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| Model Number 1DLMCP03 |
| Device Problems
Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930)
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| Event Date 04/27/2011 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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 open incisional hernia repair on (b)(6) 2010, whereby a gore dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2010, whereby an alleged "gore-tex" device was implanted.The complaint alleges that on (b)(6) 2011, an additional procedure was performed whereby explant of the gore device was performed.The complaint alleges that on (b)(6) 2011, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: adhesions, infection, mesh removal, additional surgeries.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated result code 2 for sterilization evaluation.Conclusion code remains unchanged.
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Manufacturer Narrative
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D7: corrected explant date.H6: updated result code 1 for manufacturing evaluation.Conclusion code remains unchanged.H6: added method/result/conclusion code 2 for sterilization evaluation.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 2009, including records detailing the ¿gastric stapling¿ noted in the (b)(6) 2009 records and the origin of the ¿previous incisional scar¿ noted in the (b)(6) 2010 records, were not provided.Operative records dated (b)(6) 2009 state the patient underwent ¿esophagogastroduodenoscopy with biopsy.Colonoscopy with biopsy polypectomy.¿ postoperative diagnoses state: ¿abdominal bloating, upper abdominal pain.History of gastric stapling.Need for colon screening.Multiple fistulizations between the upper gastric pouch and the lower area of the stomach through the previous gastric stapling.Gastritis.Duodenitis.Small hiatal hernia.Multiple colon polyps.¿ pathology report dated (b)(6) 2009 regarding specimens collected (b)(6) 2009state: ¿clinical history: abdominal pain, bloating, change in bowel habits.Specimen(s) submitted: a) gastric biopsy; b) descending colon biopsy; c) sigmoid colon biopsy.¿ ¿diagnosis: a.Stomach, biopsies: -gastric antral/fundic transition zone mucosa with moderate chronic gastritis.-there is no intestinal metaplasia or gastric atrophy.-helicobacter pylori organisms are present.B.Colon, descending, biopsies: -fragments of tubulovillous adenoma with low-grade dysplasia.C.Colon, sigmoid, biopsies: -fragments of tubulovillous adenoma with low-grade dysplasia.¿ operative records dated (b)(6) 2010 state the patient underwent ¿incarcerated incisional hernia repair with mesh, small bowel enterotomy repair, extensive lysis of adhesions.¿ postoperative diagnosis states: ¿incarcerated incisional hernia, with small bowel involvement and extensive adhesive disease.¿ the records state: ¿an upper midline incision was created through the previous incisional scar sharply with a knife extending approximately 5 inches.This was taken down to the very large hernia sac, which was seen to be tensely incarcerated.This was opened, seen to contain large amount of greater omentum as well as 1 loop of small bowel, which was not identified until it was actually entered inferiorly in the sac.There was a small amount of bile spill in the wound.This was thoroughly irrigated.The hernia neck required enlargement in order to reduce the incarcerated greater omentum, which also required lysis of adhesions from the hernia sac, itself, in all directions as well as from the anterior abdominal wall.This was done sharply.¿ the (b)(6) 2010 records state: ¿there were multiple loops of small bowel, which were contained both in the sac as well as adhesed to the sac, the greater omentum, and to themselves.This was all sharply lysed as well in order to visualize the loop that had the enterotomy in it well enough to repair this.This was repaired with a 2-layer closure of 3-0 silk popoff suture.The viscera were allowed to decompress back down into the abdominal cavity, the hernia sac excised from the subcutaneous tissue down to the level of the fascia.This actually left a fascial hernia defect of approximately 3 inches x 4 inches.A dual gortex [sic] mesh of 10 x 15 cm was used to patch this.It was placed smooth side down intraabdominally with the greater omentum between the gortex [sic] and the small bowel.Again, the area had been thoroughly irrigated and the mesh soaked in antibiotic-containing saline prior to insertion.The mesh was tacked in place with 12 interrupted 0 prolene sutures with overlap of at least 2 cm in each direction.Subcutaneous tissues were then closed with interrupted 2-0 vicryl.The skin edges were reapproximated with 4-0 subcuticular monocryl suture.¿ the records indicate a gore dualmesh® plus biomaterial (1dlmcp03/05738520) was implanted during the procedure.Operative records dated (b)(6) 2010 state the patient underwent ¿wound exploration with removal of infected mesh, drainage of infected liquified hematoma, with culture.Lysis of adhesions.Pulse irrigation of the abdominal wall.Placement of permacol tissue implant.¿ postoperative diagnosis states: ¿chronic draining periumbllical wound.Possible infected ventral hernia mesh.¿ the (b)(6) 2010 records state: ¿the draining sight of this wound was ellipsed-out full-thickness with a knife, with the resulting incision in the upper abdomen, midline, extending 5 inches.This was taken down to the level of the fascia encompassing the entire area of inflamed tissue, which tracked down to the hernia mesh.The mesh, itself, was excised and an infected liquefied hematoma expressed from beneath this.Cultures were obtained.The mesh was entirely removed, passed off the field, and sent to pathology.The underlying inflamed tissue was removed as well.This was seen to be mainly omentum.There was no evidence of involvement in other underlying viscera, though this was explored.Lysis of adhesions was undertaken to allow for adequate visualization and exposure of the anterior abdominal wall.This took at least 25 minutes of the case.That being done, the abdominal wall and subcutaneous tissue was pulse irrigated.This was with ancef-containing irrigant fluid.The permacol mesh, 15 x 20 cm, was placed intra-abdominally and tacked in all areas with o vicryl suture interrupted.The subcutaneous tissue was closed in a similar fashion.The skin edges were reapproximated with skin staples.¿ the records indicate a permacol device (non-gore) was used during the procedure.Pathology records dated (b)(6) 2010 regarding a specimen collected (b)(6) 2010states: ¿clinical history: status post hernia surgery, presents with weeping wound; rule out infected mesh.Specimen(s) submitted: a) infected mesh and sinus tract.¿ ¿gross description: a is labeled "infected mesh in sinus tract" and consists of a portion of synthetic graft material, which measures 8 x 6.5 cm.Attached to this mesh is subcutaneous tissue, which measures 13 x 6 x 4.1 cm as well as an attached ellipse of skin, which measures 5.7 x 1.3 cm.Sectioning through the specimen demonstrates an abscess cavity within the subcutaneous tissue, immediately adjacent to the synthetic graft material and measures 5 x 4.7 x 3.1 cm and is filled with hemorrhagic, necrotic and fibrinous debris.It has a fistulous tract that extends to the epidermis.Two representative se ctions, including a portion of abscess cavity and fistulous tract, are submitted as al-2.¿ ¿diagnosis: mesh and sinus tract: - skin and subcutaneous tissue showing abscess with sinus tract.¿ mesh material (gross diagnosis).Comment: special status for fungus and acid fast bacilli appear negative.¿ operative records dated (b)(6) 2010 state the patient underwent ¿exploratory laparotomy.Lysis of adhesions.Repair of incarcerated recurrent ventral hernia with mesh.Placement of fibrin glue.¿ postoperative diagnosis states: ¿small bowel obstruction secondary to recurrent incarcerated ventral hernia.¿ the records state: ¿an upper midline incision was created through the skin with a knife extending approximately 12 inches.This was taken down into the hernia sac, which was seen to contain a large amount of distended small bowel.Lysis of adhesions was performed and the site of obstruction was seen to be at the inferior aspect of the hernia sac, itself.This was lysed and the bowel obstruction was freed.The bowel contents were milked superiorly back up to the stomach and brought out through the og tube to allow for placement of the small bowel loops back actually into the true abdomen.There was a large hernia sac as well as old permacol mesh.¿ the (b)(6) 2010 records state: ¿the permacol mesh had seen to be ripped away from the left side of the hernia defect and then crumpled up a bit.This was straightened out.The greater omentum was stuck to the underside of the permacol mesh.This was freed.The largest gore-tex mesh available, approximately 1 foot x 10 inches was used, smooth side down, intraabdominally and tacked in place with multiple o prolene sutures at its edges, well back away from the hernia defect.The permacol mesh was then placed back over the defect as well and tacked to the fascia on the other side.The hernia sac in the subcutaneous tissue was then excised at the level of the permacol mesh with bovie cautery.The subcutaneous tissue was then tacked down to the edges of the hernia as well as to the permacol mesh with multiple o vicryl suture and this space also obliterated with fibrin glue, 3 vials of 5 ml.The edges were then reapproximated with multiple vertical mattress sutures of 2-0 nylon as well as skin staples.Sterile dressings and abdominal binder were placed.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp08/05515651) was implanted during the procedure.Operative records dated (b)(6) 2011 state the patient underwent ¿exploratory laparotomy with extensive lysis of adhesions, removal of old gore-tex mesh and permacol mesh, abdominal wall reconstruction with lysis of the external oblique fascia bilaterally, primary midline abdominal hernia repair over vicryl mesh, flexible cystoscopy and placement of coude catheter over a wire, and jp drain placement x2.¿ postoperative diagnosis states: ¿large recurrent ventral wall hernia, incarcerated, with known intraabdominal adhesive disease and loss of intraabdominal domain.Prostatic hypertrophy with initial iatrogenic false passage created with attempted foley insertion.¿ the (b)(6) 2011 operative report states: ¿a midline incision was created through the previous incisional scar, and taken down into the hernia sac, where the small bowel was lysed off of the gore-tex mesh and permacol mesh.Both the large and small bowel, as well as greater omentum were densely adhered to the mesh, as well as to the anterior abdominal wall and to each other.This took at least an hour and a half of the case, and was done with sharp dissection.The bowel being completely freed, was then attempted to be placed actually down intra-abdominally.It was clear that there had been a loss of intraabdominal domain.The large hernia sac was dissected free from the surrounding overlying subcutaneous tissue down to the level of the fascia on all sides, and passed off the field.¿ the (b)(6) 2011 operative report continues: ¿the subcutaneous adipose tissue was dissected free off of the exterior oblique on both sides, and the oblique divided just lateral to the rectus, both to the right and to the left from the edge of the costal margin down to the inguinal canal area.That being done, then the midline fascia could be reapproximated with only a small amount of tension.A vicryl mesh was placed in a 2-layer fashion beneath the entire midline defect.The defect was seen to extend approximately 2 feet.This was closed with multiple 1 looped pds sutures in an interrupted running fashion using 3 of these for the entire closure of the abdomen at the level of the fascia.The subcutaneous tissue on the anterior abdominal wall then had a large subcutaneous defect secondary to the large nature of the hernia sac.Two jp drains were placed through separate stab wound incisions, both out through the right lower quadrant skin, and placed in these defects, 1 on the right side of the lower abdomen, and 1 on the left lower abdomen.The drains were stitched in place at the level of the skin with 3-0 prolene suture, and placed to bulb suction.¿ the (b)(6) 2011 operative records state: ¿the skin edges were reapproximated with skin staples.Sterile dressings were applied.It was then noted, the patient had not had any urine output during the case, and prior to closure of the abdomen, the bladder was palpated, and the foley catheter balloon could not be identified.Therefore, the catheter was inspected.There was blood at the urethral meatus, and nothing in the catheter.The balloon was deflated, and the catheter removed, resulting in more blood from the urethral meatus.The coude catheter was then attempted to be passed without good results.There was some resistance at the level of the external aspect of the prostate, and therefore, this was not passed, but rather a flexible cystoscopy was performed, which did reveal a false passage at the level of the prostate with what appeared to have been a balloon inflation point at the external aspect of the prostate.¿ the (b)(6) 2011operative report continues: ¿the cystoscope could be passed up into the bladder with some gentle manipulation through the true urethral passage, and a guidewire placed through the cystoscope.The cystoscope was removed, and then a coude catheter was placed over the guidewire.In order to pass this, the very tip of the coude catheter had to be cut for passage of the wire through the midline of that tip.That being done, the coude passed without significant concern, and the guidewire removed, and the balloon inflated without difficulty, and the bladder irrigated with a small amount of saline until there was good urine backflow and no other significant clots.This was placed to bulb suction.The patient was extubated and transferred to the recovery room in stable condition.¿ operative records dated (b)(6) 2012 state the patient underwent ¿washout of abdominal wound with removal of large hematoma, control of hemorrhage, arterial bleed, and placement of jackson-pratt drain.¿ postoperative diagnosis is noted as delayed subcutaneous hemorrhage.The records state: ¿the previously placed abdominal incisional staples were all removed and the incision opened its entire length.A large amount of clot was removed, several liters.This was done manually.The areas were then thoroughly irrigated and then tacked with dry laps and the quadrants individually evaluated.¿ the (b)(6) 2012 records continue: ¿in the left lower quadrant of the subcutaneous tissue area, there was seen to be 1 small arterial bleeder in the subcutaneous tissue, unusual position for any significant artery; however, there was approximately a 2-3 mm small artery actively oozing and/or pumping in that area.This was cauterized after being clamped and seen to be then completely hemostatic.Avitene was also placed on that area.The rest of the quadrants were seen to be without any evidence of active bleeding.They were again thoroughly irrigated and a clot product that was available for removal was removed.One jp drain and one 10-french flat was placed back into the abdominal subcutaneous tissue on the anterior abdominal wall through the more medial of the 2 previously made jp sites and placed to bulb suction after being sutured in at the level of the skin with 3-0 prolene.The abdomen was again closed at the skin level with skin staples over 3-0 chromic interrupted's.¿ records dated (b)(6) 2014 state the patient underwent egd with biopsy and colonoscopy with biopsy.Pre-procedural diagnosis states: ¿personal history of adenomatous colon polyps.Nausea alone.Abdominal pain ¿ epigastric.Obesity.¿ postoperative diagnoses states: ¿gastritis.Post surgical anatomy.Gastric sleeve within the stomach protruding through.¿ findings state: ¿esophagus was normal in appearance.Distorted post surgical anatomy with a normal sized stomach and an area of stomach with a gastric sleeve seen within the lumen of the stomach.Duodenum normal in appearance.Biopsies obtained from the stomach and duodenum.¿ pathology report dated (b)(6) 2014 regarding specimens collected (b)(6) 2014 state: ¿clinical history: epi gastric pain, nausea and history of adenomatous colon polyps.Specimen(s) submitted: a) polyps; b) fold biopsies of ascending colon; c) duodenal biopsy; d) stomach biopsy pre-op diagnosis: same.Post-op diagnosis: same.¿ ¿diagnosis: a.Polyps: - tubular adenorna(s).B.Fold biopsy of ascending colon: -hyperplastic polyp(s).C.Duodenal biopsy: -duodenal mucosa showing no significant histopathologic abnormalities.D.Stomach biopsy: -mild chronic gastritis.-no acute inflammation and no organisms consistent with h.Pylori seen on he stain.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient code (1695) was reported based on the original complaint and is no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2009 through (b)(6) 2014, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: [none provided].Prior surgical procedures: ¿gastric stapling.¿ implant preoperative complaints: [none provided].Implant procedure #1: incarcerated incisional hernia repair with mesh, small bowel enterotomy repair, extensive lysis of adhesions.Implant gore® dualmesh® plus biomaterial (05738520/1dlmcp03) 10cm x 15cm, oval.Implant date #1: (b)(6) 2010 [hospitalization dates unknown].Description of hernia being treated: ¿an upper midline incision was created through the previous incisional scar sharply with a knife extending approximately 5 inches.This was taken down to the very large hernia sac, which was seen to be tensely incarcerated.This was opened, seen to contain large amount of greater omentum as well as 1 loop of small bowel, which was not identified until it was actually entered inferiorly in the sac.There was a small amount of bile spill in the wound.This was thoroughly irrigated.The hernia neck required enlargement in order to reduce the incarcerated greater omentum, which also required lysis of adhesions from the hernia sac, itself, in all directions as well as from the anterior abdominal wall.This was done sharply.There were multiple loops of small bowel, which were contained both in the sac as well as adhesed to the sac, the greater omentum, and to themselves.This was all sharply lysed as well in order to visualize the loop that had the enterotomyin it well enough to repair this.This was repaired with a 2-layer closure of 3-0 silk popoff suture.The viscera were allowed to decompress back down into the abdominal cavity, the hernia sac excised from the subcutaneous tissue down to the level of the fascia.This actually left a fascial hernia defect of approximately 3 inches x 4 inches.¿ implant size and fixation: ¿a dual gortex [sic] mesh of 10 x 15 cm was used to patch this.It was placed smooth side down intraabdominally with the greater omentum between the gortex [sic] and the small bowel.Again, the area had been thoroughly irrigated and the mesh soaked in antibiotic-containing saline prior to insertion.The mesh was tacked in place with 12 interrupted 0 prolene sutures with overlap of at least 2 cm in each direction.¿ no post-operative records were provided.Explant preoperative complaints: [none provided].Explant procedure #1: wound exploration with removal of infected mesh, drainage of infected liquefied hematoma, with culture.Lysis of adhesions.Pulse irrigation of abdominal wall.Placement of permacol tissue implant.Explant date #1: (b)(6) 2010 [hospitalization dates unknown].¿the draining sight of this wound was ellipsed-out full-thickness with a knife, with the resulting incision in the upper abdomen, midline, extending 5 inches.This was taken down to the level of the fascia encompassing the entire area of inflamed tissue, which tracked down to the hernia mesh.The mesh, itself, was excised and an infected liquefied hematoma expressed from beneath this.Cultures were obtained.The mesh was entirely removed , passed off the field, and sent to pathology.The underlying inflamed tissue was removed as well.This was seen to be mainly omentum.There was no evidence of involvement in other underlying viscera, though this was explored.Lysis of adhesions was undertaken to allow for adequate visualization and exposure of the anterior abdominal wall.This took at least 25 minutes of the case.That being done, the abdominal wall and subcutaneous tissue was pulse irrigated.This was with ancef-containing irrigant fluid.The permacol mesh, 15 x 20 cm, was placed intra-abdominally and tacked in all areas with o vicryl suture interrupted.Records confirm a non-gore device was implanted during the (b)(6) 2010 procedure.Relevant medical information: (b)(6) 2010: pathology: ¿specimen(s) submitted: a) infected mesh and sinus tract.¿ ¿gross description: a is labeled "infected mesh in sinus tract" and consists of a portion of synthetic graft material, which measures 8 x 6.5 cm.Attached to this mesh is subcutaneous tissue, which measures 13 x 6 x 4.1 cm as well as an attached ellipse of skin, which measures 5.7 x 1.3 cm.Sectioning through the specimen demonstrates an abscess cavity within the subcutaneous tissue, immediately adjacent to the synthetic graft material and measures 5 x 4.7 x3.1 cm and is filled with hemorrhagic, necrotic and fibrinous debris.It has a fistulous tract that extends to the epidermis.¿ implant preoperative complaints: [none provided].Implant procedure #2: exploratory laparotomy.Lysis of adhesions.Repair of incarcerated recurrent ventral hernia with mesh.Placement of fibrin glue.Implant: gore® dualmesh® plus biomaterial (05515651/1dmlcp08) 26cm x 34cm, oval.Implant #2 date: (b)(6) 2010 [hospitalization dates unknown].Description of hernia being treated: ¿an upper midline incision was created through the skin with a knife extending approximately 12 inches.This was taken down into the hernia sac, which was seen to contain a large amount of distended small bowel.Lysis of adhesions was performed and the site of obstruction was seen to be at the inferior aspect of the hernia sac, itself.This was lysed and the bowel obstruction was freed.The bowel contents were milked superiorly back up to the stomach and brought out through the og tube to allow for placement of the small bowel loops back actually into the true abdomen.There was a large hernia sac as well as old permacol mesh.The permacol mesh had seen to be ripped away from the left side of the hernia defect and then crumpled up a bit.This was straightened out.The greater omentum was stuck to the underside of the permacol mesh.This was freed.¿ implant size and fixation: ¿the largest gore-tex mesh available, approximately 1 foot x 10 inches was used, smooth side down, intraabdominally and tacked in place with multiple o prolene sutures at its edges, well back away from the hernia defect.The permacol mesh was then placed back over the defect as well and tacked to the fascia on the other side.The hernia sac in the subcutaneous tissue was then excised at the level of the permacol mesh with bovie cautery.The subcutaneous tissue was then tacked down to the edges of the hernia as well as to the permacol mesh with multiple o vicryl suture and this space also obliterated with fibrin glue, 3 vials of 5 ml.¿ no post-operative records were provided.Explant preoperative complaints: [none provided].Explant procedure #2: exploratory laparotomy with extensive lysis of adhesions, removal of old gore-tex mesh and permacol mesh, abdominal wall reconstruction with lysis of the external oblique fascia bilaterally, primary midline abdominal hernia repair over vicryl mesh, flexible cystoscopy and placement of coude catheter over a wire, and jp drain placement x2.Explant #2 date: (b)(6) 2011 [hospitalization dates unknown].¿a midline incision was created through the previous incisional scar, and taken down into the hernia sac, where the small bowel was lysed off of the gore-tex mesh and permacol mesh.Both the large and small bowel, as well as greater omentum were densely adhered to the mesh, as well as to the anterior abdominal wall and to each other.This took at least an hour and a half of the case, and was done with sharp dissection.The bowel being completely freed, was then attempted to be placed actually down intra-abdominally.It was clear that there had been a loss of intraabdominal domain.The large hernia sac was dissected free from the surrounding overlying subcutaneous tissue down to the level of the fascia on all sides, and passed off the field.The subcutaneous adipose tissue was dissected free off of the exterior oblique on both sides, and the oblique divided just lateral to the rectus, both to the right and to the left from the edge of the costal margin down to the inguinal canal area.That being done, then the midline fascia could be reapproximated with only a small amount of tension.A vicryl mesh was placed in a 2-layer fashion beneath the entire midline defect.The defect was seen to extend approximately 2 feet.This was closed with multiple 1 looped pds sutures in an interrupted running fashion using 3 of these for the entire closure of the abdomen at the level of the fascia.The subcutaneous tissue on the anterior abdominal wall then had a large subcutaneous defect secondary to the large nature of the hernia sac.Two jp drains were placed through separate stab wound incisions, both out through the right lower quadrant skin, and placed in these defects, 1 on the right side of the lower abdomen, and 1 on the left lower abdomen.The drains were stitched in place at the level of the skin with 3-0 prolene suture, and placed to bulb suction.¿ records confirm the previously implanted gore device and non-gore device were explanted and a non-gore device was implanted during the (b)(6) 2011 procedure.Relevant medical information: (b)(6) 2012: washout of abdominal wound with removal of large hematoma, control of hemorrhage, arterial bleed, and placement of jackson-pratt drain.¿ ¿the previously placed abdominal incisional staples were all removed and the incision opened its entire length.A large amount of clot was removed, several liters.This was done manually.The areas were then thoroughly irrigated and then tacked with dry laps and the quadrants individually evaluated.In the left lower quadrant of the subcutaneous tissue area, there was seen to be 1 small arterial bleeder in the subcutaneous tissue, unusual position for any significant artery; however, there was approximately a 2-3 mm small artery actively oozing and/or pumping in that area.This was cauterized after being clamped and seen to be then completely hemostatic.Avitene was also placed on that area.The rest of the quadrants were seen to be without any evidence of active bleeding.They were again thoroughly irrigated and a clot product that was available for removal was removed.One jp drain and one 10-french flat was placed back into the abdominal subcutaneous tissue on the anterior abdominal wall through the more medial of the 2 previously made jp sites and placed to bulb suction after being sutured in at the level of the skin with 3-0 prolene.The abdomen was again closed at the skin level with skin staples over 3-0 chromic interrupted's.¿ 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 gore® dualmesh® plus biomaterial instructions for use also states: "staged repairs should be considered when gore dualmesh® plus biomaterial will be subjected to gross contamination or infection." 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.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.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.C1: name: plus antimicrobial product coating; manufacturer/compounder: w.L.Gore & associates, inc.Lot #: 05738520.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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