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| Model Number 1DLMC02 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Hernia (2240); Not Applicable (3189); No Code Available (3191)
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| Event Date 08/23/2016 |
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Event Type
Injury
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Manufacturer Narrative
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(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: ¿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.¿.
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2006, whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: contraction of mesh, recurrent hernia, removal of mesh, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 2/27/2006, including any prior surgical procedures, were not provided.Operative records dated on (b)(6) 2006, indicate the patient underwent ventral hernia repair with goretex dualmesh.Preoperative and postoperative diagnosis ¿ventral hernia.¿ records state: ¿findings: a 5 x 6cm supraumbilical fascial defect.¿ operative records dated on (b)(6) 2006 state: ¿this patient is a 29 year old male with a long standing history of supraumbilical bulge for which he was recently seen in the emergency department due to pain in this area.¿ the records state: ¿a scalpel was used to incise the skin in a midline vertical fashion just superior to the umbilicus.Electrocautcry was used to further carry the dissection down through the subcutaneous tissue to the level of the bulging fascia.¿ operative records dated on (b)(6) 2006 continue: ¿the surrounding subcutaneous tissue was dissected away from the hernia sac.The hernia sac was entered.There was some fat tissue within it, which was all viable.There was no bowel herniated through the defect.The excess hernia sac was excised and passed off the field as a specimen.The fascial defect was found to be 5 x 6 cm in size.A goretex dual mesh batch code: 03706617 8 x 12-cm in size was used as an underlay to repair this defect.There were 0 ethibond sutures used in an interrupted fashion circumferentially.There were 8 of these used in toto [sic].¿ operative reports dated on (b)(6) 2006 state: ¿the mesh was then pulled tightly against the deep surface of the peritoneum taking care to place the smooth side towards the bowel and rough surface up towards the abdominal wall.Care was taken to avoid trapping any peritoneal contents in the repair.The subcutaneous defect was loosely rcapproximated with interrupted 3-0 vicryl stitches.There was 4-0 monocryl used in a running fashion to reapproximate the skin edges.This was done after irrigating the wound.Steri-strips were applied.The records confirm a gore® dualmesh® biomaterial (1dlmc02/03706617) was used during the procedure.Records between 2/27/2006 and 8/23/2016 were not provided.Operative records dated on (b)(6) 2016 indicate the patient underwent 1.Robotic-assisted laparoscopic umbilical hernia repair, no evidence of obstruction with incarcerated omental fat.2.Robotic-assisted laparoscopic implantation of mesh.3.Laparoscopic robot-assisted lysis of adhesion.Preoperative and postoperative diagnosis ¿1.Recurrent umbilical hernia.2.Contraction of the old hernia mesh.3.Intraabdominal omental adhesions to the anterior abdominal wall and previous hernia repair.¿ operative records dated on (b)(6) 2016 state: ¿this is a 40-year-old man who some years ago had an umbilical hernia repair done with mesh, it appears in an open fashion.He had pain with lifting something heavy feeling a tearing and burning sensation has been going on for several weeks now.The area of his previous umbilical hernia scar is very tender to palpation.There are some palpable defects.I discussed again the risks, benefits, alternatives, risk of bleeding, infection, bowel injury, the possibility of recurrence.¿ operative records dated on (b)(6) 2016 state: ¿a 15 blade scalpel was used to make 10 mm skin incision in the left upper quadrant, 2 cm below the costal margin in the midclavicular line using optiview technique.I then placed 8 mm trocars x3, one across from the umbilicus, one 2 cm above the asis left lower quadrant, and one in the left upper quadrant, anterior and lateral to the initial port.I then docked the robot."he had a large recurrent hernia about the umbilicus and the mesh had contracted and drawn cephalad.¿ operative records dated on (b)(6) 2016 state: ¿using prograsp and vessel sealer, i performed laparoscopic lysis of adhesions tripping down omentum and small [sic] bowel from adhesions to mesh.Once i had all this down, i was able to reduce the incarcerated omentum out of the hernia sac and visualized the hernia itself it was about 4 cm partially covered by the old mesh.I pulled away the old mesh dissecting it away with cautery revealing [sic] a second defect a total of about 4 cm total side by side.I then began removing the old mesh was densely fixed, using electrocautery, sharp scissors, and blunt dissection switching to a cobra grasper because the mesh was so dense and was contracted that it was difficult to grasp.¿ operative records dated on (b)(6) 2016 state: ¿i dissected it free from the anterior abdominal wall dividing the ethibond sutures that were holding in place, this was some sort composite piece of mesh and was very hard like plastic, the other parts of it appeared to be ptfe with some sort of fabric mesh on the abdominal wall side.The ptfe down towards the intra- abdominal side.The mesh was then retrieved from the abdomen through the assisted port.This required spreading and dilating this port, removing the pieces of the mesh through this port that also require inserting an endocatch bag and including the little crumbled pieces of plastic in the bag that we can make sure we got them all out.¿ operative records dated on (b)(6) 2016 state: ¿inspected the operative field and found that they were all gone and cleared them all away.They were sent to path.Also, inverted the hernia sac and excised it as well as.I then used a 0 absorbable v-loc to close the hernia defect partially desufflated the abdomen down to 10.I then anchored my stitch to run the fascia close and then i ran back over this with another run with the same stitch and doubled back on itself to lock it in place, cut, and removed the needle.¿ operative records dated on (b)(6) 2016 continue: ¿i then placed the ventralite mesh with echo positioning system rolled and passed through the 12 mm trocar sites.An 11 blade stick site was made at the umbilicus and the carter-thomason was passed through here and the echo positioning system was drawn out and was inflated, the mesh was positioned into the 10 x 15 oval, which provided excellent coverage.I sutured this in place with a running 2-0 v-loc.We used a single stitch to run from 12 oclock down to 3 oclock.Then another stitch to run from 6 oclock all the way to 12 oclock and then a third stitch to finish the run from 6 oclock to 3 oclock.¿ operative records dated on (b)(6) 2016 state: ¿the mesh was in good position and well apposed anterior abdominal wall and laid out well.Before placing all my trocars, i had previously performed a bilateral tap block with marcaine ¼ percent with epinephrine.After inspecting the abdomen again inspected my landing zone to make sure that there was no bowel injury and no bleeding.The entire field was hemostatic.I then proceeded to close the dilated 12 mm trocar site with a 0 vicryl suture passer carter-thomason and then removed each of the trocars closing the skin with 4-0 inverted interrupted monocryl and dermabond.The operative records dated on (b)(6) 2016 state: ¿specimen: 1.Recurrent umbilical hernia sac.2.Old mesh.¿ pathology reports for the specimen obtained during on (b)(6) 2016 procedure were not provided.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: ¿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.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.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 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.¿ 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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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: [missing records: the operative report for the prior umbilical hernia repair with mesh was not provided.] on (b)(6) 2016: (b)(6) medical center.(b)(6), md.Radiology-ultrasound abdomen.Clinical history: k46.9/r10.33 [unspecified abdominal hernia without obstruction or gangrene/periumbilical pain].Conclusion: midline anterior abdominal wall mass consistent with a ventral hernia.No bowel loops identified within the hernia.Fatty changes of the liver.On (b)(6) 2016: [provider ni].Accident form.Date of injury/accident: (b)(6) 2016; work.Description of accident: picking up a door.On (b)(6) 2016: (b)(6), md.Consultation.History of present illness: presents for a surgical evaluation of a probable umbilical hernia.Current symptoms include a non-reducible bulge in the umbilicus and pain which have been present for 1 week.Pain is located near the umbilicus, occurs frequently, moderate in severity.Has had previous umbilical hernia surgery approximately 10 years ago using unknown mesh.It is reported to be recurring.Ultrasound in er shows 7cm midline mass unclear if this is omentum or hematoma reported to be over area of tenderness to palpation, needs ct to reeval [sic].Past medical/surgical/social history: asthma, hernia surgery, tobacco/alcohol never.Exam: weight 244 lbs, bmi 35.01.Tender ventral hernia present.Assessment/plan: ventral hernia without obstruction or gangrene, asthma, abdominal mass.Laparoscopic ventral hernia repair pending ct results.On (b)(6) 2016: (b)(6) medical center.Dr.(b)(6).Radiology-ct abdomen/pelvis.Reason for exam: ventral hernia without obstruction.Impression: small fat containing right periumbilical hernia.Prior supraumbilical hernia repair.Fatty liver.On (b)(6) 2016: the university of (b)(6) medical center.(b)(6), md.Pathology report.Accession #: (b)(6).Final pathologic diagnosis: ventral hernia sac and old mesh, excision: fibrofatty tissue with focal ossification, consistent with ventral hernia sac.No evidence of malignancy seen.Microscopic description: a microscopic examination was performed and the findings are reflected in the diagnosis.Specimen(s) received: 1.Ventral hernia sac and old mesh.Clinical history: ventral hernia, old mesh- hernia.Gross description: specimen #1 is received in formalin labeled with patient¿s name, medical record number, ¿ventral hernia sac and old mesh¿ and consists of a segment of tan-yellow mesh (8.1 x 4.2 x 0.5 cm) with adhered tan-brown soft tissue.Additionally in the container is an aggregate of tan-white calcifications (3.5 x 2.1 x 0.3 cm).Representative sections are submitted in 1a-b, post decal.On (b)(6) 2016: (b)(6), md.Office visit.History of present illness: returns for a post-operative follow up visit after undergoing a laparoscopic umbilical hernia repair.He reports abdominal pain and soreness.States he is feeling better, but not back to normal.Exam: no hernias present, incision healing well.Assessment/plan: postoperative visit.Done well after surgery with no apparent complications.Return to clinic in 3 weeks.On (b)(6) 2016: (b)(6), md.Office visit.History of present illness: follow up after laparoscopic umbilical hernia repair.Reports abdominal pain and soreness.Exam: no hernias present, incision healing well, without any swelling or bruising present.Assessment/plan: post op visit, no apparent complications.Return to work monday.Follow up prn.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: ¿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.
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Manufacturer Narrative
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Previous patient codes (2240, 3191: appropriate term/code not available for ¿contraction of mesh¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation 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.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2006 through (b)(6) 2016, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Records from (b)(6) 2006 through (b)(6) 2016 were not provided.Patient information: medical history: asthma.Hypertension.Obesity. (b)(6) 16: 244lbs., bmi 35.Prior surgical procedures: [none provided].Implant preoperative complaints: (b)(6) 2006: [the patient has] ¿a long standing history of supraumbilical bulge for which he was recently seen in the emergency department due to pain in this area.¿ implant procedure: ventral hernia repair with ¿goretex dualmesh¿.Implant: gore® dualmesh® biomaterial (03706617/1dlmc02) 8 cm x 12 cm.Implant date: (b)(6) 2006 description of hernia being treated: ¿the surrounding subcutaneous tissue was dissected away from the hernia sac.The hernia sac was entered.There was some fat tissue within it, which was all viable.There was no bowel herniated through the defect.The excess hernia sac was excised and passed off the field as a specimen.The fascial defect was found to be 5 x 6 cm in size.¿ implant size and fixation: ¿a goretex dual mesh batch code 03706617 8 x 12-cm in size was used as an underlay to repair this defect.There were 0 ethibond sutures used in an interrupted fashion circumferentially.There were 8 of these used in toto [total].The mesh was then pulled tightly against the deep surface of the peritoneum taking care to place the smooth side towards the bowel and rough surface up towards the abdominal wall.Care was taken to avoid trapping any peritoneal contents in the repair.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2016: accident form: ¿description of accident: picking up a door.¿ (b)(6) 2016: records indicate the patient was injured and [sic] work ¿picking up a door¿ and workers compensation approved a diagnostic abdominal ultrasound.(b)(6) 2016: ultrasound abdomen: ¿midline anterior abdominal wall mass consistent with a ventral hernia.No bowel loops identified within the hernia.Fatty changes of the liver.¿ explant preoperative complaints: (b)(6) 2016: ¿current symptoms include a non-reducible bulge in the umbilicus and pain which have been present for 1 week.Pain is located near the umbilicus , occurs frequently, moderate in severity.Has had previous umbilical hernia surgery approximately 10 years ago using unknown mesh.It is reported to be recurring.Ultrasound in er shows 7cm midline mass unclear if this is omentum or hematoma reported to be over area of tenderness to palpation, needs ct to reeval [sic].¿ (b)(6) 2016: ct abdomen: ¿small fat containing right periumbilical hernia.Prior supraumbilical hernia repair.Fatty liver.¿ explant procedure: robotic assisted laparoscopic umbilical hernia repair with mesh, lysis of adhesions.Explant date: (b)(6) 2016.¿he had pain with lifting something heavy feeling a tearing and burning sensation has been going on for several weeks now.The area of his previous umbilical hernia scar is very tender to palpation.There are some palpable defects.¿ "he had a large recurrent hernia about the umbilicus and the mesh had contracted and drawn cephalad.Using prograsp and vessel sealer, i performed laparoscopic lysis of adhesions tripping down omentum and small [sic] bowel from adhesions to mesh.Once i had all this down, i was able to reduce the incarcerated omentum out of the hernia sac and visualized the hernia itself it was about 4 cm partially covered by the old mesh.I pulled away the old mesh dissecting it away with cautery revealing [sic] a second defect a total of about 4 cm total side by side.I then began removing the old mesh was densely fixed, using electrocautery, sharp scissors, and blunt dissection switching to a cobra grasper because the mesh was so dense and was contracted that it was difficult to grasp.I dissected it free from the anterior abdominal wall dividing the ethibond sutures that were holding in place, this was some sort composite piece of mesh and was very hard like plastic, the other parts of it appeared to be ptfe with some sort of fabric mesh on the abdominal wall side.The ptfe down towards the intra- abdominal side.The mesh was then retrieved from the abdomen through the assisted port.This required spreading and dilating this port, removing the pieces of the mesh through this port that also require inserting an endocatch bag and including the little crumbled pieces of plastic in the bag that we can make sure we got them all out.¿ ¿i then placed the ventralite mesh with echo positioning system rolled and passed through the 12 mm trocar sites.An 11 blade stick site was made at the umbilicus and the carter-thomason was passed through here and the echo positioning system was drawn out and was inflated, the mesh was positioned into the 10 x 15 oval, which provided excellent coverage.I sutured this in place with a running 2-0 v-loc.We used a single stitch to run from 12 oclock down to 3 oclock.Then another stitch to run from 6 oclock all the way to 12 oclock and then a third stitch to finish the run from 6 oclock to 3 oclock.The mesh was in good position and well apposed anterior abdominal wall and laid out well.¿ records indicate a non-gore device was implanted after the gore device was explanted during the (b)(6) 2016 procedure.Relevant medical information: (b)(6) 2016: pathology: ¿consists of a segment of tan-yellow mesh (8.1 x 4.2 x 0.5 cm) with adhered tan-brown soft tissue.Additionally in the container is an aggregate of tan-white calcifications (3.5 x 2.1 x 0.3 cm).¿ (b)(6) 2016: ¿he reports abdominal pain and soreness.States he is feeling better, but not back to normal.¿ (b)(6) 2016: ¿no hernias present, incision healing well, without any swelling or bruising present.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes 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® biomaterial instructions for use also states: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿when suturing gore® dualmesh® biomaterial to the host tissue, a bite and spacing ratio of 1:1 in both gore® dualmesh® biomaterial and the host tissue is recommended.The same ratio applies when suturing two pieces of gore® dualmesh® biomaterial together.Follow the curve of the needle when piercing the material and pierce through the full thickness of the material to ensure adequate mechanical strength of the material.Interrupted sutures can provide additional security against recurrence due to suture failure.Mattress suturing can provide additional strength to the suture line.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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 device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.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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