|
|
| Model Number |
1DLMC08 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
|
| Health Effect - Clinical Code |
Unspecified Infection (1930)
|
| Date of Event |
05/11/2012
|
|
Type of Reportable Event
|
Serious Injury
|
|
Additional Manufacturer Narrative
|
|
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.".
|
| |
|
Event or Problem Description
|
|
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2012 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, surgery to remove mesh, hole in stomach, bothered sex life, severe and chronic pain.Additional event specific information was not provided.
|
| |
|
Additional Manufacturer Narrative
|
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2012: (b)(6).(b)(6) , md.Hospital admission note.Chief complaint: symptomatic ventral hernia as well as a hepatic mass.History of present illness: ¿this is a 54-year-old female who presented with a symptomatic ventral hernia who is being admitted today for a open ventral hernia repair.Initially, mrs.Ash presented because of a symptomatic ventral hernia.Because of the size and extent of the hernia, a ct scan was obtained.Our ct scan subsequently revealed a liver lesion as well as a right adrenal mass.This morning before surgery we were informed that the liver lesion was in fact a benign hemangioma so we will plan to proceed with ventral hernia repair without any liver resection.¿ physical exam: abdomen: obese.Large non-reducible ventral hernia in the left lower quadrant.Multiple loops of bowel palpable beneath the skin.Midline abdominal scar as well as a lower transverse abdominoplasty scar.Impression: outside ct scans have been reviewed which demonstrate a 3.5 x 3.1 cm mass in the left lateral lobe.As well, the ct demonstrates a very large abdominal hernia with multiple nonobstructed loops of small bowel in the hernia.Implant procedure: open ventral hernia repair with gore-tex mesh.Implant: gore® dualmesh® biomaterial [1dlmco8/9798120, 26cm x 34cm x 1mm] implant date: (b)(6) 2012 (hospitalization (b)(6) , 2012) (b)(6) 2012: (b)(6) , md.Operative report.Assistant: (b)(6) , md.Preoperative and postoperative diagnosis: ventral hernia.Anesthesia: general.Wound type: type i ¿ clean.Procedure: ¿the patient was identified, brought to the operating room, and prepped and draped in standard sterile fashion after general endotracheal anesthesia was established.Arms were out.Her old scar was incised in its entirety from xyphoid to approximately 5 cm cephalic to the pubic bone.At this point, we dissected down through fat and subcutaneous tissue and ultimately entered into the peritoneal cavity.There were abundant adhesions to the anterior abdominal wall laterally and cephalad and caudally.These were freed with a combination of cautery and metzenbaum scissors.Liver was examined in its entirety given the preoperative ct findings of liver hemangioma.On examination it did appear to be consistent with hemangioma.We did not do any additional biopsy or resection of this lesion.The omentum was densely adhesed in the pelvis.This was freed with electrocautery.The patient had minimal interloop adhesions.Adhesions between a loop of small bowel and colon were lysed.At this point, we were able to identify the large suprafascial hernia defect on the left.We were able to reduce the contents from the sac easily.Patient had a large hernia from the xyphoid to approximately the level of the umbilicus.Bowel that had herniated was in the subcutaneous tissue on the left.This created a huge hernia sac laterally on the left side.Having circumferentially freed all adhesed bowel and omentum, we raised suprafascial skin flaps for approximately 5 cm bilaterally cephalad and caudad as well.We then took 24- x 36- cm gore-tex mesh and cut it to fit our defect, which was approximately 20 x 30 cm.We used no.1 prolenes to circumferentially sew the mesh to the fascia.The fascia was in good condition overall and held stitches.After the gore-tex mesh had been anchored to the patient¿s left side, we tied down the individual sutures and then proceeded to anchor the mesh on the patient's right side again with no.1 prolene sutures.These were then tied tightly.At the rostral most aspect of the hernia, we did have to go around a rib on the left and through the xyphoid process in the midline.After all the sutures were tied down, we examined the repair to ensure that no bowel could flip between our sutures.At the rostral most portion of the wound, we used two simple sutures to close potential sites of herniation between the mesh and fascia.It should be noted that in all other locations a vertical mattress suture was used.Additionally, it should be noted that the hernia sac that extended out on the left was resected in its entirety.After we were confident that our repair was secure, we placed two drains exiting the patient¿s left upper quadrant.These were subcutaneous drains.The left most one was placed in the large left lateral hernia sac, and the more medial drain was placed in the caudad most portion of the incision along the fascia in the skin flap such that it did not touch the gore-tex mesh when the wound was closed.At this point, we closed the subcutaneous tissue in two layers with 2-0 vicryls, and the skin was then closed with 4-0 monocryl.All counts were correct at the end of the procedure.The patient tolerated the procedure well and was taken to pacu in stable condition.¿ (b)(6) 2012: graft/implant information: ¿lot/serial #: (b)(6) , catalog/model #: 1dlmco8, implant name: patch, dual mesh 1mm 26.0 x 34, manufacturer: w.L.Gore co.Implant placement: abdominal.¿ (b)(6) 2012: (b)(6) md.Discharge summary.Final primary diagnosis: status post ventral hernia repair-open, with mesh placement.Pathology of liver: ¿hemangioma.Small fragments of benign hepatic parenchyma are also present showing marked macrovesicular steatosis and mildly active steatohepatitis.¿ hospital course: course was complicated by an exacerbation of asthma which improved with nebulizer treatments and diuresis.Pain was well managed with iv and oral pain medications.Diet was advanced slowly as tolerated.Drain in place, to be removed when output is 50 ml or less for 2 consecutive days.Followup with dr.Kendrick.Explant preoperative complaints: (b)(6) 2012: (b)(6) , pa-c.Hospital admission note.Chief complaint: suspected mesh infection status post ventral hernia repair on (b)(6) 2012.History of present illness: ¿following dismissal, she on sunday had her drain removed at an outside facility.Wednesday, she reported going to an emergency department due to her wound having opened.At that time, an emergency room physician reported he could see mesh.We were contacted, and as primary service, we stated that we needed to sec mrs.Ash back in clinic.We saw her today in clinic; and indeed, her wound is open with purulence on top of her mesh.Her mesh is visible.It was felt at this time that she does need to be admitted with iv antibiotics and possible exploration of mesh.¿ physical exam: abdomen: an 8-cm opening of the periumbilical portion of her midline incision.There is visible mesh at the base of the wound and foul-smelling, purulent fluid.Impression: given overall clinical findings, admit to the hospital for iv antibiotics and iv fluids.Obtain ct scan to assess the extent of infection through the abdominal wall given the extent of her previous dissection.Plan to remove mesh tomorrow.(b)(6) 2012: (b)(6) , md.Radiology.Ct abdomen/pelvis with contrast.Indications: infected mesh, questionable fistula, abscess.Findings: since (b)(6) 2012, there has been repair of the ventral hernia with gore-tex mesh.There is a soft tissue thickening with multiple locules of air in the subcutaneous tissues anterior to the mesh repair, consistent with the history of the anterior abdominal wall wound being open and infected.No drainable fluid collections anterior to the mesh.There is a lenticular- shaped simple fluid collection deep to the mesh measuring 3.5 cm x 14 cm x 16.5 cm.Impression: soft tissue thickening and gas bubbles in the soft tissues of the anterior abdominal wall anterior to the mesh repair consistent with open wound and infection.Large lenticular shaped simple fluid collection below the mesh.Explant procedure: removal of ventral abdominal wall mesh.Abdominal washout.Vicryl mesh placement and subcutaneous wound packing.Explant date: (b)(6) , 2012 (hospitalization (b)(6) 2012) (b)(6) 2012: (b)(6) , md.Operative report.Assistant: (b)(6) , md.Preoperative diagnosis: wound infection.Postoperative diagnosis: midline abdominal wound infection with contaminated mesh.Procedure: ¿the patient was identified, brought to the operating room and prepped and draped in the standard sterile fashion in the supine position.At the site of the open skin incision, we proceeded to open the remainder of the incision.Purulent fluid was in the subcutaneous spaces and overlying the gortex mesh.The fascia, which had been partially closed over the top of the gortex mesh, was opened as well with electrocautery and blunt finger fracture dissection.The fascia was elevated, and we were able to see our transfascial sutures, which had fixed mesh to the fascia.These were cut circumferentially, and the mesh was removed from the wound.Fibrinous exudate coated the agglutinated bowel underneath.There was no clear evidence intraabdominal infection.Cultures were sent of subcutaneous purulent fluid.All old suture was removed from the wound.The wound was irrigated with 2 l of normal saline.At this point , we decided to sew in a piece of vicryl mesh to the facial edges.This was doubled on itself, and then secured to the fascial edges using interrupted 0 vicryl suture in a circumferential.Fascia was (taunt) at the end of the case.The former subcutaneous space on the left side of the patient' s abdomen was debrided with kashiwagi curette.A drain was placed into this subcutaneous cavity through the skin.Additionally on the right side, we placed another 15-french round jp drain through the rostral portion of the skin.Kerlix was placed over the top of the vicryl mesh, and then an ioban drape was the applied over the kerlix.Suction was applied to the drains.They held suction.All counts were correct at the end of the case.Patient tolerated the operation well and was taken to the pacu in stable condition.¿ (b)(6) 2012: (b)(6) , md.Operative report.Assistant: (b)(6) , md.Preoperative and postoperative diagnosis: infected abdominal wound.Procedure: partial skin closure.Irrigation and debridement of abdominal wound.Procedure: the patient was identified, brought to the operating room and placed supine on the operating room table where general endotracheal anesthesia was established.She was prepped and draped in the standard sterile fashion after removing the abdominal dressing.We proceeded by raising the previously raised skin flaps.These were moderately agglutinated to the fascia.Inspection of the wound revealed it overall was very clean.There was no purulence.There were some areas of fat necrosis.These were debrided with electrocautery and sharply.Hemostasis was obtained.The former site of the left hernia sac was inspected closely as well.This had some areas of granulation tissue and does appear clean as well.Both drains that had previously been placed were left in place.We then proceeded to pulsavac the wound with 3 l of warm saline.We then closed the middle portion of the wound with 2-0 nylon sutures, and the inferior or caudadmost portion of the wound additionally was closed.This left two defects in the abdominal skin.It should be noted that inspection of the vicryl mesh that had previously been placed showed that it was in proper position with the beginning of granulation tissue showing through it.Xeroform gauze was placed at the base of the wound, and the hernia sac on the left was packed with kerlix gauze as was the wound over the top of the xeroform which had been placed over the top of the vicryl mesh.V and tire wound was covered with a steri-drape, and suction was applied to the drains.Suction held.The patient tolerated the procedure well.All counts were correct.The patient was taken to the pacu in stable condition.¿ (b)(6) 2012: (b)(6) , md.Discharge summary.Discharge diagnoses: status post removal of ventral abdominal wall mesh, abdominal washout, vicryl mesh placement and subcutaneous wound packing on (b)(6) 2012 and a partial skin closure and irrigation and debridement of abdominal wound on (b)(6) 2012.Status post ventral hernia repair with mesh placement on (b)(6) 2012.Open abdominal wound with purulence.Exposed mesh.Hospital course: initiated on iv ancef for mssa which was discontinued on 5/17/12.Discharged to home with home health services.Condition: stable.Follow up visit in one week.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.
|
| |
|
Additional Manufacturer Narrative
|
|
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.
|
| |
|
Additional Manufacturer Narrative
|
|
H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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.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.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
|
|
|
