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| Model Number |
1305010020 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Codes |
Abscess (1690); Unspecified Infection (1930)
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| Date of Event |
01/29/2005
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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It was reported to gore that the patient underwent open left flank hernia repair on (b)(6) 2002 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2005 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, hernia recurrence, seroma, open draining wound, severe and chronic pain/discomfort.Additional event specific information was not provided.
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Additional 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: relevant medical information: on (b)(6)2001: (b)(6) hospital.(b)(6) md.History and physical.Chief complaint: incisional hernia over midline surgical scar and surgical scar over left flank area, for surgery.History of present illness: (b)(6) 1999, underwent total abdominal hysterectomy, bilateral salpingo-oophorectomy and staging pelvic and paraaortic lymph node dissection for stage iii, grade ii endometrial carcinoma.Tumor invaded superficially into the myometrium but there were six pelvic lymph nodes showing metastatic disease.Developed left psoas abscess after four rounds of chemotherapy and underwent incision and drainage of the left psoas abscess via a left flank incision with placement of drains in (b)(6) 1999.During that hospital stay, also developed left leg deep vein thrombosis.On recent follow up, noted to have an incisional hernia over the midline subumbilical surgical scar as well as a large hernia over the incision and drainage site on the left groin and flank for which she is admitted for surgery.Denies abdominal or pelvic pain.Medications: coumadin; stopped 3 days prior to surgery.Does not drink or smoke.Weight: 232 lbs.Abdomen: midline surgical scar with 5 cm lower incisional hernia.Incision and drainage scar over the left flank with and 8-10 cm hernia over the left groin.Hernia reducible.No abdominal mass or tenderness.Impression: status post chemoradiation, incision/drainage left psoas abscess.Incisional hernia and hernia over left flank.Plan: repair of incisional hernia over midline surgical scar and over the incision and drainage scar on left flank and groin area.At this time, no evidence of recurrent endometrial carcinoma as evidenced by clinical exam and recent ct scan in (b)(6).Will undergo an exploratory laparotomy, repair of the two abdominal hernias.Use of mesh may be necessary.On (b)(6) 2001: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: left lower abdominal hernia from previous drainage of retroperitoneal abscess.Midline incisional hernia.Postoperative diagnosis: left lower abdominal hernia from previous drainage of retroperitoneal abscess.Midline incisional hernia.Name of operations: repair of midline incisional hernia.Repair of left flank incisional hernia.Anesthesia: general.Findings: there was an 8 by 6-centimeter hernia over the left lower abdomen and left flank from previous incision and drainage of a left psoas abscess.Over the midline surgical scar there was a 5-centimeter, incisional hernia at the upper end.The contents was bowel and was reducible.Description of operative procedure: ¿the patient was placed in the dorsal supine position and a vaginal and abdominal prep were performed.A foley was placed into the bladder and the abdomen draped for the above procedure.An incision was made over the left flank hernia, and the hernia sac was entered.The neck of the hernia was identified.The bowels were freed all around from the neck of the hernia.The remnant of the oblique fascia was able to be identified.Using #1 prolene in a modified smead-jones technique, the retracted oblique muscle and fascia were reapproximated.The sutures were initially placed and this was tied after they were placed.A jackson-pratt drain was then placed in the subcutaneous tissues.The subcutaneous tissues were undermined all around the neck of the hernia for a distance of 1.5 to 2 centimeters.Vicryl 2-0 was then used to approximate the subcutaneous tissues and clips were used to approximate the skin edges.The jackson-pratt drain was positioned in place using 3-0 prolene.Next a repair of the midline surgical incisional hernia was made.An incision was made over the hernia on the upper end of the incision.The surgical scar was excised and the hernia sac was identified.The contents were reduced.The subcutaneous tissues around the neck of the hernia were dissected and undermined for about 2 centimeters to expose the retracted rectus fascia.On palpating the lower abdominal wound through the abdomen, there was a defect noted about 3 centimeters over the lower incisional hernia.This small hernia was reduced and incision was made over the skin with the sac excised.Two hernias above and below were then closed with #1 prolene using the smead-jones technique.No drain was placed in the midline incisional hernia.The dead space was occluded using 2-0 vicryl approximating the subcutaneous layers, and clips were used to approximate the skin edges.Estimated blood loss 250 cubic centimeters.¿ on (b)(6) 2001: (b)(6) health system.Operative record.Asa: 2.On (b)(6) 2001: (b)(6) hospital.(b)(6) md.Discharge summary.Discharge diagnosis: stage iii uterine carcinoma, status post total abdominal hysterectomy, bilateral salpingo-oophorectomy and lymph node staging.Status post chemotherapy and radiation.Status post incision and drainage of left psoas abscess.Midline incisional hernia and large hernia over the left flank and groin, history of deep venous thrombosis of left leg.Status post repair of midline surgical incisional hernia and repair of large left groin hernia.Hospital course: underwent exploration of the midline surgical scar with a finding of a 4 cm incisional hernia over the upper incision and this was repaired with a layered closure.The large incisional hernia on left groin was similarly repaired.Discharged with a jackson-pratt drain in place.Will have home health nursing visits to assist with care of the jackson-pratt drain and its removal when the output is less than 15 cc.On (b)(6) 2001: (b)(6) health system.Discharge instructions.Activity: no heavy lifting; no driving x 2 weeks.Home health to see 3x/week.On (b)(6) 20/01: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: chronic sinus infection of abdominal wound.Previous incision of hernia repair.Postoperative diagnosis: chronic sinus infection of abdominal wound.Previous incision of hernia repair.Name of operation: excision of sinus tract abdominal wound, removal of prolene sutures.Anesthesia: general.Findings: the patient previously has had a hernia repair over the left flank incision where she had had drainage of psoas abscess.There is a recurrent incisional hernia measuring about 6-7 cm in diameter.There is a chronic sinus tract measuring 1.5 cm in length and 2 centimeters in depth.There were four prolene sutures that were removed at and around the base of the sinus tract.The sinus tract was sent for histological examination.Procedure: ¿the patient was placed in the dorsosupine position.The abdomen and the left flank were prepared and draped.A circumferential incision was made around the sinus tract and the incision was deepened until the apex of the tract was reached.Continued care was taken to avoid entering the peritoneal cavity since the patient has had recurrent hernia over the site.All prolene sutures that were palpable or visible were removed and there were four of them.The apex of the sinus tract was cleaned as much as possible.The wound was then packed with a single 4 x 4 soaked with betadine and a dressing was applied over it.Blood loss was 5 to 6 cubic centimeters.The patient tolerated the procedure well.¿ on (b)(6) 2001: (b)(6) hospital.(b)(6) md.Pathology report.Path#: (b)(4).Preoperative diagnosis: chronic wound infection, cancer uterus.Specimens: sinus, sinus tract-abdominal wound.Gross examination: the specimen is received in a container labeled with the name of the patient and identified as sinus tract, abdominal wound.The specimen consists of a tan ellipse of skin and subcutaneous tissue measuring 1.7 x 1.0 x 0.7 cm.There is a central probe-patent tract extending into the subcutaneous tissue.Representative sections submitted for routine processing.Diagnosis based on gross and microscopic examination: skin and subcutaneous tissue, abdominal wound: scar and granulation tissue reaction.On (b)(6) 2001: (b)(6) health system.Discharge instructions.Procedure: wound exploration.Diet: advance to regular.Activity: rest today.Call dr.(b)(6) for follow up appointment in 2 weeks.On (b)(6) 2002: (b)(6) hospital.Nurse notes.Weight 220 lbs., bmi 33.48.On (b)(6) 2002: (b)(6) hospital.(b)(6) md.History and physical.Chief complaint: ventral hernia.History of carcinoma of uterus; had surgery and postoperatively developed a large psoas abscess.This required drainage through a flank incision.She ultimately healed from that very well, and then developed a hernia through that flank incision.Repaired a couple times by doctor (b)(6), but has now become increasingly symptomatic.Sent to my office for evaluation and presents at this time for elective herniorrhaphy.She has never noticed any herniation through her midline incision.Surgical history: hysterectomy, two drainages of retroperitoneal abscesses and two incisional herniorrhaphies; last in (b)(6) 2001.Nonsmoker, nondrinker.Exam: obese.Temperature 100.4.Abdomen had an easily identifiable left flank hernia, which was about 5.0 cm in diameter through an old flank incision.The midline incision was well-healed and had no palpable herniation.No other palpable abdominal masses.Impression: left flank hernia.History of uterine carcinoma.Plan: repair of flank hernia.On (b)(6) 2002: (b)(6) health system.Operative record.Wound class: 2.Asa: 3.Implant #1 procedure: ventral herniorrhaphy with mesh placement.Implant: gore® dualmesh® biomaterial [1dlmc07/0133913, 20cm x 30cm x 1mm thick] implant #1 date: (b)(6) 2002 (hospitalization (b)(6) 2002).On (b)(6) 2002: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: left flank hernia.Postoperative diagnosis: ventral hernia.Complications: none.Estimated blood loss: less than 50 cubic centimeters.Findings: at exploration, the patient was found to have a large flank hernia and some multiple previous drainages of psoas abscesses.Procedure: ¿the patient was placed in the supine position.The abdomen was prepared with duraprep and draped with cloth towels and paper drapes.An incision was made through a previous incision and carried sharply into the subcutaneous tissue.The hernia was identified.A gore-tex dual mesh was then placed and tacked far back along the fascial edges with running #1 prolene.The fascia was then closed over the dual mesh with running 0 vicryl and copious irrigation carried out with antibiotic-impregnated irrigate.A jackson-pratt drain was placed into the subcutaneous tissue.The subcutaneous tissue was reapproximated with 2-0 vicryl.The skin was closed with skin clips.The patient tolerated the procedure well and was taken to recovery in good condition.¿ on (b)(6) 2002: (b)(6) health system.Implant record.Description: gore-tex mesh.Quantity: (b)(4).Catalog number: 1dlmc07.Lot number: 01333913.Expiration: 2007-03-06.On (b)(6) 2002 [assigned]: [facility ni].Implant sticker.Gore-tex dualmesh biomaterial.Item#: 1dlmc07.Lot#: 0133913.Relevant medical information: on (b)(6) 2002: (b)(6) hospital.(b)(6) md.Discharge summary.Discharge diagnoses: ventral hernia, uterine carcinoma.Procedure: ventral herniorrhaphy on (b)(6) 2002.Complications: none.Consultants: none.This is a 66-year-old with a ventral hernia in left flank from previous drainage of a psoas abscess.She had had a uterine carcinoma and developed this abscess, required multiple drainage procedures.She is now over a year out from this and is doing very well and presented for an incisional herniorrhaphy.After admission, underwent a ventral herniorrhaphy with placement of gore-tex dual mesh which she tolerated very well.Postoperatively, she had quite a bit of drainage from her blake drains.She was very sore for the first 72 hours, but pain slowly resolved.Began to ambulate well.Maintained of keflex by mouth while drain in place.Continued to have serous sanguineous drainage, but on third postoperative day, was deemed ready for discharge.Discharged home to follow in with me in office in one week.Discharge medications were keflex and lortab.Instruction for taking care of blake drain.On (b)(6) 2002: (b)(6) health system.Discharge instructions.Activity: no lifting greater than 15 pound for 2 weeks.No driving until after next visit to doctor¿s office or while on pain medicine.Call for temperature greater than 101.On (b)(6) 2004: (b)(6) hospital.(b)(6) md.History and physical.Chief complaint: enlarging midline incisional hernia; for exploratory laparotomy and incisional hernia repair.Noted to have recurrent midline incisional hernia in (b)(6) 2003.Has increased from 6 to 8 cm over the ensuing half year.In spite of patient not having symptoms, patient is concerned about further enlargement of the midline incisional hernia; has consented to repair.Does not smoke or drink.Weight: 216 lbs.Abdomen: midline incisional hernia below the umbilicus about 6 to 8 cm in diameter with reducible contents, no tenderness or mass.Surgical scar over left flank with no tenderness or recurrent hernia.Impression: recurrent midline incisional hernia.Has opted to undergo herniorrhaphy.Exploration of abdomen and pelvis will also be done to reassess the endometrial cancer.Implant #2 procedure: repair of recurrent incisional hernia with mesh.Implant: gore-tex® soft-tissue patch [01993450/1305010020, 5.0x10.0x2.0cm].Implant #2 date: (b)(6) 2004 (hospitalization (b)(6) 2004).On (b)(6) 2004: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnoses: recurrent incisional hernia.History of uterine carcinoma.Previous incisional hernia repair.Postoperative diagnosis: [ni].Anesthesia: general.Findings: there is an upper midline incision hernia 5 centimeters in diameter with omentum being adherent to the neck of the hernia.There is no evidence of recurrent uterine carcinoma.Abdominal washings and omentum as well as hernia sac were sent for oncological examination.Procedure: ¿the patient was placed in the dorsal supine position with an abdominal preparation and placement of a foley catheter.The abdominal wound was then draped.The hernia site was located below the umbilicus.An incision was made.The incision was carried through the various layers of the abdomen.Omental adhesions were freed all around the neck of the sac.Exploration of the midline surgical scar all around revealed no additional sites of hernia.Abdominal washings were obtained and exploration of the abdomen revealed no evidence of recurrent uterine carcinoma.An omental biopsy was taken.The peritoneum was reflected from the underlying rectus sheath.The edge of the neck was trimmed.The subcutaneous tissue was mobilized away from the rectus fascia for about 1.5 centimeters.Interceed was then placed over the bowel.Gore-tex 5 by 9 centimeters was then sutured underneath the rectus sheath using 0 prolene in a bulk closure technique with two sutures.A jackson-pratt drain 510 was introduced into the subcutaneous tissue via a stab wound incision.The subcutaneous tissues were then reapproximated with 3-0 vicryl.The clips were then used to approximate the skin edges.The blood loss was about 80 cubic centimeters.The 3-0 prolene was used to anchor the jackson-pratt drain.¿ on (b)(6) 2004: (b)(6) health system.Operative record.Asa 2.Implant record.Gortex soft tissue patch 5.0cmx10.0cmx2cm.Quantity: (b)(4).Catalog no.1305010020.Expiration: 2005-01-21.Lot number: 01993450.To back and [illegible] ¿ seprafilm.On (b)(6) 2004 [assigned]: implant sticker.Gore-tex soft tissue patch.Lot: 01993450.Item: 1305010020.Relevant medical information: on (b)(6) 2004: (b)(6) hospital.(b)(6) md.Pathology report.Path#: (b)(4).Specimens: hernia sac, incisional.Omentum.Frozen diagnosis: [ni].Gross examination: a.The specimen is received in a container labeled with the name of the patient and labeled as hernia sac, incisional.The specimen consists of irregular pieces of fibromembranous tissue and attached yellow adipose tissue measuring 4.5 x 3.5 x 0.8 cm in aggregate.Representative sections are submitted.B.The specimen is received in a container labeled with the name of the patient and labeled as omentum.The specimen consists of an irregular piece of yellow fibrofatty tissue measuring 6.0 x 1.8 x 0.8 cm.The specimen is sectioned and totally submitted.Diagnosis based on gross and microscopic examination: a.Incisional region: incisional hernia sac with bordering fibroadipose tissue.B.Portion of omentum: site of reactive fibrosis with bordering adipose tissue corresponding to site of chronic inflammation with overlying layered fibrin and old hemorrhage.Organized thrombus within omental vein.On (b)(6) 2004: (b)(6) hospital.(b)(6) md.Discharge summary.Underwent exploratory laparotomy, biopsy of omentum and hernia sac, as well as repair of midline incisional hernia with mesh.No evidence of recurrent endometrial carcinoma and biopsies, abdominal washings were negative.Discharged with jackson-pratt drain and skin staples in place.Has home health nurse visits to assist with the care of the drain and to have the jackson-pratt removed when drainage is less than 25 cubic centimeters over 24-hour period.On (b)(6) 2004: (b)(6) health system.Discharge instructions.Activity: independent as tolerated, no driving, no lifting.On (b)(6) 2004: (b)(6) hospital.(b)(6) md.History and physical.Chief complaint: finding of abdominal wound abscess for incision and drainage.Underwent repair of recurrent incisional hernia with mesh (b)(6) 2004.Noted to have cellulitis (b)(6) 2004 with a needle aspiration showing no pus obtained.Treated with cleocin and levaquin for cellulitis of abdominal wound.On follow up (b)(6) 2004, the redness on abdominal incision site showed somewhat indurated measuring 4 to 5 cm with no fluctuance or drainage, no tenderness.A cat scan of abdomen 3/19/04, showed a 9.7 x 6.9 cm subcutaneous abscess about 2 to 3 cm caudal to the umbilicus with some hazy density and some gas in it, as well as mass effect indenting the anterior abdominal wall.Pelvis and abdomen unremarkable.White blood cell count 11.5.Admitted for incision and drainage.Other than abdominal wall swelling and subjective discomfort over the incision , patient has no other complaints.Abdomen: midline surgical scar with no drainage or wound separation.There is a fullness and flare of 4 to 5 cm in diameter around the umbilicus with no tenderness or fluctuance.The patient is moderately obese.No mass palpable.Impression: recent repair of recurrent incisional hernia with mesh.Abdominal wound abscess.Plan: incision and drainage of abdominal wound abscess.Attempt will be made to leave the gore-tex mesh in place.Consultation will be sought with infectious disease for optimal antibiotic treatment.Vac wound treatment will likely be instituted.Explant #1 procedure: incision and drainage of abdominal wall abscess, extensive wound debridement, removal of gore-tex mesh.It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Additional Manufacturer Narrative
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H6: conclusion code remains unchanged.It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore-tex® soft tissue patch 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Additional Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following complications among others: ¿possible complications with the use of any tissue deficiency prosthesis: complications which may occur include, but are not limited to: infection, seroma formation, adhesions, hematomas, inflammation, fistula formation, and recurrence.¿ the instructions for use further state: ¿any postoperative infection should be aggressively treated at the earliest possible time.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 persistent/symptomatic seroma and 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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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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