, md.Operative report.Preoperative diagnoses: synthetic mesh infection with intra-abdominal abscess.Subcutaneous abdominal wall abscess.Postoperative diagnosis: synthetic mesh infection with intra-abdominal abscess.Subcutaneous abdominal wall abscess.Resident: dr.Genz.Anesthesia: general endotracheal.Indications for procedure: ¿the patient is a 72-year-old female who underwent a laparoscopic ventral hernia repair with ptfe mesh approximately 7 years ago.She presented in january of this year with a small bowel obstruction requiring exploratory laparotomy.She subsequently developed a mesh infection, which was treated with irrigation and drainage as well as a vac placement and healing of the wound by secondary intention.She was managed with intravenous antibiotics and subsequently oral antibiotics as an outpatient.She has done well over the past 2 months and now presents with a subcutaneous abdominal wall abscess in the upper abdomen as well as a ct scan demonstrating fluid and air deep to the previous mesh.Percutaneous aspiration of the fluid reveals frank purulence.She now has fevers and leukocytosis, and is therefore taken to the operating room for exploratory laparotomy and removal of the previous mesh.Description of procedure: ¿the patient was identified in the operating room and placed in supine position on the operating table.General anesthesia induced.A foley catheter inserted.The abdomen widely prepped and draped in the usual sterile fashion.A midline laparotomy was made through the patient¿s previous midline scar.The inferior aspect of the unstable scar below the umbilicus was also excised.Dissection was carried using cautery down to the gore-tex mesh.The mesh had been previously closed in the midline with #1 prolene.Prolene sutures were removed and a large amount of frankly purulent fluid was immediately encountered and evacuated.Specimen was sent for culture.The remaining prolene sutures were removed and the mesh opened in the midline, such that the abdominal cavity could be irrigated copiously with saline and all purulence suctioned.There was a thick rind on top of the intestine over the majority of the visible area, although there was ultimately some small bowel visible at the margins along the periphery where there was no coverage by the rind.In order to remove the prior mesh, we carefully dissected the mesh away from the anterior abdominal wall on the anterior surface.We similarly very meticulously dissected the mesh away from the rind on the deep side of the mesh.The mesh was able to be freed circumferentially with the exception of very densely adherent mesh to the abdominal wall along the entire periphery related to prior fixation with prolene and gore-tex sutures as well as multiple spiral tacks.We spent approximately 1.5 hours carefully freeing the mesh from the abdominal wall and cutting transfascial sutures as well as freeing the mesh from underlying tacks.In many areas, the tacks could be freed from the abdominal wall and from the underlying rind and removed with the mesh.In other areas, particularly on the left side, the tacks were intimately associated with the rind and we were concerned that attempts to remove the tacks could result in injury to the underlying bowel.We therefore carefully freed the mesh from the tacks and removed the entire ptfe mesh from the abdominal cavity.The mesh was sent to pathology.The operative field was irrigated and inspected.The bowel was visible in the right lower quadrant and in the left upper quadrant where the rind was not present.There were no serosal injuries and the visible bowel was healthy and viable.We irrigated the entire abdominal cavity copiously with warm saline as well as antibiotic solution (bacitracin and gentamicin).We then placed a 15-fluted blake drain and a 24-fluted blake drain into the subfascial space and secured the drains at the skin with nylon.In the upper abdomen, there was a subcutaneous abscess superficial to the fascia.This area was sharply debrided and also resected using electrocautery over an area of approximately 5 x 3 x 4 cm.All necrotic subcutaneous fat was excised and completely debrided back to healthy viable tissue.We then raised minimal skin and soft tissue flaps superficial to the fascia to allow for subsequent reapproximation of the fascia in the midline.The midline fascia was closed using running looped #1 pds.Complete fascial closure was achieved.The fascial integrity was very good.The subcutaneous space was then irrigated copiously with saline and a large wound vac placed.A complete seal was achieved.Sponge and needle counts were reported as correct.The patient tolerated the procedure well.Plans will be made for vac change at the bedside every 2 days over the next 3-5 days with plans for subsequent return to the operating room for delayed primary closure of the skin and subcutaneous space.Final cultures are pending.Antibiotics will be adjusted accordingly.¿ relevant medical information: ¿ 5/02/19: carolinas medical center.Joanna kosko, md.Pathology report.Case number: s19-27732.Final pathologic diagnosis: mesh, explant: fragments of surgical mesh (see gross description) with adherent fibroadipose tissue.Clinical information/surgical procedure: infected mesh, abdomen; laparotomy, mesh removal.Specimen(s) received: mesh (c).Gross description: received fresh and subsequently placed into formalin in a single container labeled with the patient¿s name, medical record number and ¿mesh¿ are four pieces of mesh material having an aggregate measurement of 30.0 x 22.0 x 1.0 cm.There is a small amount of attached subcutaneous tissue which is free of malignancy or abscess formation.Summary of sections: a ¿ m-representative sections.¿ (b)(6) 2019: carolinas healthcare system laboratory.Microbiology.Culture, anaerobic abscess.Source: intra-abdominal.Culture: no growth.Culture, surgery (gram stain culture).Source: intra-abdominal.Gram smear: 3+ pmn.No organisms seen.Culture: no growth.Culture, surgery (gram stain).Source: abdominal fluid pocket 2 superior.Special request: syringe.Gram smear: 1+ pmn.No organisms seen.Culture: no growth.Culture, surgery (gram stain culture).Source: abdominal wall fluid pocket 1 mesh.Special request: syringe.Gram smear: no pmns, no organisms seen.Culture: no growth.Culture, fluid (gram stain).¿ (b)(6) 2019: [facility ni].Kent william kercher, md.Operative report.Preoperative diagnosis: open abdominal wound, status post removal of infected mesh.Postoperative diagnosis: open abdominal wound, status post removal of infected mesh.Procedures: excisional debridement of open abdominal wound.Delayed primary closure of skin and subcutaneous tissue.Resident: dr.Genz.Anesthesia: general endotracheal.Indications for procedure: the patient is a 72-year-old female who is 5 days status post exploratory laparotomy and removal of chronically infected ptfe mesh.The fascia was closed at the time of the initial operation and the skin and subcutaneous tissue left open.She has undergone 2 wound vac changes at the bedside over the past 5 days.The wound is now beginning to granulate and she remains afebrile with a normal white blood count.Cultures have not grown out any organisms.Deep subfascial drains are removed at the beginning of the operation and plans are to proceed with delayed primary closure of the open wound.Description of procedure: ¿the patient was identified in the operating room and placed in supine position on the operating table.General anesthesia induced.Intravenous antibiotics (cefepime) delivered.The midline wound vac was removed, as were 2 deep drains.The open wound and skin was then prepared with betadine.The previously removed drain sites were closed with figure-of-eight 2-0 nylon.The open abdominal wound was irrigated and inspected.There were some areas of slough and partially viable adipose tissue which were sharply debrided along the wound edges.All debridement was carried back to healthy bleeding tissue.There was no evidence of purulence or any ongoing infection.The midline fascial closure was intact, although a portion of the suture in the lower midline was noted to be somewhat loose.We therefore pulled up on the previous looped #1 pds suture and then placed a new pds looped suture through the fascia multiple times through the area of the loose stitch.We then tied the 2 sutures together to achieve complete, relatively tight fascial approximation.The fascia itself was viable and of good integrity throughout the wound.The wound was irrigated and hemostasis confirmed.A 19-fluted blake drain was placed in the subcutaneous space and brought out through a left-sided stab incision and secured with nylon.The wound was then closed with multiple 2-0 monocryl deep dermal sutures and then the skin loosely approximated with staples.The patient tolerated the procedure well.Sponge and needle counts were reported as correct x3.¿ 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® 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® 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.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® 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® 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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.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® 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.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.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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