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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); Pain (1994); Hernia (2240); Not Applicable (3189)
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| Event Date 07/03/2012 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2010 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure was performed whereby the gore device was explanted.It was reported the patient alleges the following injuries: abdominal pain, hernia recurrence, mesh infection, mesh removal, abscess.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Corrected results code.Code 3233 - sterilization results pending completion of the evaluation.Corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated on (b)(6) 2010 indicate the patient underwent laparoscopic repair of a ventral hernia.The records state: ¿this is a 34-year-old female who was transferred from florida hospital/(b)(4) with what was thought to be an incarcerated ventral hernia.She stated that she had 6 months of abdominal pain that was related to the bulge superior to her umbilicus.She had previously been able to reduce this.Prior to presenting to the emergency department, she was unable to reduce this and her pain had increased.Once she arrived to florida hospital/(b)(4), the hernia was found to be reduced a little.A ct scan was performed, which showed ventral hernia superior to the umbilicus with fat and some inflammatory changes in the hernia sac.However, no bowel was seen within the hernia sac.It was recommended given her length of symptoms and the episode of incarceration that we take her to the operating room and have this hernia fixed with mesh.We will originally attempt a laparoscopic ventral repair with mesh.She did understand that this could possibly be converted to an open repair.¿ on (b)(6) 2010, operative report states: ¿the abdomen was explored.There was an area of adhesions where the hernial defect was noted.These adhesions were taken down carefully not to injure any bowel.It appeared that it was mostly the hernia sac that was densely adhered and in the hernia.The adhesions were then taken down with bovie cautery.There were more adhesions encountered on the right midabdomen.There were intestines noted and this was dissected down sharply careful not to injure any small bowel.Once the adhesions were cleared, the defect was measured and it measured to be 2 cm in diameter.We measured out our planned mesh size extracorporeally.We measured it so that it would give us a good coverage.We then chose to use a 10 x 15-cm piece of gore-tex mesh.Gore-tex sutures were then placed about 1 cm apart circumferentially.The mesh was then placed in the abdomen.With the carter-thomason suture passer, the sutures were then brought out of the abdomen.Once all sutures were brought out, they were then tied in place.The abdomen was then explored and the mesh was found to be in good position allowing good coverage over the hernial defect.This suture tacker was then used to place a crown of tacks circumferentially.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp03/7393866) was used during the procedure.Operative records dated on (b)(6) 2012 indicate the patient underwent open recurrent ventral hernia repair with mesh.The records state: ¿this is a 37-year-old female with a previous history of laparoscopic ventral hernia repair in 2010 who came into the emergency room complaining of abdominal pain and swelling.The patient reports that approximately 6 months after her original repair in 2010, she had a bulging epigastric area.Patient reports that the bulge has slowly grown larger over time.The patient states she was originally able to reduce the bulge, however, she is currently unable.The patient denies nausea and vomiting.Reports regular bowel movements and flatus.¿ on (b)(6) 2012, records state: ¿a ct scan of the abdomen and pelvis showed: 1.A midline ventral hernia appearing larger from previous exam, now containing a short segment of transverse colon in addition to omental fat with fluid and stranding of the herniated fat.Findings raise the possibility for incarceration.No mural thickening of the colon or dilatation evident.2.Interval placement of an anterior hernia mesh just inferior to the above-described hernia.3.Fibroid uterus.4.Right adnexal low-attenuation lesion suggestive of a follicular cyst.5.Hepatic steatosis.Based on these findings, an open repair of recurrent ventral hernia was discussed with the patient.¿ on (b)(6) 2012, operative report states: ¿a midline incision of approximately 12 cm was made overlying the palpable bulge.Dissection was carried down through the fascia and subcutaneous fat using bovie electrocautery with hemostasis ensured along the way.The dissection was carried down through the subcutaneous fat to the abdominal fascia.At this point, manual palpation was used to detect the hernia sac which was located at the inferior portion of the wound.Bovie electrocautery was used to separate the hernia contents from the surrounding hernia sac, and the abdominal contents were then reduced inside the abdomen.The hernia sac was then separated from the underlying fascia and surrounding fat using bovie electrocautery.Once the hernia sac had been removed, manual palpation was used to explore the incision, and a small approximately 1 cm x 1 cm defect was noted approximately 2 cm superior to the superior edge of the incision.Preperitoneal fat was noted to have herniated through this defect.The preperitoneal fat was separated from surrounding tissue using bovie electrocautery and remaining content and truncated at its base.The remaining preperitoneal fat was reduced through the defect.A 0 pds suture was used to close the superior defect in a figure-of-eight fashion with care taken not to injure underlying abdominal contents.¿ on (b)(6) 2012, records continue: ¿at this point, attention was turned back to the larger fascial defect, and bovie electrocautery was used to separate the fascia from the overlying subcutaneous fat providing adequate margin for mesh placement.Once a satisfactory dissection had been obtained, a 10 x 16 cm strattice mesh [non-gore device] was sized to better fit the wound and was then inserted into the defect.0 pds sutures were placed at the superior and inferior end of the mesh and fascia under an adequate amount of tension to actually close the defect.Interrupted 0 pds sutures were then placed circumferentially around the wound again with care taken to provide adequate tension to close the defect.Care was taken not to injure the intra-abdominal contents during this process.The circumferential sutures were tied down and repair was inspected for adequate tension on the underlying mesh.Once examination was satisfactory, attention was turned to closing the fascia overlying the mesh.2-0 pds sutures were used in running fashion to close the defect with 1 suture beginning at the superior end and the other beginning at the inferior end and were tied down in the middle, and adequate fascial closure was obtained.¿ operative records dated on (b)(6) 2012 indicate the patient underwent incision and drainage of infected abdominal wall fluid collection and removal of infected abdominal wall mesh.The records state: ¿this is a 37-year-old female with a history of ventral hernia status post repair x2.Patient's initial repair was done with a gore-tex mesh and the second repair was done with a strattice mesh [non-gore device].Since the second repair the patient has had recurrent fluid collections with pain, swelling, and erythema at the incision site.Patient has had a drain placed by interventional radiology and multiple courses of antibiotics.However the fluid collection has remained.For these reasons, incision and drainage of infected abdominal wall fluid collection was discussed with the patient.¿ records detailing the drain placement and multiple courses of antibiotics were not provided to gore.On (b)(6) 2012, records state: ¿radiologic imaging studies were reviewed and the location of the fluid collection was determined based on the location of the drain.It was noted that the drain traveled a straight course from lateral to medial, from the abdominal wall to the fluid collection.The skin was opened with a 10 blade scalpel overlying the fluid collection.Dissection was carried down through the fat and subcutaneous tissue using bovie electrocautery.Hemostasis was assured along the way.Dissection was continued down following the ir drain for guidance until the tip of the drain was reached.It was noted that no significant fluid collection was present; however, a cavity was encountered.The cavity was explored and an extension was noted running inferiorly along the course of the incision.Exploration of this tract was continued.Continued exploration demonstrated that the cavity continued down to the site of the previous mesh placement.On (b)(6) 2012, operative report continues: ¿the gore-tex mesh was encountered and was dissected free from surrounding connective tissue.All encountered suture and tacks were removed along with the mesh.The tract was further opened with bovie electrocautery to allow for full explantation of the mesh upon initial encounter of the mesh, a cloudy thick fluid was noted to be leaking from the mesh.This fluid was sent for culture.Dissection revealed an intact mesh and sutures.However, due to the chronic infected nature of the wound, and the fluid noted to be leaking from the area where the mesh was, it was decided that the mesh should be removed.Once all tacks and sutures holding the mesh in place were removed, the mesh sutures and tacks were sent for pathology.The wound was inspected for hemostasis and no bleeding was noted.A kerlix gauze was tacked inside the wound and the wound was left open to heal by secondary intention.¿ pathology report dated on (b)(6) 2012 regarding a specimen collected on (b)(6) 2012 states: ¿diagnosis: explanted mesh: synthetic material with reactive fibrosis.¿ gross description states: ¿received in formalin labeled "explanted mesh" is an irregular portion of tan surgical mesh material measuring 11 x 8 x 0.1 cm.No attached soft tissues are identified.¿ operative records dated on (b)(6) 2014 indicate the patient underwent incision and drainage of an abdominal wall abscess.The records state: ¿this is a 39-year-old female.She has a history of a laparoscopic ventral hernia repair several years ago that recurred.The recurrence was subsequently repaired with mesh in an open fashion.The patient then developed a mesh infection and the mesh had to be explanted.She now presents with a recurrent ventral hernia; however, she has had a chronic draining sinus from this area for several months.Ct scan revealed an abscess cavity.She was offered incision and drainage of this abscess in the operating room.¿ on (b)(6) 2014 records state: ¿there was an area of erythema on the left abdomen just lateral to the umbilicus.This was fluctuant as well.An incision was made over this area.Dissection down through the soft tissue was performed, and the abscess cavity was entered.This abscess fluid was then cultured and sent off for culture, sensitivity, and gram stain.The abscess cavity was then explored.It tracked down to the abdominal wall.Care was taken to stay away from the hernia sac.At this time, the wound was then copiously irrigated.Adequate hemostasis was achieved with electrocautery.The wound was then packed with a 1-inch gauze dressing.Sterile gauze and paper tape were applied to the wound.¿ pathology report dated on (b)(6) 2014 regarding a specimen collected on (b)(6) 2014 states: ¿diagnosis: abdominal wall mass, biopsy: histologic changes consistent with a scar.¿ 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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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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Conclusion code remains unchanged.
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Manufacturer Narrative
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A2: added date of birth.A4: added patient weight.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 1/27/10; including cesarean sections, appendectomy, bilateral tubal ligation and cholecystectomy, were not provided.(b)(6) 2010: [facility ni].Christopher wasyliw, md.Radiology ¿ ct abdomen/pelvis with contrast.Clinical data: upper abdominal pain, possible hernia.Comparison: 06/07/07.Findings: ventral hernia with fat within it.Hernia sac measures 7.4 x 4.6 x 6.2 cm.Fluid and inflammatory changes in hernia sac, could be related to incarceration, correlate point tenderness.Hernia increased in size.Bowel not obstructed.(b)(6) 2012: florida hospital.Teresa roth, md.Emergency room visit [hand written].Abdominal pain, 1 week.Patient says she is usually able to push back in.[illegible] feels full and bloated.Nausea, loss appetite.Constipation.Exam: large hernia, tenderness, [illegible] with overlying skin erythema.Impression: abdominal pain, incarcerated ventral hernia.Admit.(b)(6) 2012: [facility ni].Donald nies, md.Radiology ¿ xr abdomen series with chest 1 view.Indication: abdominal pain.Impression: nonspecific bowel gas pattern.(b)(6) 2012: [facility ni].Sameet k.Rao, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain.Comparison: 01/27/10.Impression: midline ventral hernia, larger from previous exam, containing segment transverse colon, omental fat, with fluid and stranding of herniated fat.Possibility incarceration.No mural thickening of colon or dilatation evident.Interval placement of anterior hernia mesh, inferior to above-described hernia.(b)(6) 2012: [facility ni].Jeffrey chiu, md; joseph d.Portoghese, md.History and physical.Admitting diagnoses: incarcerated recurrent ventral hernia.Underwent laparoscopic ventral hernia repair 01/27/10.6 months after repair, bulge in epigastric area.Slowly grew larger.Able to reduce bulge initially.Gotten so large, unable to completely push back in.Having bowel movements, passing flatus.Denies nausea, vomiting, experiencing reflux.To emergency room for evaluation.Exam: abdomen obese, large pannus, epigastric area 8 x 8 cm ventral hernia.Partially reducible; entire hernia contents unable to be reduced into hernia defect.Right upper quadrant scar.Ct scan abdomen/pelvis reveals ventral hernia with transverse colon.Hernia defect superior to previously placed mesh.Omentum within hernia.Plan: admit patient, schedule for repair of recurrent ventral hernia.(b)(6) 2012: florida hospital.Implant record.Tissue strattice firm 10 x 16.Lifecell corporation.(b)(6) 2012: [facility ni].Discharge instructions.Follow up with primary care provider in 2 weeks.Resume diet, exercise as tolerated, no heavy lifting (more than 10 pounds).(b)(6) 2012: [missing record: record for ¿wound seroma¿ were not provided.] (b)(6) 2012: [missing record: record for ¿ct abdomen/pelvis¿ were not provided.] (b)(6) 2012: [facility ni].Josiah w.Bancroft, md.Radiology ¿ ct abdomen/pelvis with contrast.Reason for exam: abdominal abscess post-surgery.Indication: abdominal, pelvic pain.Comparison: ct abdomen/pelvis 03/01/12.Findings: small hiatal hernia.Peritoneal cavity: small fluid collection in region of previously drainage catheter in soft tissues measures 5.7 x 2.5 cm.Air noted superior aspect of fluid collection with mildly thickened walls.Stranding of soft tissues of abdomen from portion of rectus.Postsurgical change from hernia repair.Stranding of mesenteric fat adjacent to hernia repair.Impression: fluid collection within soft tissues anterior abdominal wall in region of previously removed drainage catheter may represent a seroma or abscess.Small amount air within area superiorly, no herniation of bowel.(b)(6) 2012: [facility ni].Amir salmanzadeh, md.Radiology ¿ ct abscess drainage.Indication: supraumbilical midline abdominal wall abscess collection.Comparison: ct abdomen 04/23/12.Findings: direct ct guidance a 19-gauge yueh needle placed within abscess collection.10 french locking pigtail drainage catheter placed within collection, without complications.Drainage catheter secured to overlying skin with 2-0 silk suture, connected to jackson-pratt bag.10 ml pus removed and sent for gram stain, culture and sensitivity.(b)(6) 2012: florida hospital.Microbiology ¿ fine needle aspirate culture with gram stain.Specimen: fine needle aspirate midabdominal wall abscess.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain result: 3+ wbc¿s; no organisms seen.(b)(6) 2012: [facility ni].Andrea hong, md.Radiology ¿ ct abdomen with contrast.Indication: ventral hernia repair, postsurgical fluid collection.Comparison: 04/23/12.Findings: anterior midline subcutaneous fluid collection at site of prior hernia repair is decreased in size, currently measuring 4.2 x 4.3 x 1.9 cm (7.1 x 6.3 x 2.7 cm on 04/23/12).No change in stranding of adjacent subcutaneous fat.Underlying hernia repair with mesh again noted.Impression: residual 4.3 cm fluid collection in subcutaneous fat overlying prior hernia repair.(b)(6) 2012: [facility ni].Ronald scott shill, md.Radiology ¿ ct abscess drainage.Reason for exam: seroma post-surgical fluid collection.Technique: under ct guidance an 18-gauge needle advanced to fluid collection within anterior abdominal wall in subcutaneous tissues, catheter placed within collection.20 ml fluid removed.Catheter secured with single stitch of 2-0 silk and left to external drainage.Impression: successful placement of drainage catheter within anterior abdominal wall subcutaneous tissue fluid collection.Follow up imaging one week with abscessogram.(b)(6) 2012: florida hospital.Microbiology ¿ fungus culture with smear.Specimen: fine needle aspirate seroma post-surgical abdominal wall fluid aspiration.Culture results: no fungus isolated after 4 weeks.Fungus smear results: no fungal elements seen.(b)(6) 2012: florida hospital.Microbiology ¿ fine needle aspirate culture with gram stain.Specimen: fine needle aspirate seroma post-surgical abdominal wall fluid aspiration.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain result: 2+ wbc¿s; no organisms seen.(b)(6) 2012: florida hospital.Josiah w.Bancroft, md.Radiology ¿ ir angio drainage procedures.History: abdominal wall abscess.Procedure: abscessogram and sclerosis of residual collection.Procedure/findings: placed in supine position, existing catheter injected with contrast 12 ml cavity, no evidence of communication to bowel.Collection recurred after precious catheter removal; such sclerosis was felt beneficial.Betadine solution injected into residual cavity; catheter capped.Patient instructed to uncap catheter in 8 hours and flush saline.Impression: residual collection within soft tissues with no enteric communication.Sclerosis of cavity performed and cavity will be re-evaluated following week.(b)(6) 2012: [facility ni].Dr.David j.Moskovitz.Radiology ¿ ct abdomen without contrast.Indication: abscess drainage catheter placed in anterior abdominal wall presents with recurrent drainage and followup.Evaluate cavity drain.Comparison: (b)(6) 2012.Findings: pigtail catheter within anterior abdominal wall fluid collection persists, measures 5.8 cm in transverse dimension and 2.2 cm in ap dimension.Pigtail catheter is stable.Hernia mesh stable.Impression: persistent fluid collection in anterior abdominal wall just anterior to prior hernia with stable positioning of pigtail catheter.Discussed with patient options, will proceed with injection of betadine 5 ml twice a day allowing betadine to sit within fluid collection for one hour prior to placing the catheter back to drainage.She will call if decrease in drainage prior to followup.(b)(6) 2012: florida hospital.Dr.Derrick jones.Radiology ¿ ir angio drainage procedures.Exam: tube sinogram.Indication: follow up evaluation.States drainage from catheter increased.Comparison: ct 06/08/12.Small persistent fluid collection seen, 2 focal areas which communicate by small tract.Catheter resutured to skin, reconnected to bulb suction.Impression: persistent fluid collection anterior abdominal wall.Continue betadine.Will inject betadine volume of half the amount of drainage obtained twice daily.Follow up 2 weeks.(b)(6) 2012: [facility ni].Joseph d.Portoghese, md.History and physical.Persistent abdominal wall infected seroma.Seen with painful recurrent incisional hernia.Taken to surgery for open repair with strattice mesh.Post op developed an infected seroma and despite prolonged drainage it has not resolved.Exam: right sided drainage catheter with erythema midline incision well-healed with thickening in sub q upper midline.Impression: choric infected abdominal wall seroma.Plan: incision and drainage of seroma with post-op open packing of wound.(b)(6) 2012: florida hospital.Microbiology ¿ fungus culture.Specimen: tissue/bone chronic granulation tissue swab.Culture results: no fungus isolated after 4 weeks.(b)(6) 2012: florida hospital.Microbiology ¿ soft tissue or bone culture with gram stain.Specimen: tissue/bone chronic granulation tissue swab.Culture results: 1 colony staphylococcus aureus for susceptibilities refer to previous report from culture no.T4590140; no anaerobes isolated.Gram stain results: no wbc¿s seen; no organisms seen.(b)(6) 2012: florida hospital.Microbiology ¿ fungus culture.Specimen: surgical deep abscess.Culture results: no fungus isolated after 4 weeks.(b)(6) 2012: florida hospital.Microbiology ¿ wound culture surgical with gram stain.Specimen: surgical deep abscess.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain results: no organisms seen; 1+ wbc¿s.(b)(6) 2012: [facility ni].Lucas watkins, md.Discharge summary.Admission diagnosis: recurrent incarcerated ventral hernia.Discharge diagnosis: recurrent incarcerated ventral hernia status post ventral hernia repair.Presented to emergency room complaints of enlarging bulge, nonreducible in abdomen site of previous hernia.Reporting changes in bowel habits, no other symptoms.Exam: abdomen soft, nontender.8 x 8 cm bulge partially reducible, midline.Ct scan revealed ventral hernia with transverse colon, omentum present without fat stranding.Hospital course: patient admitted, treated symptomatically preparation for surgery.Underwent open ventral hernia repair with mesh, previous mesh removed.Patient did well, return of bowel function and pain control, discharged home stable, tolerating regular diet.Followup 2 weeks.(b)(6) 2012: [facility ni].Discharge instructions.Follow up home health care for wound packing.No heavy lifting or strenuous exercise for 1 week.(b)(6) 2012: florida hospital.W.Randal poole, md.Emergency room visit [hand written].Abdominal pain, status post wound debridement on 07/03/12.History of abdominal wall infected seroma, infected abdominal wall mesh.Seen in ed by general surgery who admit for [illegible].Impression: cellulitis, fever, [illegible], post op pain.(b)(6) 2012: [facility ni].Dr.Donald nies.Radiology ¿ ct abdomen/pelvis with contrast.Indication: pain, wound seroma with ventral hernia repair.Comparison: 06/08/12.Findings peritoneal cavity: above umbilicus a midline opened wound has inflammation.Defect extends to inner surface of abdominal rectus muscles.Right of this lateral by more than 10 cm, is a 5.5 x 4.3 x 2.9 cm multifocal area of inflammation and fluid that has phlegmon fluid, fluid components have ct density of 11.Along right flank some anasarca.To the left there is rounded 4.3 x 3.7 cm high-attenuation area could represent resolving postoperative hematoma, inflammation or phlegmon, this is not fluid.There was mesh along anterior abdominal wall, was removed.Impression: right of midline incision, there is a 5 x 5 x 4.3 x 2.9 cm multifocal area of inflammation and fluid.To left of midline incision there is 4.3 x 3.7 cm focal area of soft tissue that is high in attenuation, could represent hematoma.Thickening and scarring along anterior abdominal wall where mesh was removed.Wound contains gas which extends to the fascial plane, separates abdominal rectus muscles from intraabdominal fat.No incarcerated loops of small bowel or small bowel obstruction.07/09/12: [facility ni].Nurse notes ¿ emergency room visit.Patient elected to leave ama [against medical advice] instead of being admitted to inpatient area.Patient given verbal instructions by physician and proscription for antibiotics.(b)(6) 2012: [missing record: record for ¿collecting abdominal abscess fluid¿ was not provided.] (b)(6) 2012: florida hospital.Microbiology ¿ abscess culture with gram stain.Specimen: abdomen abscess.Culture results: 2+ staphylococcus aureus; no anaerobes isolated.Gram stain results: occasional wbc¿s; occasional gram-positive cocci.(b)(6) 2014: florida hospital.Cabatu.Emergency room visit [hand written].Abdominal pain, cellulitis.Onset today, persistent.Has had 3 hernia repairs, tonight when tried to reduce hernia, it hurt and felt hot to touch, she couldn¿t.Moderate pain.Exam: erythema, induration, fluctuance left lower quadrant abdominal wall.No deep tenderness, no hernia present.Progress: condition improved, abdomen soft, tolerating po.Impression: abdominal wall cellulitis.Disposition home on antibiotics.02/05/14: [missing record: records for ¿culture of abscess abdominal wound cellulitis¿ were not provided.] (b)(6) 2014: florida hospital.Microbiology ¿ abscess culture with gram stain.Specimen: abscess abdominal wound cellulitis.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain results: 1+ wbc¿s; no organisms seen.(b)(6) 2014: [facility ni].Dr.Rahul mehta, md.Radiology ¿ ct abdomen/pelvis without contrast.Indication: cellulitis of trunk, possible hernia.Comparison: 07/09/12.Findings peritoneal cavity: midline epigastric ventral hernia.Craniocaudal dimension 12 cm, extends from subxiphoid area to above umbilicus.Mediolateral dimension 12 cm and ap dimension is 3.6 cm.Has wide neck.Large and small bowel extending hernia.No bowel obstruction.Edema present in subcutaneous fat around hernia site.Thickening of skin.Left of midline inferiorly is area of soft tissue measuring 4 cm seen involving left rectus muscle (sequence 20/8/50 post-parentheses).Could represent area of fibrosis.Does not have appearance of abscess.No definite abscess or collection present.Impression: ventral hernia containing small and large bowel.Soft tissue stranding present in fat in anterior abdominal extending to skin.Findings nonspecific, could represent cellulitis.Records between 02/10/14 and 05/13/14 were not provided.(b)(6) 2014: florida hospital.Jalma massucci, md.Emergency room visit.Abscess, onset 2-3 months, painful.Identified cause: yes, possibly hernia mesh.Presents to ed with abdominal abscess, symptoms began after hernia repair, onset 3 months ago, still present.Patient notes allergic reaction to hernia repair mesh and has abdominal pain and nausea.Exam: abscess, skin rash, erythema.Location: abdomen with warmth, tenderness, swelling, induration, thickening.Impression: cellulitis abdominal wall.Admit, condition improved.(b)(6) 2014: [facility ni].Dr.Nicholas feranec, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain.Comparison: 02/10/14.Findings peritoneal cavity: several midline ventral hernias.One anterior to left lobe of liver contains small amount of fat.Next one much bigger, contains portion of transverse colon.Just below it, complex supraumbilical hernia containing fat, few loops of small bowel.Stable thickening involving left rectus sheath measuring 4.9 cm.Tubular portion extends from inferiorly and anteriorly.Impression: no explanation for acute abdominal pain.Several midline ventral hernias.Chronic inflammation and edema involving subcutaneous fat of anterior abdominal wall.(b)(6) 2014: florida hospital.Microbiology ¿ wound culture drainage with gram stain.Specimen: other abdomen.Culture results: 3+ staphylococcus aureus.Gram stain results: 3+ wbc¿s; no organisms seen.(b)(6) 2014: [facility ni].Dr.Lisa langmo, md.Radiology ¿ us abdomen limited.Indication: evaluate rectus muscle for possible abscess.Comparison: ct 05/13/14.Impression: diffuse edema in this region.Some fluid possibly able to be aspirated along lower margin of bandage using ultrasound guidance.(b)(6) 2014: [facility ni].Yaphet tilahun, md.History and physical.Abdominal pain.History infected mesh with explantation in 2012, persistent left abdominal wall infection with draining sinus.Undergone multiple incision and drainage with wound healing with secondary intention.Now to ed with left sided abdominal pain superior and deep to draining sinus.Pain worse over last few days, worse with movement, only improves when sitting still or laying on back.Exam gastrointestinal: soft, non-distended, normal bowel sounds, tender to deep palpation along left midline, palpable abdominal wall defects in midline with reducible bowel, left of midline on inferior border of pannus, two small openings with serous/purulent drainage.Erythema and induration around draining sites.Diagnosis: cellulitis, abscess.Chronic draining sinus, thickened rectus muscle.Evidence of cellulitis around draining sites.Unclear if drainable fluid collection around/within left rectus muscle.Admit, ultrasound to evaluate rectus muscle thickness.Start antibiotics.(b)(6) 2014: florida hospital.Natesha ambs, md.History and physical [hand written].Abdominal abscess secondary to hernia, with pus drainage, opening and closing.States 2 years of polyuria, polydipsia, as well as recurrent fungal infections in [illegible] areas.Comorbidities affecting management of chief complaint: multiple hernias.Medications: keflex, bactrim.Exam: redness, erythema at periumbilical and to the left mild area of drainage, no pus.Assessment/plan: fungal infection: nystatin powder.Hernia recurrent.Newly diagnosed diabetes mellitus type 2, obesity, start insulin.(b)(6) 2014: [facility ni].Nejda lugo mandes, md.Consultation.Reinfection of hernia site.Past 3 weeks, hernia site oozing pus, having secretions as well as the periumbilical, mostly to left periumbilical area, tender to palpation.Exam gastrointestinal: no tenderness, mass or inguinal hernia.Does have area of induration, redness, discoloration, tenderness periumbilically to left.Measures 5 cm.Small area of opening.Not draining purulent material at the time.Assessment/plan: recurrent abdominal cellulitis with pus draining and fistula, will undergo explorative laparoscopic surgery, on vancomycin.(b)(6) 2014: florida hospital.Tien-anh n.Tran, m.D.Pathology report.Diagnosis: abdominal wall mass, biopsy: histologic changes consistent with a scar.Clinical history: abdominal abscess.Material submitted: abdominal wall mass.Gross description: surgical requisition slip and specimen container match patient¿s name, date of birth, and specimen description.Received in formalin labeled ¿abdominal wall mass¿ is an irregular portion of indurated tan-yellow fibrofatty tissue measuring 0.5 x 0.5 x 0.3 cm that is inked, bisected, and entirely submitted in one cassette labeled s14-9651.Microscopic examination: microscopic examination has been performed and the findings are incorporated in the diagnosis.(b)(6) 2014: florida hospital.Microbiology ¿ fungus culture.Specimen: surgical abdominal wall wound.Fungus culture results: no fungus isolated after 4 weeks.(b)(6) 2014: florida hospital.Microbiology - acid fast bacteria culture.Specimen: surgical abdominal wall wound.Culture results: no acid-fast bacilli isolated after 6 weeks.Acid fast bacteria smear results: no acid-fast bacilli seen.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain results: 1+ wbc¿s; no organisms seen.(b)(6) 2014: [facility ni].Van b.Foles, md; joseph d.Portoghese, md.Discharge summary.Procedure: incision and drainage of complicated recurrent abdominal wall abscess.Hospital course: postoperative uneventful, return of bowel function, toleration regular diet, pain controlled.Discharged home followup outpatient with surgery.(b)(6) 2014: [facility ni].Jeffrey chiu, md.Discharge information.Repack wound twice daily, wet to dry gauze, may shower, no baths.Clindamycin every six hours.Records between 05/19/14 and 10/19/14 were not provided.Continued on attachment.- attachment: [event 36819 continuation h10.11.Pdf].
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2010: (b)(6) hospital.(b)(6) , md; (b)(6) , md.History and physical.Incarcerated ventral hernia.Had 6 months abdominal pain related to bulge superior to umbilicus.Able to reduce.Bulge increasing over past 6 months.Episodes where unable to reduce hernia, but will resolve with spontaneous reduction.This morning, unable to reduce hernia, had severe abdominal pain in epigastric region where bulge is, presented to florida hospital/apopka ed.Complaining of nausea, clear emesis.Normal bowel movements and appetite, pain increases with po [by mouth] intake.Exam: abdomen soft, non-distended, tender to palpation in epigastric region, bulge measuring 3 x 3 cm, reducible, pain decreased with manual reduction.Assessment: reducible ventral hernia.Will be repaired as inpatient or outpatient.No signs of obstruction, ventral hernia is non-emergent.(b)(6) 2010: (b)(6) hospital.(b)(6) md; (b)(6) md.Discharge summary.Admission/discharge diagnosis: ventral hernia.Procedure: laparoscopic ventral hernia repair.Hospital course: to hospital because incarcerated ventral hernia.Hernia confirmed on ct scan.No involvement of bowels.Bulge increasing over last 6 months.Complaining of nausea, emesis.To operating room, ventral incisional hernia repair with mesh done.Postoperative course unremarkable.At time of discharge tolerating diet, no nausea, vomiting.No complaints of pain, was ambulating.Follow up dr.P(b)(6) ortoghese in 2 weeks.(b)(6) 2010: [facility ni].Discharge instructions.No heavy lifting more than 10 pounds.May shower, abdominal binder for support.(b)(6) 2010: (b)(6) , md; (b)(6) , md.Office visit.Initially seen for what was thought to be incarcerated ventral hernia.Upon arrival to fh orlando we were able to fully reduce it.Had abdominal pain and bulge for 6 months.Bmi 52.89.Exam: obese, soft, appropriate tender to palpation.Small area of seroma.2 weeks status post ventral hernia repair.Doing well.Discussed the seroma and it will resolve slowly.(b)(6) 2010: (b)(6).Office visit.Doing well after lap ventral hernia repair in january.Has discernible upper midline hernia at medial edge of open cholecystectomy incision that was not seen previously.Repair site looks good.Advised that she should continue to lose weight (has lost 20 lbs), we need to wait at least 6 months after previous repair before attempting to fix this new defect.(b)(6) 2012: (b)(6) phone call.Patient states pain is 8 out of 10, is not well managed by percocet.Surgical wound is red, warm to touch and jackson-pratt drains intact with drain output about 25 ml for yesterday.States flatus and no bowel movement; advised to begin over the counter stool softener and increase fluid intake.Will come in to see jose rios, pa for further evaluation of surgical site and unrelieved pain.(b)(6) 2012: (b)(6) pa.Office visit.Recently began noticing redness around abdomen that progressively has been getting worse.Denies fever, drainage from wound or excessive pain.Pain slowly improving, controlled with pain medication.Continues to use abdominal binder around the clock.Weight 247 lb.Bmi 51.62.Abdomen: binder in place with erythroderma on all areas of abdomen touched by binder but not on areas not touched by the binder.Two j.P.Drains in place with serosanguinous fluid.Impression: contact dermatitis.Advised to remove binder and not use.(b)(6) 2012: (b)(6) , pa.Office visit.Had contact dermatitis caused by abdominal binder.Abdomen: erythroderma on all areas of abdomen significantly improved.Jp on right side and every other staple were removed.(b)(6) 2012: (b)(6) phone call.Chills.Oral temp 102.9-103.Spoke with jose rios, pa, advised patient to begin course of bactrim ds.(b)(6) 2012: (b)(6) phone call.Last night developed nausea, large increase of clear output in jp drain.Temp reached 104 deg.Will be seen in clinic today.(b)(6) 2012: (b)(6) , pa.Office visit.Fever of 104.Jackson-pratt drain completely filled 3 times during night.Abdomen: right-sided abdominal wound looks more red than yesterday, entire abdomen tender to deep palpation only.Full workup including ct scan of abdomen and pelvis.Change from bactrim to doxyclycline.(b)(6) 2012: [facility ni].(b)(6) md.Radiology-chest xray 2 views.Reason for exam: ventral hernia, fever, abdominal pain, status post surgery.Impression: no pathology identified.(b)(6) 2012: [facility ni].(b)(6) , do.Radiology-ct abdomen/pelvis.Indication: ventral hernia, fever.Impression: postoperative changes in keeping with ventral hernia repair.No abscess.No recurrent hernia.(b)(6) 2012: (b)(6) phone call.All results ok except wbc 19.97.Denies fevers and feels much better today.If fevers return advised to contact us immediately.If no fevers recheck cbc monday.(b)(6) 2012: (b)(6) phone call.Taking antibiotic, no more fevers but low grade temps of 99 to 100 persist.(b)(6) 2012: (b)(6) office visit.Ct scan of abdomen and pelvis demonstrated no abnormalities.Pain improved fevers now up to 100.Jackson-pratt continued to put out 40 ml every 24 hours.Abdomen: right-sided abdominal wound looks less red than last week, remaining staples in place.Jackson-pratts with serosanguineous drainage noted.Plan: continue doxycycline.Staples removed, steri-strips placed.(b)(6) 2012: (b)(6) office visit.Pain improved, fevers up to 99.Jp continued to put out 25 ml every 24 hours.Abdomen: right-sided abdominal wound not red and no signs of infection.(b)(6) 2012: (b)(6) phone call.Patient called concerned she needs abdominal binder.(b)(6) 2012: (b)(6) phone call.Pain is uncontrolled.Surgical incision redness, swelling size of hand at top of surgical site.New onset of acid reflux.(b)(6) 2012: (b)(6) pa.Office visit.Pain slowly increased since last visit with slowly development of bulging at old hernia site.Abdomen: obese, positive bowel sounds, soft, no masses.Incision dry, clean, intact.Proximal incision demonstrates bulging with no redness.Area tender to palpation consistent with seroma.Measures 10 x 12 cm.Plan: healing well now with seroma developed since removal of last jackson-pratt drain.No evidence of infection.Will monitor closely.Will not drain seroma because of mesh to prevent infection for now.If any concerns develop including area grows, gets red, or develops fevers she is to contact us immediately to start antibiotics.Advised to stop using binder.(b)(6) 2012: (b)(6) phone call.Incisional area still red, bit swollen, hot, painful to touch, white spot on area, no discharge.Pain at 3-4 out of 10.Took antibiotic she had left over.Appointment to see dr.Portoghese tomorrow.(b)(6) 2012: (b)(6) pa.Phone call.Started on antibiotics, only two days worth from old rx.Continue antibiotic and see in a.M.Prescription will be called for bactrim.(b)(6) 2012: (b)(6) , pa.Office visit.Pain slowly increased since last visit along with slowly development of redness.States last night she had fever.Abdomen: proximal incision demonstrates bulging with redness that feels warm and tender to palpation.Area of concern measures 9 x 12.5 cm.Impression: cellulitis of trunk.Plan: discussion with patient regarding cellulitis versus abscess.Started on bactrim twice daily yesterday and recommend to continue until finish.Will obtain order for interventional radiology.(b)(6) 2012: (b)(6) phone call.Jackson-pratt drain placed today.States abscess that was under incision opened up surgical incision.(b)(6) 2012: (b)(6) phone call.Will need to be seen tomorrow for further evaluation of new wound.Patient describes small amount of yellowish clear drainage from site.Apply dry gauze as needed.(b)(6) 2012: (b)(6) pa.Office visits.Drainage was done yesterday with immediate resolution of pain.Since last visit developed small blister at incision site.Abdomen: proximal incision demonstrates small blister with clear fluid in it.Area of concern measures about 2 cm in diameter.Jackson-pratt drainage in place with sanguineous and slightly purulent fluid.Plan: healing well.Will leave blister alone to resolve on its own useless signs of infection develop.(b)(6) 2012: (b)(6) pa.Office visit.Jackson-pratt drainage still putting out about 35-40 ml every twelve hours.Microbiology: 1+ staph aureus susceptibility reviewed.Abdomen: proximal incision demonstrates small blister area that is gone.Jackson-pratt drainage in place with purulent fluid.Remaining of incision is dry, clean and intact with mild erythroderma, no tenderness.Plan: continues to complain of tenderness and pain.Fluid/drainage is always changing colors from serosanguinous to clear to purulent.Will change antibiotics to dicloxacillin and continue ibuprofen.(b)(6) 2012:(b)(6) phone call.Patient changing clothes when notices she pulled jackson-pratt tube.Advised her to go to nearest er, call with hospital information.(b)(6) 2012: (b)(6) md.Office visit.Drain placed several weeks ago and drainage was less than 15 ml per day when drain ¿fell out¿.Was out of state, could not come in for evaluation.Has been off antibiotics for last 3-4 days.Exam: no erythema, area of seroma in upper abdomen is firm but not fluctuant.Impression: rule out residual seroma.Plan: ct of abdomen, no new antibiotics at present.(b)(6) 2012: (b)(6) , pa.Office visit.Follow up for ct results after infected seroma status post open ventral incisional hernia.Impression: residual 4.3 cm fluid collection in subcutaneous fat overlying prior hernia repair.Plan: continues to have seroma and pain.Will get interventional radiology to drain and send specimen for cultures.If cultures positive will start antibiotics.(b)(6) 2012: (b)(6) pa.Office visit.Drainage continues to put out 15 ml per day and she is currently scheduled for appointment with interventional radiology to reevaluate seroma.Fluid sent for culture and sensitivity came back with few white cells noted and no organisms grow/seen.Abdomen: mid abdominal jackson-pratt drainage in place with no fluctuant area or any erythroderma.Plan: healing well.Followup with interventional radiology tomorrow for new ct scan and possible jackson-pratt removal.(b)(6) 2012: (b)(6) pa.Office visit.Drainage continues to put out 40 ml per day.Last ct was done last week on june 8 with an impression of persistent fluid collection in anterior abdominal wall just anterior to prior hernia repair with stable positioning of tail catheter.Currently injecting 5 ml of betadine twice a day as per interventional radiology¿s recommendation.Dose admit to having elevated temperature last friday but did not really take temperature.Currently on no antibiotics.Abdomen: mid abdominal jackson-pratt drainage in place with no fluctuant area or any erythroderma.Continue drainage in place for one more week.(b)(6) 2012: (b)(6) phone call.Patient indicated she was running fever 103 degree on friday, saturday, sunday.Drain area is hard, hot and red; like a size of apple.Drainage from last night to this morning is about 50 cc and yesterday mid-day to the night was also same amount with brownish in color both times.Temperature 99.5 now.06/20/12: centr specialized surg.Joseph d.Portoghese, md.Office visit.Now volume continues high and interventional radiology has her irrigating with betadine.I asked her to stop this as she is boiling and reusing syringes to do this.Exam: drainage still cloudy on stripping the tube.Some erythema around drain site which patient states is improved.Impression: resolving cellulitis at drain site; persistent seroma drainage.Plan: if drainage remains by next week then wound will need to be opened in or.(b)(6) 2012: [facility ni].(b)(6) md.History and physical.Persistent abdominal wall infected seroma.Seen with painful recurrent incisional hernia.Taken to surgery for open repair with strattice mesh.Post op developed an infected seroma and despite prolonged drainage it has not resolved.Exam: right sided drainage catheter with erythema midline incision well-healed with thickening in sub q upper midline.Impression: choric infected abdominal wall seroma.Plan: incision and drainage of seroma with post-op open packing of wound.Bmi 49.96.(b)(6) 2012: centr specialized surg.Phone call.Seen in er diagnosed with cellulitis and abscess near surgical site.Started doxycycline as prescribed, pain is still an issue.Unrelieved with ibuprofen.Per jose pain may be secondary to hematoma.Expect that it should decrease in size and should become more tolerable.(b)(6) 2012: (b)(6) md; (b)(6) , md.Office visit.Wound care has been assisting with dressing changes to wound.States per wound care, lower part of incision should not be packed.Does complain of left flank abdominal pain, worse with movement.Reports localized tenderness, swelling, erythema, warmth at previous drain site.Weight 243 lb.Bmi 50.79.Abdomen: mild tender to palpation over left flank, bowel sounds positive; midline incision open with packing, good granulation tissue on sidewalls with fibrinous exudate over inferior portion, extension of wound superiorly with narrow tract, extension to right lateral side with exudate; small area of erythema and warmth at pervious drain site, with palpable fluctuance.Examination suggestive of well healing wound, left flank hematoma, abscess at drain site.Need for adequate packing of midline incision discussed with patient, as well as need to pack lateral extension.An incision and drainage of drain site abscess offered.Risks, benefits, complication and alternatives were discussed, including the need for wound packing and minor bleeding, and the patient agreed to proceed.Wound repacked.Drain site prepped, anesthetized, incised with purulent fluid draining.Cultures taken, packed with iodoform gauze.Recommend once daily dry-dry dressing changes at midline wound with iodoform gauze packing of drain site incision.Continue with home health care.(b)(6) 2012: (b)(6) pa.Office visit.Follow up explantation of infected mesh, removal of drain (b)(6) 2012.Doing well, pain improving.Continues packing.Abdomen: open mid abdominal wound measures 3.8 x 1.8 x 5 cm deep.No erythroderma or evidence of infection.(b)(6) 2012: (b)(6) md.Office visit.Status post removal of infected goretex mesh.Wound has closed to where only a spot a few mm wide and deep remains.Treated with silver nitrate today and redressed.Return in 3 weeks for wound check.(b)(6) 2012: centr specialized surg.Joseph d.Portoghese, md.Office visit.Open wound has been granulating.Small depression in midline wound epithelialized.No open wound remains.Healed wound.(b)(6) 2014: (b)(6) , md.Office visit.Bmi: 51.01.New patient presents with abdominal pain.Seen in ed on first of february for new onset abdominal pain located along left side of umbilicus.Noticed an area of erythema and swelling.Area growing in size and had appearance of cellulitis.Prescribed bactrim and keflex, has been taking.Area initially started to improve, however over past 2 days area has become larger in size with apex of fluctuance noted.Mildly tender to touch.Skin: area just left of umbilicus swollen with approximately 1-2 cm in diameter raised, fluctuant to palpation.Apex of skin appears ischemic.Surrounding erythema and thickening of skin.Area of circumferential induration that measures approximately 8x8 cm.Minimally tender.Impression: cellulitis of trunk with deep abscess.Will perform incision, drainage and debridement of the area with most fluctuance and nonviable skin.Wound will be packed and dressing applied.Will order ct scan.Continue on antibiotics.Gram stain and culture of drainage.(b)(6) 2014: (b)(6) dr.(b)(6) procedure note.Preoperative diagnosis: abdominal wall abscess/cellulitis.Postoperative diagnosis: abdominal wall abscess/cellulitis.Procedure: incision and drainage and debridement of abdominal wound abscess.Physician: dr.Joseph portoghese.Assistant: s.Zenoni pgy-2.Anesthesia: 0.25% marcaine.Complications: none: specimen: fluid from abscess cavity collected and sent from gram stain and culture.Indications for procedure: 38 y/o [year old] female with one week onset of abdominal wall cellulitis/abscess formation.Patient was seen early in the week in the ed for same complaint.Patient was placed on abx and had minimal resolution of abscess.Due to continued increase in size of abscess patient is here for i&d [incision and drainage].Patient was given the risks, benefits, complications, and alternatives to the procedure and requested to proceed.Procedure in detail: ¿after informed consent was obtained the patient was taken to the procedure room and placed in supine position.The abdomen was prepped and draped in the usual sterile fashion.A timeout was taken at that time to verify the correct patient and correct procedure being performed.All staff in the room were in agreement and the procedure continued.An area surrounding the apex of the wound was infiltrated with 0.25% marcaine.Using an #11 blade scalpel an area of devitalized skin approximately 1-2 cm in diameter was incised, unroofing the abscess cavity.There was an immediate rush of purulent fluid noted.Cultures were obtained.The wound was irrigated with normal saline.Once satisfied that all fluid was drained and all devitalized tissue was removed, the wound was packed with sterile packing, 4x4 gauze was placed over the wound with paper tape applied.Patient tolerated the procedure well.Dr.Portoghese was present and scrubbed for the entire procedure.Patient seen and examined.Agree with plans.¿ (b)(6) 2014: (b)(6) md.Office visit.Post-operative visit.Wound healing well with betadine packing.Medication: insulin glargine.Abdomen: open wound in left lower quadrant -1 1/2inches in length, no signs of infection, no discharge.Doing well after surgery.Continue packing 1-2 x daily.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® 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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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.Previous patient codes (1690, 1930, 1994, 2240) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Patient information: medical history: colonic diverticula.Diabetes type ii.(b)(6) 2014: new onset, metformin, lantus and humalog.(b)(6) 2018: ¿history diabetic, no longer after bariatric surgery.¿ morbid obesity: (b)(6) 2009: 257 lbs., bmi 51.9.(b)(6) 2010: 262 lbs., bmi 52.89.(b)(6) 2012: 247 lbs., bmi 49.9.(b)(6) 2014: 239 lbs., bmi 48.3.(b)(6) 2017: 167 lbs., bmi 33.7.Prior surgical procedures: 1991: cesarean section.1998: cesarean section.2003: cesarean section.Unknown date: appendectomy.Unknown date: open cholecystectomy.Unknown date: bilateral tubal ligation.Implant preoperative complaints: (b)(6) 2010: ct abdomen: ¿ventral hernia with fat within it.Hernia sac measures 7.4 x 4.6 x 6.2 cm.Fluid and inflammatory changes in hernia sac, could be related to incarceration, correlate point tenderness.Hernia increased in size.Bowel not obstructed.¿ (b)(6) 2010: history and physical: ¿incarcerated ventral hernia.Had 6 months abdominal pain related to bulge superior to umbilicus.Able to reduce.Bulge increasing over past 6 months.Episodes where unable to reduce hernia, but will resolve with spontaneous reduction.This morning, unable to reduce hernia, had severe abdominal pain in epigastric region where bulge is, presented to (b)(6) hospital/(b)(6) ed.Complaining of nausea, clear emesis.¿ ¿abdomen soft, non-distended, tender to palpation in epigastric region, bulge measuring 3 x 3 cm, reducible, pain decreased with manual reduction.Reducible ventral hernia.Will be repaired as inpatient or outpatient.No signs of obstruction, ventral hernia is non-emergent.¿ implant procedure: laparoscopic ventral hernia repair with ¿gore-tex mesh.¿ implant: gore® dualmesh® plus biomaterial (1dlmcp03/7393866, 10cm x 15cm).Implant date: (b)(6) 2010 [hospitalization (b)(6) 2010].Description of hernia being treated: ¿an incision was made infraumbilically and this was taken down to the fascia.The kocher grasper was used to grasp the fascia.Two stay sutures were placed on either side.The fascia was then entered sharply and the abdomen was entered.The 10-mm trocar was then placed.Four other 5-mm ports were placed, 2 in the right midabdominal and 2 in the left midabdominal.The abdomen was insufflated.The abdomen was explored.There was an area of adhesions where the hernia defect was noted.These adhesions were taken down carefully not to injure any bowel.It appeared that it was mostly the hernia sac that was densely adhered and in the hernia.The adhesions were then taken down with bovie cautery.There were more adhesions encountered on the right midabdominal.There were intestines noted and this was dissected down sharply careful not to injure any small bowel.Once the adhesions were cleared, the defect was measured and it measured to be 2 cm in diameter.¿ implant size and fixation: ¿we measured out our planned mesh size extracorporeally.We measured it out so that it would give us good coverage.We then chose to use 10 x 15-cm piece of gore-tex mesh.Gore-tex sutures were then placed about 1 cm apart circumferentially.The mesh was then placed in the abdomen.With the carter-thomason suture passer, the sutures were then brought out of the abdomen.Once all sutures were brought out, they were then tied in place.The abdomen was then explored and the mesh was found to be in good position allowing good coverage over the hernial defect.This suture tacker was then used to place a crown of tacks circumferentially.The abdomen was then desufflation.The ports were removed under direct visualization prior to desufflation.The 10-mm trocar site was closed at the fascia with the carter-thomason suture passer using pds suture.This was tied and found to have good closure.Skin incisions were then closed with a 4-0 vicryl.¿ o (b)(6) 2010: discharge summary: ¿postoperative course unremarkable.¿ relevant medical information: (b)(6) 2010: ¿obese, soft, appropriate tender to palpation.Small area of seroma.2 weeks status post ventral hernia repair.Doing well.Discussed the seroma and it will resolve slowly.¿ (b)(6) 2010: ¿has discernible upper midline hernia at medial edge of open cholecystectomy incision that was not seen previously.Repair site looks good.Advised that she should continue to lose weight (has lost 20 lbs), we need to wait at least 6 months after previous repair before attempting to fix this new defect.¿ (b)(6) 2012: hospitalization.(b)(6) 2012: er visit: ¿abdominal pain, 1 week.Patient says she is usually able to push back in.[illegible] feels full and bloated.Nausea, loss appetite.Constipation.Exam: large hernia, tenderness, [illegible] with overlying skin erythema.Impression: abdominal pain, incarcerated ventral hernia.Admit.(b)(6) 2012: ct abdomen: ¿midline ventral hernia, larger from previous exam, containing segment transverse colon, omental fat, with fluid and stranding of herniated fat.Possibility incarceration.No mural thickening of colon or dilatation evident.Interval placement of anterior hernia mesh, inferior to above-described hernia.¿ (b)(6) 2012: history and physical: ¿underwent laparoscopic ventral hernia repair (b)(6) 2010, 6 months after repair, bulge in epigastric area.Slowly grew larger.Able to reduce bulge initially.Gotten so large, unable to completely push back in.Abdomen obese, large pannus, epigastric area 8 x 8 cm ventral hernia.Partially reducible; entire hernia contents unable to be reduced into hernia defect.Right upper quadrant scar.Ct scan abdomen/pelvis reveals ventral hernia with transverse colon.Hernia defect superior to previously placed mesh.¿ (b)(6) 2012: open ventral hernia repair with mesh.[implant tissue strattice firm 10 x 16] ¿at this point, attention was turned back to the larger fascial defect, and bovie electrocautery was used to separate the fascia from the overlying subcutaneous fat providing adequate margin for mesh placement.Once a satisfactory dissection had been obtained, a 10 x 16 cm strattice mesh [non-gore device] was sized to better fit the wound and was then inserted into the defect.0 pds sutures were placed at the superior and inferior end of the mesh and fascia under an adequate amount of tension to actually close the defect.Interrupted 0 pds sutures were then placed circumferentially around the wound again with care taken to provide adequate tension to close the defect.Care was taken not to injure the intra-abdominal contents during this process.The circumferential sutures were tied down and repair was inspected for adequate tension on the underlying mesh.Once examination was satisfactory, attention was turned to closing the fascia overlying the mesh.2-0 pds sutures were used in running fashion to close the defect with 1 suture beginning at the superior end and the other beginning at the inferior end and were tied down in the middle, and adequate fascial closure was obtained.¿ (b)(6) 2012: ¿surgical wound is red, warm to touch and jackson-pratt drains intact with drain output about 25 ml for yesterday.¿ (b)(6) 2012: ct abdomen: ¿postoperative changes in keeping with ventral hernia repair.No abscess.No recurrent hernia.¿ (b)(6) 2012: ¿right-sided abdominal wound not red and no signs of infection.¿ (b)(6) 2012: ¿pain slowly increased since last visit with slowly development of bulging at old hernia site.Proximal incision demonstrates bulging with no redness.Area tender to palpation consistent with seroma.Measures 10 x 12 cm.Plan: healing well now with seroma developed since removal of last jackson-pratt drain.No evidence of infection.Will monitor closely.Will not drain seroma because of mesh to prevent infection for now.¿ (b)(6) 2012: ¿area of concern measures 9 x 12.5 cm.Impression: cellulitis of trunk.Plan: discussion with patient regarding cellulitis versus abscess.Started on bactrim twice daily yesterday and recommend to continue until finish.Will obtain order for interventional radiology.¿ (b)(6) 2012: ct abdomen: ¿fluid collection within soft tissues anterior abdominal wall in region of previously removed drainage catheter may represent a seroma or abscess.Small amount air within area superiorly, no herniation of bowel.¿ (b)(6) 2012: ct abscess drainage: ¿direct ct guidance a 19-gauge yueh needle placed within abscess collection.10 french locking pigtail drainage catheter placed within collection, without complications.Drainage catheter secured to overlying skin with 2-0 silk suture, connected to jackson-pratt bag.10 ml pus removed and sent for gram stain, culture and sensitivity.¿ (b)(6) 2012: microbiology: ¿culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain result: 3+ wbc¿s; no organisms seen.¿ (b)(6) 2012: patient states, ¿ abscess that was under incision opened up surgical incision.¿ (b)(6) 2012: ¿jackson-pratt drainage still putting out about 35-40 ml every twelve hours.¿ ¿continues to complain of tenderness and pain.Fluid/drainage is always changing colors from serosanguinous to clear to purulent.Will change antibiotics to dicloxacillin and continue ibuprofen.¿ (b)(6) 2012: ct abdomen: ¿residual 4.3 cm fluid collection in subcutaneous fat overlying prior hernia repair.¿ (b)(6) 2012: ct abscess drainage: ¿under ct guidance an 18-gauge needle advanced to fluid collection within anterior abdominal wall in subcutaneous tissues, catheter placed within collection.20 ml fluid removed.Catheter secured with single stitch of 2-0 silk and left to external drainage.¿ (b)(6) 2012: microbiology fine needle aspirate culture with gram stain.¿1+ staphylococcus aureus; no anaerobes isolated.¿ (b)(6) 2012: ir angio drainage procedures: ¿residual collection within soft tissues with no enteric communication.Sclerosis of cavity performed and cavity will be re-evaluated following week.¿ (b)(6) 2012: ct abdomen: ¿hernia mesh stable.Impression: persistent fluid collection in anterior abdominal wall just anterior to prior hernia with stable positioning of pigtail catheter.¿ (b)(6) 2012: ¿abdomen: mid abdominal jackson-pratt drainage in place with no fluctuant area or any erythroderma.Continue drainage in place for one more week.¿ (b)(6) 2012: ¿drain area is hard, hot and red; like a size of apple.Drainage from last night to this morning is about 50 cc and yesterday mid-day to the night was also same amount with brownish in color both times.¿ (b)(6) 2012: ¿now volume continues high and interventional radiology has her irrigating with betadine.I asked her to stop this as she is boiling and reusing syringes to do this.Exam: drainage still cloudy on stripping the tube.Some erythema around drain site which patient states is improved.Resolving cellulitis at drain site; persistent seroma drainage.Plan: if drainage remains by next week then wound will need to be opened in or.¿ explant preoperative complaints: (b)(6) 2012: history and physical: ¿persistent abdominal wall infected seroma.Seen with painful recurrent incisional hernia.Taken to surgery for open repair with strattice mesh.Post op developed an infected seroma and despite prolonged drainage it has not resolved.Exam: right sided drainage catheter with erythema midline incision well-healed with thickening in sub q upper midline.Choric [chronic] infected abdominal wall seroma.Plan: incision and drainage of seroma with post-op open packing of wound.¿ (b)(6) 2012: ¿ history of ventral hernia status post repair x2.Patient¿s initial repair was done with a gore-tex mesh and second repair was done with a strattice mesh.Since the second repair the patient has had recurrent fluid collections with pain, swelling and erythema at the incision site.Patient has had a drain placed by interventional radiology and multiple courses of antibiotics.However the fluid collection has remained.For these reasons, incision and drainage of infected abdominal wall fluid collection was discussed with the patient.¿ explant procedure: incision and drainage of infected abdominal wall fluid collection and removal of infected abdominal wall mesh.Explant date: (b)(6) 2012 [hospitalization (b)(6) 2012].¿the skin was opened with a 10 blade scalpel overlying the fluid collection.Dissection was carried down through the fat and subcutaneous tissue using bovie electrocautery.Hemostasis was assured along the way.Dissection was continued down following the ir drain for guidance until the tip of the drain was reached.It was noted that no significant fluid collection was present; however, a cavity was encountered.The cavity was explored and an extension was noted running inferiorly along the course of the incision.Exploration of this tract was continued.Continued exploration demonstrated that the cavity continued down to the site of the previous mesh placement.The gore-tex mesh was encountered and was dissected free from surrounding connective tissue.All encountered suture and tacks were removed along with the mesh.The tract was further opened with bovie electrocautery to allow for full explantation of the mesh upon initial encounter of the mesh, a cloudy thick fluid was noted to be leaking from the mesh.This fluid was sent for culture.Dissection revealed an intact mesh and sutures.However, due to the chronic infected nature of the wound, and the fluid noted to be leaking from the area where the mesh was, it was decided that the mesh should be removed.Once all tacks and sutures holding the mesh in place were removed, the mesh sutures and tacks were sent for pathology.The wound was inspected for hemostasis and no bleeding was noted.A kerlix gauze was tacked inside the wound and the wound was left open to heal by secondary intention.¿ (b)(6) 2012: pathology: explanted mesh: synthetic material with reactive fibrosis.¿ gross description states: ¿received in formalin labeled "explanted mesh" is an irregular portion of tan surgical mesh material measuring 11 x 8 x 0.1 cm.No attached soft tissues are identified.¿ (b)(6) 2012: microbiology: ¿surgical deep abscess.Culture results: 1+ staphylococcus aureus; no anaerobes isolated.Gram stain results: no organisms seen; 1+ wbc¿s.¿ (b)(6) 2012: discharge summary: ¿underwent open ventral hernia repair with mesh, previous mesh removed.Patient did well, return of bowel function and pain control, discharged home stable, tolerating regular diet.Followup 2 weeks.¿ relevant medical information: (b)(6) 2012: er visit: ¿cellulitis, fever, [illegible], post op pain.¿ (b)(6) 2012: ct abdomen: ¿right of midline incision, there is a 5 x 5 x 4.3 x 2.9 cm multifocal area of inflammation and fluid.To left of midline incision there is 4.3 x 3.7 cm focal area of soft tissue that is high in attenuation, could represent hematoma.Thickening and scarring along anterior abdominal wall where mesh was removed.Wound contains gas which extends to the fascial plane, separates abdominal rectus muscles from intraabdominal fat.No incarcerated loops of small bowel or small bowel obstruction.¿ (b)(6) 2012: ¿patient elected to leave ama [against medical advice] instead of being admitted to inpatient area.¿ (b)(6) 2012: ¿mild tender to palpation over left flank, bowel sounds positive; midline incision open with packing, good granulation tissue on sidewalls with fibrinous exudate over inferior portion, extension of wound superiorly with narrow tract, extension to right lateral side with exudate; small area of erythema and warmth at pervious drain site, with palpable fluctuance.Examination suggestive of well healing wound, left flank hematoma, abscess at drain site.¿ (b)(6) 2012: ¿microbiology ¿abscess culture with gram stain.Specimen: abdomen abscess.2+ staphylococcus aureus; no anaerobes isolated.Gram stain results: occasional wbc¿s; occasional gram-positive cocci.¿ (b)(6) 2012: ¿follow up explantation of infected mesh, removal of drain 7/3/12.Doing well, pain improving.Continues packing.Abdomen: open mid abdominal wound measures 3.8 x 1.8 x 5 cm deep.No erythroderma or evidence of infection.¿ 8/22/12: ¿status post removal of infected goretex mesh.Wound has closed to where only a spot a few mm wide and deep remains.Treated with silver nitrate today and redressed.Return in 3 weeks for wound check.¿ (b)(6) 2012: ¿no open wound remains.¿ (b)(6) 2014: incision and drainage and debridement of abdominal wound abscess.(b)(6) 2014: microbiology: ¿1+ staphylococcus aureus; no anaerobes isolated.¿ (b)(6) 2014: incision and drainage of abdominal wall abscess.(b)(6) 2015: bariatric surgery, roux-en-y gastric bypass.[no operative records].(b)(6) 2017: er visit: ¿abdominal stitches coming out.Had hernia surgery years ago and noted her hernia wound was draining green liquid earlier.When she popped it, the stitches came out.¿ incision and drainage.¿abscess.Location: abdomen.Incision: 2 cm incision was made, fluid collection manually decompressed, drainage small, purulent, not bloody.Irrigation: copious with saline.Wound left open to heal, stitch removed.¿ conclusion: 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.¿ the ifu also warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may 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 7393866.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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