|
|
| Model Number 1DLMC08 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 01/30/2009 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(6).It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent an open ventral/incisional hernia repairs on (b)(6) 2005 and (b)(6) 2009 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009 and (b)(6) 2009, additional procedures occurred whereby the gore devices were explanted.It was reported the patient alleges the following injuries: recurrence, adhesions, wound dehiscence.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
H6: updated results code.Conclusion code remains unchanged.
|
| |
|
Manufacturer Narrative
|
|
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) 2005: (b)(6) hospital.[signature illegible].Anesthesia record.Asa 3 e.History of anesthetic complications: ¿almost lost me secondary to lungs.¿ system review: diabetes secondary to steroids.(b)(6) 2005: (b)(6) hospital.[signature illegible].Anesthesia record.Asa 3 e.(b)(6) 2005: (b)(6) hospital.[signature illegible].Anesthesia record.Asa 3.Asa criteria: hypertension, asthma, copd [chronic obstructive pulmonary disease], diabetes mellitus.System review: diverticulosis.(b)(6) 2005: (b)(6) hospital.[signature illegible].Anesthesia record.Asa 3.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 instructions for gore® dualmesh® biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Manufacturer Narrative
|
|
Added medical history.Conclusion code remains unchanged.Added medical record information.The medical records include the following medical history: additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: prior records including surgical records for multiple laparotomies, hysterectomy, oophorectomy, and repair of small bowel fistula were not provided.(b)(6) 2005: (b)(6).Operative report.Preoperative diagnosis: giant incisional ventral hernia with recurrent episodes of partial small-bowel obstruction.Postoperative diagnoses: giant incisional ventral hernia with multiple loculations.Multiple midline incisional hernias.Procedures: insertion of triple-lumen left subclavian central line.Exploratory laparotomy.Extensive lysis of adhesions.Segmental resection of distal small bowel.Repair of giant incisional ventral hernia and multiple midline defects using duomesh gore-tex.Anesthesia: general.Description of procedure: ¿the patient was taken to the operating room and placed on the operating table in the supine position.After an adequate endotracheal anesthesia was given, a left subclavian triple-lumen central venous catheter was inserted using seldinger technique and sterile technique.The line was then given to anesthesia for use during the case.The skin of the abdomen was then prepped and draped in a sterile fashion, and then an incision was made in the midline over the previous midline scar.This was carried down through the subcutaneous tissue and fascia.In the lower portion of the incision, there were loops of bowel that were densely adhesed to the fascia that could not be adequately separated from it and, therefore, enterotomies were the result.The dissection was continued into the sides of the abdominal wall where multiple loculations of a giant ventral hernia were identified.These loculations were transected, freeing the bowel that was densely adhesed to them.The dissection continued until all the abdominal wall was freed, and then the dissection was continued within the colon and small bowel until all the adhesions had been freed.All the enterotomies had been repaired with #2-0 silk stitches.Once all the small bowel had been lysed, the areas of the enterotomies were all confined to the last 40 cm of the distal ileum.Therefore, it was decided to resect this segment proximally and distally until the bowel was healthy appearing.Using a gia stapler, the bowel was transected proximally and distally, and then the mesentery was clamped between hemostats, transected, and tied with #2-0 silk freehand ties.A side-to-side anastomosis was constructed using the gia stapler, and the holes for the stapler were closed with a ta-30 stapler.Following this, the abdomen was irrigated with several liters of antibiotic solution, and then a gore-tex duomesh was brought to the field.There was a large defect in the lower abdomen probably from the previous pfannenstiel incisions that the patient had and, at this time, the duomesh was tailored in a pear-shaped fashion with broader base toward the lower part of the abdomen.Using a #0 prolene, the mesh was sewn to the rim of the muscles laterally and then to about the level of the umbilicus.At this time, the fascia in the midline was adequate, although it had been opened and multiple defects had been incorporated into the incision where segments of omentum were trapped.The mesh was then sewn to both edges of the fascia and then around the broader side on the bottom part of the abdomen on the other side.The defect was felt to be satisfactory.Following this, the subcutaneous tissue was irrigated with antibiotic solution and then two 10 mm jackson-pratt drains were placed in the subcutaneous tissue and brought out the skin and secured with #2-0 silk stitches.The subcutaneous tissue was then closed with a running #0 pds.Following this, staples were placed on the skin.A sterile dressing was applied, and the patient was transferred to the surgical intensive care unit in stable condition.¿ estimated blood loss: 250 cc.Transfusions: none.Complications: none.Condition: condition of the patient on arrival to the icu was satisfactory.(b)(6) 2005: (b)(6).Implant record.Dual mesh gore-tex.Lot #: 03370237.Serial #: (b)(6).Size: 26 x 34 x 1.Exp.Date: 2007-11.The records confirm a gore® dualmesh® biomaterial (1dlmco8/03370237) was implanted during the procedure.(b)(6) 2005: (b)(6).Pathology report.Case: (b)(6).Anatomic pathology diagnosis: ileum, partial resection: stricture.Focal superficial mucosal necrosis.Focal chronic serositis.Serosal hemorrhage.Surgical margins of resection viable.Material: ileum.History: 43-yo woman with ventral hernia.Gross: received in formalin as ¿ileum,¿ is a 40 cm small bowel segment with staples at both ends.The serosal surface is tan-purple with an area of tan-brown dusky discoloration at the distal end, extending 16 cm proximal to that end, 13 cm from the proximal end.There are multiple adhesions present on the surface.There is attached peri ileal fat along the bowel surface.The opened specimen exposes a moderate amount of partially digested food in the proximal small bowel and ending at the region of stricture.The mucosal surface ranges in circumference from 7.0-3.5 cm in the area of the stricture.The proximal bowel mucosal surface is tan-pink to tan-green and appropriately plicated.There is focal small intramucosal hemorrhage.There is also a dilated region with thinning of the bowel wall, immediately proximal to the area of stricture.The mucosal surface distal to the strictured region is pale tan-pink, with focal punctate hemorrhage, as well.The mucosal surface at the area of stricture is tan-red and slightly hemorrhagic.No other lesion is present on the mucosal surface.Representative tissue submitted: gross: a1: proximal surgical margin.A2: distal surgical margin.A3-5: representative sections, area of stricture.A6: representative sections, areas of hemorrhage proximal to stricture.A7: representative areas of dilation proximal to area of stricture.A8-9: areas of hemorrhage distal to area of structure [sic].A10: representative sections, normal-appearing bowel proximal to stricture.A11: representative sections, normal-appearing bowel proximal to stricture.A12: two possible lymph nodes.Microscopic: sections of the ileum demonstrate viable surgical margins at both ends.Sections from around the stricture demonstrate focal chronic serositis.The inflammation does not extend into the wall of the ileum.The mucosa in this area is intact and viable.Distal to the stricture, however, there is focal superficial necrosis of the mucosa with serosal hemorrhage.Additional serosal hemorrhage is present distal to the stricture.The mucosa in this area is intact with some areas of submucosal hemorrhage.Sections of the mucosa described as ¿normal-appearing¿ have focal areas of superficial necrosis of the mucosa with serosal hemorrhage.These necrotic changes are confined to mucosa proximal to the stricture.Distal from the stricture, the mucosa is viable.Several fragments of suture material are present throughout the specimen.These have no cellular or fibrous reaction.Two small lymph nodes are identified that have normal follicular architecture.There is no dysplasia or malignancy seen in the ileal specimen.No metastatic or primary malignancy is seen in the lymph nodes.[bchapman-1ppr-brn-00097-98] (b)(6) 2005: (b)(6).Operative report.Preoperative diagnosis: infection of abdominal wound.Status post repair of giant incisional hernia with gore-tex patch.Postoperative diagnosis: infection of abdominal wound.Status post repair of giant incisional hernia with gore-tex patch.Procedure performed: debridement of abdominal wound.Wound packed open.Anesthesia: general.Operative procedure in detail: ¿the patient was taken to the operating room and placed on the operating room table in the supine position.After an adequate general anesthesia was given, the skin of the abdomen was prepped and draped in a sterile fashion.There was a small opening in the abdominal wound and through here, an aspirator was placed and it was noted that there was a large subcutaneous cavity.The incision was opened and superiorly and inferiorly in almost entirety and purulent material was aspirated and sent for culture.The wound was thoroughly debrided of many necrotic tissue and debris and then thoroughly irrigated with antibiotic solution.The wound was then packed with a wet kerlix gauze and then a sterile dressing was applied.The patient tolerated the procedure well and then she was awakened up and transferred to the recovery room in stable and satisfactory condition.¿ [missing records: a culture report detailing analysis of the specimens collected during the 03/06/05 procedure was not provided.] (b)(6) 2005: (b)(6).Operative report.Preoperative diagnoses: open abdominal wound.Status post repair of incisional hernia.Postoperative diagnoses: open abdominal wound.Status post repair of incisional hernia.Procedure: debridement of abdominal wound, pulsavac irrigation, and closure of abdominal wound.Description of procedure: ¿the patient was taken to the operating room and placed on the operating table in the supine position.After an adequate general anesthesia was given, the skin of the abdomen was prepped and draped in a sterile fashion.The abdominal wound was thoroughly irrigated with antibiotic solution and then all necrotic material identified was thoroughly debrided using scissors and a curet [sic].Following this, the wound was irrigated with a pulsavac irrigation and then two 10 mm jackson-pratt drains were placed in the subcutaneous tissue and brought out the skin through the upper level of the incision, and were secured with a 2-0 silk.The incision was then closed with interrupted #2-0 nylon stitches in the skin and subcutaneous tissue, and staples between the stitches to make the wound airtight.The drains were placed to a suction device.A sterile dressing was applied.The patient was awakened and transferred to the recovery room in stable and satisfactory condition.¿ (b)(6) 2005: (b)(6).Operative report.Preoperative diagnosis: infected abdominal wound.Status post repair of large incisional ventral hernia using mesh.Postoperative diagnosis: infected abdominal wound.Status post repair of large incisional ventral hernia using mesh.Procedure: debridement of abdominal wound, postoperative irrigation and placement of wound v.A.C.Description of procedure: ¿the patient was taken to the operating room and placed on the operating table in a supine position.After an adequate general anesthesia was given, the skin of the abdomen was prepped and draped in a sterile fashion.The abdominal wound was then debrided in the area that had necrotic tissue leaving the dualmesh underneath.A pulsavac irrigation was then performed and once the wound was cleaned, a wound v.A.C.Was applied and placed to suction.Following this, a sterile dressing was applied on top and then the patient was awakened and transferred to the recovery room in stable condition.Estimated blood loss was minimal.Condition of the patient on arrival to the recovery room was satisfactory.¿ (b)(6) 2005: (b)(6).Discharge summary.Admitted: (b)(6) 2005.Discharge diagnoses: abdominal ventral hernia repair with chronic infection, later requiring wound care with a wound vacuum assisted closure and doing well.History of present illness: seeking care for large abdominal ventral hernia that no surgeon would operate on due to finances and difficulty.Past medical history significant for tobacco abuse, asthma, and large ventral hernia, known since 2003.Presented with abdominal and back pain secondary to the large ventral hernia.Ct showed no obstruction, large amount of pain, admitted for further care.Past surgical history: hysterectomy with oophorectomy.Social history: 1 pack per day for 30 years; smoking.Occasional drinking.Course: ventral abdominal hernia repair.Surgery was quite extensive requiring large mesh placed into the abdomen.Patient recognized that her risk for surgery was high and possibility of infection was equally high.Did relatively well with surgery.Has area of drainage without noted infection requiring chronic wound care.Seen by infectious disease, continued long term antibiotics, now on wound vac, doing well.Transferred to skilled nursing facility to continue wound care.Disposition: chronic wound requires careful observation for at least another 2 weeks.Follow up with primary provider upon discharge from skilled nursing facility.[missing records: a ct report showing ¿no obstruction¿ was not provided.] (b)(6) 2005: (b)(6).Discharge summary.Course: small area of dehiscence for which the patient is now on a wound vac.Has responded well to this treatment.Patient now wishes to be discharged home to louisiana to continue her care.It has been arranged for the patient to have home health visits for continued wound care.Records between (b)(6) 2005 and (b)(6) 2009 were not provided.(b)(6) 2009: (b)(6).Operative report.Assistant: (b)(6).Preoperative diagnoses: ventral hernia ¿ recurrent ¿ incarcerated.Gerd [gastroesophageal reflux disease].Postoperative diagnoses: ventral hernia ¿ recurrent ¿ incarcerated.Gerd [gastroesophageal reflux disease].Gastroparesis.Anesthesia: general endotracheal.Procedure: ventral hernia repair with synthetic mesh.Esophagogastroduodenoscopy.Findings: the patient had a very large multiloculated ventral hernia which involved most of the central abdominal wall from just below the xiphoid to the pubis.There was colon attached then [sic] there, but no strangulation was noted.This was consistent with preoperative imaging with a small amount of synthetic mesh incorporated into the tissues in the upper abdominal wall in the midline from remote hernia repair.Egd revealed fairly normal appearing anatomy to the upper gi tract without evidence of reflux esophagitis; however, there was food retaining in the stomach, and there was reduced motility of the stomach consistent with gastroparesis.Technique: ¿with the patient supine on the operating table under general anesthesia, abdomen was prepared and draped sterilely.The old incision was opened and, with meticulous care, we were able to get the small bowel and colon released from the lowered hernia sac and cleared the abdominal wall back to muscle so that we might have something to repair using the mesh.Once this was all clear, the hernia sac was excised and then a 20 x 30 cm dual mesh gore-tex sewn into place with interrupted mattress sutures of #1 prolene and, once this was done, then we were actually able to get some muscle and some scar tissues that were attached to the left rectus muscle to close over the mesh in the midline using running tom jones sutures of #1 vicryl.The abdominal wall and peritoneal cavity was irrigated thoroughly with saline containing kantrex.Then, two 10 mm jackson-pratt drains were placed with separate stab wounds in the subcutaneous tissue.Then, the subcutaneous tissue was closed with running 3-0 vicryl and skin with skin staples.Sterile dressing was applied.Then esophagogastroduodenoscopy was performed with above-mentioned findings, and the scope was removed.There was no evidence of trauma.Patient was then awakened, extubated, and taken to recovery in good condition having tolerated the procedure well.Sponge, needle, and instrument counts reported x2 as correct and estimated blood loss was 150 ml.¿ [missing records: records for ¿preoperative imaging¿ were not provided.] product identification records for the alleged ¿dual mesh gore-tex¿ were not provided.(b)(6) 2009: (b)(6).Operative report.Assistant: (b)(6).Preoperative diagnosis: abdominal wall wound dehiscence post hernia repair.Postoperative diagnosis: abdominal wall wound dehiscence post hernia repair.Anesthesia: general endotracheal.Procedure: debridement and reconstruction of abdominal wall using z-plasty technique.Findings: the patient had exposed gore-tex dualmesh underneath the skin and soft tissue in the midportion of her midline abdominal wound.The area of defect was approximately 2.5 cm in diameter.Underneath the subcutaneous tissue overlying the mesh, there was a pocket of about 12 cm diameter.There was no evidence of gross infection and there was no evidence of recurrent hernia.Technique: ¿with the patient supine on operating table under general anesthesia, the abdomen was prepared and draped sterilely.Lines were drawn out for z-plasty and incision made and bleeding controlled with electrocautery.Care was taken to preserve blood supply to the skin edges as much as possible.Then, the granulation tissue and debris underneath the skin and subcutaneous tissue overlying the mesh was debrided out.The wound was irrigated thoroughly with gentamicin solution and then the undermining was required to promote the z-plasty was accomplished and then the z-plasty was performed in the usual fashion using interrupted 2-0 nylon sutures in various styles including vertical mattress, horizontal mattress, tom jones, and simple sutures.Just prior to closing the area fully, a jackson-pratt drain 10 mm had been inserted underlying the subcutaneous tissue through a separate stab wound above the main wound and it was secured with 2-0 nylon to the skin.Once the repair was completed, then the wound was injected with 30 ml of marcaine 0.25% plain for pain relief and was irrigated through the jackson-pratt drain with more gentamicin solution.Then, suction was applied.There were no leaks.The wound was dressed with xeroform, 4 x 4, and tape.The patient was awakened, extubated, and taken to recovery in a good condition having tolerated estimated blood loss was 30 to 40 ml.¿ disposition: the patient was released with family after recovery from anesthesia.She is given vicodin es #25 to take 1 every 4 hours p.R.N.[as needed for] pain.She will be followed in 5 days in the office.She is not to get her wound wet before the office visit and she is to leave her bandage in place.She is well aware of care of her suction having previously had 1 and she is not to do any lifting more than 5 pounds.She is not to get down in a bathtub.There is no mention of gore device removal in the records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Manufacturer Narrative
|
|
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: on (b)(6) 2009:[facility ni].Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp07.Lot batch code: 05580201.W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp07/05580201) was implanted during the procedure.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Manufacturer Narrative
|
|
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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes (1695, 2240, and 2502) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records: the known medical records span (b)(6) 2005 through (b)(6) 2009 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial and the gore® dualmesh® plus biomaterial devices.Medical records from (b)(6) 2005 through (b)(6) 2009 were not provided.Patient information: medical history: multiple midline incisional hernias; diabetes type ii secondary to steroids; asthma; chronic obstructive pulmonary disease [copd]; diverticulosis; hypertension; gastroesophageal reflux disease [gerd]; obesity; (b)(6) 2005: 200 lbs., bmi 34.3; smoking; (b)(6) 2005: ¿smoked 1 pack of cigarettes per day for 30 years.¿ ¿stopped recently.¿; (b)(6) 2005: giant incisional ventral hernia with multiple loculations; (b)(6) 2005: infection of abdominal wound; (b)(6) 2009: ventral hernia ¿ recurrent ¿ incarcerated; (b)(6) 2009: abdominal wall wound dehiscence post hernia repair.Surgical procedures: unknown dates: multiple laparotomies.Unknown date: hysterectomy and oophorectomy.(b)(6) 2005: repair small bowel fistula.Insertion of triple-lumen left subclavian central line.Exploratory laparotomy.Extensive lysis of adhesions.Segmental resection of distal small bowel.Repair of giant incisional ventral hernia and multiple midline defects using duomesh gore-tex.Implant: gore® dualmesh® biomaterial.(b)(6) 2005: debridement of abdominal wound.Wound packed open.(b)(6) 2005: debridement of abdominal wound, pulsavac irrigation, and closure of abdominal wound.(b)(6) 2005: debridement of abdominal wound, postoperative irrigation and placement of wound vac.(b)(6) 2009: ventral hernia repair with synthetic mesh.Esophagogastroduodenoscopy.Implant: gore® dualmesh® plus biomaterial.(b)(6) 2009: debridement of reconstruction of abdominal wall using z-plasty technique.Implant #1 preoperative complaints: (b)(6) 2005: history: ¿seeking care for large abdominal ventral hernia that no surgeon would operate on due to finances and difficulty.Past medical history significant for tobacco abuse, asthma, and large ventral hernia, known since 2003.Presented with abdominal and back pain secondary to the large ventral hernia.Ct showed no obstruction, large amount of pain, admitted for further care.¿ implant #1 procedure: insertion of triple-lumen left subclavian central line.Exploratory laparotomy.Extensive lysis of adhesions.Segmental resection of distal small bowel.Repair of giant incisional ventral hernia and multiple midline defects using ¿duomesh gore-tex.¿ [implant: gore® dualmesh® biomaterial, 1dlmc08/03370237, 26cm x 34cm x 1mm thick, oval].Implant #1 date: (b)(6) 2005 [hospitalization dates (b)(6) 2005 through (b)(6) 2005]: wound classification: not provided [2° to enterotomies - contaminated].Description of hernia being treated: ¿an incision was made in the midline over the previous midline scar.This was carried down through the subcutaneous tissue and fascia.In the lower portion of the incision, there were loops of bowel that were densely adhesed to the fascia that could not be adequately separated from it and, therefore, enterotomies were the result.The dissection was continued into the sides of the abdominal wall where multiple loculations of a giant ventral hernia were identified.These loculations were transected, freeing the bowel that was densely adhesed to them.The dissection continued until all the abdominal wall was freed, and then the dissection was continued within the colon and small bowel until all the adhesions had been freed.All the enterotomies had been repaired with #2-0 silk stitches.Once all the small bowel had been lysed, the areas of the enterotomies were all confined to the last 40 cm of the distal ileum.Therefore, it was decided to resect this segment proximally and distally until the bowel was healthy appearing.Using a gia stapler, the bowel was transected proximally and distally, and then the mesentery was clamped between hemostats, transected, and tied with #2-0 silk freehand ties.A side-to-side anastomosis was constructed using the gia stapler, and the holes for the stapler were closed with a ta-30 stapler.¿ implant size and fixation: ¿following this, the abdomen was irrigated with several liters of antibiotic solution, and then a gore-tex duomesh was brought to the field.There was a large defect in the lower abdomen probably from the previous pfannenstiel incisions that the patient had and, at this time, the duomesh was tailored in a pear-shaped fashion with broader base toward the lower part of the abdomen.Using a #0 prolene, the mesh was sewn to the rim of the muscles laterally and then to about the level of the umbilicus.At this time, the fascia in the midline was adequate, although it had been opened and multiple defects had been incorporated into the incision where segments of omentum were trapped.The mesh was then sewn to both edges of the fascia and then around the broader side on the bottom part of the abdomen on the other side.T he defect was felt to be satisfactory.Following this, the subcutaneous tissue was irrigated with antibiotic solution and then two 10 mm jackson pratt drains were placed in the subcutaneous tissue and brought out the skin and secured with #2-0 silk stitches.The subcutaneous tissue was then closed with a running #0 pds.Following this, staples were placed on the skin.¿ (b)(6) 2005: pathology: ¿diagnosis: ileum, partial resection: stricture.Focal superficial mucosal necrosis.Focal chronic serositis.Serosal hemorrhage.Surgical margins of resection viable.¿ (b)(6) 2005: preoperative diagnosis: infection of abdominal wound : debridement of abdominal wound.Wound packed open.Procedure: ¿there was a small opening in the abdominal wound and through here, an aspirator was placed and it was noted that there was a large subcutaneous cavity.The incision was opened and superiorly and inferiorly in almost entirety and purulent material was aspirated and sent for culture.The wound was thoroughly debrided of many necrotic tissue and debris and then thoroughly irrigated with antibiotic solution.The wound was then packed with a wet kerlix gauze and then a sterile dressing was applied.¿ (b)(6) 2005: preoperative diagnoses: open abdominal wound.Status post repair of incisional hernia.Debridement of abdominal wound, pulsavac irrigation, and closure of abdominal wound.Procedure: ¿the abdominal wound was thoroughly irrigated with antibiotic solution and then all necrotic material identified was thoroughly debrided using scissors and a curet [sic].Following this, the wound was irrigated with a pulsavac irrigation and then two 10 mm jackson-pratt drains were placed in the subcutaneous tissue and brought out the skin through the upper level of the incision , and were secured with a 2-0 silk.The incision was then closed with interrupted #2-0 nylon stitches in the skin and subcutaneous tissue, and staples between the stitches to make the wound airtight.The drains were placed to a suction device.A sterile dressing was applied.¿ (b)(6) 2005: preoperative diagnosis: ¿infected abdominal wound.Status post repair of large incisional ventral hernia using mesh.¿ debridement of abdominal wound, postoperative irrigation and placement of wound v.A.C.Procedure: ¿the abdominal wound was then debrided in the area that had necrotic tissue leaving the dualmesh underneath.A pulsavac irrigation was then performed and once the wound was cleaned, a wound v.A.C.Was applied and placed to suction.Following this, a sterile dressing was applied on top.¿ (b)(6) 2005: discharge summary.¿hospital course: ventral abdominal hernia repair.Surgery was quite extensive requiring large mesh placed into the abdomen.Patient recognized that her risk for surgery was high and possibility of infection was equally high.Did relatively well with surgery.Has area of drainage without noted infection requiring chronic wound care.Seen by infectious disease, continued long term antibiotics, now on wound vac, doing well.Transferred to skilled nursing facility to continue wound care.¿ (b)(6) 2005: discharge summary.¿small area of dehiscence for which the patient is now on a wound vac.Has responded well to this treatment.Patient now wishes to be discharged home to louisiana to continue her care.It has been arranged for the patient to have home health visits for continued wound care.¿ implant #2 preoperative complaints: (b)(6) 2009: preoperative diagnoses: ¿ventral hernia ¿ recurrent ¿ incarcerated.¿ implant #2 procedure: ventral hernia repair with synthetic mesh.Esophagogastroduodenoscopy [implant: gore® dualmesh® plus biomaterial, 1dlmcp07/05580201, 20cm x 30cm x 1mm thick].Implant #2 date: (b)(6) 2009: wound classification: not provided.Findings: ¿the patient had a very large multiloculated ventral hernia which involved most of the central abdominal wall from just below the xiphoid to the pubis.There was colon attached then [sic] there, but no strangulation was noted.This was consistent with preoperative imaging with a small amount of synthetic mesh incorporated into the tissues in the upper abdominal wall in the midline from remote hernia repair.Egd revealed fairly normal appearing anatomy to the upper gi tract without evidence of reflux esophagitis; however, there was food retaining in the stomach, and there was reduced motility of the stomach consistent with gastroparesis.¿ description of hernia being treated: ¿the old incision was opened and, with meticulous care, we were able to get the small bowel and colon released from the lowered hernia sac and cleared the abdominal wall back to muscle so that we might have something to repair using the mesh.¿ implant size and fixation: ¿once this was all clear, the hernia sac was excised and then a 20 x 30 cm dual mesh gore-tex sewn into place with interrupted mattress sutures of #1 prolene and, once this was done, then we were actually able to get some muscle and some scar tissues that were attached to the left rectus muscle to close over the mesh in the midline using running tom jones sutures of #1 vicryl.The abdominal wall and peritoneal cavity was irrigated thoroughly with saline containing kantrex.Then, two 10 mm jackson-pratt drains were placed with separate stab wounds in the subcutaneous tissue.Then, the subcutaneous tissue was closed with running 3-0 vicryl and skin with skin staples.Sterile dressing was applied.Then esophagogastroduodenoscopy was performed with above-mentioned findings, and the scope was removed.There was no evidence of trauma.¿ revision preoperative complaints: (b)(6) 2009: preoperative diagnosis: ¿abdominal wall wound dehiscence post hernia repair.¿ revision procedure: debridement and reconstruction of abdominal wall using z-plasty technique.Revision date: (b)(6) 2009: findings: ¿the patient had exposed gore-tex dualmesh underneath the skin and soft tissue in the midportion of her midline abdominal wound.The area of defect was approximately 2.5 cm in diameter.Underneath the subcutaneous tissue overlying the mesh, there was a pocket of about 12 cm diameter.There was no evidence of gross infection and there was no evidence of recurrent hernia.¿ procedure: ¿lines were drawn out for z-plasty and incision made and bleeding controlled with electrocautery.Care was taken to preserve blood supply to the skin edges as much as possible.Then, the granulation tissue and debris underneath the skin and subcutaneous tissue overlying the mesh was debrided out.The wound was irrigated thoroughly with gentamicin solution and then the undermining was required to promote the z-plasty was accomplished and then the z-plasty was performed in the usual fashion using interrupted 2-0 nylon sutures in various styles including vertical mattress, horizontal mattress, tom jones, and simple sutures.Just prior to closing the area fully, a jackson-pratt drain 10 mm had been inserted underlying the subcutaneous tissue through a separate stab wound above the main wound and it was secured with 2-0 nylon to the skin.Once the repair was completed, then the wound was injected with 30 ml of marcaine 0.25% plain for pain relief and was irrigated through the jackson-pratt drain with more gentamicin solution.¿ disposition: ¿she will be followed in 5 days in the office.She is not to get her wound wet before the office visit and she is to leave her bandage in place.She is well aware of care of her suction having previously had 1 and she is not to do any lifting more than 5 pounds.¿ conclusion: #1 gore® dualmesh® biomaterial, 1dlmc08/03370237: it should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 shrinkage, 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.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing 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.
|
| |
|
Search Alerts/Recalls
|
|
|
