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| Catalog Number 1DLMCP02 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)
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| Event Date 03/05/2014 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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 laparoscopic ventral hernia repair on (b)(6) 2005 whereby an alleged ¿gore-tex¿ device was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, contraction of mesh, hernia recurrence, mesh removal.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/corrected details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2005 indicate the patient underwent laparoscopic ventral hernia repair.The records state: ¿the patient is a young woman who noticed a worsening ventral hernia after the birth of her child.She was interested in undergoing a ventral hernia repair.In addition to the palpable ventral hernia, she also has a diastasis.She is aware that the ventral hernia repair is not going to address the diastasis, but rather will address only the ventral hernia defect.¿ the (b)(6) 2005 operative report states: ¿a vi-drape was placed over the abdomen and a small stab incision for the veress needle was made after infiltration of 0.5% marcaine with epinephrine in the patient's left upper quadrant just below the costal margin.¿ ¿once this had been done, it was noticed that there was a defect near the umbilicus; however, there was no incarcerated intestine or omentum.At this time the defect was measured and a piece of gore-tex dual mesh approximately 8 x 12 cm was brought onto the table.It was trimmed to the appropriate size and gore-tex sutures were placed in all four corners.The mesh was rolled and placed into the abdomen through the large port site and was unrolled and oriented properly to match the markings on the anterior abdominal wall.Once this was done, using small stab incisions at the appropriately marked places on the abdominal wall, the suture passer was used to grasp the stay sutures and pull them up through the abdominal wall.¿ the (b)(6) 2005 operative report continues: ¿once all four were placed and held taught, it was clear that the mesh was appropriately positioned and was straight.The four corner stay sutures were tied down into the subcutaneous tissues.The pro-tacker was brought into the field and was used to tack the edges in a circumferential fashion to the abdominal wall.Care was taken to seat all of the tacks appropriately and deeply into the abdominal wall so that there was no overlap.The edges were secured and there was no overlap.The corrugated edge was secured up and there was no exposure of the corrugated edge to the intestinal contents.The bowel was inspected again and noted to be pristine.The suture passer device with a heavy o vicryl was used to close the 12 mm port site in a figure-of-eight fashion.The remaining 5 mm trocars were removed under direct visualization.The final trocar was used to desufflate the abdomen and it was then removed.All the wounds were irrigated and the wound edges were reapproximated using a 4-0 monocryl suture in a running subcuticular fashion.¿ product identification records for the alleged ¿gore-tex dual mesh¿ were not provided.Records between 2005 and 2011 were not provided.Records dated (b)(6) 2011 state: ¿chief complaint: blood draw.[patient] comes in today for evaluation of the following conditions: ovarian cyst-ct abdomen reveal 2.2cm ovarian cyst.Pt [patient] saw dr.(b)(6) today for vaginal itching but was not aware of the results.Still has intermittent lower abdominal pain.Chronic abdominal pain-pt [patient] reports constipation and gas.Following with dr.(b)(6).Recently saw dr.(b)(6) who plans to do a gallbladder w/u [workup] due to intermittent nausea.Pt [patient] is concerned as her father died of colon cancer.¿ review of symptoms states: ¿gastrointestinal: positive for abdominal pain ¿ (chronic).Negative for nausea, vomiting, diarrhea, constipation, blood in stool and abdominal distention.¿ exam notes state: ¿abdominal: soft.Bowel sounds are normal.She exhibits no distension and no mass.No tenderness.She has no rebound and no guarding.¿ operative records dated (b)(6) 2012 indicate the patient underwent laparoscopic cholecystectomy and laparoscopic umbilical hernia repair.Postoperative diagnoses are noted as biliary dyskinesia and umbilical hernia.Findings from the procedure state: ¿preoperatively [the patient] was seen in the office regarding upper abdominal pain.She had a right upper quadrant ultrasound which was negative but a pipida scan revealed a decreased gallbladder ejection fraction of 26%.On physical examination, there was evidence of an umbilical hernia which had been repaired previously with mesh.However, there was evidence of a recurrence.After a lengthy discussion and physical examination, the decision was made to proceed with laparoscopic cholecystectomy and umbilical herniorrhaphy.She had grossly normal biliary anatomy.She underwent a laparoscopic cholecystectomy and laparoscopic repair of the recurrent umbilical hernia, and tolerated the procedures well.¿ 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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: (b)(6) 05: brief op note.Preop dx: ventral hernia.Postop dx: umbilical hernia.Procedure: laparoscopic umbilical hernia repair.Surgeons: (b)(6).Anesthesia: [illegible] eta.Ivf: 800 ml.Ebl: minimal.U/o [urine output]: 700 ml.Drains: none.Disp: [blank].(b)(6) 05: progress notes.Is able to go today if she feels up to it but if inadequate pain control can be d/c¿d in am.Has not been oob [out of bed] yet.(b)(6) 05: discharge instructions.Remove bandage on saturday.White strips will fall off, remove if not after one week.Activity: no heavy lifting.May shower on saturday.(b)(6) /07: ambulatory record.Hpi: abdomen pain 4/10.Frequency often, duration 5 min, aching, shooting pain, nausea, vomiting.(b)(6) 07: procedure report.Colonoscopy.Impression: one 5mm polyp in descending colon, biopsied.Otherwise normal.Signed.Records between (b)(6) 07 and (b)(6) 11 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® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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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A4: added patient weight.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: (b)(6)2005: history and physical.¿hpi: umbilical hernia x 5 yrs.Nausea, cramping in abdomen.Pmh: hypoglycemia.Social hx: no alcohol or tobacco use.Ros: unremarkable except abdominal pain, diarrhea, constipation, nausea.Exam: unremarkable except; abdomen ventral hernia.Ht 5¿9,¿ wt 146 lbs.¿ (b)(6)2005: discharge summary.¿d/c dx: repair of hernia.Hospital course: worsening ventral hernia after birth of child.Abdominal cramping and some nausea.Pt taken to operating room (b)(6)2005.Procedure was performed w/out difficulty.No complications.D/c home in stable condition.Will f/u outpatient w/ dr.Turner in 2 weeks.No heavy lifting.¿ 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® plus 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: conclusion code remains unchanged.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) 2005 indicate the patient underwent laparoscopic ventral hernia repair.The records state: ¿the patient is a young woman who noticed a worsening ventral hernia after the birth of her child.She was interested in undergoing a ventral hernia repair.In addition to the palpable ventral hernia, she also has a diastasis.She is aware that the ventral hernia repair is not going to address the diastasis, but rather will address only the ventral hernia defect.¿ the (b)(6) 2008 operative report states: ¿a vi-drape was placed over the abdomen and a small stab incision for the veress needle was made after infiltration of 0.5% marcaine with epinephrine in the patient's left upper quadrant just below the costal margin.¿ ¿once this had been done, it was noticed that there was a defect near the umbilicus; however, there was no incarcerated intestine or omentum.At this time the defect was measured and a piece of gore-tex dual mesh approximately 8 x 12 cm was brought onto the table.It was trimmed to the appropriate size and gore-tex sutures were placed in all four corners.The mesh was rolled and placed into the abdomen through the large port site and was unrolled and oriented properly to match the markings on the anterior abdominal wall.Once this was done, using small stab incisions at the appropriately marked places on the abdominal wall, the suture passer was used to grasp the stay sutures and pull them up through the abdominal wall.¿ the (b)(6) 2008 operative report continues: ¿once all four were placed and held taught, it was clear that the mesh was appropriately positioned and was straight.The four corner stay sutures were tied down into the subcutaneous tissues.The pro-tacker was brought into the field and was used to tack the edges in a circumferential fashion to the abdominal wall.Care was taken to seat all of the tacks appropriately and deeply into the abdominal wall so that there was no overlap.The edges were secured and there was no overlap.The corrugated edge was secured up and there was no exposure of the corrugated edge to the intestinal contents.The bowel was inspected again and noted to be pristine.The suture passer device with a heavy o vicryl was used to close the 12 mm port site in a figure-of-eight fashion.The remaining 5 mm trocars were removed under direct visualization.The final trocar was used to desufflate the abdomen and it was then removed.All the wounds were irrigated and the wound edges were reapproximated using a 4-0 monocryl suture in a running subcuticular fashion.¿ product identification records for the alleged ¿gore-tex dual mesh¿ were not provided.Records between 2008 and 2011 were not provided.Records dated (b)(6) 2011 state: ¿patient is here for evaluation abdominal pain.The pain is described as aching and burning, and is mild in intensity.Pain is located in the luq, ruq and bilateral periumbilical area without radiation.Onset was several years ago.Symptoms have been waxing and waning since then.Aggravating factors include none.Alleviating factors include none.The patient denies reports anorexia, nausea, vomiting, diarrhea, constipation and dysuria.Patient has tried nothing for pain.¿ review of symptoms states: ¿gastrointestinal: positive for abdominal pain.Negative for nausea, vomiting, diarrhea, constipation, blood in stool and abdominal distention.¿ exam notes state: ¿abdominal: soft.Bowel sounds are normal.She exhibits no distension and no mass.Tenderness (umbilical) is present.She has no rebound and no guarding.¿ records dated (b)(6) 2011 indicate the patient had a ct performed for abdominal pain.Findings from the ct state: ¿the lung bases appear clear.The liver and spleen appear homogeneous.The gallbladder appears unremarkable.The adrenals appear normal.The pancreas appears unremarkable.The kidneys demonstrate normal bilateral nephrograms with mild extrarenal pelves.There are no stones identified.The mesenteric structures appear unremarkable.The appendix-is not definitively visualized.There is mesh noted in the interanterior abdomen with prior hernia repair.The uterus is visualized and there appears to be a right ovarian cyst measuring approximately 2.5 x.1.8 cm.There appears to be a ring in the cul-de-sac.¿ ¿impression: anterior abdominal wall mesh for an anterior abdominal wall hernia.There are no fluid collections or masses noted.There is no bowel extending superficial to the mesh.Probably right ovarian cyst measuring 2.5 cm.Ultrasound confirmation is suggested.There appears to be a ring in the cul-de-sac, with linear sac.I suspect that this has been placed.This should be correlated clinically.¿ records dated (b)(6) 2011 indicate the patient had an ultrasound performed for abdominal pain.Findings from the ultrasound state: ¿the liver appears to be homogeneous without focal lesions.The gallbladder appears unremarkable.There is no intrahepatic or extrahepatic ductal dilatation.The common bile duct measures 0.3 cm.The head and body of the pancreas appears normal.The right kidney measures 10.8 cm with mild pelvic caliectasis.There are no stones nor masses noted.The left kidney measures 11.2 cm.There are no stones, masses or hydronephrosis.¿ records dated (b)(6) 2012 indicate the patient had an abdominal and pelvic ultrasounds performed for abdominal pain.Impression from the abdominal ultrasound state: ¿normal abdominal ultrasound.¿ impression from the pelvic ultrasound state: ¿1.Ultrasound of the pelvis with endometrial thickness of 13 mm should be correlated with the patient¿s menstrual cycle.This apparently is a premenstrual endometrium and follow should be based on clinical grounds.2.Ovaries are within normal limits.3.Tiny amount of free fluid in the cul-de-sac that may be physiologic in nature and less likely related to abdominopelvic pathology.¿ operative records dated (b)(6) 2012 indicate the patient underwent laparoscopic cholecystectomy and laparoscopic umbilical hernia repair.Postoperative diagnoses are noted as biliary dyskinesia and umbilical hernia.Findings from the procedure state: ¿preoperatively [the patient] was seen in the office regarding upper abdominal pain.She had a right upper quadrant ultrasound which was negative but a pipida scan revealed a decreased gallbladder ejection fraction of 26%.On physical examination, there was evidence of an umbilical hernia which had been repaired previously with mesh.However, there was evidence of a recurrence.After a lengthy discussion and physical examination, the decision was made to proceed with laparoscopic cholecystectomy and umbilical herniorrhaphy.At time of the procedure, [the patient] did indeed have recurrence of a hernia at the inferior left lateral aspect of the repair.She had grossly normal biliary anatomy.She underwent a laparoscopic cholecystectomy and laparoscopic repair of the recurrent umbilical hernia, and tolerated the procedures well.¿ the (b)(6) 2012 operative report states: ¿a 5 -mm incision was made over the palpable hernia defect, and some of the herniated fatty tissues which appeared to be omentum were reduced back down into the abdominal cavity.I placed a 5 -mm trocar through this defect, and the abdomen was insufflated to 15 mmhg.The 5 -mm video scope was inserted, and the abdomen was surveyed.There were moderate omental adhesions in this area but i was able to place two more 5 -mm trocars; one in the subxiphoid region and one in the right upper quadrant, both under direct visualization.I then looked back at the periumbilical region and noted the aforementioned omental adhesions.These were taken down with blunt dissection and electrocautery.This revealed a piece of mesh which appeared to have been placed laparoscopically.The recurrent defect was at the left inferolateral position of the mesh.¿ the (b)(6) 2012 operative report continues: ¿the gallbladder was then grasped and placed on stretch.The triangle of calot was dissected out so that the cystic artery, cystic duct and junction the cystic duct with the common bile duct could be clearly visualized.Once these structures were identified, the cystic artery and cystic duct were doubly clipped proximally, singly clipped distally, and divided between clips.Next, electrocautery was used to remove the gallbladder from the liver bed.Small bleeding sites were coagulated as they were encountered.Once the gallbladder was completely removed, the region of the cystic artery and cystic duct was irrigated and all irrigation was suctioned dry.There was no evidence of bleeding or bile spillage.This area was observed for several minutes, and there was no sign of any bile leakage or bleeding.The gallbladder was then placed in a specimen bag and delivered from the abdomen through the umbilical trocar site.¿ the (b)(6) 2012 operative report states: ¿next, attention was turned to repairing the recurrent umbilical hernia defect.The trocar here was removed, and the subcutaneous tissues were cleared off of the anterior aspect of the fascia for several centimeters in all directions.Next, utilizing a laparoscopic fascia' closure device, approximately 4 sutures were placed across the defect under direct laparoscopic visualization and secured under direct laparoscopic visualization as well, thus repairing the recurrent umbilical hernia defect laparoscopically.The repair was tested and found to be quite satisfactory.Hemostasis was excellent.The remaining trocars were removed.The pneumoperitoneum was allowed to escape.The skin incisions were copiously irrigated and dried.They were closed with 44-0 monocryl, injected with 0.25% marcaine, cleansed and dried.¿ the (b)(6) 2012 operative report states: ¿it should be noted that this during the laparoscopic repair of the umbilical hernia defect, the hernia sac was separated from the surrounding structures and reduced back down into the abdominal cavity prior to clearing the anterior aspect of the fascia.¿ there was no mention of infection and mention of device removal in the records.Records between 2012 and 2014 were not provided.Operative records dated (b)(6) 2014 indicate the patient underwent ¿laparoscopic repair of twice recurrent umbilical/incisional hernia with mesh.¿ the records state: ¿the patient is a 35-year-old african american female that i originally saw back in september for a twice recurrent hernia at the umbilicus.The patient's original surgery was a laparoscopic umbilical hernia repair done in 2005/2006.Patient had a subsequent surgery done a few years later.Patient apparently was doing okay until she became pregnant with her third child.Apparently, she gave birth last year, and some time during that pregnancy, the hernia recurred.After i saw her in september, i ordered a ct scan to get a better appreciation of where the mesh was in relation to the hernia itself.What the ct showed was that the mesh had contracted a lot and pulled off over to the right.Essentially, it pulled away from the left abdominal wall, allowing the hernia to come back.I recommended taking the patient to the operating room for laparoscopic lysis of adhesions with possible explantation of that mesh and placement of a new larger piece of mesh.¿ description of findings from the (b)(6) 2014 procedure states: ¿the hernia was just as the ct had shown.The mesh had pulled away from the left side of the umbilical area.There were still tacks in some parts of the mesh that were down inferior to the umbilicus.We found 2 pieces of ptfe-appearing mesh, essentially one overlapped over the other, that had contracted at least 50% or 60% and pulled away, letting the hernia recur.There was omentum up in the hernia defect and to the pieces of mesh that had pulled away.There was a loop of transverse colon that was just below the omentum, but it was not in the defect at the time of surgery.After explanting 2 pieces of mesh, we measured the defect out to be approximately 3 cm across and i wanted a 5-cm overlap on each side.That gave us approximately 13 cm to 14 cm, and we selected a 15-cm round piece that would give us all the overlap we would require.¿ the (b)(6) 2014 operative report states: ¿a small incision was made, and a 5-mm bladeless trocar with a camera inside of it was then inserted through this opening and into the abdominal cavity.Insufflation was already connected, and we were able to achieve a pressure of 15 mmhg without difficulty.With the camera inside, i could appreciate the adhesions up to the mesh and the anterior abdominal wall.We did not appreciate any other significant pathology other than some small uterine fibroids.We then placed the following trocars under direct vision: a 5-mm left lower quadrant trocar, 5-mm right upper quadrant trocar and a 12-mm right lower quadrant trocar.Once we had our ports in place, we allowed dr.Stern to perform the tubal ligation.¿ the (b)(6) 2014 operative report continues: ¿once dr.Stern was done, we resumed our procedure and used the thunderbeat device to take down the adhesions of the omentum to the 2 pieces of mesh.We also used it to take the omentum out of the hernia sac itself.With that done, we decided we needed to explant those 2 pieces of mesh.Otherwise, we would not get good contact of our new mesh to the anterior abdominal wall when we were placing our tacks.The patient might also be left with a bulge that would be palpable through the skin, and she might think that that was a recurrence.We then very carefully, using the thunderbeat and at times cautery scissors, took the 2 pieces of mesh off of the anterior abdominal wall.Once that was done, we measured out our defect, and as mentioned above, it was approximately 3 cm.¿ the (b)(6) 2014 operative report states: ¿wanting a 5-cm overlap on either side, we selected a 15-cm round ventralight st patch to effect our repair.The mesh was rolled up and placed through our 12-mm trocar into the abdominal wall.A small nick was made in the middle of the umbilicus, and the suture passer was placed through this opening and grabbed in tubing for the mesh, and it was pulled up to the anterior abdominal wall.The tip of the blue tubing was snipped, and it was inserted into our inflation device.The echo scaffolding of the mesh was inflated and blue tubing clamped.I then used the protack and placed clips in both of the edges caudad, cephalad.I then worked in a 4- quadrant fashion to secure the mesh with the outer row.The echo device was deflated and withdrawn through the 12-mm trocar.I then used the protack to place an inner round of fasteners.This effected a very nice repair.¿ the (b)(6) 2014 operative report continues: ¿with that done, the 12-mm trocar was removed, and a carter-thomason fascial closure device and single o vicryl suture were used to close the fascia at that location.The trocars in the right upper quadrant and left lower quadrant were removed under direct vision.There was no bleeding.The laparoscope was then removed and the insufflation disconnected.All the insufflation as possible was expressed out, and then the last trocar was removed.The skin incisions were approximated in a subcuticular fashion using a 4-0 monocryl on a ps-2 needle.The wounds were washed off and dried.Dressings consisted of 1/2-inch steri-strips, 2 x 2 gauze and opsites.Over the small nick in the umbilical area, we placed steri-strip, cottonball and a tegaderm.¿ the records indicate a non-gore device was used during the procedure.There was no mention of infection in the records.Surgical pathology report dated (b)(6) 2014 regarding a specimen collected (b)(6) 2014 states: ¿final diagnosis: ¿mesh from two prior surgeries¿: surgical mesh (gross identification only).¿ gross description states: ¿mesh from two prior surgeries¿ the specimen is received in formalin and consists of multiple fragments of brownish tan and yellow-tan rubbery tissue with enmeshed metallic mesh material, having an aggregate dimension of 6 x 6 x 1 cm.No sections are taken.For gross identification only.¿ 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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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It should be noted that the gore® dualmesh® plus 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 (1994, 2240, 3191 used for ¿contraction of mesh¿) were reported based on the original complaint and are no longer applicable and/or not reportable 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.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2005 through (b)(6) 2014, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Records from (b)(6) 2007 through (b)(6) 2011; (b)(6) 2012 through (b)(6) 2014 were not provided.Medical history: umbilical hernia.Hypoglycemia.Prior surgical procedures: on 2012 cholecystectomy.Implant preoperative complaints: on (b)(6) 2005 ¿umbilical hernia x 5 yrs.Nausea, cramping in abdomen.¿ on (b)(6) 2005 ¿noticed a worsening ventral hernia after the birth of her child.She was interested in undergoing a ventral hernia repair.In addition to the palpable ventral hernia, she also has a diastasis.She is aware that the ventral hernia repair is not going to address the diastasis, but rather will address only the ventral hernia defect.¿ implant procedure: laparoscopic umbilical hernia repair.Implant: gore® dualmesh® plus biomaterial (03262145/1dlmcp02) 8cm x 12cm.Implant date: on (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿it was noticed that there was a defect near the umbilicus; however, there was no incarcerated intestine or omentum.¿ implant size and fixation: ¿at this time the defect was measured and a piece of gore-tex dual mesh approximately 8 x 12 cm was brought onto the table.It was trimmed to the appropriate size and gore-tex sutures were placed in all four corners.The mesh was rolled and placed into the abdomen through the large port site and was unrolled and oriented properly to match the markings on the anterior abdominal wall.Once this was done, using small stab incisions at the appropriately marked places on the abdominal wall, the suture passer was used to grasp the stay sutures and pull them up through the abdominal wall.Once all four were placed and held taught, it was clear that the mesh was appropriately positioned and was straight.The four corner stay sutures were tied down into the subcutaneous tissues.The pro-tacker was brought into the field and was used to tack the edges in a circumferential fashion to the abdominal wall.Care was taken to seat all of the tacks appropriately and deeply into the abdominal wall so that there was no overlap.The edges were secured and there was no overlap.The corrugated edge was secured up and there was no exposure of the corrugated edge to the intestinal contents.The bowel was inspected again and noted to be pristine.¿ post-operative period: [one day].On (b)(6) 2005 discharge summary: ¿d/c dx [discharge diagnosis]: repair of hernia.Hospital course: worsening ventral hernia after birth of child.Abdominal cramping and some nausea.Pt taken to operating room (b)(6) 2005.Procedure was performed w/out difficulty.No complications.D/c home in stable condition.Will f/u [follow up] outpatient w/ dr.(b)(6) in 2 weeks.No heavy lifting.¿ relevant medical information: on (b)(6) 2011 ¿patient is here for evaluation abdominal pain.The pain is described as aching and burning, and is mild in intensity.Pain is located in the luq [left upper quadrant], ruq [right upper quadrant] and bilateral periumbilical area without radiation.Onset was several years ago.Symptoms have been waxing and waning since then.Aggravating factors include none.Alleviating factors include none.The patient denies reports anorexia, nausea, vomiting, diarrhea, constipation and dysuria.Patient has tried nothing for pain.¿ ¿abdominal: soft.Bowel sounds are normal.She exhibits no distension and no mass.¿ on (b)(6) 2011 ct abdomen: ¿anterior abdominal wall mesh for an anterior abdominal wall hernia.There are no fluid collections or masses noted.There is no bowel extending superficial to the mesh.¿ on (b)(6) 2011 ¿positive for abdominal pain ¿ (chronic).Negative for nausea, vomiting, diarrhea, constipation, blood in stool and abdominal distention.¿ on (b)(6) 2012 ¿on physical examination, there was evidence of an umbilical hernia which had been repaired previously with mesh.However, there was evidence of a recurrence.After a lengthy discussion and physical examination, the decision was made to proceed with laparoscopic cholecystectomy and umbilical herniorrhaphy.¿ on (b)(6) 2012 laparoscopic cholecystectomy and laparoscopic umbilical hernia repair.¿a 5 -mm incision was made over the palpable hernia defect, and some of the herniated fatty tissues which appeared to be omentum were reduced back down into the abdominal cavity.I placed a 5 -mm trocar through this defect, and the abdomen was insufflated to 15 mmhg.The 5 -mm video scope was inserted, and the abdomen was surveyed.There were moderate omental adhesions in this area but i was able to place two more 5 -mm trocars; one in the subxiphoid region and one in the right upper quadrant, both under direct visualization.I then looked back at the periumbilical region and noted the aforementioned omental adhesions.These were taken down with blunt dissection and electrocautery.This revealed a piece of mesh which appeared to have been placed laparoscopically.The recurrent defect was at the left inferolateral position of the mesh.¿ ¿attention was turned to repairing the recurrent umbilical hernia defect.The trocar here was removed, and the subcutaneous tissues were cleared off of the anterior aspect of the fascia for several centimeters in all directions.Next, utilizing a laparoscopic fascia' closure device, approximately 4 sutures were placed across the defect under direct laparoscopic visualization and secured under direct laparoscopic visualization as well, thus repairing the recurrent umbilical hernia defect laparoscopically.The repair was tested and found to be quite satisfactory.Hemostasis was excellent.¿ ¿it should be noted that this during the laparoscopic repair of the umbilical hernia defect, the hernia sac was separated from the surrounding structures and reduced back down into the abdominal cavity prior to clearing the anterior aspect of the fascia.¿ explant preoperative complaints: on (b)(6) 2014 ¿patient apparently was doing okay until she became pregnant with her third child.Apparently, she gave birth last year, and some time during that pregnancy, the hernia recurred.After i saw her in september, i ordered a ct scan to get a better appreciation of where the mesh was in relation to the hernia itself.What the ct showed was that the mesh had contracted a lot and pulled off over to the right.Essentially, it pulled away from the left abdominal wall, allowing the hernia to come back.¿ explant procedure: ¿laparoscopic repair of twice recurrent umbilical/incisional hernia with mesh¿.Explant date: (b)(6) 2014 [hospitalization dates unknown].The hernia was just as the ct had shown.The mesh had pulled away from the left side of the umbilical area.There were still tacks in some parts of the mesh that were down inferior to the umbilicus.We found 2 pieces of ptfe-appearing mesh, essentially one overlapped over the other, that had contracted at least 50% or 60% and pulled away, letting the hernia recur.There was omentum up in the hernia defect and to the pieces of mesh that had pulled away.There was a loop of transverse colon that was just below the omentum, but it was not in the defect at the time of surgery.After explanting 2 pieces of mesh, we measured the defect out to be approximately 3 cm across and i wanted a 5-cm overlap on each side.That gave us approximately 13 cm to 14 cm, and we selected a 15-cm round piece that would give us all the overlap we would require.¿ ¿we resumed our procedure and used the thunderbeat device to take down the adhesions of the omentum to the 2 pieces of mesh.We also used it to take the omentum out of the hernia sac itself.With that done, we decided we needed to explant those 2 pieces of mesh.Otherwise, we would not get good contact of our new mesh to the anterior abdominal wall when we were placing our tacks.The patient might also be left with a bulge that would be palpable through the skin, and she might think that that was a recurrence.We then very carefully, using the thunderbeat and at times cautery scissors, took the 2 pieces of mesh off of the anterior abdominal wall.Once that was done, we measured out our defect, and as mentioned above, it was approximately 3 cm.Wanting a 5-cm overlap on either side, we selected a 15-cm round ventralight st patch to effect our repair.The mesh was rolled up and placed through our 12-mm trocar into the abdominal wall.A small nick was made in the middle of the umbilicus, and the suture passer was placed through this opening and grabbed in tubing for the mesh, and it was pulled up to the anterior abdominal wall.The tip of the blue tubing was snipped, and it was inserted into our inflation device.The echo scaffolding of the mesh was inflated and blue tubing clamped.I then used the protack and placed clips in both of the edges caudad, cephalad.I then worked in a 4-quadrant fashion to secure the mesh with the outer row.The echo device was deflated and withdrawn through the 12-mm trocar.I then used the protack to place an inner round of fasteners.This effected a very nice repair.¿ conclusion: it should be noted that the gore® dualmesh® plus 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.¿ with the use of permanent implants in patients with the potential for growth or tissue expansion (e.G.Infants, children, or women who may become pregnant), the surgeon should be aware that the device will not stretch significantly as the patient grows.This risk, as relates to all surgical mesh products and any permanent implantable device, are well-understood by physicians and described in clinical literature, professional society, and regulatory guidance.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.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.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.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: 03262145.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.
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