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| Catalog Number 1DLMC03 |
| Device Problems
Insufficient Information (3190); Migration (4003)
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| Patient Problems
Adhesion(s) (1695); Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061)
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| Event Date 10/28/2013 |
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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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that a patient alleges to have underwent hernia repair on or about (b)(6) 2010 whereby a gore dualmesh® biomaterial was implanted.The complaint states that on or about (b)(6) 2016, the patient ¿¿underwent removal of the failed dualmesh by at (b)(6) hospital.The operative report notes that the gore dual mesh had migrated, contracted, there were adhesions and dense scarring, and the device ¿was all bunched up to create a little foreign body in the groin.¿ this was noted as the likely source of plaintiff¿s severe pain.¿ the complaint alleges that the patient ¿¿suffered severe post-operative complications and required further surgical intervention.As noted in a (b)(6) 2016 operative report, [the patient] suffered ¿necrotic tissue all over the skin (in his groin area).¿ he was also diagnosed with an abscess and underwent incision and drainage and debridement on (b)(6) 2016.The complaint states that ¿¿the plaintiff has suffered and continues to suffer both injuries and damages, including, but not limited to: past, present and future physical and mental pain and suffering; physical disability, and past, present, and future medical, hospital, rehabilitative, and pharmaceutical expenses, and other related damages.¿ furthermore, it was reported that ¿specifically, the dualmesh implanted caused plaintiff to suffer chronic infections, numerous hospitalizations and surgeries, impairing her [sic] quality of life and necessitating future medical treatments.¿ the complaint states ¿¿plaintiff has sustained and will continue to sustain severe and debilitating injuries, economic loss, and other damages including, but not limited to, cost of medical care, rehabilitation, lost income, permanent instability and loss of balance, immobility, and pain and suffering¿¿ additional, event specific information was not provided.
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Manufacturer Narrative
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As only one device sticker was provided in the medical records, it is assumed that the physician used the same device and cut it into two pieces for the right and left repairs.The instructions for use provides the following warning: "if gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect." (b)(4).Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2010 indicate the patient underwent laparoscopic treatment of bilateral inguinal hernias.The records state: ¿evaluation of the abdomen was done.This was unremarkable, except on the right side there was a large indirect inguinal hernia.Some of the small bowel was there but as soon as we put the patient in trendelenburg, the bowel just came out.There were no adhesions.The sac was quite large, so it had to be dissected.To fill up the gap, we first used a mesh plug, which was fixed to wall using some tacks.Then to reinforce and do the full repair, a piece of dual mesh was used to cover the defect.The mesh was fixed to the wall again using the protack.¿ the (b)(6) 2010 operative report continues: ¿at this point, we looked on the left side.There was not a large but a small indirect inguinal hernia and we felt at this point the best thing for the patient would be to do the repair because most likely he is going to develop a full-blown inguinal hernia.So the sac was dissected.A piece of mesh was used to patch the defect and the mesh was fixed again using the protack.¿ the operative records confirm a gore dualmesh® biomaterial was used during the (b)(6) 2010, in addition to a bard mesh hernia plug.As only one device sticker was provided in the medical records, it is assumed that the physician used the same device and cut it into two pieces for the right and left repairs.Records dated (b)(6) 2012 indicate the patient was seen for discomfort in the lower abdomen.Exam notes state: ¿gastrointestinal: soft, non-tender, no distention, no obvious mass, organomegaly or bruit.¿ the records indicate no ventral or umbilical hernias were revealed upon palpation.Records dated (b)(6) 2013 indicate the patient was seen for ¿severe left groin pain for past few weeks, [patient] reports bloating and pain on lower left side, when sitting in chair can't get back up from pain in that area, lower spine problems, blood in stool a few weeks ago and noticed problems started after that.¿ ¿[patient] reports coughing all night one night before this pain started.¿ exam notes state: ¿¿gastrointestinal: soft, non-tender, no distention, no obvious mass, organomegaly or bruit.¿ the records indicate no ventral or umbilical hernias were revealed upon palpation.The (b)(6) 2013 records continue: ¿[patient] developed severe pain and swelling in l groin after coughing strongly.Has a l femoral hernia with possible irritation from l inguinal hernia repair mesh.Will plan laparoscopic possible open l femoral hernia repair.¿ operative records dated (b)(6) 2013 indicate the patient underwent laparoscopic left femoral hernia repair and lysis of adhesions.The records state: ¿the abdomen was exposed.Pneumoperitoneum was created through a small infraumbilical incision and evaluation of the abdomen was done.This was unremarkable, except in both inguinal areas where the mesh had been placed before there were adhesions.On the left side, there was sigmoid colon stuck to the mesh.On the right side, it was small bowel.¿ the (b)(6) 2013 records continue: ¿the first thing we did was dissect the sigmoid colon away from the left groin area where the patient had symptoms.Indeed, there was defective bulging of the left femoral hernia just below the inguinal ligament.We dissected as much as we could and then put another piece of large mesh to cover the previous mesh, as well as the femoral defect.Absorbable tacks were used to fix the mesh to the wall.¿ the (b)(6) 2013 records state: ¿after this was done, on the right side, the small bowels were dissected with use of blunt and sharp dissection and taken down from the mesh itself.Since the patient had no symptoms and there was no hernia that is all that was done.¿ the (b)(6) 2013 records indicate a non-gore device was implanted during the procedure.Records dated (b)(6) 2013 indicate the patient was seen for follow up after his hernia repair.The records state: ¿doing well after bilateral inguinal hernia repair.¿ records dated (b)(6) 2015 indicate the patient was seen for ¿¿severe [right upper quadrant] pain and tenderness in past 3-4 weeks.Some intolerance to fatty and fried foods.Also [patient] has severe gerd and in last few episodes he developed severe chest pain.¿ records dated (b)(6) 2015 indicate the patient was seen for follow up of a right upper quadrant ultrasound, which reportedly showed a gall bladder polyp.The records indicate the patient was scheduled for a laparoscopic cholecystectomy.Operative records dated (b)(6) 2016 indicate the patient underwent ¿laparoscopic cholecystectomy and removal of displaced mesh.¿ the records indicate a post-operative diagnosis of ¿cholecystitis, right groin pain, displaced gore-tex mesh of the right groin.¿ the (b)(6) 2016 operative report states: ¿the abdomen was exposed.Pneumoperitoneum was created through a small infraumbilical incision.Evaluation of the abdomen was done.This showed a gallbladder with adhesions to the omentum.Also looking at the groins, the left side of the groin had parietex type of mesh [non-gore device] which was laying in place nicely.The right side had gore-tex repair, which was all bunched up to create a little foreign body in the groin.This possibly explains why the patient felt a knot there and was causing pain.¿ the (b)(6) 2016 operative report continues: ¿so at this point, trocars were introduced.First, dissection of the gallbladder was done from those adhesions.Cystic duct and cystic artery were dissected and divided between clips.Once this was done the gallbladder was peeled of the liver bed using electrocautery and placed in endobag.At this point we approached the mesh.Using the thermocautery we were able to peel off the rolled up gore-tex mesh in the right groin easily.We didn't see any hernia defect, scarring was pretty much covering everything.So, what we did was just pull up both the mesh and the gallbladder through the umbilical port.Irrigation of subhepatic space was done.Pneumoperitoneum was evacuated.¿ records dated (b)(6) 2016 indicate the patient was seen for follow up.The records state: ¿doing well after [laparoscopic] [cholecystectomy] and removal of gore tex mesh from r going hernia repair.His leg pain has disappeared.[patient] still has some back pain.¿ records dated (b)(6) 2016 indicate the patient was seen for follow up.The records state: ¿[patient] developed an ulcerated area in r groin with cellulitis in past 2 days.No fever.Will start bactrim and recheck in 2 days.¿ record lists problem as ¿furuncle of thigh¿.Records dated (b)(6) 2016 indicate the patient was again seen for follow up.The records state: ¿r thigh area worse today in spite of po antibiotics.Some ulceration of skin noted.[patient] will need to be started on iv vancomycin and plan surgical debridement.¿ operative records dated (b)(6) 2016 state the patient underwent incision and drainage and debridement of about 8 square centimeters of the area.The post-operative diagnosis states: ¿abscess and necrotic tissue of the right groin.¿ findings from the procedure state: ¿the right groin was exposed.There was necrotic tissue all over the skin.This was debrided completely.A small amount of purulent material was drained.The tissue was completely removed.The wound was irrigated with peroxide and packed with iodoform gauze.¿ the medical records indicate the (b)(6) 2016 procedure was performed laparoscopically, so the area in which the reported infection developed would not have been surgically disrupted.It is unclear from the records provided if the post-operative cellulitis, furuncle, abscess and groin tissue necrosis were related to the (b)(6) 2016 laparoscopic procedure.Records dated (b)(6) 2016 indicate the patient was seen for follow up, stating the site was still very irritated.The records state: ¿doing well after i&d abscess r groin.Wound healing well.Packing removed.Cellulitis decreased.¿ records dated (b)(6) 2016 indicate the patient was seen for follow up, stating he is still sore and is having issues with swallowing.The records state: ¿doing well after i&d abscess r groin.No erythema.Still some gap.Continue dressing changes.¿ records dated (b)(6) 2016 indicate the patient was seen for follow up, stating he had pain and bloating in the area, with redness in the scrotal area.The records state: ¿r groin area almost completely healed.No drainage.No pain.[patient] has developed some abdominal distention and retaining some fluid after had a steroid injection for r knee pain.¿ records dated (b)(6) 2016 indicate the patient was seen for right groin pain and bulging in the past two weeks.The records state: ¿[patient] developed a r inguinal hernia in past 2 months after doing some heavy lifting during the summer.At times bowel [loops] get trapped and cause pain but [patient] is able to reduce the hernia by laying down.No hernia detected in l groin.[patient] would like to have open r inguinal hernia repair.¿ operative records dated (b)(6) 2016 indicate the patient underwent open repair of a recurrent right inguinal hernia with removal of old mesh.The records state: ¿the right groin was exposed.There was a right recurrent inguinal hernia.¿ ¿dissection was done down to the external oblique fascia.At this point, we were able to see the cord.The external oblique fascia was opened exposing the cord.The cord was dissected from the wall of the inguinal canal and the hernia sac was noted.It was dissected.Within the hernia sac, in part of the wall of it, there was a piece of hard, all crumbled up together piece of old mesh, which was excised.The opening of the sac itself was closed with a pursestring suture of 3-0 vicryl.¿ as the records provided indicate the gore mesh was previously removed from this location on (b)(6) 2016, the "crumpled up together piece of old mesh" is likely the non-gore hernia plug that was not removed at the time of gore mesh explant.The (b)(6) 2016 records continue: ¿at this point, we were able to do the repair.The repair was done by opening up the transversalis fascia, dissecting the peritoneal fat away, and then approximating in a triple layer with external oblique, internal oblique and transversalis fascia to the inguinal ligament.¿ ¿¿the repair was done starting from the pubic area all the way up to the internal ring making sure to leave enough space for the cord to be passing easily without being strangulated.Once this repair was done with six sutures of interrupted nurolon, the repair itself was reinforced by imposing in it, overlying on it, a piece of polypropylene mesh, and this was fixed to the wall also using nurolon sutures.Once this was done, the cord was positioned on top of the mesh and subcutaneous tissue was approximated with a running suture¿¿ the records indicate a non-gore device was used during the procedure.Records dated (b)(6) 2016 indicate the patient was seen for follow up.The records state: ¿doing well after open r inguinal hernia repair.Had some incisional pain in first few days after surgery, but since yesterday he has noted marked improvement.¿ records dated (b)(6) 2016 indicate the patient was seen for follow up.The records state: ¿doing well after open r inguinal hernia repair.Staples removed.Wound clean and dry.¿ records dated (b)(6) 2017 indicate the patient was seen for testicle pain.The records state: ¿[patient] is complaining of r testicular pain which appeared after open surgery for r inguinal hernia.There is no recurrence of the hernia.His testicle is normal.Incision area has some numbness.The scrotum at the lower pole has paresthesia.Just hurts with burning sensation just by gently touching it.[patient] concerned.This could be related to genito-femoral nerve irritation from post op scarring.¿ it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ "if gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect." ¿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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Manufacturer Narrative
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Corrected initial reporter address and phone number.Date rec'd by mfr: corrected date.Added new medical record information.Conclusion code remains unchanged.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2016 state the patient presented ¿¿today after noticing what appeared to be some sort of infection on (b)(6) 2016.He states at that time he noticed this infection in his right groin.He states that he had just had surgery at this facility on (b)(6) 2016, for cholecystectomy and removal of mesh from a left-sided hernia.He states he noticed this infection.He¿was started on bactrim.He did not get it filled on monday.He got the bactrim filled on tuesday, the 29th, and took two doses.He said the area was extremely large and swollen.He put ice on it.However, this morning, he follow up with dr.(b)(6) office where he was found to still have infection after three doses of bactrim.He states it is much better than it was but does not appear to be going to completely resolve, and therefore, he was made a direct admit for iv vancomycin and clearance for incision and drainage.¿ it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ "if gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect." ¿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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B7: added medical history.G4: corrected date.H10/11: added medical record information.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: records dated 5/14/2008 state: ¿abdominal right lower quadrant, cramp like, no nausea or vomiting.¿ records dated 8/9/2010 state: ¿this patient is a 60-year-old male who has been complaining of pain and swelling in the right groin for quite sometime.According to him, all things started when he was doing some heavy lifting.At that time, he left some pulling but did not notice any swelling.Recently, the swelling has got worse, some more pain.When his knees does some lifting, it aggravates the bulging, especially when he moves his bowels.Even passing gas, he can see the bulging get worse and become more tender.¿ ¿in the right groin, there is a large what seems to be an indirect inguinal hernia.Bowels are present.It can be reduced quite easily.The left groin is also a little tender but no hernia could be palpated.Testicles are well descended in place.¿ the 8/17/2010 operative records confirm a gore dualmesh® biomaterial was used during the procedure, in addition to a bard mesh hernia plug.Item number 1dlmc03 was implanted which is a 10cm x 15cm oval configuration.Records dated 11/11/2010 state: ¿repaired inguinal hernia by dr.Lanasa with appropriate [follow up].¿ records dated 2/11/2016 state: ¿this patient is a 65 year old male who is being seen in the office today for update of history and physical examination prior to laparoscopic cholecystectomy for ruq pain and gallbladder polyp.Patient was unable to have surgery last month due to his wife having surgery.He reports that he continues to have right sided pain, intermittent, with chest pressure, heartburn, and episodes where he feels like he can¿t check his breath.¿ ¿assessment: biliary colic, gallbladder polyp.¿ records dated 3/16/2016 state: ¿his main problem is two fold.One is symptomatic sinusitis with post-nasal drip and occasionally non-productive cough and then number two problems is right upper quadrant discomfort after eating due to cholelithiasis.He is scheduled for elective gallbladder removal this friday¿¿ records dated 1/17/2017 state: ¿his main problem is right testicular pain without swelling.In december he had a right inguinal hernia repair¿with no obvious complications, which resolution of his abdominal pain and constipation, which at that time was his main problem.¿ assessments state: ¿right testicular pain intermittent, rule out torsion of the testicle.¿ ¿[status post] right inguinal hernia repair.¿ ¿he needs a urological exam because of the occasional testicular pain.Dr.Lanasa has already checked this, saw some swelling and told him it was normal in face of the surgery¿¿ records dated 5/18/2017 state: ¿66 y.O.Male previously seen for pelvic pain in 2013 by dr.Luttge.He reports intermittent right orchalgia since right hernia repair several years ago.He states the pain is intermittent however when it occurs it is moderate to severe pain.¿ records dated 6/1/2017 state: ¿he has fatigue and weight gain.He also has fullness of the inguinal areas where hernia repair has been done.¿ records dated 7/11/2017 indicate the patient was seen for a recurrent right inguinal hernia.¿he had a ct of the abdomen and pelvis which shows an abdominal wall hernia containing small bowel without obstruction.He has this repaired on 8/17/10 laparoscopically and open on 12/6/16 at st.Joseph hospital.He also had a right groin debridement for abscess on 3/31/16.Also [reports] that he had his gallbladder removed after the 2010 repair and that at the time the surgeon removed the mesh from the previous repair.He is very active and works on a farm.States he is often moving wood and working.¿ the records indicate the patient will proceed with inguinal hernia repair with mesh.There is no indication as to which ¿mesh from the previous repair¿ was removed.Operative records dated 8/3/2017 indicate the patient underwent laparoscopic repair of a right recurrent inguinal hernia using a non-gore mesh.Records dated 9/12/2017 state: ¿comes in for his regular visit to discuss chronic problems.In the interval he had [an] inguinal hernia repair¿he has some bulging on physical exertion which is not as bad as before but still noticeable.He is going back¿in 2 weeks for follow up.There is no severe pain.No evidence of incarceration or the hernia but still a concern as to whether the surgery was a complete success.¿ ¿no musculoskeletal problems, other than chronic back issues.¿ exam of the abdomen states: ¿soft, non-tender, active bowel sounds.No masses, free fluid or organomegaly.No flank tenderness or hernias noted.¿ impression states: ¿[status post] right inguinal hernia with persistence of symptoms, but without incarceration.¿ records dated 9/26/2017 state ¿has cough and is lifting heavy weight.Feels swelling is back.Most likely recurrent hernia.¿ records dated 10/6/2017 indicate a ct of the pelvis was performed for an indication of groin swelling and right groin pain.The ct impression states: ¿loculated fluid in the right lower quadrant abdominal wall at site of previous hernia.This could represent postsurgical seroma.¿ records after 10/6/2017 indicate continued complaints of groin pain and swelling.Records dated 10/6/2017 indicate a ct of the pelvis was performed for an indication of right groin pain.The ct impression states: ¿1.Large right inguinal hernia containing small bowel loops.Mild inflammatory change within the mesentery of the right lower quadrant.2.Severe spinal canal stenosis at l4-l5.3.Multiple low density left renal lesions.Ultrasound is suggested to confirm benign cysts.¿ operative records dated 3/21/2018 indicate the patient underwent laparoscopic repair of a right inguinal hernia using a non-gore mesh.¿ the records state: ¿there was a lot of scar tissue and mesh from previous repairs.¿ there is no indication as to which ¿mesh from pervious repairs¿ was observed during the procedure.Records dated 4/6/2018 state: he is s/p robotic right inguinal hernia repair with mesh on 3/21/18.He denies pain.Has not been wearing hernia belt for the last five days.Complains of swelling.¿ records dated 4/9/2018 state: ¿his main interval problem has been some right inguinal swelling after the redo of his inguinal hernia¿the pain however has subsided substantially.There are no other gi or gu complaints.¿ impression notes state: ¿localized edema, post incisional edema, secondary to recent right inguinal hernia repair.¿ records dated 7/12/2018 state: ¿his hernia which was previously a problem, appears to be totally disappeared.¿ impression states: ¿rt inguinal hernia, stable.¿ it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ "if gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect." ¿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 patient codes.H6: updated conclusion codes.H6: additional patient codes: 1994; 3274.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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 2 for sterilization.Conclusion code remains unchanged.
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Manufacturer Narrative
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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.Previous patient codes (c3303, c26726, c54685, c26689, c34483) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: known medical records span from may 14, 2008 to july 12, 2018 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial and therefore not described in the summary.Records between (b)(6) 2008 and (b)(6) 2010; (b)(6) 2010 and (b)(6) 2012; (b)(6) 2013 and (b)(6), 2015 were not provided.Patient information: medical history: non-insulin dependent diabetes mellitus.Chronic fibromyalgia.Back pain, degenerative disc disease of lumbar spine.Benign prostatic hyperplasia.Gouty arthritis.Peripheral vascular disease.Hypertension.Hyperlipidemia.Chronic costochondritis.Grave¿s disease.Hiatal hernia.Diverticulosis prior surgical procedures: right knee surgery 2008 implant preoperative complaints: (b)(6) 2008: ¿abdominal right lower quadrant, cramp like, no nausea or vomiting.¿ (b)(6) 2010: ¿this patient is a 60-year-old male who has been complaining of pain and swelling in the right groin for quite sometime.According to him, all things started when he was doing some heavy lifting.At that time, he left some pulling but did not notice any swelling.Recently, the swelling has got worse, some more pain.When his knees does some lifting, it aggravates the bulging, especially when he moves his bowels.Even passing gas, he can see the bulging get worse and become more tender.¿ ¿in the right groin, there is a large what seems to be an indirect inguinal hernia.Bowels are present.It can be reduced quite easily.The left groin is also a little tender but no hernia could be palpated.¿ implant procedure: laparoscopic treatment of bilateral inguinal hernias.Implant: gore® dualmesh® biomaterial ((b)(6)/05521789) 10cmx15cm oval.Implant date: (b)(6), 2010 [unknown hospitalization dates] description of hernia being treated: ¿evaluation of the abdomen was done.This was unremarkable, except on the right side there was a large indirect inguinal hernia.Some of the small bowel was there but as soon as we put the patient in trendelenburg, the bowel just came out.There were no adhesions.The sac was quite large, so it had to be dissected.¿ implant size and fixation: ¿to fill up the gap, we first used a [non-gore] mesh plug, which was fixed to wall using some tacks.Then to reinforce and do the full repair, a piece of dual mesh was used to cover the defect.The mesh was fixed to the wall again using the protack.¿ ¿at this point, we looked on the left side.There was not a large but a small indirect inguinal hernia and we felt at this point the best thing for the patient would be to do the repair because most likely he is going to develop a full-blown inguinal hernia.So the sac was dissected.A piece of mesh was used to patch the defect and the mesh was fixed again using the protack.¿ post-operative period: [three months] - (b)(6) 2010: ¿repaired inguinal hernia by (b)(6) with appropriate [follow up].¿ relevant medical information: (b)(6) 2012: records indicate the patient was seen for discomfort in the lower abdomen.Exam notes state: ¿gastrointestinal: soft, non-tender, no distention, no obvious mass, organomegally or bruit.¿ the records indicate no ventral or umbilical hernias were revealed upon palpation.(b)(6) 2013: ¿severe left groin pain for past few weeks, [patient] reports bloating and pain on lower left side, when sitting in chair can¿t get back up from pain in that area, lower spine problems, blood in stool a few weeks ago and noticed problems started after that.¿ ¿[patient] reports coughing all night one night before this pain started.¿ exam notes state: ¿gastrointestinal: soft, non-tender, no distention, no obvious mass, organomegally or bruit.¿ the records indicate no ventral or umbilical hernias were revealed upon palpation.(b)(6) 2013: ¿[patient] developed severe pain and swelling in l groin after coughing strongly.Has a l femoral hernia with possible irritation from l inguinal hernia repair mesh.Will plan laparoscopic possible open l femoral hernia repair.¿ (b)(6) 2013: laparoscopic left femoral hernia repair and lysis of adhesions.¿the abdomen was exposed.Pneumoperitoneum was created through a small infraumbilical incision and evaluation of the abdomen was done.This was unremarkable, except in both inguinal areas where the mesh had been placed before there were adhesions.On the left side, there was sigmoid colon stuck to the mesh.On the right side, it was small bowel.¿ ¿the first thing we did was dissect the sigmoid colon away from the left groin area where the patient had symptoms.Indeed, there was defective bulging of the left femoral hernia just below the inguinal ligament.We dissected as much as we could and then put another piece of large mesh to cover the previous mesh, as well as the femoral defect.Absorbable tacks were used to fix the mesh to the wall.¿ ¿after this was done, on the right side, the small bowels were dissected with use of blunt and sharp dissection and taken down from the mesh itself.Since the patient had no symptoms and there was no hernia that is all that was done.¿ records indicate a non-gore device was implanted during the (b)(6) 2013 procedure.(b)(6) 2013: ¿doing well after bilateral inguinal hernia repair.¿ explant preoperative complaints: (b)(6) 2015: ¿¿severe [right upper quadrant] pain and tenderness in past 3-4 weeks.Some intolerance to fatty and fried foods.Also [patient] has severe gerd and in last few episodes he developed severe chest pain.¿ (b)(6) 2015: right upper quadrant ultrasound: gall bladder polyp.- patient was scheduled for a laparoscopic cholecystectomy.(b)(6) 2016: ¿this patient is a 65 year old male who is being seen in the office today for update of history and physical examination prior to laparoscopic cholecystectomy for ruq pain and gallbladder polyp.Patient was unable to have surgery last month due to his wife having surgery.He reports that he continues to have right sided pain, intermittent, with chest pressure, heartburn, and episodes where he feels like he can¿t check his breath.¿ ¿assessment: biliary colic, gallbladder polyp.¿ (b)(6) 2016: ¿his main problem is two fold.One is symptomatic sinusitis with post-nasal drip and occasionally non-productive cough and then number two problems is right upper quadrant discomfort after eating due to cholelithiasis.He is scheduled for elective gallbladder removal this friday¿¿ explant procedure #1: laparoscopic cholecystectomy and removal of displaced mesh explant date: (b)(6) 2016 [unknown hospitalization dates] (b)(6) 2016: ¿the abdomen was exposed.Pneumoperitoneum was created through a small infraumbilical incision.Evaluation of the abdomen was done.This showed a gallbladder with adhesions to the omentum.Also looking at the groins, the left side of the groin had parietex type of mesh [non-gore device] which was laying in place nicely.The right side had gore-tex repair, which was all bunched up to create a little foreign body in the groin.This possibly explains why the patient felt a knot there and was causing pain.¿ (b)(6) 2016: ¿so at this point, trocars were introduced.First, dissection of the gallbladder was done from those adhesions.Cystic duct and cystic artery were dissected and divided between clips.Once this was done the gallbladder was peeled of the liver bed using electrocautery and placed in endobag.At this point we approached the mesh.Using the thermocautery we were able to peel off the rolled up gore-tex mesh in the right groin easily.We didn¿t see any hernia defect, scarring was pretty much covering everything.So, what we did was just pull up both the mesh and the gallbladder through the umbilical port.Irrigation of subhepatic space was done.Pneumoperitoneum was evacuated.¿ relevant medical information: (b)(6) 2016: ¿doing well after [laparoscopic] [cholecystectomy] and removal of gore tex mesh from r groin hernia repair.His leg pain has disappeared.[patient] still has some back pain.¿ (b)(6) 2016: ¿[patient] developed an ulcerated area in r groin with cellulitis in past 2 days.No fever.Will start bactrim and recheck in 2 days.¿ ¿furuncle of thigh¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also state: ¿cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ 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 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 records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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