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| Model Number 1DLMC02 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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| Event Date 07/19/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 laparoscopic ventral hernia repair on (b)(6) 2007, whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: recurrent hernia, additional surgery, mesh removal, mesh failure, pain, adhesions.Additional event specific information was not provided.
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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: on (b)(6) 2006: office notes.Has small finger sized reducible incisional hernia at laparoscopy site.Informed to see md if this small hernia causes pain or is not reducible.Exam: mid-abd ventral hernia, reducible, size of golf ball.Impression: ventral hernia; copd.Records between 2/15/2007 and 6/8/2016 were not provided.On (b)(6) 2016: office notes.Hpi: lap ventral hernia repair in 2009 [sic] presents to clinic with abdominal pain.Noticed the bulge following hernia repair, and bulge has only increased in size.Admits to discomfort and wishes to have it repaired.Exam: abdominal: ventral hernia with palpable defect, approximately 3 cm in size.Assessment/plan: ventral hernia, reducible.Ct abd/pelvis.On (b)(6) 2016: [missing records: records for the ct scan showing the ¿no gross recurrent hernia seen¿ were not provided.] on (b)(6) 2017: office notes.Hpi: evaluation of recurrent ventral hernia.Underwent laparoscopic cholecystectomy and subsequently developed an incisional hernia at the periumbilical extraction site.Subsequently, underwent laparoscopic ventral hernia repair at the (b)(6) va in 2007.A piece of 7 cm x 8 cm dual mesh was used for a 2 cm x 3 cm defect.After that procedure, reports that always had a lump at the hernia site.It is now growing larger in size and becoming bothersome.Exam: reducible ventral hernia in epigastrium.Ct abd/pelvis on (b)(6) 2016: impression: mild nodular change left lower lobe of uncertain significance.6-12 months ct suggested for followup evaluation.Prior cholecystectomy with additional changes along the anterior abdominal wall suggestive of abdominal wall hernia repair.No gross recurrent hernia is seen.Streaky densities in the groin may reflect postsurgical change as well.Moderate sigmoid diverticulosis.Numerous renal cysts.Assessment/plan: recurrent ventral hernia clearly palpated and seen on ct by my read (comes around the superior edge of the mesh).Will plan for laparoscopic recurrent ventral hernia repair in july/august.On (b)(6) 2017: discharge summary.Diagnosis: recurrent ventral hernia.Hospital course: did well postop, pain well controlled, able to void without any difficulty.Discharge instructions: d/c home, f/u 2 weeks, no heavy lifting until seen in clinic.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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Please note the initial medwatch indicates an incorrect date gore aware of (b)(6)2018.The date gore aware of information for the initial report is (b)(6)2018.B7: added medical history.H6: corrected results code.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: records prior to (b)(6)2007, including records for the ¿previous laparoscopic cholecystectomy¿ noted in the (b)(6)2007 records, were not provided.Records dated (b)(6)2007 indicate the patient was seen for pre-operative evaluation.¿this is a 51-year-old male with chronic obstructive pulmonary disease, who presents to the general surgery clinic requesting a laparoscopic ventral hernia repair for a hernia at his upper midline trocar site from a previous laparoscopic cholecystectomy.He states the hernia is always reducible and has not been causing any obstructive symptoms.¿ ¿¿known for chronic [low blood pressure], mild to moderate copd (on scheduled albuterol), [hypertension] since 7 years ago and hyperlipidemia, is consulted for pre-op evaluation.¿ prior medical history includes cholecystectomy, bilateral open inguinal hernia repair, ¿used to smoke 35 [packs per year], quit 3 years ago¿, premature coronary artery disease, and copd.The (b)(6)2007 records note the following: ¿[patient] with several risk factors for post op pulmonary complications including copd, hx of >20 [packs per year] smoking, upper abdominal procedure and general anesthesia.However, symptoms remain stable since years ago.¿ ¿the patient has a 26-year history of tobacco use.¿ ¿assessment: [patient] has incisional hernia approx 2-3cm at laparoscopic trocar site 10cm above umbilicus but well below xiphoid.Also has come diastasis.He desires laparoscopic repair¿¿ operative records dated (b)(6)2007 state the patient underwent laparoscopic ventral incisional hernia repair.¿this patient is a 51-year-old male who has had an enlarging bulge at his superior port site from a previous laparoscopic cholecystectomy performed at another institution.He has had no obstructive complaints but has suffered discomfort from it.¿ ¿findings: a 2 x 3 cm fascial defect.¿ the (b)(6)2007 operative report states: ¿a 5 mm trocar was placed in the left upper quadrant through a small skin incision using an optical trocar with 5 mm 0 degree camera in it.The abdomen was entered atraumatically at this position and a second 5 mm port was placed in the left lower quadrant under visualization of the scope from the other port site.A 12 mm trocar was then placed directly left and lateral from the ventral hernia again using a blunt insertion.A 25-gauge needle was then used through the anterior abdominal wall to delineate the borders of the fascial defect , which was found to be 2 cm in width x 3 cm in its superior to inferior dimension.This was marked with the skin marker on the anterior abdominal wall and a small dualmesh was cut to the size of 7 cm x 8 cm giving it enough size to overlap the fascial defect by 2.5 to 3 cm in all directions.The superficial rough surface was marked with a skin marker and 0 ethibonds were placed peripherally one at each corner and one in the center of each side of the mesh.¿ the (b)(6)2007 records state: ¿it was then rolled and inserted into the abdomen to the 12 mm trocar where it was then opened and a percutaneous suture passer was used to now retrieve each pair of suture tails through the anterior abdominal wall at its respective location.This was done through a small 11 blade skin nick at each site.The sutures were then pulled tight and the mesh was confirmed to lay flat against the abdominal wall.They were then tied and cut below the level of the skin.The skin was lifted from the suture knot with a pair of hemostats at each suture site.Spiral titanium tacks were then used around the entire circumference of mesh to further approximate to the anterior abdominal wall as well as several tacks within the central portion of the mesh.The mesh was confirmed to be flat and the surgical site was confirmed to be hemostatic at this point.The insufflation was stopped and the cameras in ports were removed.This was done after endoscopic closure of the 12 mm trocar site with 0-prolene.The skin at all port sites were closed using a 4-0 monocryl in a subcuticular fashion.¿ the records confirm a gore dualmesh® biomaterial (1dlmc02/03273419) was implanted during the procedure.Records dated(b)(6)2007 state: ¿51 [year old] [white male] [status post] laparoscopic incisional hernia repair, doing well, tolerating diet, pain ok, port sites ok, no hernia, well healed.¿ records between (b)(6)2007 and (b)(6)2017 were not provided.Operative records dated (b)(6)2017 state the patient underwent ¿robotic-assisted ventral hernia repair with mesh¿ for a diagnosis of ¿recurrent ventral hernia.¿ indications state: ¿[the patient] is a 61-year-old man with history significant for anxiety and hypertension, who presents to the va surgery clinic complaining of a bulge in his abdomen.Of note, the patient had a previous history of a ventral hernia repair approximately 7 years prior with mesh.It was then decided to proceed with robotic-assisted versus laparoscopic versus open ventral hernia repair.¿ the (b)(6)2017 records state: ¿the patient was noted to have a significant amount of adhesions which were then removed using a combination of blunt and sharp dissection.The patient was noted to have an approximately 2 cm ventral hernia defect and his old mesh was visible which included a synthetic mesh with some [sic] tacks.A pair of scissors was then inserted along with atraumatic grasper which was then used to carefully remove the previous mesh, which was then explanted from the patient.The hernia sac was also excised and it was also reduced and excised.¿ the(b)(6)2017 operative report state: ¿once the fascial edges had been cleaned up of any surrounding tissues.The synthetic mesh was then inserted into the abdominal cavity.This was then placed against the abdominal cavity providing adequate coverage of any defects.The diagonal course cores of the mesh were then secured down with a running barbed prolene suture with few of the corners were then secured down with titanium tacks.Rest of the mesh was then secured down using a titanium tack to make the mesh flushed with the peritoneum.The repair appeared to be adequate.¿ ¿the port sites were then closed with a running 4-0 monocryl suture and dermabond was applied over the incision sites.¿ there was no mention of infection and no mention of any issues involving the gore device.A pathology report dated (b)(6)2017 regarding specimens collected (b)(6)2017 states: ¿gross description: ¿received in formalin, labeled¿¿mesh¿ is a yellow-tan, smooth, glistening, flattened segment of mesh measuring 7.0 x 5.0 x 3.0 cm with multiple silver metallic coiled wires and adherent brown-tan soft tissue.No inscriptions are identified.¿ ¿final diagnosis: old ventral hernia mesh, removal: - mesh (medical device) ¿ benign fibroadipose tissue with chronic inflammation.¿ 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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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 1994: (b)(6).[provider ni].Pathology report.Specimen: 1.Foreign body from right groin.2.Lipoma lt [left] cord.Brief clinical history: hernia.Preoperative diagnosis: right inguinal hernia.Postoperative diagnosis: same.Diagnosis: right groin: foreign body encased by fibrovascular tissue and multinucleated giant cells.Left groin: fibroadipose tissue.(b)(6) 1994: (b)(6).[provider ni].Microbiology.Collection sample: abscess.Site: inguinal region.Culture results: 1.Proteus mirabilis ¿ quantity: rare.Staphylococcus aureus ¿ quantity: abundant.(b)(6) 2013: [missing records: records for ct ¿consistent with a low grade incomplete small bowel obstruction¿ were not provided.] (b)(6) 2014: [facility ni].(b)(6).Radiology ¿ lumbar spine.Findings: surgical clips present in the gallbladder fossa with additional material likely reflecting abdominal hernia repair seen overlying the mid lumbar region.(b)(6) 2016: [facility ni].(b)(6).Radiology ¿ ct abdomen.History: rule out additional anterior wall defects.Findings: apparent mesh material can be seen along the midline anterior abdominal wall.Few streaky densities in the overlying subcutaneous tissue without densities in the overlying subcutaneous tissue without discrete hernia identification.There some streaky densities in a well regions bilaterally possibly postsurgical as well without distinct hernia.Impression: prior cholecystectomy with additional changes along the anterior abdominal wall suggestive of abdominal wall hernia repair.No gross recurrent hernia is seen.Streaky densities in the groin may reflect postsurgical change as well.Moderate sigmoid diverticulosis.(b)(6) 2017: (b)(6).Pathology.Specimen: tu: s-3571-17.Final diagnosis: old ventral hernia mesh, removal: mesh (medical device).Benign fibroadipose tissue with chronic inflammation.Gross description: received in formalin, labeled with the patient¿s name, medical record number and ¿mesh¿ is a yellow-tan, smooth, glistening, flattened segment of mesh measuring 7.0 x 5.0 x 0.3 cm with multiple silver metallic coiled wires and adherent brown-tan soft tissue.No inscriptions are identified.Representative sections with soft tissue are submitted in cassette 1a.(b)(6) 2018: [facility ni].(b)(6).Radiology ¿ l-spine.History: chronic pain.Findings: surgical clips are noted in the right upper quadrant with additional small metal densities probably relating to abdominal wall hernia repair are seen.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 1994: [missing records: records for ¿bilateral inguinal hernia repair¿ were not provided.] (b)(6) 1994: (b)(6).Microbiology.Collection sample: abscess.Site: scrotal septum.Gram stain: 2+ (few) epithelial cells, 2+ (few) polymorphonuclear cells seen, 3+ (moderate) gram positive rods (diphtheroid in appearance), 2+ (few) gram positive cocci in pairs, 1+ (rare) gram negative rods.Culture results: proteus mirabilis- moderate.Staphylococcus aureus- moderate.(b)(6) 2002: (b)(6).(b)(6).Office note.Substance abuse: mostly marijuana, for 1st three years inhaled what was described as ¿horse tranque¿, and used cocaine on one occasion.Filed for bankruptcy 2 months ago.History of chronic obstructive pulmonary disease, gastroesophageal reflux disease, double hernia repair.(b)(6) 2004: (b)(6).(b)(6), md.Office note.Thinks he is developing a hernia in lower abdomen, stopped smoking 10 months ago, gained 30 lbs.Of weight.Weight 232 lbs.Examination: abdomen; no masses.(b)(6) 2006: (b)(6).(b)(6), md.Office notes.Has small finger sized reducible incisional hernia at laparoscopy site.Informed to see md if this small hernia causes pain or is not reducible.Exam: mid-abd ventral hernia, reducible, size of golf ball.Impression: chronic sinusitis; being treated with steroid, ventral hernia; copd.(b)(6) 2006: [facility ni.] (b)(6), np.Office note.No-showed for two consecutive appointments.Letter mailed requesting to call clinic to re-schedule appointment.(b)(6) 2007: [facility ni, not indicated.] (b)(6), md (resident), (b)(6), md.History and physical.Presents requesting laparoscopic ventral hernia repair for hernia at upper midline trocar site from previous laparoscopic cholecystectomy.States hernia reducible and not causing obstructive symptoms.Past medical history: hypertension.Allergies: demerol, vicodin, percocet.26-year history tobacco use.Abstinent for 3 years.No alcohol and denies recreational drug use.Weight 232 lbs.Abdomen: obese, soft and nontender.Midline diastasis present and what feels to be reducible hernia with approximate 3 cm fascial defect at superior port site from cholecystectomy which is approximately 10 cm superior to umbilicus.Assessment/plan: incisional hernia, requesting laparoscopic repair.Repair hernia (b)(6) 2007.(b)(6) 2007: [facility ni.] (b)(6), md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Procedure: laparoscopic ventral hernia repair.Anesthesia: general.Findings: a 2 cm x 3 cm fascial defect.Complications: none.Estimated blood loss: minimal.Indications for procedure: this is a 51-year-old male who has had an enlarging bulge at this superior port site from a previous laparoscopic cholecystectomy performed at another institution.He has had no obstructive complaints but has suffered discomfort from it.The patient was preop from clinic including a description of procedure as well as its risks, benefits and alternatives.The patient requested that this procedure be performed and he was taken to the operating room electively for it on (b)(6) 2007.Details of procedure: ¿the patient was laid supine on the operating table.After induction of general anesthesia, his anterior abdominal wall was prepped and draped in the standard surgical fashion.An ioban was included in that prep.A 5 mm trocar was placed in the left upper quadrant through a small skin incision using an optical trocar with 5 mm 0 degree camera in it.The abdomen was entered atraumatically at this position and a second 5 mm port was placed in the left lower quadrant under visualization of the scope from the other port site.A 12 mm trocar was then placed directly left and lateral from the ventral hernia again using a blunt insertion.A 25-gauge needle was then used through the anterior abdominal wall to delineate the borders of the fascial defect, which was found to be 2 cm in width x 3 cm in its superior to inferior dimension.This was marked with the skin marker on the anterior abdominal wall and a small dualmesh was cut to the size of 7 cm x 8 cm giving it enough size to overlap the fascial defect by 2.5 to 3 cm in all directions.The superficial rough surface was marked with a skin marker and 0 ethibond were placed peripherally one at each corner and one in the center of each side of the mesh.It was then rolled and inserted into the abdomen to the 12 mm trocar where it was then opened and a percutaneous suture passer was used to now retrieve each pair of suture tails through the anterior abdominal wall at its respective location.This was done through a small 11 blade skin nick at each site.The sutures were then pulled tight and the mesh was confirmed to lay flat against the abdominal wall.They were then tied and cut below the level of the skin.The skin was lifted from the suture knot with a pair of hemostats at each suture site.Spiral titanium tacks were then used around the entire circumference of mesh to further approximate to the anterior abdominal wall as well as several tacks within the central portion of the mesh.The mesh was confirmed to be flat and the surgical site was confirmed to be hemostatic at this point.The insufflation was stopped and the cameras in ports were removed.This was done after endoscopic closure of the 12 mm trocar site with 0-prolene.The skin at all port sites were closed using a 4-0 monocryl in a subcuticular fashion.Sponge, needle, and instrument counts were correct at the end of the case.The patient tolerated the procedure well and was taken to the recovery room in good condition.¿ (b)(6) 2007: [facility ni.] (b)(6), md (resident), (b)(6), md.Brief op note.Operative note.Pre-operative diagnosis: incisional hernia.Post-operative diagnosis: incisional hernia.Operative procedure: laparoscopic ventral hernia repair with duomesh.Residents/assistants: calcote.Findings: 2cmx3cm defect.Specimens removed: none.Complications: none.Estimated blood loss: minimal.Addendum: findings: ¿3x2cm defect at prior supraumbilical incision repaired with 8x8cm goretex dual mesh.No comps.¿ (b)(6) 2007: [facility ni.] (b)(6), rn.Discharge instructions.Instructed may resume previous diet, walking encouraged, but avoid heavy lifting 20 pounds or more and any strenuous activity.Report excessive bleeding, swelling [sic] redness, drainage, odor, and elevated temperature 101 or greater.(b)(6) 2007: [facility ni.].(b)(6), md (resident), (b)(6), md.Office notes.Status post incisional hernia repair, doing well, tolerating diet, pain ok, port sites ok, no hernia, well healed.Return to clinic as needed.(b)(6) 2007: (b)(6).(b)(6), rn.Nurses notes.Complaint of intermittent nonproductive cough.(b)(6) 2009: (b)(6).(b)(6), md.Office note.Left lower extremity hurts when walking; burning for years.History bilateral inguinal hernia 1994.Smokes at most 4 packs per day; quit 2004, smoked marijuana; quit 1994.Takes aspirin.Weight 251 lbs., bmi 36.1.Impression/plan: chronic pain; tylenol #3, opiate use agreement signed.(b)(6) 2009: (b)(6).(b)(6), rn.Nurses notes.Reports onset of dry cough, post-nasal drainage and nasal discharge x 2 days.(b)(6) 2010: (b)(6).(b)(6), rn.Nurses notes.Reports onset dry cough throughout day, sinus pain and pressure, nasal congestion x 2 days.(b)(6) 2012: (b)(6).(b)(6), rn.Nurses notes.Sinus infection; past month, treated with cephalexin and steroid, did not help, cough but no production, states ¿at night he coughs a lot and has a feeling like something is loose in his chest area.¿ (b)(6) 2012: [facility ni].(b)(6).Radiology-right ribs 3 views.Findings: surgical clips in right upper quadrant.Additional surgical material over lower abdomen.Impression: multiple fractures and postsurgical changes present as described.(b)(6) 2012: [facility ni].(b)(6).Radiology-ct thorax.Reason for study: emphysema, exposure to asbestos.Findings: ventral midline abdominal wall hernia mesh noted.Impression: mild upper zone centrilobular emphysema.(b)(6) 2013: (b)(6).(b)(6).Office note.Complaints of right lower abdominal pain x 2 days, started as ¿blunt¿ pain upon palpation, last night right lower quadrant pain was ¿intense¿ changing back to blunt on palpation.Takes aspirin.Examination: abdomen; tenderness right lower quadrant.Right lower abdominal pain- report called to (b)(6) emergency room.Weight 248.9 lbs., bmi 34.8.(b)(6) 2013: (b)(6).Office note.Complaints of right lower quadrant abdominal pain, eructation, bloating, flatulence, loose bowel movements, for ulcerative colitis- now after one and a half weeks of twice a day, no longer has any gastrointestinal symptoms except for looser bowel movements.History small bowel obstruction, ulcerative colitis, emphysema, sinusitis, chronic low back pain, general osteoarthritis.Weight loss of 20 lbs., (b)(6) most of time, at worst 10/10, aching/sharp/burning/shocking with numbness in both feet, paresthesia, aggravated by prolonged sitting, driving, standing, walking.Aching in shoulders, left hip, chronic pain and spasms bilateral masseters.Tobacco; quit 7 years ago, prior 2 packs per day, marijuana quit 1995.Examination: abdomen; without palpable/percussible masses or hernias.(b)(6) 2013: (b)(6), md.Discharge summary.Emergency room report dated (b)(6) 2013.Addendum: treated for mesenteric adenitis, colitis and partial bowel obstruction after presenting with abdominal pain.(b)(6) 2013: [facility ni].(b)(6).Radiology-lumbar spine.Findings: abdominal wall mesh repair and right upper quadrant surgical clips are again seen.Impression: mild interval progression of multilevel degenerative disk disease and lower lumbar facet arthrosis.(b)(6) 2014: (b)(6).Email to (b)(6).Productive cough with thick mucosa sometimes clear, sometimes pale-yellow x 2 weeks.(b)(6) 2014: [facility ni].(b)(6).Radiology-lumbar spine.Findings: additional material likely reflecting abdominal hernia repair seen overlying the mid lumbar region.Impression: surgical changes over the right upper quadrant and mid abdomen.(b)(6) 2014: (b)(6), md.Office note.History diverticulosis of colon (b)(6) 2014, small bowel obstruction and ulcerative colitis (b)(6) 2013, chronic low back pain (b)(6) 2012, general osteoarthritis (b)(6) 1999.(b)(6) 2015: (b)(6), rn.Nurses note.Nonproductive cough.(b)(6) 2015: (b)(6).Office note.First used marijuana around age 18, used marijuana 10 times in past year; usually has a bowl each time, heavier prior to last marriage.Motor vehicle accident (b)(6) 2014, motorcycle accident (b)(6) 1986.Endorsed chronic pain in lower back, neck and shoulder; pain prevents from walking long distances (¿a block¿), cleaning house and ¿just about everything else¿, indicated able to complete all activities of daily living.Preoccupied by physical health concerns and there is likely a psychological component to somatic complaints.Endorsed significant problems with gastrointestinal complaints and chronic pain.(b)(6) 2015: (b)(6).Office note.History bilateral inguinal hernia repair.History of abdominal pain or jaundice, heartburn and reflux.Weight 242.6 lbs., bmi 33.9.(b)(6) 2015: (b)(6).Office note.Reports a ventral hernia that will bother him as he does the heavy [sic], requesting non-va care for general surgery.Weight 229 lbs., bmi 32.Examination: abdomen; ventral [h]ernia.(b)(6) 2016: (b)(6).Email to dr.(b)(6).Still waiting for surgery consult to address ventral hernia which grows daily and protrudes more often.I¿m getting to a critical point here as i can literally insert my finger into the hernia about ½ inch deep.I keep a close eye on it.A truss would help if you can get me one.However, i have terrible sinuses and cough a lot.(b)(6) 2016: (b)(6), rn.Nurses notes.Weight 217 lbs., bmi 30.3.Abdominal hernia not painful unless coughs or pushes it back in 4/10, pain is sharp and does not last very long, some nausea not sure it is related.Since last seen by primary care physician in [sic] (b)(6) 29 hernia has been ¿poking out more¿ is more uncomfortable, and thinks he feels a hard surface ¿staple¿ on the edge of the opening.Abdomen not distended.Concerned and wants to know if he should go to emergency room or wait until seen by surgery, consult had been cancelled due to unable to contact, has not picked up abdominal binder previously ordered.Refer to primary care physician for evaluation, dr.(b)(6) will reorder consult, veteran to pick up binder, cautioned not to stick foreign objects in hernia site.(b)(6) 2017: (b)(6).Office note.Reports not going to emergency room for hypokalemia as instructed, requesting pre-operative [clearance] for ventral hernia repair- however cannot clear until electrolytes normalize.Weight 224 lbs., bmi 31.3.Examination: abdomen; soft, non-tender, positive bowel sounds, positive ventral hernia.Ventral hernia, awaiting repair [sic], await results of labs prior to clearing for pre-operative.(b)(6) 2017: (b)(6), md.Office note.Ventral hernia evaluation today, history of laparoscopic cholecystectomy and subsequent laparoscopic ventral hernia repair.Continues to do well and denies any obstructive symptoms.Hernia remains somewhat bothersome, saw primary care provider cleared from medical standpoint, did have hypokalemia; resolved.Weight 230.8 lbs., bmi 32.3.Examination: abdomen; soft, nontender, nondistended, well-healed laparoscopic scars, reducible ventral hernia above his umbilicus, difficult to appreciate size of defect but approximately 2-3 cm.Impression/plan: recurrent ventral incisional hernia; will plan for robotic versus laparoscopic recurrent ventral hernia repair.Risks and benefits of surgery discussed, likely will check potassium day of surgery.(b)(6) 2017: (b)(6), md.Office note.Post-operative visit status post robotic ventral hernia repair, doing well, without major complaints, pain resolved.Previously had pain near right upper quadrant incision, improved, back to all normal activities.Weight 227.8 lbs., bmi 31.8.Examination: abdomen; soft, nontender, nondistended, laparoscopic incisions clean/dry/intact without erythema or drainage.Activity as tolerated, return to clinic as needed.(b)(6) 2018: (b)(6).Email to dr.(b)(6) [sic].I need you to revise your notes to reflect that the surgery you performed was revision of a previous ventral hernia.Additionally, can you generate a letter reflecting the same? and send it to me [address included].This is the truth so i¿m not asking you to falsify anything.You did the surgery in (b)(6) 2017.(b)(6) 2018: (b)(6), md.Office note.My notes all specify that this was a recurrent ventral hernia related to a prior surgery.I am unsure what additional documentation is needed.(b)(6) 2018: (b)(6).Office note.Issues with indigestion and constipation.History of chronic obstructive lung disease (b)(6) 2017, vitamin d deficiency (b)(6) 2015.Tobacco use; quit 2004.Impression/plan: constipation; miralax.Chronic obstructive pulmonary disease, left hip pain.Weight 246 lbs., bmi 34.4.(b)(6) 2019: (b)(6), md; (b)(6), md, facc.Office note.Active problems: pre- diabetes mellitus.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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 device code.H6: updated conclusion codes.Previous patient codes (1695, 1994, 2240, 3191: appropriate term/code not available for ¿mesh failure¿) 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) 1994 through (b)(6) 2019, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Patient information: medical history: obesity. (b)(6) 2000: 208 lbs., bmi 29. (b)(6) 2004: 232 lbs., bmi 32.4. (b)(6) 2006: 237 lbs., bmi 33.1. (b)(6) 2007: 242 lbs., bmi 33.8. (b)(6) 2009: 251 lbs., bmi 35. (b)(6) 2015: 243 lbs., bmi 33.9. (b)(6) 2017: 231 lbs., bmi 32.2. (b)(6) 2018: 246 lbs., bmi 34.4.Osteoarthritis.Chronic obstructive pulmonary disease.Gastroesophageal reflux disease.Smoker ¿ 4 pack/day, quit 2004.Hypertension.Chronic pain.Emphysema.Ulcerative colitis.Diverticulitis.(b)(6) 2002: substance abuse. ¿mostly marijuana¿. ¿for three years inhaled what was described as ¿horse tranque¿¿.Prior surgical procedures: (b)(6) 1992: laparoscopic cholecystectomy.(b)(6) 1994: bilateral inguinal hernia repair.Implant preoperative complaints: (b)(6) 2006: ¿has small finger sized reducible incisional hernia at laparoscopy site.Informed to see md if this small hernia causes pain or is not reducible.¿ (b)(6) 2007: ¿requesting a laparoscopic ventral hernia repair for a hernia at his upper midline trocar site from a previous laparoscopic cholecystectomy.He states the hernia is always reducible and has not been causing any obstructive symptoms.¿ implant procedure: laparoscopic ventral hernia repair.Implant: gore® dualmesh® biomaterial (03273419/1dlmc02) 8 x 12 cm.Implant date: (b)(6) 2007.Description of hernia being treated: ¿a 25-gauge needle was then used through the anterior abdominal wall to delineate the borders of the fascial defect, which was found to be 2 cm in width x 3 cm in its superior to inferior dimension.This was marked with the skin marker on the anterior abdominal wall.¿ implant size and fixation: ¿a small dualmesh was cut to the size of 7 cm x 8 cm giving it enough size to overlap the fascial defect by 2.5 to 3 cm in all directions.The superficial rough surface was marked with a skin marker and 0 ethibond were placed peripherally one at each corner and one in the center of each side of the mesh.It was then rolled and inserted into the abdomen to the 12 mm trocar where it was then opened and a percutaneous suture passer was used to now retrieve each pair of suture tails through the anterior abdominal wall at its respective location.This was done through a small 11 blade skin nick at each site.The sutures were then pulled tight and the mesh was confirmed to lay flat against the abdominal wall.They were then tied and cut below the level of the skin.The skin was lifted from the suture knot with a pair of hemostats at each suture site.Spiral titanium tacks were then used around the entire circumference of mesh to further approximate to the anterior abdominal wall as well as several tacks within the central portion of the mesh.The mesh was confirmed to be flat and the surgical site was confirmed to be hemostatic at this point.¿ post-operative period: [two weeks] (b)(6) 2007: ¿status post incisional hernia repair, doing well, tolerating diet, pain ok, port sites ok, no hernia, well healed.¿ relevant medical information: (b)(6) 2013: ¿complaints of right lower abdominal pain x 2 days, started as ¿blunt¿ pain upon palpation, last night right lower quadrant pain was ¿intense¿ changing back to blunt on palpation.¿ (b)(6) 2013: ¿complaints of right lower quadrant abdominal pain, eructation, bloating, flatulence, loose bowel movements, for ulcerative colitis-now after one and a half weeks of twice a day, no longer has any gastrointestinal symptoms except for looser bowel movements.¿ (b)(6) 2015: ¿reports a ventral hernia that will bother him as he does the heavy [sic], requesting non-va care for general surgery.¿ (b)(6) 2016: ¿still waiting for surgery consult to address ventral hernia which grows daily and protrudes more often.I¿m getting to a critical point here as i can literally insert my finger into the hernia about ½ inch deep.¿ (b)(6) 2016: ¿since last seen by primary care physician in (b)(6) [sic] hernia has been ¿poking out more¿ is more uncomfortable, and thinks he feels a hard surface ¿staple¿ on the edge of the opening.Abdomen not distended.Concerned and wants to know if he should go to er or wait until seen by surgery, consult had been cancelled due to unable to contact, has not picked up abdominal binder previously ordered.Refer to primary care physician for evaluation, dr.Thurston will reorder consult, veteran to pick up binder, cautioned not to stick foreign objects in hernia site.¿ (b)(6) 2016: ¿noticed the bulge following hernia repair, and bulge has only increased in size.Admits to discomfort and wishes to have it repaired.Exam: abdominal: ventral hernia with palpable defect, approximately 3 cm in size.¿ (b)(6) 2016: ct abdomen: ¿prior cholecystectomy with additional changes along the anterior abdominal wall suggestive of abdominal wall hernia repair.No gross recurrent hernia is seen.Streaky densities in the groin may reflect postsurgical change as well.Moderate sigmoid diverticulosis.¿ explant preoperative complaints: (b)(6) 2017: ¿underwent laparoscopic ventral hernia repair at the (b)(6) in 2007.A piece of 7 cm x 8 cm dual mesh was used for a 2 cm x 3 cm defect.After that procedure, reports that always had a lump at the hernia site.It is now growing larger in size and becoming bothersome.¿ (b)(6) 2017: ¿reports not going to er for hypokalemia as instructed, requesting pre-operative [clearance] for ventral hernia repair-however cannot clear until electrolytes normalize.¿ explant procedure: robotic-assisted ventral hernia repair with mesh, lysis of adhesions, explantation of mesh.Explant date: (b)(6) 2017.The patient was noted to have a significant amount of adhesions which were then removed using a combination of blunt and sharp dissection.The patient was noted to have an approximately 2 cm ventral hernia defect and his old mesh was visible.The superior edge of the old mesh had pulled away from the anterior abdominal wall, accounting for the recurrence.Several titanium tacks were identified.The previous mesh and tacks were explanted as one specimen using a combination of hot and cold scissors.The specimen was removed through the 12 mm port.The hernia sac was also excised.Once the fascial edges were cleaned up of any surrounding tissue.A small 1 cm hernia defect was also noted at the umbilicus.The decision was made to use one mesh to cover both defects.The outer edges of the area containing both defects measured 6 cm x 8 cm.A 15 cm x 20 cm ventralite st mesh was chosen.0-goretex suture was placed at the midpoint of the mesh.The mesh was then inserted into the abdominal cavity.A small incision was made of the center of the hernia defects, and a carter thomason device was used to grab the goretex suture and pull it up through the abdominal wall.Two sides of the mesh were then secured down with a running v-lock suture.The rest of the mesh was then secured down using absorbable tacks to make the mesh flush with the anterior abdominal wall.The repair provided sufficient coverage of the hernia defect.Records confirm a non-gore device was implanted during the procedure on (b)(6) 2019.Relevant medical information: (b)(6) 2017: ¿status post robotic ventral hernia repair, doing well, without major complaints, pain resolved.Previously had pain near right upper quadrant incision, improved, back to all normal activities.¿ 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.¿ 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.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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Search Alerts/Recalls
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