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| Model Number 1DLMC04 |
| Device Problems
Microbial Contamination of Device (2303); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Tissue Breakdown (2681); No Code Available (3191)
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| Event Date 01/08/2010 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The initial reporter's complete address is (b)(6).It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® 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 laparoscopic ventral hernia repair on (b)(6) 2009 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, mesh removal, abdominal wound washout, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Added age at time of event and date of birth.Conclusion code remains unchanged.
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Manufacturer Narrative
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B7: added patient medical history.E1: corrected spelling of reporters last name.H6: updated results code.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2006: clinical sheet-surgery.Implant sticker.Diagnosis: incisional hernia.Operation: incisional hernia repair.Findings: 1.Mod.Sized defect.2.Onlay mesh placed (prolene).Prolene® mesh.Size: 6¿ x 6¿ (15cm x15cm).On (b)(6) 2009: operative report.Operations: ¿open ventral hernia repair and extensive lysis of adhesions¿.Pre/postop diagnosis: ¿recurrent incisional hernia¿.Indication: ¿he has had multiple laparotomies and bowel resections for his crohns disease.Most recently, 4 years ago had an incisional hernia repair with a primary closure in an onlay of prolene mesh.This hernia has recurred and he is now taken to the operating room for repair of recurrent hernia¿.Operative findings: ¿had dense abdominal adhesions and some loops of bowel that were adherent to the previously placed prolene mesh.These adhesions were lysed and no enterotomies were created¿.Operative procedure: ¿the previous scar was excised and the incision was carried down with a bovie cautery to the midline fascia above the level of the hernia.The fascia was entered and there were dense adhesions in the abdominal cavity.The dissection involved extensive lysis of adhesions.These were carefully lysed sharply and the fascia opened inferiorly and sequentially as the dissection continued downward.There was loop of bowel adherent to the prolene mesh and we were able to develop a plane and get this bowel removed from the prolene mesh without causing an enterotomy.There was also hernia inferior to the mesh with a loop of bowel incarcerated in the hernia that was non-obstructed.This again was carefully reduced without causing any bowel injury.Once we had opened the entire fascia to the length of the incision, we created a working space in the abdominal cavity by performing sharp lysis of adhesions circumferentially around the defect.The anterior fascial flaps were then raised circumferentially and a 15 x 19 piece of gore-tex mesh was placed in the abdominal cavity and sewn in place with u stitches of #0 prolene with a 5 cm overlap on good fascia circumferentially.Once the mesh was sewn in place, the sutures were secured down and then the fascia was closed primarily over the gore-tex mesh with running #1 prolene suture.Hemostasis was achieved in the subcutaneous flaps and the wound was irrigated, drains were placed bilaterally, and the subcutaneous flaps brought out through separate stab incision and sewn into place.The subcutaneous tissue was closed with interrupted 2-0 vicryl sutures and the stapler was used to close the skin incision.Patient tolerated the procedure well and was taken to the recovery room extubated in stable condition.¿ on (b)(6) 2009: brief operative report.Implant sticker.Gore® dualmesh® biomaterial.Ref catalog number: 1dlmc04.Lot batch code: 04785908.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc04/04785908) was implanted during the procedure.On (b)(6) 2009: pathology.Final diagnosis: ¿abdominal region, excision ¿ skin with dense dermal scar¿.Specimen submitted: scar tissue.Clinical data: incisional hernia.Gross description: ¿received in formalin labeled ¿scar tissue¿ are two irregular segments of skin with underlying soft tissue measuring 5.5 and 18.5 cm in greatest length.The skin surfaces demonstrate linear white-pink scar-like areas measuring 5.5 x 0.4 cm and 18.5 x 0.6 cm in greatest length, and extending to both tips.Representative sections are submitted in formalin in one cassette¿.Records between (b)(6) 2009 and (b)(6) 2010 were not provided.On (b)(6) 2010: operative report.Operations: ¿removal of infected mesh, abdominal wound washout and packing¿.Pre/postop diagnosis: ¿infected mesh, status post open ventral hernia repair¿.Operative indications: ¿chronic history of crohn¿s disease who had a repair of a recurrent ventral hernia last year.He subsequently developed a hematoma that became infected and now has a mesh infection with some mesh extruding through the midportion of the wound.He was now taken to the operating room for mesh removal and abdominal wound washout¿.Operative findings: ¿the mesh was covered with induration and fascia with the exception of the area that had extruded through the fascial opening.Beneath the mesh, there was a large amount of purulent material and a rind of granulation tissue.The fascia above and below the mesh was intact.No bile was seen.No evidence of any fistula was seen and otherwise the wound looked clean after we washed it out¿.Operative procedure: ¿the previous scar was opened above and below the exposed mesh, and the mesh was incised and the pus from beneath the mesh was sent for culture.We opened the fascia 2 cm above and below the exposed mesh to allow access to the parameter of the mesh.These circumferential transfixion sutures were cut and removed one by one until the mesh was fully freed and completely removed.All the suture material was also removed.The wound was then copiously irrigated and suctioned.No evidence of any fistula was seen.There was good hemostasis after we washed the wound out.The wound was then packed with kerlix gauze.The corners of the skin incision were closed with mattress sutures and a dry dressing was applied.The patient tolerated the procedure well, was taken to the recovery room, and extubated in stable condition.¿ ¿specimens: abdominal abscess fluid.¿ on (b)(6) 2010: pathology.Final diagnosis: ¿infected hernia mesh, excision ¿ hernia mesh (gross diagnosis only)¿.Specimen submitted: ¿infected hernia mesh¿.Clinical data: ¿open wound of abdominal wall¿.Gross description: ¿received fresh labeled ¿infected hernia mesh¿ is a specimen of mesh measuring 15 x 7 x 0.2 cm.No attached soft tissue is identified.This is for gross diagnosis only.No sections are submitted¿.There is no information detailing the etiology of the infection.On (b)(6) 2011: letter to [the patient].¿it was a pleasure to visit with you in the department of colorectal surgery at the cleveland clinic on march 24, 2011.From our conversation and my examination, it appears that you suffer from a recurrent, abdominal hernia with associated wound sinus.As we discussed, you should undergo elective repair of this hernia without mesh because of the risk of infection resulting from the existing wound sinus.On (b)(6) 2011: operative report.Operations: ¿excision of the abdominal wound sinus.Repair of recurrent incisional hernia with component separation.Examination under anesthesia¿.Preop diagnosis: ¿1) recurrent incisional hernia.2) crohn¿s disease of the perianum [sic]¿.Postop diagnosis: ¿1) recurrent incisional hernia.2) crohn¿s disease of the perianum [sic].3) posterior anal skin tag¿.Operative indications: ¿history of crohn¿s disease affecting the terminal ileum.He has undergone four ileocolic resections and resection of one small bowel gastrointestinal stromal tumor.His last resection was performed in august 2005.He underwent repair of an incisional hernia with overlay polypropylene mesh in november 2006.He then underwent a partial right nephrectomy in june 2008.He required repeat incisional hernia repair with excision of the overlay mesh and placement of underlay gore-tex mesh in september 2009.The gore-tex mesh subsequently became infected and he had this removed in january 2010 without repair of the residual fascial defect.He experienced a persistently draining sinus that requires gauze dressing to be changed twice daily.He also had complaints of perianal pain without fever, rigors, or difficulty urinating¿.Operative findings: ¿the recurrent incisional hernia was located in the midline.Following lateral component release, the fascial edges were found to easily approximate without tension.No residual polypropylene or gore-tex mesh was noted.No obvious abnormalities affecting the visible small bowel were noted.The abdominal wall sinus appeared to be originating from a prolene suture at the inferior aspect of the wound.Examination of the perineum revealed a posterior skin tag without associated induration or fluctuance.No abscesses, fissures, or fistulas were noted¿.Operative procedure: ¿a midline incision was made and carried into the peritoneal cavity.The fascial margins were cleared of underlying adhesions.The skin and subcutaneous tissue was then mobilized off of the anterior abdominal wall out to the mid axillary line.The sinus tract was excised and the associated prolene suture was removed.Any other prolene sutures along the length of the wound were also excised.The hernia sac and redundant skin margins were also excised.The aponeurosis of the external oblique was then bilaterally incised extending from the costal margin down to a point near the anterior superior iliac crest providing approximately 4 cm of separation.With these maneuvers, the fascial margins of the linea alba were found to be easily lie juxtaposed without tension.The peritoneal cavity was irrigated with normal saline and hemostasis was assured.The fascia of the midline wound was closed using #1 pds suture placed in a running manner.Interrupted #1 pds sutures were also placed in a figure-of-eight manner.The subcutaneous tissue was irrigated with normal saline and hemostasis was assured.Jackson-pratt drains were placed through bilateral stab incisions to lie within the respective subcutaneous gutters.The subcutaneous was then approximated using interrupted #1 chromic sutures.The skin margins were approximated with metal clips.The drains were secured with 2-0 silk sutures.A sterile dressing was applied.The patient was then placed in the lithotomy position.Digital examination and anoscopy revealed findings as above.The patient was returned to the supine position.He was then transferred to the post-anesthesia care unit in stable condition.¿ 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.¿ the gore® dualmesh® 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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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) 2005, including records for prior abdominal surgical procedures, were not provided.(b)(6) 2005: (b)(6) clinic.(b)(6) md.Radiology¿ct limited abdomen.Indication: right sided flank pain.Hx of crohn¿s disease.Findings: scans through the lung bases are unremarkable.There is a punctate 2-3 mm obstructing stone in the proximal right ureter.There is proximal dilation of the ureter and a small amount of periureteral fat stranding.There is associated mild hydronephrosis.Additionally there is perinephric fat stranding, a finding that can be seen in caliceal rupture.No other stones are identified within the collecting systems bilaterally.Within the limits of a noncontrast study the liver, spleen, pancreas, and adrenal glands are normal.There is cholelithiasis, stable from the prior exam.Evaluation of the bowel demonstrates prior resection at the terminal ileum.Additionally, there is fat within the walls of the small bowel, a finding commonly seen in crohn¿s disease.There is surgical suture material in the midline abdominal musculature.There is an incisional hernia containing only fat.Scans through the pelvis demonstrate no significant lymphadenopathy, mass, or free fluid.Impression: obstructing proximal ureteral stone with mild hydronephrosis and perinephric fat stranding.Findings within the small bowel consistent with patient¿s history of crohn¿s disease.(b)(6) 2005: (b)(6) clinic.(b)(6) md.Operative report.Operation: exploratory laparotomy.Resection of the terminal ileum and ileocolostomy with creation of neo-ileocolostomy (side-to-side 55-mm stapled), cholecystectomy, wedge excision of jejunal gastrointestinal stromal tumor.Assistant: matthew kalady, md.Postop diagnosis: crohn¿s disease of the neoterminal ileum, cholelithiasis, gastrointestinal stromal tumor of the jejunum.Operative indications: the patient is a 30-year-old male with a greater than 20-year history of crohn¿s disease affecting the terminal ileum and anoperineum.He has been hospitalized approximately four times for control of disease symptoms and has undergone three separate ileocolic resections.His disease is currently refractory to medical therapy.A colonoscopy performed in january 2005 revealed moderate terminal ileal disease without evidence of colitis.A subsequent small bowel series revealed significant stricture into the terminal ileum without fistulas.A ct scan of the abdomen and pelvis in (b)(6) 2005 revealed terminal ileum thickening, and an incisional hernia and cholelithiasis.Operative findings: ¿with laparotomy, the stomach, duodenum, liver and large bowel were normal to palpation and inspection.The terminal ileum was affected by obvious recurrent disease.In addition, a 2-cm lesion was noted in the mid-jejunum along the antemesentery aspect of the bowel.Excision of this revealed findings consistent with a gastrointestinal stromal tumor.Following resection, approximately 315 cm of small bowel remained.Operative procedure: the patient was brought to the operating room in stable condition.He was placed on the operating room table in the supine position and delivered a general anesthetic via endotracheal tube.A foley catheter and orogastric tube were passed.The abdomen was prepared with betadine and draped in the usual sterile fashion.A midline incision was made and carried down into the peritoneal cavity.Abdominal exploration was undertaken with findings as above.The entirety of the small bowel was freed of adhesions and inspected.The above-mentioned finding in the mid-jejunum was identified.This was excised off of the bowel wall and sent for frozen section which revealed a gastrointestinal stromal tumor.Accordingly, the site of the lesion was re-addressed.A wedge excision of the bowel wall was performed with greater than 1-cm margin.This was closed transversely using 3-0 pds in an interrupted manner taking seromuscular bites.Attention was then directed to the neoterminal ileum.The area of disease was readily identified.The bowel was divided using the tlc 55-mm stapler approximately 4 cm proximal to the palpable diseased area.The large bowel was divided approximately 5 cm distal to the ileocolostomy.The intervening mesentery was then sequentially clamped, divided and suture ligated.An ileocolostomy was then fashioned using a single firing of the tlc 55-mm stapler to approximate the antemesentery aspect of the two bowel limbs.After assuring hemostasis of the staple line, the anastomosis was complete with a pi-55 stapler.This latter staple line was oversewn and the mesenteric defect closed.Attention was then directed to the gallbladder where adhesions to surrounding tissue and cholelithiasis were noted.The cystic artery was identified, doubly clipped proximally and single clipped distally and then transected.The peritoneum just off the liver was incised and the gallbladder mobilized from the liver bed clipping any small vessels as the neck of the gallbladder was approached.Ultimately, the cystic duct was identified where it joined the common duct.A right angle bowel clamp was then placed across the neck of the gallbladder and two metal clips placed just distal to this.The gallbladder was then amputated.Opening on the table revealed no evidence of malignancy.Inspection of the liver bed revealed no active bleeding or biliary leak.Perineal cavity was then irrigated with a large amount of normal saline.Hemostasis was assured.Of note, palpation of the common bile duct revealed no evidence of choledocholithiasis.A pedicle of omentum was brought down over the ileocolostomy and secured in this region to quarantine the area.The bowel was returned to the peritoneal cavity in an orderly manner.Two sheets of seprafilm were placed over the bowel and the linea alba closed in running fashion with #1 pds.The subcutaneous tissue was irrigated and metal clips used to approximate the skin margins.A sterile dressing was applied.The patient was transferred to recovery in stable condition.¿ (b)(6) 2005: (b)(6) clinic.(b)(6) md.Discharge summary.Principle procedure: exploratory laparotomy, extensive lysis of adhesions, resection of ileocolostomy with neo-ileocolostomy formation, open cholecystectomy, resection of jejunal mass.Repair of incisional hernia.(b)(6) 2006: (b)(6) clinic.(b)(6) md.Office notes.Hpi: abdominal pain is due to incisional hernia.Smokes 2-3 cigars/d.Exam: unremarkable except abdomen: mid line surgical scar, small supra-umbilical hernia, reduced small bowel.Impression: has ventral hernia, advised to see dr.(b)(6).(b)(6) 2006: (b)(6) clinic.(b)(6) md.Operative report.Operation: incisional herniorrhaphy with polypropylene mesh.Assistant: polaka kiran, md.Postoperative diagnosis: recurrent incisional hernia.Operative indications: the patient is a 40-year-old male who underwent resection of the terminal ileum with ileocolostomy on (b)(6) 2005, for recurrent crohn¿s disease.He now presents with complaints suggestive of an incisional hernia located near the umbilicus as well as upper abdomen.Operative findings: ¿three separate hernia defects were noted in the midline wound in the above-mentioned distribution.The lower part of the wound appeared to be without fascial defect.No enterotomies were created during the course of the procedure.Operative procedure: the patient was brought to the operating room in stable condition.He was placed on the or table in supine position and delivered a general anesthetic via an endotracheal tube.A foley catheter and orogastric tubes were passed.The abdomen was prepared with betadine and draped in usual sterile fashion.A midline incision was made to the existing scarring and carried into the peritoneal cavity.The hernia sac was excised.All of the hernia defects were opened into one central defect.The overlying subcutaneous tissue was elevated off the anterior sheath.Underlying adhesions were incised.A series of #1 prolene sutures were then passed from the subcutaneous portion of the wound through the fascia into the peritoneal cavity, advanced 2 to 3 cm, and then passed back out through this around the perimeter of the defects staying approximately 4 cm away from the edge.The peritoneal cavity was then irrigated with normal saline and hemostasis assured.The fascial margins were approximated with #1 prolene in a figure-of-8 manner.A sheath of 6 x 6 inch polypropylene mesh was then cut to approximately sized and onlayed onto the repair.With this, the previously placed prolene sutures were passed through the openings of the mesh using this prolene to secure the mesh to the anterior fascia.The wound was irrigated with normal saline and hemostasis assured.A jackson-pratt drain was placed through a stab incision to lie within the subcutaneous space.The subcutaneous tissue was approximated with 0 chromic in an interrupted manner.Metal clips were used to approximate the skin margins.A sterile dressing was applied.The patient was transferred to recovery in stable condition.¿ (b)(6) 2006: (b)(6) clinic.(b)(6) md.Discharge summary.Discharge instructions: activity: no heavy lifting greater than 15 lb.Or strenuous activities x6 weeks.(b)(6) 2008: (b)(6) clinic.(b)(6) md.Discharge instructions.Activity after discharge: no heavy lifting.Weight bearing as tolerated and do not lift, push or pull more than 10 pounds or drive for 6 weeks.(b)(6) 2009: (b)(6) clinic.(b)(6) md.Radiology¿ct enterography w contrast.Indication: reg enteritis, sm intestine.Result: gi tract: small bowel: there is mild wall thickening, increased enhancement and narrowing of the neoterminal ileum, estimated at approximately 6 cm in length.There is no evidence for bowel obstruction.There is mild stranding of the adjacent fat probably due to postoperative changes.There is a stable 2 x 1.2 cm mesenteric lymph node in the right mid abdomen.Additional nonenlarged mesenteric nodes are also present.Colon: postoperative changes of the right hemicolectomy noted.There is minimal colonic wall thickening, slightly more prominent in the rectosigmoid colon than the remaining portions of the colon.Strictures: there is narrowing of the neoterminal ileum.Fistulae/sinus tracts: none abscesses: none abdomen: the gallbladder has been removed.There is no biliary dilation.No lesions are identified in the liver, spleen or pancreas.There is a mild diastases of the rectus muscles and mild herniation of nonobstructed small bowel loops in the mid to lower abdomen.There is less than 1 cm low-density lesion at the pole of the kidney, too small to characterize but likely a cyst.Postoperative changes of the right partial nephrectomy are again noted.There is a 3.5 cm cyst at the posterior lower pole of the right kidney.There is no hydronephrosis.No enlarged lymph nodes seen in the abdomen.Pelvis: no enlarged lymph nodes masses or fluid collections.Impression: findings compatible with crohn¿s disease involving the neoterminal ileum.There is also minimal colonic wall thickening.Mild diastases of the rectus muscles and mild herniation of nonobstructed small bowel loops in the abdomen.(b)(6) 2009: (b)(6) clinic.(b)(6) md.Office notes.Exam: unremarkable except abdomen: hernia at surgical site.Impression: active crohn¿s disease manifested by diarrhea.Also has a ventral hernia that troubles him.(b)(6) 2009: (b)(6) clinic.(b)(6) md; stacy brethauer, md.Office notes.Hpi: evaluation of ventral hernia.Most recent surgery was approximately 2 years ago which was a hernia repair by dr.Strong.At that time had a primary repair with an onlay of prolene mesh.Since then has had a recurrent hernia, which is now symptomatic.Review of ct scan one month ago shows displacement anteriorly of the prolene mesh with hernia defect and bowel adjacent to the prolene mesh above the fascial level.Wt 88.134 kg (194 lb.4.8 oz.).Exam: unremarkable except; hernia palpated, but some laxity between upper rectus muscles.Impression/plan: recurrent ventral hernia.(b)(6) 2009: (b)(6) clinic.(b)(6), (res).Discharge instructions.Activity after discharge: no heavy lifting.(b)(6) 2009: (b)(6) clinic.(b)(6) md.Office notes.F/u ventral hernia repair.Having some muscle spasms.Afebrile, abd soft, incision healed, intact, no erythema or infection.Moderate seroma.Staples removed.Binder given.F/u one month, will aspirate seroma if getting bigger.??/??/09: [missing records: records for the ct scan showing the ¿subfascial seroma¿ were not provided.] (b)(6) 2009: (b)(6) clinic.(b)(6) md; (b)(6) md.Office notes.Hpi: had a recurrent hernia repair several weeks ago with primary closure with an underlay of permacol mesh.Chronic abdominal pain, worsening severe abdominal pain underneath incision.Examination is significant for firmness and a bulge in the midportion of incision.Incision is intact and there is no discharge from wound itself.Brought a ct scan from parma hospital from several days ago that shows a subfascial seroma that seems to be pushing out of repair.Was aspirated in the office for a total of 200 ml of serous fluid with some improvement on symptoms.Refilled pain meds and cipro for his crohn¿s.(b)(6) 2009: (b)(6) clinic.(b)(6) md.Office notes.Hpi: seroma drained 2 weeks ago, ruptured 1 week ago and has been draining fluid since.Subsequently, had dehiscence of skin incision with decompression of the seroma and significant improvement in abdominal pain.Very little fluid coming from the small opening and within the mid-portion of incision.There are no signs of infection, and abdomen less tender than last visit.Exam: abdomen; soft, hypogastric tenderness to palpation alond [sic] edges of incision.Midline incision draining serosanguinous fluid.Impression/plan: midline incision seroma currently draining, continue dressing changes and binder at home.Dx: open wound of abdominal wall, anterior.(b)(6) 2009: (b)(6) clinic.(b)(6), md; stacy brethauer, md.Office notes.Cc: drainage from incision.Possible wound infection after seroma.Hpi: postoperative course has been complicated by recurrent symptomatic seroma as well as wound dehiscence at the skin level.Does have an opening in the mid portion of scar with some purulent drainage.On exam, abdomen mildly tender around the edges.Has 1 cm opening in the mid portion of incision.The gore-tex is visible at the base of the wound.Did pack the wound with iodoform gauze and instructed on how to change daily.Based on exam at this point, most likely going to need mesh removed, although this is not urgent.It is unlikely we will be able to salvage this mesh.Give more time for any granulation tissue to form beneath the mesh and at some point in the future, will have to take to the operating room, remove the gore-tex and try to reapproximate fascia with biologic reinforcement.(b)(6) 2009: (b)(6) clinic.(b)(6), md.Office notes.Hpi: now has a chronically draining sinus tract.Has a 1 cm opening in the midportion of incision with some granulation tissue around it.There is exposed gore-tex mesh at the base of wound.Long discussion regarding the fact he has infected gore-tex mesh and will ultimately need to have this removed.He is interested in waiting until january 1 due to insurance reasons and i am fine with that as long as he is clinically stable.Will see back on january 1 and will arrange for a return trip to the operating room for laparotomy, removal of infected mesh with possible biologic closure.(b)(6) 2009: ccf cleveland clinic.Stacy brethauer, md.Office notes.Hpi: has a 1 cm opening in midline incision with exposed gore-tex.Has been afebrile and has no other constitutional symptoms.The risks, benefits, and alternatives of laparotomy with removal of the infected mesh and abdominal washout were discussed.Agrees to proceed and scheduled for 01/08/10.Understands may have recurrent hernia after we remove the mesh and may require a wound vac and is agreeable to this.12/31/09: ccf cleveland clinic.Brian christopher allen, md; erick m.Remer, md.Radiology¿ct abdomen w contrast.Indication: infected mesh, status post ventral hernia repair.Crohn¿s disease.Results: there has been interval ventral hernia repair with mesh.The mesh is redundant and appears bunched up and tented.There is fluid deep to the mesh repair, without a well defined wall.There is a small amount of gas adjacent to the mesh, but no deep to the mesh.No extension into the intra-abdominal cavity.The liver is unremarkable.No intra-or extrahepatic biliary dilatation.The spleen is mildly enlarged at 14-cm.The pancreas, adrenal glands, and left kidney are normal.There is a stable cyst in the right kidney and post surgical changes of partial nephrectomy.The neoterminal ileum is mildly dilated, concerning for narrowing at the anastomosis.There is inner wall hyper enhancement and thickening of the sigmoid colon, suspicious for colitis.There is no lymphadenopathy.Pelvis: there are no masses, fluid collections or lymphadenopathy.Bones: no destructive osseous lesions.Lung bases: the visualized lung bases are clear.Impression: interval ventral hernia repair with mesh that appears redundant and bunched up.There is fluid deep to the mesh and small amount of gas superficial to the mesh.No intra-abdominal extension.Anastomotic stricture at the neo-terminal ileum and sigmoid colitis.01/04/10: ccf cleveland clinic.Stacy brethauer, md.Office notes.Hpi: ventral hernia repair, complicated by a seroma that was drained in the office and ultimately developed a wound infection.Wound broke down and now has exposed gore-tex mesh in the base of wound.Ct scan was done and was consistent with infected mesh.Proceed with surgery that is scheduled next friday for mesh removal and probably open wound care during postoperative period.01/08/10: ccf cleveland clinic.Lab¿anaerobe culture + stain.Specimen description: abscess abd.Smear result: many gram positive cocci in pairs and clusters.Many polymorphonuclear leukocytes.Few mononuclear cells.Culture result: many methicillin resistant staphylococcus aureus.(b)(6) 2010: ccf cleveland clinic.Lab¿fungal culture + smear.Specimen description: abscess abd.Smear result: no fungus seen.Culture result: no fungus isolated after 28 days.(b)(6) 2010: ccf cleveland clinic.Stacy brethauer, md.Discharge summary.Diagnosis: infected mesh.Post-op day 3 doing well.Wound vac placed over white sponge and adaptec.Home health and wound vac equipment arranged, 3x/wk dressing changes.(b)(6) 2010: ccf cleveland clinic.Stacy brethauer, md.Office notes.Hpi: uneventful postop course other than having a significant amount of pain and getting wound vac therapy at home and doing well with this.Wound is granulating very nicely.It is approximately 50% of the size that is was after the drainage.(b)(6) 2010: ccf cleveland clinic.Stacy brethauer, md.Office notes.Hpi: wound vac was removed and has a nice bed of granulation tissue with a markedly smaller wound from last visit, about 2 x 3 cm and about one and a half cm deep.Does still have some induration around wound opening, but this is improved as well.(b)(6) 2010: ccf cleveland clinic.Stacy brethauer, md.Office notes.No longer has wound vac on and is healing well.No new wound problems.On exam, granulating well, no infection.Likely will have recurrent hernia once healed.(b)(6) 2011: ccf cleveland clinic.Nyati p sheth, do.Office notes.Cc: self referral for sinus tract infection with hx of mrsa in the wound.Pmh: mesh removed in 01/2010; abdominal culture from abscess revealed mrsa (treated with parenteral vanco 01/11-01/13 then discharged on po bactrim).Wound did not close 100% but did ok through majority of 2010.Started having pain around distal abdominal incision site (sinus tract open with copious viscous yellow foul smelling drainage per patient).Bactrim x 10 day course; improved; approximately 4 days after completing course, sinus tract started draining and pain returned.Another 5 day course of bactrim.After completing course had another episode of pain accompanied by drainage.Started another course of bactrim 01/21/11 and decided to see infectious disease.Tobacco use: occasional cigars.Quit cigarettes in 1993.Work hx: works in maintenance at a power plant with electrics.Does heavy lifting at work.Exam: unremarkable except skin: incision site over abdomen is healed completely except for a small 1 cm x 1 cm superficial draining sinus tract that is not actively draining at this time.The area is moist, no foul smell, no purulence, no induration, no surrounding erythema.Abdomen: large ventral hernia without mesh that protrudes.(b)(6) 2011: ccf cleveland clinic.Lab¿cult + stain.Specimen description: abdominal swab.Smear result: no organisms seen.No polymorphonuclear leukocytes.Culture result: moderate methicillin resistant staphylococcus aureus and mixed flora.[lcolantuono-8ccf-kba-01580-1581] (b)(6) 2011: ccf cleveland clinic.Nyati p sheth, do.Office notes.Ct abdomen (b)(6) 2011: impression: status post partial nephrectomy right kidney.Bilateral renal cysts.No evidence for local recurrence or metastatic disease in abdomen or pelvis.Stable subcentimeter solitary hypervascular right hepatic dome lesion that may represent a hemangioma.No other liver lesion is seen.Operative changes of bowel surgery.Stable indeterminate 1.3-cm enhancing nodule at the anastomotic site, and stable findings of indolent crohn¿s colitis.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.The gore® dualmesh® 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: updated health effect- clinical code h6: updated investigation findings h6: updated investigation conclusions h6: health effect impact code: f1903: device explantation previous patient code (3191: appropriate term/code not available for "abdominal wound washout.¿) was reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: ¿ the known medical records span may 12, 2005 through may 23, 2011 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.¿ records prior to may 12, 2005, including records for prior abdominal surgical procedures, were not provided.Patient information: medical history: ¿ 1991: crohn¿s disease ¿ (b)(6) 2003: enteropathic arthritis ¿ (b)(6) 2005: incisional hernia.¿ smoking ? (b)(6) 2006: smokes 2-3 cigars/day ¿ (b)(6) 2006: ventral hernia ¿ (b)(6) 2006: 86.2 kg (190 lbs.) prior surgical procedures: ¿ 1988: bowel resection for crohn¿s and appendectomy ¿ 1991 and 1993: bowel resection for crohn¿s ¿ (b)(6) 2003: ileocolonic resection with anastomosis ¿ (b)(6) 2005: exploratory laparotomy.Resection of the terminal ileum and ileocolostomy with creation of neo-ileocolostomy (side-to-side 55-mm stapled), cholecystectomy, wedge excision of jejunal gastrointestinal stromal tumor ¿ (b)(6) 2006: incisional herniorrhaphy with polypropylene mesh.Recurrent incisional hernia ¿ (b)(6) 2008: partial excision right kidney- renal cell carcinoma; excision renal cyst ¿ (b)(6) 2009: ileum biopsy, anastomosis biopsy, multiple colonic biopsies from transverse colon through rectosigmoid ¿ (b)(6) 2009: open ventral hernia repair, extensive lysis of adhesions ¿ (b)(6) 2010: removal of infected mesh, abdominal wound washout and packing ¿ (b)(6) 2010 and (b)(6) 2010: terminal ileum biopsy, transverse colon biopsy, descending colon biopsy, sigmoid colon biopsy, rectum biopsy ¿ (b)(6) 20 11: sinus tract excision, hernia sac, herniorrhaphy ¿ (b)(6) 20 11: terminal ileum biopsy, anastomosis biopsy, colon, transverse, descending, sigmoid and rectum biopsies, distal rectum biopsy ¿ (b)(6) 20 12: terminal ileum biopsy, anastomotic site biopsy, transverse colon biopsy, descending colon biopsy, rectum biopsy ¿ (b)(6) 20 13: terminal ileum biopsy, anastomosis colon ulceration biopsy relevant medical information: ¿ (b)(6) 20 05: ct abdomen: evaluation of the bowel demonstrates prior resection at the terminal ileum.Additionally, there is fat within the walls of the small bowel, a finding commonly seen in crohn¿s disease.There is surgical suture material in the midline abdominal musculature.There is an incisional hernia containing only fat.¿ (b)(6) 20 05: exploratory laparotomy.Resection of the terminal ileum and ileocolostomy with creation of neo-ileocolostomy (side-to-side 55-mm stapled), cholecystectomy, wedge excision of jejunal gastrointestinal stromal tumor.¿ (b)(6) 20 05: exploratory laparotomy, extensive lysis of adhesions, resection of ileocolostomy with neo-ileocolostomy formation, open cholecystectomy, resection of jejunal mass.Repair of incisional hernia.¿ (b)(6) 20 06: ¿abdominal pain is due to incisional hernia.Smokes 2-3 cigars/d.Exam: unremarkable except abdomen: mid line surgical scar, small supra-umbilical hernia, reduced small bowel.Impression: has ventral hernia, advised to see dr.Strong.¿ (b)(6) 20 06: incisional herniorrhaphy with polypropylene mesh.¿the patient is a 40-year-old male who underwent resection of the terminal ileum with ileocolostomy on (b)(6) 20 2005, for recurrent crohn¿s disease.He now presents with complaints suggestive of an incisional hernia located near the umbilicus as well as upper abdomen.¿ operative findings: ¿three separate hernia defects were noted in the midline wound in the above-mentioned distribution.The lower part of the wound appeared to be without fascial defect.No enterotomies were created during the course of the procedure.¿ operative procedure: ¿the patient was brought to the operating room in stable condition.He was placed on the or table in supine position and delivered a general anesthetic via an endotracheal tube.A foley catheter and orogastric tubes were passed.The abdomen was prepared with betadine and draped in usual sterile fashion.A midline incision was made to the existing scarring and carried into the peritoneal cavity.The hernia sac was excised.All of the hernia defects were opened into one central defect.The overlying subcutaneous tissue was elevated off the anterior sheath.Underlying adhesions were incised.A series of #1 prolene sutures were then passed from the subcutaneous portion of the wound through the fascia into the peritoneal cavity, advanced 2 to 3 cm, and then passed back out through this around the perimeter of the defects staying approximately 4 cm away from the edge.The peritoneal cavity was then irrigated with normal saline and hemostasis assured.The fascial margins were approximated with #1 prolene in a figure-of-8 manner.A sheath of 6 x 6 inch polypropylene mesh was then cut to approximately sized and onlayed onto the repair.With this, the previously placed prolene sutures were passed through the openings of the mesh using this prolene to secure the mesh to the anterior fascia.The wound was irrigated with normal saline and hemostasis assured.A jackson-pratt drain was placed through a stab incision to lie within the subcutaneous space.The subcutaneous tissue was approximated with 0 chromic in an interrupted manner.Metal clips were used to approximate the skin margins.A sterile dressing was applied.The patient was transferred to recovery in stable condition.¿ ? implant sticker: onlay mesh placed (prolene).Prolene® mesh.Size: 6¿ x 6¿ (15cm x15cm).¿ (b)(6) 20 09: ct enterography w contrast: ¿findings compatible with crohn¿s disease involving the neoterminal ileum.There is also minimal colonic wall thickening.Mild diastases of the rectus muscles and mild herniation of nonobstructed small bowel loops in the abdomen.¿ ¿ (b)(6) 20 09: "active crohn¿s disease manifested by diarrhea.Also has a ventral hernia that troubles him.¿ implant preoperative complaints: ¿ (b)(6) 20 09: "most recent surgery was approximately 2 years ago which was a hernia repair by dr.Strong.At that time had a primary repair with an onlay of prolene mesh.Since then has had a recurrent hernia, which is now symptomatic.Review of ct scan one month ago shows displacement anteriorly of the prolene mesh with hernia defect and bowel adjacent to the prolene mesh above the fascial level.Wt 88.134 kg (194 lb.4.8 oz.).Exam: unremarkable except; hernia palpated, but some laxity between upper rectus muscles.Impression/plan: recurrent ventral hernia.¿ ¿ (b)(6) 20 09: ¿he has had multiple laparotomies and bowel resections for his crohn¿s disease.Most recently, 4 years ago had an incisional hernia repair with a primary closure in an onlay of prolene mesh.This hernia has recurred and he is now taken to the operating room for repair of recurrent hernia.¿ implant procedure: open ventral hernia repair and extensive lysis of adhesions.Implant: gore® dualmesh® biomaterial.(1dlmc04/04785908) 15 x 19 cm, oval.Implant date: (b)(6) 20 2009 [hospitalization (b)(6) 20 2009] ¿ description of hernia being treated: ¿the previous scar was excised and the incision was carried down with a bovie cautery to the midline fascia above the level of the hernia.The fascia was entered and there were dense adhesions in the abdominal cavity.The dissection involved extensive lysis of adhesions.These were carefully lysed sharply and the fascia opened inferiorly and sequentially as the dissection continued downward.There was loop of bowel adherent to the prolene mesh and we were able to develop a plane and get this bowel removed from the prolene mesh without causing an enterotomy.There was also hernia inferior to the mesh with a loop of bowel incarcerated in the hernia that was non-obstructed.This again was carefully reduced without causing any bowel injury.¿ ¿ implant size and fixation: ¿once we had opened the entire fascia to the length of the incision, we created a working space in the abdominal cavity by performing sharp lysis of adhesions circumferentially around the defect.The anterior fascial flaps were then raised circumferentially, and a 15 x 19 piece of gore-tex mesh was placed in the abdominal cavity and sewn in place with u stiches of #0 prolene with a 5 cm overlap on good fascia circumferentially.Once the mesh was sewn in place, the sutures were secured down and then the fascia was closed primarily over the gore-tex mesh with running #1 prolene suture.Hemostasis was achieved in the subcutaneous flaps and the wound was irrigated, drains were placed bilaterally, and the subcutaneous flaps brought out through separate stab incision and sewn into place.The subcutaneous tissue was closed with interrupted 2-0 vicryl sutures and the stapler was used to close the skin incision.Patient tolerated the procedure well and was taken to the recovery room extubated in stable condition.¿ ¿ ¿received in formalin labeled ¿scar tissue¿ are two irregular segments of skin with underlying soft tissue measuring 5.5 and 18.5 cm in greatest length.The skin surfaces demonstrate linear white-pink scar-like areas measuring 5.5 x 0.4 cm and 18.5 x 0.6 cm in greatest length, and extending to both tips.Representative sections are submitted in formalin in one cassette.Relevant medical information: ¿ (b)(6) 20 09: f/u [follow up] ventral hernia repair.Having some muscle spasms.Afebrile, abd [abdomen] soft, incision healed, intact, no erythema or infection.Moderate seroma.Staples removed.Binder given.F/u one month, will aspirate seroma if getting bigger.¿ (b)(6) 20 09: ¿had a recurrent hernia repair several weeks ago with primary closure with an underlay of permacol mesh.Chronic abdominal pain, worsening severe abdominal pain underneath incision.Examination is significant for firmness and a bulge in the midportion of incision.Incision is intact and there is no discharge from wound itself.Brought a ct scan from parma hospital from several days ago that shows a subfascial seroma that seems to be pushing out of repair.Was aspirated in the office for a total of 200 ml of serous fluid with some improvement on symptoms.Refilled pain meds and cipro for his crohn¿s.¿ ¿ (b)(6) 20 09: ¿seroma drained 2 weeks ago, ruptured 1 week ago and has been draining fluid since.Subsequently, had dehiscence of skin incision with decompression of the seroma and significant improvement in abdominal pain.Very little fluid coming from the small opening and within the mid-portion of incision.There are no signs of infection, and abdomen less tender than last visit.Exam: abdomen; soft, hypogastric tenderness to palpation alond [sic] edges of incision.Midline incision draining serosanguinous fluid.Impression/plan: midline incision seroma currently draining, continue dressing changes and binder at home.Dx: open wound of abdominal wall, anterior.¿ ¿ (b)(6) 20 09: drainage from incision.Possible wound infection after seroma.Hpi: postoperative course has been complicated by recurrent symptomatic seroma as well as wound dehiscence at the skin level.Does have an opening in the mid portion of scar with some purulent drainage.On exam, abdomen mildly tender around the edges.Has 1 cm opening in the mid portion of incision.The gore-tex is visible at the base of the wound.D id pack the wound with iodoform gauze and instructed on how to change daily.Based on exam at this point, most likely going to need mesh removed, although this is not urgent.It is unlikely we will be able to salvage this mesh.Give more time for any granulation tissue to form beneath the mesh and at some point in the future, will have to take to the operating room, remove the gore-tex and try to reapproximate fascia with biologic reinforcement.¿ (b)(6) 20 09: now has a chronically draining sinus tract.Has a 1 cm opening in the midportion of incision with some granulation tissue around it.There is exposed gore-tex mesh at the base of wound.Long discussion regarding the fact he has infected gore-tex mesh and will ultimately need to have this removed.He is interested in waiting until january 1 due to insurance reasons and i am fine with that as long as he is clinically stable.Will see back on january 1 and will arrange for a return trip to the operating room for laparotomy, removal of infected mesh with possible biologic closure.¿ (b)(6) 20 09: has a 1 cm opening in midline incision with exposed gore-tex.Has been afebrile and has no other constitutional symptoms.The risks, benefits, and alternatives of laparotomy with removal of the infected mesh and abdominal washout were discussed.Agrees to proceed and scheduled for 01/08/10.Understands may have recurrent hernia after we remove the mesh and may require a wound vac and is agreeable to this.¿ (b)(6) 20 09: ct abdomen w contrast.Infected mesh, status post ventral hernia repair.Crohn¿s disease.Results: there has been interval ventral hernia repair with mesh.The mesh is redundant and appears bunched up and tented.There is fluid deep to the mesh repair, without a well defined wall.There is a small amount of gas adjacent to the mesh, but no deep to the mesh.No extension into the intra-abdominal cavity.The liver is unremarkable.No intra-or extrahepatic biliary dilatation.The spleen is mildly enlarged at 14-cm.The pancreas, adrenal glands, and left kidney are normal.There is a stable cyst in the right kidney and post surgical changes of partial nephrectomy.The neoterminal ileum is mildly dilated, concerning for narrowing at the anastomosis.There is inner wall hyper enhancement and thickening of the sigmoid colon, suspicious for colitis.There is no lymphadenopathy.Pelvis: there are no masses, fluid collections or lymphadenopathy.Bones: no destructive osseous lesions.Lung bases: the visualized lung bases are clear.Impression: interval ventral hernia repair with mesh that appears redundant and bunched up.There is fluid deep to the mesh and small amount of gas superficial to the mesh.No intra-abdominal extension.Anastomotic stricture at the neo-terminal ileum and sigmoid colitis.Explant preoperative complaints: ¿ (b)(6) 20 10: ventral hernia repair, complicated by a seroma that was drained in the office and ultimately developed a wound infection.Wound broke down and now has exposed gore-tex mesh in the base of wound.Ct scan was done and was consistent with infected mesh.Proceed with surgery that is scheduled next friday for mesh removal and probably open wound care during postoperative period.¿ (b)(6) 20 10: ¿chronic history of crohn¿s disease who had a repair of a recurrent ventral hernia last year.He subsequently developed a hematoma that became infected and now has a mesh infection with some mesh extruding through the midportion of the wound.He was now taken to the operating room for mesh removal and abdominal wound washout.Explant procedure: removal of infected mesh, abdominal wound washout and packing.Explant date: (b)(6) 2010] ¿ ¿the mesh was covered with induration and fascia with the exception of the area that had extruded through the fascial opening.Beneath the mesh, there was a large amount of purulent material and a rind of granulation tissue.The fascia above and below the mesh was intact.No bile was seen.No evidence of any fistula was seen and otherwise the wound looked clean after we washed it out.Operative procedure: the previous scar was opened above and below the exposed mesh, and the mesh was incised and the pus from beneath the mesh was sent for culture.We opened the fascia 2 cm above and below the exposed mesh to allow access to the parameter of the mesh.These circumferential transfixion sutures were cut and removed one by one until the mesh was fully freed and completely removed.All the suture material was also removed.The wound was then copiously irrigated and suctioned.No evidence of any fistula was seen.There was good hemostasis after we washed the wound out.The wound was then packed with kerlix gauze.The corners of the skin incision were closed with mattress sutures and a dry dressing was applied.The patient tolerated the procedure well, was taken to the recovery room, and extubated in stable condition.¿ ¿specimens: abdominal abscess fluid.¿ ¿ (b)(6) 20 10: ¿lab¿anaerobe culture + stain.Specimen description: abscess abd.Smear result: many gram positive cocci in pairs and clusters.Many polymorphonuclear leukocytes.Few mononuclear cells.Culture result: many methicillin resistant staphylococcus aureus [mrsa].¿ ¿ (b)(6) 20 10: ¿lab¿fungal culture + smear.Specimen description: abscess abd.Smear result: no fungus seen.Culture result: no fungus isolated after 28 days.¿ ¿ (b)(6) 20 10: pathology: ¿final diagnosis: infected hernia mesh, excision ¿ hernia mesh (gross diagnosis only).Specimen submitted: infected hernia mesh.Clinical data: open wound of abdominal wall.Gross description: received fresh labeled ¿infected hernia mesh¿ is a specimen of mesh measuring 15 x 7 x 0.2 cm.¿ ¿ (b)(6) 20 10: discharge summary: ¿diagnosis: infected mesh.Post-op day 3 doing well.Wound vac placed over white sponge and adaptec.Home health and wound vac equipment arranged, 3x/wk dressing changes.¿ relevant medical information: ¿ (b)(6) 20 10: ¿uneventful postop course other than having a significant amount of pain and getting wound vac therapy at home and doing well with this.Wound is granulating very nicely.It is approximately 50% of the size that is [sic] was after the drainage.¿ ¿ (b)(6) 20 10: ¿wound vac was removed and has a nice bed of granulation tissue with a markedly smaller wound from last visit, about 2 x 3 cm and about one and a half cm deep.Does still have some induration around wound opening, but this is improved as well.¿ ¿ (b)(6) 20 10: ¿no longer has wound vac on and is healing well.No new wound problems.On exam, granulating well, no infection.Likely will have recurrent hernia once healed.¿ ¿ (b)(6) 20 11: ¿self referral for sinus tract infection with hx [history] of mrsa in the wound.Pmh [past medical history]: mesh removed in (b)(6) 2010; abdominal culture from abscess revealed mrsa (treated with parenteral vanco 01/11-01/13 then discharged on po bactrim).Wound did not close 100% but did ok through majority of 2010.Started having pain around distal abdominal incision site (sinus tract open with copious viscous yellow foul smelling drainage per patient).Bactrim x 10 day course; improved; approximately 4 days after completing course, sinus tract started draining and pain returned.Another 5 day course of bactrim.After completing course had another episode of pain accompanied by drainage.Started another course of bactrim (b)(6) 20 11 and decided to see infectious disease.Tobacco use: occasional cigars.Quit cigarettes in 1993.Work hx: works in maintenance at a power plant with electrics.Does heavy lifting at work.Exam: unremarkable except skin: incision site over abdomen is healed completely except for a small 1 cm x 1 cm superficial draining sinus tract that is not actively draining at this time.The area is moist, no foul smell, no purulence, no induration, no surrounding erythema.Abdomen: large ventral hernia without mesh that protrudes.¿ ¿ (b)(6) 20 11: abdominal swab: ¿moderate methicillin resistant staphylococcus aureus and mixed flora.¿ ¿ (b)(6) 20 11: ct abdomen (b)(6) 20 11: ¿impression: status post partial nephrectomy right kidney.Bilateral renal cysts.No evidence for local recurrence or metastatic disease in abdomen or pelvis.Stable subcentimeter solitary hypervascular right hepatic dome lesion that may represent a hemangioma.No other liver lesion is seen.Operative changes of bowel surgery.Stable indeterminate 1.3-cm enhancing nodule at the anastomotic site, and stable findings of indolent crohn¿s colitis.¿ ¿ (b)(6) 20 11: excision of the abdominal wound sinus.Repair of recurrent incisional hernia with component separation.Examination under anesthesia.Conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the gore® dualmesh® biomaterial instructions for use also warns, ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The 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.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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