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| Model Number 1DLMCP03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Seroma (2069); Discharge (2225); Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/10/2009 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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¿.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material".
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted.It was reported an additional hernia repair (type unknown) was performed on (b)(6) 2008 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure occurred whereby the gore devices were explanted.It was reported the patient alleges the following injuries: seroma, infection, drainage of wound, additional surgeries, and mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated result code 1 for manufacturing evaluation.Conclusion code remains unchanged.Added method/results/conclusions code 2 for sterilization evaluation.
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Manufacturer Narrative
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H6: updated result code 2.Conclusion code 2 remains unchanged.
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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: records prior to (b)(6) 2008, including records for sigmoid resection and exploratory lap, were not provided.Operative records dated (b)(6) 2008 indicate patient underwent repair of recurrent ventral hernia with a mesh.Findings: ventral hernia times 2.The records state: ¿an incision was then made over the previous scar and the scar was then excised.The incision was then carried through subcutaneous tissue until the hernia sac was encountered.The hernia sac was noted to be a large sac.The same was then dissected free from the fascia circumferentially.After this was done the sac was then opened and the contents were examined.¿ operative records dated (b)(6) 2008 continue: ¿it contained small bowel and omentum.Then i proceeded by carefully taking down the adhesions of the bowel and omentum to the hernia sac, care taken not to injure the bowel.After this was extensively done, the bowel was then carefully reduced back into the abdominal cavity.The excess omentum was then carefully excised using the harmonic scalpel.After this was done hemostasis was looked for and noted to be adequate.¿ the records dated (b)(6) 2008 state: ¿the hernia sac was then also excised circumferentially and the fascia edge was inspected and noted to be clean.After this was done a dual-mesh was then cut into appropriate oval size and the same was then used to cover the hernia defect.The dual-mesh was sutured in place to the fascia circumferentially using 0 prolene u-stitches.After this was done, inspection confirmed adequate closure of the fascia defect with no tension.Then copious amounts of antibiotic irrigation was carried out.¿ the operative records dated (b)(6) 2008 continue: ¿i proceeded by placing a 7 mm jackson-pratt drain in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The drain was sutured in place using 2-0 silk stitch.The subcutaneous tissue was then approximated together using 2-0 vicryl stitch.Skin was approximated together using skin staples.Sterile dressings were then applied.¿ the records confirm a gore dualmesh® biomaterial (1dlmc06/05478724) was used during the procedure.The operative records dated (b)(6) 2008 indicate the patient underwent repair recurrent ventral hernia with mesh.Findings: extensive intraabdominal adhesions of bowel and omentum to anterior abdominal wall, intact previous mesh, hernia below the previous one.The operative records dated (b)(6) 2008state: ¿an incision was then made over the previous midline scar.The same was carried through skin and subcutaneous tissue and scar tissue until the hernia sac was identified.The hernia sac was noted to be lower abdomen and then i proceeded by opening the hernia sac.Upon opening the hernia sac, i noticed that there was a lot of bowel in the sac and i proceeded by carefully reducing this.¿ operative records dated (b)(6) 2008 continue: ¿i noticed that there were multiple adhesions of bowel to the hernia sac itself.So, i proceeded by carefully taking these down.As i was doing this, i noticed that on either side of the hernia itself there were multiple intraabdominal adhesions of omentum and bowel to the anterior abdominal wall and i proceeded by carefully taking most of this down to straighten the bowel.¿ records dated (b)(6) 2008 state: ¿after this was extensively done, care taken not to injure any of the bowel, i was able to straighten most of the bowel out and then i proceeded by excising the hernia sac itself.There was excess omentum in the sac and i excised this as well.After this was done, i proceeded by carefully examining the previously placed mesh, which was superior to where this new hernia is, and i noticed that the mesh itself was intact.¿ operative records dated (b)(6) 2008 state: ¿so i proceeded by copiously irrigating the abdominal cavity and hemostasis was looked for and found to be adequate.So, i proceeded by placing a larger mesh to cover the lower abdomen.The same was sutured in place to the fascia using 0 prolene u-stitches interrupted and this was sutured circumferentially.After this was done it was noted to be without tension.¿ records dated (b)(6) 2008 continue: ¿copious amount of antibiotic irrigation was carried out again and i proceeded by approximating together the subcutaneous tissue using 2-0 vicryl in a running fashion.A 7-mm jackson-pratt drain was then placed in the lower abdomen in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The skin was then approximated together using skin staples.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmcp03/05214810) was used during the procedure.Operative records dated (b)(6) 2008 indicate patient underwent incision and drainage of abdominal wound.Postoperative diagnosis-infected abdominal wound.Operative findings: soft tissue seroma and induration, intact mesh.The operative records dated (b)(6) 2009 state: ¿a small midline incision was then made over the swollen fluctuant area.The same was carried through skin and subcutaneous tissue until the pocket of fluid was encountered.This fluid was drained.It was non-pussy.Some of this was sent for gram stain, culture and sensitivity.Just adjacent to this was an indurated area.So i proceeded by carefully opening this to examine what is causing the induration.¿ the operative records dated (b)(6) 2009 continue: ¿after this was explored there was no area of pus.Copious amount of antibiotic irrigation was started at this point.The mesh was also noted to be intact.So i proceeded by carefully irrigating this area one more time.Hemostasis was achieved using bovie cautery.Then i proceeded by packing the hole with iodoform gauze.Sterile dressings were then applied.¿ there is no mention of infection of the gore devices in the records.The results of the gram stain and culture and sensitivity of the fluid removed during the (b)(6) 2009 procedure were not provided.Primary care visit notes dated (b)(6) 2009 state: ¿patient presents to clinic for refill of pain medication.States pain is improving.Has had mesh in, had infection then had new mesh in a few months ago.Has been having problems with staph infection.Feels better now, has follow up tomorrow with surgeon.Abdomen feels better only a little pain in lower abd [sic] near scar line.Complaints of pain after voiding in side abdomen.No fever or chills.¿ operative records dated (b)(6) 2009 indicate the patient underwent exploratory laparotomy, extensive lysis of adhesions, removal of previous meshes, repair of ventral hernia with biologic mesh, partial omentectomy.Operative findings: extensive adhesions bowel to anterior abdominal wall and bowel to bowel, especially on the right side, old mesh x3, patient's bmi is 40.74 m2.Specimens: old mesh, omentum.The operative records dated (b)(6) 2009 state: ¿a midline incision was then made through the previous scar.The incision was carried through skin, subcutaneous tissue, scar tissue until the fascia was identified.In the upper abdomen the fascia was then carefully incised and the abdominal cavity was entered.Then i proceeded by carefully extending the fascia incision all the way down to the pelvis.¿ the records dated (b)(6) 2009 continue: ¿of note is the fact that there was a lot of bowel adhesions to the anterior abdominal wall so i proceeded by carrying the incision down to the pelvis, i lysed these adhesions so i could gain access proper to the abdominal cavity.Also, the two previous mesh were encountered and i removed these.¿ operative records dated (b)(6) 2009 state: ¿after removing the meshes , i put in a bookwalter retractor.¿of note is the fact that there was extensive bowel-to-bowel adhesions as well and also there was a lot of omentum.¿ so i proceeded [sic] by carefully, lysing the bowel adhesions care taken not to injure the bowel.This was done all the way from ligament of treitz to the terminal ileum.Also i examined the colon.Then i proceeded by doing a partial omentectomy to remove excess omentum.¿ records dated (b)(6) 2009 state: ¿after this was done, a copious amount of antibiotic irrigation was carried out.Hemostasis was looked for and noted to be adequate.Also, the hernia sac which was noted on the right side was carefully cleaned out as well.Then i proceeded by closing the ventral hernia with permacol biologic mesh.Appropriate size of mesh was then cut after the defect was measured.The total mesh is 600 cm square.Then i proceeded by suturing this mesh circumferentially to the fascia using 0 prolene u-stitches interrupted.¿ operative records dated (b)(6) 2009 continue: ¿after this was adequately done and it was noted not to be tension, i copiously irrigated the wound again and then proceeded by placing 2 jackson-pratt drains, one on either side of the incision through separate stab wounds on the anterior abdominal wall.Then i proceeded by closing the subcutaneous tissue using 0 vicryl interrupted stitches and the skin was approximated together using skin staples.Sterile dressings were then applied.¿ there is no mention of infection in the records.Pathology records for the removed mesh specimens were not provided.Post op note dated (b)(6) 2011 indicates the patient underwent laparoscopic lysis of adhesions extensive, laparoscopic ventral hernia repair with mesh.Records indicate an ethicon physiomesh was used during the procedure.No operative report was provided.There is no mention of a gore device in the records.Operative report dated (b)(6) 2012 indicates the patient underwent laparoscopic extensive lysis of adhesions, laparoscopic ventral hernia repair for chronic abdominal pain, recurrent ventral hernia.Findings: very extensive bowel-to-anterior-wall and mesh adhesions, recurrent right lower quadrant ventral hernia.Records indicate an ethicon physiomesh was used during the procedure.There is no mention of a gore device in the records.Operative records dated (b)(6) 2016 indicate the patient underwent exploratory laparotomy with explant of old mesh, lysis of adhesions for greater than 1 hour, repair of enterotomy anterior and posterior component separation, abdominal wall reconstruction with 20 x 30 cm proceed mesh and excision of excess skin as well as cicatrix, placement of an incisional wound vac.The records dated(b)(6) 2016 state: ¿this is a 51-year-old female who had had a history of colon cancer.After her operation she had presented with a ventral hernia which was fixed.She ended up having a second ventral hernia and then a third one it appears that each time meshes were placed.She now presented to my office with complaints of abdominal pain secondary to a large hernia defect.Cat scan did show that she had a loss of domain of her abdominal wall.¿ records dated (b)(6) 2016 indicate a proceed surgical mesh was used during the procedure.There is no mention of a gore device.Emergency room records dated (b)(6) 2016 indicate patient seen for complaint of abdominal infection.The records state: ¿this is a 51-year-old female who arrives via ambulance to the emergency room with a complaint of having a possible abdominal infection.¿ ¿she was placed under observation for treatment of the abdominal surgical wound infection with recephin, iv flagyl, and wound care.The cultures grew antibiotic sensitive e.Coli.Her wound infection and healing improved.¿ emergency room records dated (b)(6) 2017 indicate patient was seen for complaint of infection.The records state: ¿52 year old female complaining of abdominal pain and discharge from an abdominal abscess.¿ ¿she had surgery on (b)(6) 2016.She has been treated for an open wound in that area since that time.¿ ¿she states it appeared that everything was healing up, but in the past 24 hours, a new abscess opened up and started draining.¿ cat scan shows a probable abscess formation at the anterior abdominal wall hernia repair site, slightly to the left of the midline.¿she will be placed on antibiotics.Patient to follow up with surgeon.¿ 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.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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 sigmoid resection and exploratory lap, were not provided.On (b)(6) 2007: [ni].Radiology-ct abdomen.Indication: abd pain.Findings: i see no evidence of enlarged retroperitoneal or pelvic lymph nodes.No free abdominal or pelvic fluid is seen.The small bowel and colon demonstrates generally normal caliber and distribution.Bladder, uterus, ovaries appear normal.Impression: unremarkable ct evaluation of the abdomen and pelvis as noted above.I see no evidence of enlarged retroperitoneal or pelvic lymph nodes or definite evidence of a metastatic mass.On (b)(6) 2008: pcc ambulatory.[ni].Emergency room visit.Cc: llq for over 1 yr.Quit working 1 yr ago, felt better for awhile now bad pain this weekend.Pmh: colon ca 1998, colon resection.Exam: pain radiates to incision, l groin, low back mass palpable with standing but not with [illegible].Tender with palpation just to l of incision.Needs hernia repair.Did a lot of lifting at casino.Impression: ventral hernia.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Cc: c/o abd-back pain.Plan: referral surgery.Ventral hernia.On (b)(6) 2008: [missing records: results from ¿culture obtained from drainage jp site and umbilicus¿ were not provided.] on (b)(6) 2008: (b)(6) health center.(b)(6), md.Office visit.Cc: s/p hernia repair.Plan: rx.On (b)(6) 2008: (b)(6) health center.(b)(6), md.Office visit.Cc: s/p hernia repair.Plan: rx.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Vs: wt.227.5.Cc: evaluation and management of suture removal.Exam: abd, wound well approx.Plan: abd surgery-staple removal.Pt tolerated well.On (b)(6) 2008: (b)(6) hospital.[illegible].Emergency room visit.Cc: c/o pain, redness to abdominal surgical site.States had hernia repair surgery 05/15/08 in (b)(6).Hpi: had appt for post-op recheck with surgeon [illegible] but couldn¿t make it.Says she has had 4 surgeries using same incision site.Has known scar tissue.Exam: abd, suprapubic discomfort.Incision line is clean and dry.Cough, nonproductive.Impression: bladder spasm.Post-operative pain.Plan: d/c.Rx.Need to f/u with surgeon.Pmh: dm ii.Wt 225#.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Cc: rlq pain.Hpi: had hernia surgery 05/15/08 [illegible] fell last thursday and now everything hurts.Electrical pains on r side of abdomen.[increased] pain [with] coughing, sneezing, bm.Midline scar well healed.[illegible] tender low rlq just above and lat to simplexes no cervical motion tenderness.[illegible] ¿pulled muscle¿-can¿t take motion.H/o ¿chocolate cyst¿.Impression: rlq pain.Plan: transvaginal us.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Vs: wt.223.Cc: f/u ¿ultrasound results¿/rlq pain.Hpi: transvag us complete.Saw dr.[illegible] and he felt pain was musculoskeletal [illegible] tried aleve and it works very well for the pain.Also, recent rectal bleeding.Colonoscopy 01/07 (+) tubular adenoma, needs [illegible].Plan: referral colonoscopy.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Exam: abd, small umbilical hernia-recurrence.Impression: umbilical hernia-s/p repair ? recurrence.Ovarian ca.Plan: referral to general surgery.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Impression: umbilical hernia repair.Plan: rx.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Impression: post op umbilical hernia repair.Plan: rx.On (b)(6) 2008: pcc ambulatory.[illegible].Office visit.Cc: postop hernia repair in (b)(6).On (b)(6) 2008: pcc ambulatory.Aly [illegible] fnpc.Office visit.Hpi: here for staple removal.States started with [illegible] tenderness 2 days ago.Also [illegible] a ua check when pt has staples removed.Exam: abdomen, 25 staples without problem.Large 3 x 3 [illegible] firm [illegible].Impression: postop hernia repair abdominal, infection abdominal hernia repair.Plan: f/u prn.On (b)(6) 2008: pcc ambulatory.Aly [illegible], fnpc.Office visit.Hpi: wound recheck.States feeling better.Exam: + redness continues [illegible].Impression: infection improving abdomen.Plan: f/u prn.Continue taking meds.01/12/09: pcc ambulatory.Aly [illegible], fnpc.Office visit.Hpi: c/o redness and extreme pain to abdomen.States started with [illegible].Exam: abdomen [illegible] incision scar [illegible].No drainage.Impression: infection scar line abdomen.Plan: rx.F/u 2 days.On (b)(6) 2009: pcc ambulatory.Aly [illegible] fnpc.Office visit.Hpi: f/u infection on abdomen/scar inc.Exam: no increase in redness.Impression: infected scar line abdomen.Plan: f/u friday for i&d, warm pack.On (b)(6) 2009: pcc ambulatory.Aly [illegible] fnpc.Office visit.Hpi: continues with pain to abdomen.Swelling redness.Feeling well.Exam: abdomen [illegible] no increase in redness.Will refer back to surgery.Impression: abdominal pain.Infection [illegible].Plan: referral to dr.Oyetonde 01/23/09.On (b)(6) 2009: public health nurse pcc.Nurse notes.Cc: dressing change, initial visit.Hpi: s/p ventral hernia repair.Had severe abdominal pain and underwent incision and drainage (i&d) surgery for abscess.Has incision to lower abd midline.Skin has open area to mid abd area.Wound is packed with iodoform dressing, 4 x 4 gauze and abd pad.Small amt serous drainage.Packed wound with iodoform gauze, 4 x 4 gauze and abd dressing.Tolerated well.Informed pt that phn can only provide dressing change once a day, m-f.Pt agreed to daily drsg change m-f.Cont home visits on daily basis for dressing change.Plan: revisit friday for dressing change.On (b)(6) 2009: pcc ambulatory.Aly dect, fnpc.Office visit.Impression: abdominal incisional infection.Plan: wound care supplies.F/u prn.On (b)(6) 2009: pcc.Nurse notes.Hpi: reports has been running a fever.Exam: dressings removed from abd incision area for small amt serous drainage.[no] s/s infection.Has small opening to abd incision, 1 ½ cm in depth.Packed wound with iodoform gauze and covered with 4 x 4 dressing and abd dressing and tied abd binder.Spouse will do dressing change this weekend.Spouse instructed about drsg change.Impression: dressing change s/p ventral hernia repair.[rrdecoteau-5pbe-kba-00034] on (b)(6) 2009: pcc.Nurse notes.Hpi: pt and husband did the dressing change.Phn will come out tuesday and thursday to assess wound care.Impression: dressing change s/p ventral hernia repair.On (b)(6) 2009: pcc.Nurse notes.Exam: dressing removed, small amt serous drainage about size of deck of cards.Incision area has 2 small areas that were dehisced.Wound bed has light yellow drainage.Packed wound with iodoform gauze and covered with abd dressing.Notified a.(b)(6), np about wound infection.Appt scheduled today.Impression: dressing change s/p ventral repair.On (b)(6) 2009: pcc ambulatory.Aly dect, fnpc.Office visit.Hpi: here for wound check, dressing changed.Exam: wound suture intact.Pink, no increased redness.Impression: wound check, abdominal infection.On (b)(6) 2009: pcc ambulatory.Aly [illegible], fnpc.Office visit.Abdominal pain wound infection.Plan: augmentin.On (b)(6) 2009: public health nurse pcc.Nurse notes.Contacted pt about dressing change.Pt stated ¿i don¿t need help anymore.I went to the doctor yesterday and he sewed up the two openings.¿ pt happy that wound is healing.D/c from phn services.On (b)(6) 2009: pcc ambulatory.Aly dct, fnpc.Office visit.Exam: wound, no redness.Impression: abdominal pain s/p infection.Yeast infection by hx.Plan: f/u prn.On (b)(6) 2009: (b)(6) mem hlth fac.(b)(6), np.Office visit.Hpi: pain management.Has been followed by dr.(b)(6) for abdominal hernia with infection.Has ct scheduled, f/u with possible surgery.Will do pain management here.Having some constipation.States pain with bowel movements.Has followed with dr.Swenson in past for colonoscopies.Exam: abd-obese, tender along scar line.Plan: pain rx.F/u dr.Swenson.F/u prn.On (b)(6) 2009: (b)(6) mem hlth fac.(b)(6), np.Office visit.Hpi: feeling depressed about pain to abdomen and all the surgeries.Has some nausea and bowel movements go from diarrhea to constipation.Exam: abdomen-obese, firm tender scar line.Impression: abdominal pain s/p hernia repair, nausea.On (b)(6) 2009: (b)(6) mem hlth fac.(b)(6), np.Office visit.Hpi: c/o pain to abdomen, along scar line.Has had problems with hernia repair.States infection and pain.Exam: abdomen-very firm, very tender along scar line.Plan: rx.Refer to surgery clinic.On (b)(6) 2009: (b)(6) mem hlth fac.(b)(6), np.Office visit.Hpi: continued abdominal pain.Exam: abdomen-firm tender rlq below umbilical are [sic] to suprapubic area.Impression: abdominal pain chronic s/p hernia repair/infection.Plan: has f/u with dr.(b)(6) the 23 of july.F/u prn.On (b)(6) 2009: pcc ambulatory.Aly d.Office visit.Cc: abdominal pain.On (b)(6) 2009: (b)(6) mem hlth fac.(b)(6), np.Office visit.Hpi: continued c/o abdominal pain.States ¿i am tired of hurting.¿ bowel movements are small hard, has had problem with constipation.Exam: abdomen-obese, firm very tender across lower quadrants and around suture line.Some redness noted below umbilicus approximately quarter size.Plan: keep appointment with dr.(b)(6).Kub pending radiology report.On (b)(6) 2009: pcc ambulatory.(b)(6) (b)(6).Office visit.Cc: presents to west clinic states i can¿t see (b)(6) (b)(6) no more, i have tumors in my stomach and i need a biopsy tomorrow.My doctor in (b)(6) said i need a real md for pain management.08/26/09: pcc ambulatory.Aly dct, fnpc.Office visit.Chronic abdominal pain.Plan: rx.F/u prn.On (b)(6) 2009: pcc ambulatory.Aly dct, fnpc.Phone call.Pt left message requesting refill pain meds.Abdominal pain.On (b)(6) 2009: pcc ambulatory.Aly dcot, fnpc.Office visit.Hpi: here for staple removal s/p abdominal surgery.States a couple staples fell out.Does have abdominal pain but not any different.Exam: abdomen, obese firm suture line intact without drainage or redness.49 staples removed, steri-strips applied [illegible] bs [illegible].Skin, a couple of red itchy lesions.Impression: staple removal s/p abdominal surgery.Dermatitis.Plan: f/u dr.Tunde as directed.(b)(6) 2010: pcc ambulatory.Pamela kidd.Office visit.Hpi: gaining weight.Recent surgery for multiple hernia repair, partial omentectomy, postop infection 10/09 [possible discrepancy, ¿abd surgery¿ mentioned 09/09] with mesh replacement, hx 9 surgeries in last 2 years.(b)(6) working very well for abd pain.Exam: wearing binder over abd.On (b)(6) 2010: pcc ambulatory.[illegible], fnpc.Office visit.Exam: abd-morbidly obese, large vertical scar noted, well approximated.On (b)(6) 2010: pcc ambulatory.[illegible].Office visit.Cc: recheck diab, cad.Exam: mid line surgeries scar.[illegible].Impression: abd surgeries multiple.On (b)(6) 2010: pcc ambulatory.[illegible].Office visit.Hpi: abd pain.Plan: ct abd.On (b)(6) 2010: [missing record: radiology report for ct abd was not provided.] on (b)(6) 2011: pcc ambulatory.[illegible].Office visit.Hpi: h/o hernia, following with dr.Tunde q 2 mos.Exam: abd-surgical 5 mos [illegible].Impression: hernia repair.Plan: f/u after (b)(6).On (b)(6) 2012: (b)(6) mem hlth fac.(b)(6), md.Office visit.Cc: referral needed for dr.Tunde.Hpi: had an abdominal ventral hernia remotely, which required mesh to repair.The mesh has fractured several times with repair from dr.Tunde on a couple occasions.Now having papin [sic] again, similar to when her mesh has failed, and she wants to be referred back to dr.Tuned for repair of mesh.Also wants stool softeners.Exam: gastrointestinal: tenderness all across mid and lower abdomen where mesh is in place.Some bulging of lower abdomen, below umbilicus.Impression: other ventral hernia without mention of obstruction or gangrene.On (b)(6) 2015: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: reports chronic herniation of abdominal wall and wants it revised.Exam: abdomen: large tender hernia in llq and rlq.Binder noted.Impression: hernia of abdominal wall.Plan: referral placed per pt request but discussed the fact that contract health will likely not cover this.On (b)(6) 2015: [missing records: radiology report for ¿most recent prior abdominal study here was (b)(6) 2015¿ was not provided.] on (b)(6) 2016: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: has a large abdominal wall hernia.Incisional hernia s/t prior surgery for colon ca.Has had prior repairs which have failed, was caring for her mother whom was ill and did a lot of lifting.Has a lot of pain d/t size of hernia.Has been referred for repair and needs abdominal reconstruction in addition to repair.Has spasm like pain.Exam: abdomen: large abdominal hernia, tender to palpation.Plan: referral placed for hernia repair.F/u 6 months, prn.On (b)(6) 2016: (b)(6)mem hlth fac.Nurse notes.Wound culture obtained.Dressing applied with abdominal binder.On (b)(6) 2016: [missing records: records for ¿wound culture¿ were not provided.] on (b)(6) 2016: (b)(6) mem hlth fac.(b)(6).History and physical.Cc: wound infection.Exam: abdomen: vertical surgical incision with staples.Sweet-fruity smelling discharge from wound, small amount surrounding erythema.Wound does not look to be closing well.Abd firm, protuberant, mildly tender on l.On (b)(6) 2016: (b)(6) mem hlth fac.(b)(6).Progress notes.Exam: abdomen: surgical wound with decreased erythema and drainage today.No serous drainage expressed.Small amount fibrinous exudates along incision line.Wound appears to be knitting to gether [sic] better today.Decreased firmness and protuberance today.Impression: wound infection with possible seroma.Plan: activity: ambulate halls with assist bid.Abdominal binder over dressings.On (b)(6) 2016: (b)(6) mem hlth fac.(b)(6).Progress notes.Hpi: wound culture grew abx sensitive e.Coli.Exam: abdomen: surgical wound with decreasing discharge, knitting together.Soft, non-tender.On (b)(6) 2016: (b)(6) mem hlth fac.(b)(6).Discharge summary.Dx: wound infection and probable seroma.Abdominal wall hernias s/p surgical repair (b)(6) 2016.Constipation.Plan: condition good, d/c home.Activity as tolerated.F/u with surgeon (b)(6) 2016.05/11/16-08/12/16: [missing records: records for wound care, wound vac were not provided.] on (b)(6) 2016: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: had large abdominal wall hernia.Incisional hernia s/t prior surgery for colon ca.Recently repaired.Has dehiscence of the abdominal incision, now healing by secondary intention.Had wound vac initially, now doing wet to dry packing.Exam: abdomen: open surgical wound, minimal serous drainage, no abnormal odor, granulating tissue.Plan: continue dressing changes as recommended.Rtc 4 months.On (b)(6) 2017: [ni].Radiology-ct abd/pelvis.Indication: pain, wound abd wall, abscess abd wall.Most recent prior abdominal study here was (b)(6) 2015.Findings: anterior abdominal wall mesh appreciated.The adjacent small bowel loops are mildly dilated, have thickening of tinea conniventes, appear irritated.Subtending this and at the level of the iliac wings the slightly left of midline surgical repair becomes subcutaneous mounding of soft tissues as well as one pocket of air opening to the skin.In the mixture of these findings is a focal small area of barely detectable approximately 1 cm wall enhancement suggesting an accompanying abscess.On the sagittal plane the region of irregular enhancement suggesting abscess is somewhat larger and is 3.7 cm in cephalocaudad dimension by 2.7 cm in ap dimension.There is no entrapment of bowel.Some of the bowel is immediately adjacent this finding without a clear-cut fascial plan.There is a generous panniculus present.Impression: probable abscess formation at anterior abdominal wall hernia repair slightly to left of midline.This focus measures 3.7 x 2.7 x 1.0 cm.Adjacent bowel loops appear inflamed.Hepatomegaly.Stable appearance of the 2.4 cm nodule left adrenal.On (b)(6) 2017: [missing records: results of wound cultures were not provided.] 03/01/17: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: large abdominal wall hernia repair complicated by wound dehiscence.There are persistent sites that have not completely healed and drain intermittently.Had f/u with surgeon dr.Brent, changed antibiotics and cauterized the area.Seems to be healing at this point.Plan: part of reason blood sugars may be out of control is d/t the non-healing surgical incision and infection, continue to work with surgeon to clear this up.On (b)(6) 2017: [missing records: radiology report of ct indicating ¿enterocutaneous fistula strongly suspected¿ was not provided.] on (b)(6) 2017: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: large abdominal hernia repair complicated by wound dehiscence.Open sites which have not completely healed and drain intermittently.States ct in rolla, there is some sort of perforation.Has appointment wednesday to discuss results and arrange surgery.Exam: abdomen: rlq tender.Surgical incision open near umbilicus with bloody drainage.Plan: states surgeon would like her to hold off on colonoscopy, pap smear, dental exam until her abdominal wound has healed.On (b)(6) 2017: (b)(6)mem hlth fac.(b)(6).Office visit.Hpi: had rectal cancer/ventral hernia rep with mesh infection.Seen by dr.Brandt.Issue of drainage.Dressing was soaked with serosanguineous blood.Infected mesh was removed by (her) and wound was packed with iodoform and partially closed.Impression: wound umbilical region with open/iodoform packing postop.Plan: advised to change (the dressing) as needed.Next week f/u.On (b)(6) 2017: (b)(6) mem hlth fac.Er nurse notes.Cc: assaulted.Hpi: open wound abd from infections.Exam: abdomen: large open wound abdomen past 18 month d/t repeated infections had a packing in today but took it out.Wound on abdomin [sic] packed with packing as instructed per pt.Plan: being d/c¿d.On (b)(6) 2017: (b)(6) mem hlth fac.Nurse notes.Cc: check stomach wound-pt reports she ¿still¿ has hole in it from 2001 surgery and would like referral to different surgeon d/t dr.(b)(6) not helping her.On (b)(6) 2017: (b)(6) mem hlth fac.(b)(6), md.Office visit.Cc: drainage from a persistent open surgical wound.Hpi: on 05/07/16 presented to er, wound had opened.Referred back to dr.Brandt whom performed repair [(b)(6) 2016].Wound vac was tried and wound did not completely close.Has had abscess formation within abdomen.Has been on some form of antibiotic since wound dehisced.Dr.Brandt has been changing it every 3-4 months.Had to undergo a second procedure in august, wound intentionally left open for secondary healing with wet-to-dry packing.Constantly has dark foul-smelling drainage.Uses dankins solution, does help with smell.Her last prescription from dr.Brandt was delayed and she was without medications for 2-3 days and noted increase in amount of drainage.States dr.Brandt referred her to dr.Nwaigwe, infectious disease, however he then canceled the appointment.Exam: abdomen: approximately 5 x 3, clear to serous drainage, no evident malodor.Plan: culture of wound obtained.Will make referral to infections disease.On (b)(6) 2017: [missing records: results of ¿culture of wound¿ were not provided.] on (b)(6) 2018: [ni].Radiology-ct abd/pelvis.Indication: pain.Non-healing surgical wound, s/p hernia repair, wound drainage, hx abscess, abdominal pain.Findings: multiple surgical clips are seen nearby along the anterior abdominal wall.There is a stable generalized thinning of the anterior abdominal wall with widening between the rectus muscles.There is evidence of previous abdominal wall surgery.Impression: stable appearance of anterior abdominal wall with soft tissue thickening at the level of the umbilicus without signs of expanding or enlarging hernia.There is widening between the recuts muscles and stable thickening.There is no evidence of abscess collection.Overall examination is stable.Slight interval enlargement left adrenal gland nodule measuring 2.8 x 2.0 cm.The nodule has been present over multiple prior exams as far back as 01/16/08 suggesting a benign lesion.Comparison 05/11/17.On (b)(6) 2018: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: abdominal non healing wound for past 2 ½ years post-surgery.Noncompliance with diagnostic testing.Exam: abdomen: obese with gaping wound on umbilical area, tender to touch with some discharges.Plan: refer to dr.Neweige for f/u.On (b)(6) 2018: (b)(6) mem hlth fac.(b)(6), md.Office visit.Hpi: going to (b)(6) [sic] next week to see a surgeon.Exam: abdomen: obese, draining wound still noted.Plan: advice to keep appt in (b)(6) [sic].On (b)(6) 2018: (b)(6) mem hlth fac.(b)(6), md.Phone call.Called for rx, was supposed to go to (b)(6) [sic] for surgical consult by did not go, claimed it was reschedule [sic] next month.On (b)(6) 2019: (b)(6) mem hlth fac.(b)(6).Office visit.Hpi: pt seeking a new pcp.Complicated pt, ended up with an infected abdominal mesh after surgery for colon cancer 1998.Mesh was placed in 2004, problems ever since.Last mesh related operation was in april 2016.Was left with nonhealing lower abdominal wound that is leaking malodorous fluid.Has been on augmentin for quite some time without an apparent cure of her abdominal infection.Surgical specialist in minot has referred her to another mesh specialist in fargo, north dakota.Exam: abdomen: obese.Wound at lower abdomen, almost looks like an ostomy site.Malodorous.Scant fluid.Scattered tenderness at abdomen more so around surgical site.Plan: wound culture.Addendum: wound culture positive for escherichia coli.Susceptible to levofloxacin.I will give this to her because at least it given once daily, which should avoid problems with noncompliance.Hernia specialist is dr.Gary (b)(6) at meritcare health system in fargo.E.Coli in wound fluid indicates a colonic leak.This will have to be worked up and taken care of prior to closing off wound.On (b)(6) 2019: (b)(6) mem hlth fac.(b)(6).Office visit.Hpi: h/o entero-cutaneousfistula [sic], will be addressed by surgical specialist for first time on (b)(6) 2019.Has been on levofloxacin for 26 days for e.Coli identified on secretions from abdominal wound.C/o nausea, vomiting, diarrhea.Impression: enterocutaneous fistula strongly suspected on ct scan (b)(6) 2017.On (b)(6) 2019: [missing records: office visit records for ¿surgical specialist addressing enterocutaneous fistula for first time on 03/01/19¿ were not provided.] on (b)(6) 2019: (b)(6) mem hlth fac.(b)(6).Phone call.Pt was recently seen by a hernia specialist for help with an infected hernioplasty mesh.Dr.(b)(6) said it was too complex an issue for him to resolve.He recommended pt be referred to the mayo clinic.On (b)(6) 2019: (b)(6) mem hlth fac.(b)(6).Office visit.Hpi: referral to mayo clinic surgical department.Says she is coughing and wheezing on and off.Says she has stopped smoking about 3 weeks ago.On (b)(6) 2019: (b)(6) mem hlth fac.(b)(6).Office visit.Hpi: lower abdominal pain at site of fistula.Exam: abdomen: has no umbilicus.At lower abdomen, there are 2 openings.In 1 he [sic] can see blue mesh and some gray matter.Gas from this site, smells fecal.Plan: has appointment with surgical clinic at mayo on (b)(6) 2019.On (b)(6) 2019: [missing records: office visit records at mayo surgical clinic 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 includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient codes (2069, 1930, 2225) 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), 2007 through (b)(6), 2019 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial and gore® dualmesh® plus biomaterial.Patient information: medical history: obesity (b)(6) 2008: 237lbs; bmi 40.7; (b)(6) 2008: 227.5lbs; bmi 39.0; (b)(6) 2008: 225lbs; bmi 38.6; (b)(6) 2009: 228 lbs; bmi 39.1; (b)(6) 2009: 237lbs; bmi 40.74; (b)(6) 2010: 220lbs; bmi 37.8; (b)(6) 2011: 215lbs; bmi 36.9.Diabetes hyperlipidemia hypertension gastroesophageal reflux disease colon cancer, state 2 with chemotherapy smoking prior surgical procedures: 1998: sigmoid resection.(b)(6) 1998: ovarian cystotomy and ovarian biopsy.(b)(6) 2007: exploratory laparotomy with left salpingo-oophorectomy, aspiration of ovarian cyst, lysis of pelvo-abominal adhesions, d&c [dilation and curettage]of endometrial cavity, bilateral ureteral stenting, incidental appendectomy.Implant #1 preoperative complaints: (b)(6) 2008: ¿pain radiates to incision, l groin, low back mass palpable with standing but not with [illegible].Tender with palpation just to l of incision.Needs hernia repair.Did a lot of lifting at casino.Impression: ventral hernia.¿ implant #1 procedure: repair of recurrent ventral hernia with a mesh.Implant: gore® dualmesh® biomaterial (05478724/1dlmc06) 18 x 24 cm.Implant #1 date: (b)(6), 2008 description of hernia being treated: ¿an incision was then made over the previous scar and the scar was then excised.The incision was then carried through subcutaneous tissue until the hernia sac was encountered.The hernia sac was noted to be a large sac.The same was then dissected free from the fascia circumferentially.After this was done the sac was then opened and the contents were examined.It contained small bowel and omentum.Then i proceeded by carefully taking down the adhesions of the bowel and omentum to the hernia sac, care taken not to injure the bowel.After this was extensively done, the bowel was then carefully reduced back into the abdominal cavity.The excess omentum was then carefully excised using the harmonic scalpel.After this was done hemostasis was looked for and noted to be adequate.The hernia sac was then also excised circumferentially and the fascia edge was inspected and noted to be clean.¿ implant size and fixation: ¿after this was done a dual-mesh was then cut into appropriate oval size and the same was then used to cover the hernia defect.The dual-mesh was sutured in place to the fascia circumferentially using 0prolene u-stitches.After this was done, inspection confirmed adequate closure of the fascia defect with no tension.Then copious amounts of antibiotic irrigation was carried out.I proceeded by placing a 7 mm jackson-pratt drain in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The drain was sutured in place using 2-0 silk stitch.The subcutaneous tissue was then approximated together using 2-0 vicryl stitch.Skin was approximated together using skin staples.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2008: ¿evaluation and management of suture removal.Exam: abd, wound well approx.Plan: abd surgery-staple removal.Pt tolerated well.¿ (b)(6) 2008: ¿c/o [complains of] pain, redness to abdominal surgical site.States had hernia repair surgery (b)(6) 2008 in minot.¿ ¿had appt for post-op recheck with surgeon [illegible] but couldn¿t make it.Says she has had 4 surgeries using same incision site.Has known scar tissue.¿ ¿abd [abdomen], suprapubic discomfort.Incision line is clean and dry.Cough, nonproductive.Impression: bladder spasm.Post-operative pain.¿ (b)(6) 2008: ¿had hernia surgery (b)(6) 2008 [illegible] fell last thursday and now everything hurts.Electrical pains on r side of abdomen.[increased] pain [with] coughing, sneezing, bm.Midline scar well healed.[illegible] tender low rlq [right lower quadrant] just above and lat [lateral] to simplexes no cervical motion tenderness.[illegible] ¿pulled muscle¿-can¿t take motion.H/o [history of] ¿chocolate cyst¿.¿ (b)(6) 2008: ¿f/u ¿ultrasound results¿/rlq pain.Hpi: transvag us [transvaginal ultrasound] complete.Saw dr.[illegible] and he felt pain was musculoskeletal [illegible] tried aleve and it works very well for the pain.Also, recent rectal bleeding.Colonoscopy (b)(6) 2007 (+) tubular adenoma, needs [illegible].¿ implant #2 preoperative complaints: (b)(6) 2008: ¿abd, small umbilical hernia-recurrence.Impression: umbilical hernia-s/p [status post] repair ? recurrence.¿ implant #2 procedure: repair recurrent ventral hernia with mesh.Implant: gore® dualmesh® plus biomaterial (05214810/1dlmcp03) 10 x 15 cm, oval.Implant #2 date: (b)(6), 2008 ¿extensive intraabdominal adhesions of bowel and omentum to anterior abdominal wall, intact previous mesh, hernia below the previous one.¿ description of hernia being treated: ¿an incision was then made over the previous midline scar.The same was carried through skin and subcutaneous tissue and scar tissue until the hernia sac was identified.The hernia sac was noted to be lower abdomen and then i proceeded by opening the hernia sac.Upon opening the hernia sac, i noticed that there was a lot of bowel in the sac and i proceeded by carefully reducing this.I noticed that there were multiple adhesions of bowel to the hernia sac itself.So, i proceeded by carefully taking these down.As i was doing this, i noticed that on either side of the hernia itself there were multiple intraabdominal adhesions of omentum and bowel to the anterior abdominal wall and i proceeded by carefully taking most of this down to straighten the bowel.After this was extensively done, care taken not to injure any of the bowel, i was able to straighten most of the bowel out and then i proceeded by excising the hernia sac itself.There was excess omentum in the sac and i excised this as well.After this was done, i proceeded by carefully examining the previously placed mesh, which was superior to where this new hernia is, and i noticed that the mesh itself was intact.¿ implant size and fixation: ¿so i proceeded by copiously irrigating the abdominal cavity and hemostasis was looked for and found to be adequate.So, i proceeded by placing a larger mesh to cover the lower abdomen.The same was sutured in place to the fascia using 0 prolene u-stitches interrupted and this was sutured circumferentially.After this was done it was noted to be without tension.Copious amount of antibiotic irrigation was carried out again and i proceeded by approximating together the subcutaneous tissue using 2-0 vicryl in a running fashion.A 7-mm jackson-pratt drain was then placed in the lower abdomen in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The skin was then approximated together using skin staples.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2008: ¿here for staple removal.States started with [illegible] tenderness 2 days ago.Also [illegible] a ua [urinalysis] check when pt [patient] has staples removed.Exam: abdomen, 25 staples without problem.Large 3 x 3 [illegible] firm [illegible].Impression: postop hernia repair abdominal, infection abdominal hernia repair.¿ (b)(6) 2008: ¿wound recheck.States feeling better.Exam: + redness continues [illegible].Impression: infection improving abdomen.¿ (b)(6) 2009: ¿c/o redness and extreme pain to abdomen.States started with [illegible].Exam: abdomen [illegible] incision scar [illegible].No drainage.Impression: infection scar line abdomen.¿ (b)(6) 2009: ¿f/u [follow up] infection on abdomen/scar inc [incision].Exam: no increase in redness.Impression: infected scar line abdomen.¿ (b)(6) 2009: ¿continues with pain to abdomen.Swelling redness.Feeling well.Exam: abdomen [illegible] no increase in redness.Will refer back to surgery.¿ (b)(6) 2009: incision and drainage of abdominal wound findings: ¿soft tissue seroma and induration, intact mesh¿ ¿a small midline incision was then made over the swollen fluctuant area.The same was carried through skin and subcutaneous tissue until the pocket of fluid was encountered.This fluid was drained.It was non-pussy [sic].Some of this was sent for gram stain, culture and sensitivity.Just adjacent to this was an indurated area.So i proceeded by carefully opening this to examine what is causing the induration.After this was explored there was no area of pus.Copious amount of antibiotic irrigation was started at this point.The mesh was also noted to be intact.So i proceeded by carefully irrigating this area one more time.Hemostasis was achieved using bovie cautery.Then i proceeded by packing the hole with iodoform gauze.Sterile dressings were then applied.¿ post-operative diagnosis: ¿infected abdominal wound¿ reports for the ¿gram stain, culture and sensitivity¿ for specimens collected during the (b)(6) 2009 procedure were not provided.(b)(6) 2009: ¿s/p [status post] ventral hernia repair.Had severe abdominal pain and underwent incision and drainage (i&d) surgery for abscess.Has incision to lower abd midline.Skin has open area to mid abd area.Wound is packed with iodoform dressing, 4 x 4 gauze and abd pad.Small amt serous drainage.Packed wound with iodoform gauze, 4 x 4 gauze and abd dressing.Tolerated well.Informed pt that phn [public health nurse] can only provide dressing change once a day, m-f.Pt agreed to daily drsg [dressing] change m-f.Cont [continue] home visits on daily basis for dressing change.¿ (b)(6) 2009: ¿reports has been running a fever.¿ ¿dressings removed from abd incision area for small amt serous drainage.[no] s/s infection.Has small opening to abd incision, 1 ½ cm in depth.Packed wound with iodoform gauze and covered with 4 x 4 dressing and abd dressing and tied abd binder.Spouse will do dressing change this weekend.Spouse instructed about drsg change.¿ (b)(6) 2009: ¿dressing removed, small amt serous drainage about size of deck of cards.Incision area has 2 small areas that were dehisced.Wound bed has light yellow drainage.Packed wound with iodoform gauze and covered with abd dressing.Notified (b)(6), np about wound infection.¿ (b)(6) 2009: ¿here for wound check, dressing changed.Exam: wound suture intact.Pink, no increased redness.Impression: wound check, abdominal infection.¿ (b)(6) 2009: ¿abdominal pain wound infection.Plan: augmentin.¿ (b)(6) 2009: ¿contacted pt about dressing change.Pt stated ¿i don¿t need help anymore.I went to the doctor yesterday and he sewed up the two openings.¿ pt happy that wound is healing.D/c [discharge] from phn services.¿ (b)(6) 2009: ¿wound, no redness.Impression: abdominal pain s/p infection.¿ explant preoperative complaints: (b)(6) 2009: ¿patient presents to clinic for refill of pain medication.States pain is improving.Has had mesh in, had infection then had new mesh in a few months ago.Has been having problems with staph infection.Feels better now, has follow up tomorrow with surgeon.Abdomen feels better only a little pain in lower abd [sic] near scar line.Complaints of pain after voiding in side abdomen.No fever or chills.¿ (b)(6) 2009: ¿c/o pain to abdomen, along scar line.Has had problems with hernia repair.States infection and pain.Exam: abdomen-very firm, very tender along scar line.¿ (b)(6) 2009: ¿abdominal pain chronic s/p hernia repair /infection.¿ (b)(6) 2009: ¿continued c/o abdominal pain.States ¿i am tired of hurting.¿ bowel movements are small hard, has had problem with constipation.¿ ¿abdomen-obese, firm very tender across lower quadrants and around suture line.Some redness noted below umbilicus approximately quarter size.¿ explant procedure: exploratory laparotomy, extensive lysis of adhesions, removal of previous meshes, repair of ventral hernia with biologic mesh, partial omenectomy.Explant date: (b)(6), 2009 findings: ¿extensive adhesions bowel to anterior abdominal wall and bowel to bowel, especially on the right side, old mesh x3.¿ ¿a midline incision was then made through the previous scar.The incision was carried through skin, subcutaneous tissue, scar tissue until the fascia was identified.In the upper abdomen the fascia was then carefully incised and the abdominal cavity was entered.Then i proceeded by carefully extending the fascia incision all the way down to the pelvis.Of note is the fact that there was a lot of bowel adhesions to the anterior abdominal wall so i proceeded by carrying the incision down to the pelvis, i lysed these adhesions so i could gain access proper to the abdominal cavity.Also, the two previous mesh were encountered and i removed these.After removing the meshes, i put in a bookwalter retractor.Of note is the fact that there was extensive bowel-to-bowel adhesions as well and also there was a lot of omentum.So i proceeded by carefully, lysing the bowel adhesions care taken not to injure the bowel.This was done all the way from ligament of treitz to the terminal ileum.Also i examined the colon.Then i proceeded by doing a partial omentectomy to remove excess omentum.After this was done, a copious amount of antibiotic irrigation was carried out.Hemostasis was looked for and noted to be adequate.Also, the hernia sac which was noted on the right side was carefully cleaned out as well.Then i proceeded by closing the ventral hernia with permacol biologic mesh.Appropriate size of mesh was then cut after the defect was measured.The total mesh is 600 cm square.Then i proceeded by suturing this mesh circumferentially to the fascia using 0 prolene u-stitches interrupted.After this was adequately done and it was noted not to be tension, i copiously irrigated the wound again and then proceeded by placing 2 jackson-pratt drains, one on either side of the incision through separate stab wounds on the anterior abdominal wall.Then i proceeded by closing the subcutaneous tissue using 0 vicryl interrupted stitches and the skin was approximated together using skin staples.Sterile dressings were then applied.¿ no post-operative records were provided.Conclusions: gore® dualmesh® plus biomaterial (05214810/1dlmcp03) it should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal rnay be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 05214810.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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Manufacturer Narrative
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H6: updated health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.Previous patient codes (2069, 1930, 2225) 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) 2007 through (b)(6) 2019 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial and gore® dualmesh® plus biomaterial.Patient information: medical history: obesity: on (b)(6) 2008: 237lbs; bmi 40.7.On (b)(6) 2008: 227.5lbs; bmi 39.0.On (b)(6) 2008: 225lbs; bmi 38.6.On (b)(6) 2009: 228 lbs; bmi 39.1.On (b)(6) 2009: 237lbs; bmi 40.74.On (b)(6) 2010: 220lbs; bmi 37.8.On (b)(6) 2011: 215lbs; bmi 36.9.Diabetes, hyperlipidemia, hypertension, gastroesophageal reflux disease, colon cancer, state 2 with chemotherapy, smoking.Prior surgical procedures: in 1998: sigmoid resection.In (b)(6) 1998: ovarian cystotomy and ovarian biopsy.In (b)(6) 2007: exploratory laparotomy with left salpingo-oophorectomy, aspiration of ovarian cyst, lysis of pelvo-abominal adhesions, d&c [dilation and curettage]of endometrial cavity, bilateral ureteral stenting, incidental appendectomy.Implant #1 preoperative complaints: on (b)(6) 2008: ¿pain radiates to incision, l groin, low back mass palpable with standing but not with [illegible].Tender with palpation just to l of incision.Needs hernia repair.Did a lot of lifting at casino.Impression: ventral hernia.¿ implant #1 procedure: repair of recurrent ventral hernia with a mesh.Implant: gore® dualmesh® biomaterial (05478724/1dlmc06) 18 x 24 cm.Implant #1 date: (b)(6) 2008.Description of hernia being treated: ¿an incision was then made over the previous scar and the scar was then excised.The incision was then carried through subcutaneous tissue until the hernia sac was encountered.The hernia sac was noted to be a large sac.The same was then dissected free from the fascia circumferentially.After this was done the sac was then opened and the contents were examined.It contained small bowel and omentum.Then i proceeded by carefully taking down the adhesions of the bowel and omentum to the hernia sac, care taken not to injure the bowel.After this was extensively done, the bowel was then carefully reduced back into the abdominal cavity.The excess omentum was then carefully excised using the harmonic scalpel.After this was done hemostasis was looked for and noted to be adequate.The hernia sac was then also excised circumferentially and the fascia edge was inspected and noted to be clean.¿ implant size and fixation: ¿after this was done a dual-mesh was then cut into appropriate oval size and the same was then used to cover the hernia defect.The dual-mesh was sutured in place to the fascia circumferentially using 0prolene u-stitches.After this was done, inspection confirmed adequate closure of the fascia defect with no tension.Then copious amounts of antibiotic irrigation was carried out.I proceeded by placing a 7 mm jackson-pratt drain in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The drain was sutured in place using 2-0 silk stitch.The subcutaneous tissue was then approximated together using 2-0 vicryl stitch.Skin was approximated together using skin staples.¿ no post-operative records were provided.Relevant medical information: on (b)(6) 2008: ¿evaluation and management of suture removal.Exam: abd, wound well approx.Plan: abd surgery-staple removal.Pt tolerated well.¿ on 6/13/08: ¿c/o [complains of] pain, redness to abdominal surgical site.States had hernia repair surgery (b)(6) 08 in (b)(6).¿ ¿had appt for post-op recheck with surgeon [illegible] but couldn¿t make it.Says she has had 4 surgeries using same incision site.Has known scar tissue.¿ ¿abd [abdomen], suprapubic discomfort.Incision line is clean and dry.Cough, nonproductive.Impression: bladder spasm.Post-operative pain.¿ on (b)(6) 2008: ¿had hernia surgery (b)(6) 2008 [illegible] fell last thursday and now everything hurts.Electrical pains on r side of abdomen.[increased] pain [with] coughing, sneezing, bm.Midline scar well healed.[illegible] tender low rlq [right lower quadrant] just above and lat [lateral] to simplexes no cervical motion tenderness.[illegible] ¿pulled muscle-can¿t take motion.H/o [history of] ¿chocolate cyst¿.¿ on (b)(6) 2008: ¿f/u ¿ultrasound results¿/rlq pain.Hpi: transvag us [transvaginal ultrasound] complete.Saw dr.[illegible] and he felt pain was musculoskeletal [illegible] tried aleve and it works very well for the pain.Also, recent rectal bleeding.Colonoscopy (b)(6) (+) tubular adenoma, needs [illegible].¿ implant #2 preoperative complaints: on (b)(6) 2008: ¿abd, small umbilical hernia-recurrence.Impression: umbilical hernia-s/p [status post] repair ? recurrence.¿ implant #2 procedure: repair recurrent ventral hernia with mesh.Implant: gore® dualmesh® plus biomaterial (05214810/1dlmcp03) 10 x 15 cm, oval.Implant #2 date: (b)(6) 2008.¿extensive intraabdominal adhesions of bowel and omentum to anterior abdominal wall, intact previous mesh, hernia below the previous one.¿ description of hernia being treated: ¿an incision was then made over the previous midline scar.The same was carried through skin and subcutaneous tissue and scar tissue until the hernia sac was identified.The hernia sac was noted to be lower abdomen and then i proceeded by opening the hernia sac.Upon opening the hernia sac, i noticed that there was a lot of bowel in the sac and i proceeded by carefully reducing this.I noticed that there were multiple adhesions of bowel to the hernia sac itself.So, i proceeded by carefully taking these down.As i was doing this, i noticed that on either side of the hernia itself there were multiple intraabdominal adhesions of omentum and bowel to the anterior abdominal wall and i proceeded by carefully taking most of this down to straighten the bowel.After this was extensively done, care taken not to injure any of the bowel, i was able to straighten most of the bowel out and then i proceeded by excising the hernia sac itself.There was excess omentum in the sac and i excised this as well.After this was done, i proceeded by carefully examining the previously placed mesh, which was superior to where this new hernia is, and i noticed that the mesh itself was intact.¿ implant size and fixation: ¿so i proceeded by copiously irrigating the abdominal cavity and hemostasis was looked for and found to be adequate.So, i proceeded by placing a larger mesh to cover the lower abdomen.The same was sutured in place to the fascia using 0 prolene u-stitches interrupted and this was sutured circumferentially.After this was done it was noted to be without tension.Copious amount of antibiotic irrigation was carried out again and i proceeded by approximating together the subcutaneous tissue using 2-0 vicryl in a running fashion.A 7-mm jackson-pratt drain was then placed in the lower abdomen in the subcutaneous tissue through a separate stab wound on the anterior abdominal wall.The skin was then approximated together using skin staples.¿ no post-operative records were provided.Relevant medical information: on (b)(6) 2008: ¿here for staple removal.States started with [illegible] tenderness 2 days ago.Also [illegible] a ua [urinalysis] check when pt [patient] has staples removed.Exam: abdomen, 25 staples without problem.Large 3 x 3 [illegible] firm [illegible].Impression: postop hernia repair abdominal, infection abdominal hernia repair.¿ on (b)(6) 2008: ¿wound recheck.States feeling better.Exam: + redness continues [illegible].Impression: infection improving abdomen.¿ on (b)(6) 2009: ¿c/o redness and extreme pain to abdomen.States started with [illegible].Exam: abdomen [illegible] incision scar [illegible].No drainage.Impression: infection scar line abdomen.¿ on (b)(6) 2009: ¿f/u [follow up] infection on abdomen/scar inc [incision].Exam: no increase in redness.Impression: infected scar line abdomen.¿ on (b)(6) 2009: ¿continues with pain to abdomen.Swelling redness.Feeling well.Exam: abdomen [illegible] no increase in redness.Will refer back to surgery.¿ on (b)(6) 09: incision and drainage of abdominal wound. findings: ¿soft tissue seroma and induration, intact mesh¿ ¿a small midline incision was then made over the swollen fluctuant area.The same was carried through skin and subcutaneous tissue until the pocket of fluid was encountered.This fluid was drained.It was non-pussy [sic].Some of this was sent for gram stain, culture and sensitivity.Just adjacent to this was an indurated area.So i proceeded by carefully opening this to examine what is causing the induration.After this was explored there was no area of pus.Copious amount of antibiotic irrigation was started at this point.The mesh was also noted to be intact.So i proceeded by carefully irrigating this area one more time.Hemostasis was achieved using bovie cautery.Then i proceeded by packing the hole with iodoform gauze.Sterile dressings were then applied.¿ post-operative diagnosis: ¿infected abdominal wound¿. reports for the ¿gram stain, culture and sensitivity¿ for specimens collected during the (b)(6) 2009 procedure were not provided.On (b)(6) 2009: ¿s/p [status post] ventral hernia repair.Had severe abdominal pain and underwent incision and drainage (i&d) surgery for abscess.Has incision to lower abd midline.Skin has open area to mid abd area.Wound is packed with iodoform dressing, 4 x 4 gauze and abd pad.Small amt serous drainage.Packed wound with iodoform gauze, 4 x 4 gauze and abd dressing.Tolerated well.Informed pt that phn [public health nurse] can only provide dressing change once a day, m-f.Pt agreed to daily drsg [dressing] change m-f.Cont [continue] home visits on daily basis for dressing change.¿ on (b)(6) 2009: ¿reports has been running a fever.¿ ¿dressings removed from abd incision area for small amt serous drainage.[no] s/s infection.Has small opening to abd incision, 1 ½ cm in depth.Packed wound with iodoform gauze and covered with 4 x 4 dressing and abd dressing and tied abd binder.Spouse will do dressing change this weekend.Spouse instructed about drsg change.¿ on (b)(6) 2009: ¿dressing removed, small amt serous drainage about size of deck of cards.Incision area has 2 small areas that were dehisced.Wound bed has light yellow drainage.Packed wound with iodoform gauze and covered with abd dressing.Notified (b)(6) about wound infection.¿ on (b)(6) 2009: ¿here for wound check, dressing changed.Exam: wound suture intact.Pink, no increased redness.Impression: wound check, abdominal infection.¿ on (b)(6) 2009: ¿abdominal pain wound infection.Plan: augmentin.¿ on (b)(6) 2009: ¿contacted pt about dressing change.Pt stated ¿i don¿t need help anymore.I went to the doctor yesterday and he sewed up the two openings.¿ pt happy that wound is healing.D/c [discharge] from phn services.¿ on (b)(6) 2009: ¿wound, no redness.Impression: abdominal pain s/p infection.¿ explant preoperative complaints: on (b)(6) 2009: ¿patient presents to clinic for refill of pain medication.States pain is improving.Has had mesh in, had infection then had new mesh in a few months ago.Has been having problems with staph infection.Feels better now, has follow up tomorrow with surgeon.Abdomen feels better only a little pain in lower abd [sic] near scar line.Complaints of pain after voiding in side abdomen.No fever or chills.¿ on (b)(6) 2009: ¿c/o pain to abdomen, along scar line.Has had problems with hernia repair.States infection and pain.Exam: abdomen-very firm, very tender along scar line.¿ on (b)(6) 2009: ¿abdominal pain chronic s/p hernia repair /infection.¿ on (b)(6) 2009: ¿continued c/o abdominal pain.States ¿i am tired of hurting.¿ bowel movements are small hard, has had problem with constipation.¿ ¿abdomen-obese, firm very tender across lower quadrants and around suture line.Some redness noted below umbilicus approximately quarter size.¿ explant procedure: exploratory laparotomy, extensive lysis of adhesions, removal of previous meshes, repair of ventral hernia with biologic mesh, partial omentectomy.Explant date: (b)(6) 2009.Findings: ¿extensive adhesions bowel to anterior abdominal wall and bowel to bowel, especially on the right side, old mesh x3.¿ ¿a midline incision was then made through the previous scar.The incision was carried through skin, subcutaneous tissue, scar tissue until the fascia was identified.In the upper abdomen the fascia was then carefully incised and the abdominal cavity was entered.Then i proceeded by carefully extending the fascia incision all the way down to the pelvis.Of note is the fact that there was a lot of bowel adhesions to the anterior abdominal wall so i proceeded by carrying the incision down to the pelvis, i lysed these adhesions so i could gain access proper to the abdominal cavity.Also, the two previous mesh were encountered and i removed these.After removing the meshes, i put in a bookwalter retractor.Of note is the fact that there was extensive bowel-to-bowel adhesions as well and also there was a lot of omentum.So i proceeded by carefully, lysing the bowel adhesions care taken not to injure the bowel.This was done all the way from ligament of treitz to the terminal ileum.Also i examined the colon.Then i proceeded by doing a partial omentectomy to remove excess omentum.After this was done, a copious amount of antibiotic irrigation was carried out.Hemostasis was looked for and noted to be adequate.Also, the hernia sac which was noted on the right side was carefully cleaned out as well.Then i proceeded by closing the ventral hernia with permacol biologic mesh.Appropriate size of mesh was then cut after the defect was measured.The total mesh is 600 cm square.Then i proceeded by suturing this mesh circumferentially to the fascia using 0 prolene u-stitches interrupted.After this was adequately done and it was noted not to be tension, i copiously irrigated the wound again and then proceeded by placing 2 jackson-pratt drains, one on either side of the incision through separate stab wounds on the anterior abdominal wall.Then i proceeded by closing the subcutaneous tissue using 0 vicryl interrupted stitches and the skin was approximated together using skin staples.Sterile dressings were then applied.¿ no post-operative records were provided.Conclusions: it should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal rnay be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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 and sterilization records verified that the lot met all pre-release specifications.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 05214810.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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