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| Model Number 1DLMC04 |
| Device Problems
Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Abscess (1690); Adhesion(s) (1695); Nausea (1970); Staphylococcus Aureus (2058)
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| Event Date 08/19/2010 |
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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® 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 parastomal/ventral hernia repair on (b)(6) 2010 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure was performed whereby the gore device was explanted.It was reported the patient alleges the following injuries: pain, nausea, extensive adhesions to small bowel, abscess, mesh infection, intestinal blockage.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Conclusion code remains unchanged.
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Manufacturer Narrative
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B7: added patient medical history.H6: corrected results code.Code 3233 - sterilization results pending completion of the evaluation.H6: corrected conclusion code.H10/11: 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 (b)(6) 2010 indicate the patient underwent laparoscopic repairs of a parastomal hernia and midline ventral/incisional hernias using mesh.The records state: ¿this patient presents with an enlarging and increasingly uncomfortable mass at the site of a right lower quadrant ileostomy.Examination and history was suggestive of a peristomal hernia and this was confirmed on ct scan which revealed a large amount of bowel within the hernia.Subsequently, repair was felt appropriate.¿ the (b)(6) 2010 records state: ¿the patient was noted to have a number of small fascial defects in the periumbilical region of the prior midline incision which were empty.He had a large defect at the stoma site in the right lower quadrant.¿ ¿the hernia sac was empty except for the ileostomy itself.There were some adherent loops of small-bowel along the inferolateral aspect of the defect which were taken down sharply.The mesentery of one of the loops was adherent to the mesentery of the bowel going to the ileostomy and these adhesions were taken down as well in preparation for repair.¿ the (b)(6) 2010 records state: ¿intracorporeal measurements were used to delineate the dimensions of the defect which was approximately 8 cm in diameter.Subsequently, a 15 x 19 em gore-tex dualmesh was chosen and was tailored to creating a 15 cm diameter circle.Sutures of 0 ethibond were placed at the 12, 3, 6 and 9 o'clock positions with both tails left long for later retrieval.The original 5-mm trocar was upsized to a 12-mm and this trocar was then placed in the upper midline and the mesh was rolled up and inserted into the peritoneal cavity via the 12-mm trocar.Once positioned intraperitoneally, the mesh was unrolled and using the gore suture passer through small skin incisions, the four sutures were pulled up through the anterior abdominal wall with a fascial bridge of approximately 1 cm at each site thereby allowing for wide coverage of the defect with a margin of overlap of approximately 4 cm circumferentially of the parastomal defect and again extension beyond the midline in the periumbilical region to cover the hernias in this area as well.¿ the (b)(6) 2010 records continue: ¿in the inferolateral aspect of the mesh a gap was left to allow ileum and the mesentery going to the ileostomy to travel between the mesh and the abdominal wall.Following this, three more additional transfacial fixation sutures were placed at equal distance from the 9 and 12, 12 and 3, and 3 and 6 o'clock sutures.One was not placed between the 6 and 9 o'clock suture again as this was where the bowel was positioned.All these sutures were then tied down extracorporeally burying the knots within the anterior abdominal wall within the subcutaneous tissue.Following this, the 5 mm hernia tacker was used to secure the mesh to the anterior abdominal wall circumferentially at intervals of approximately 8-10 mm and a distance of approximately 1-2 mm from the edge of the mesh.The tack and suture fixation sites were hemostatic.Survey was taken of the abdomen there was no bleeding.There was no enterotomy.Again, the bowel going to the ileostomy did not appear compromised.¿ the records confirm a gore dualmesh® biomaterial (1dlmc04/7031671) was used during the procedure.Operative records dated 8/6/2010 indicate the patient underwent incision and drainage of a parastomal abscess.The records state: ¿this patient is a 50-year-old man who is now over 3 weeks status post laparoscopic ventral/parastomal hernia repair with mesh.He was admitted early this week for parastomal cellulitis.Ct scan revealed a large fluid collection, contiguous with the mesh, most consistent clinically with a seroma.The area where the patient was symptomatic appeared to represent a phlegmon and possibly a small abscess.Subsequently, the patient was treated with intravenous antibiotics and initially improved until this morning when he began to drain spontaneously from the site.Upon examination, he had drainage from a small opening, which appeared to likely represent a prior skin incision from mesh fixation suture and subsequently a more formal incision and drainage was felt appropriate.¿ the (b)(6) 2010 records state: ¿hemostat was then used to spread the subcutaneous tissue which resulted in return of purulent fluid and old blood/hematoma.This did appear to extend down to the muscle fascia.The area was irrigated.With expression, there was a small amount of further drainage.The area was probed with cotton swabs and does not appear to extend deeper than the muscle fascia or track in any direction.There was no evidence that this communicated with the other lateral collection seen on ct scan.Subsequently, at this point, this appears likely be an infectious process relating to the previously placed mesh fixation suture.Although there was a potential concern for deeper process involving the mesh, there was no evidence of this clinically at this juncture.¿ the plan was noted as: ¿will be for continued antibiotics.The initial gram's stain revealed gram-positive cocci.We will await final culture and sensitivity and alter the antibiotics appropriately.We will also begin instituting local care to the wound with normal saline wet to dry dressings and possibly transition to a gauze wick.The patient tolerated the procedure well.¿ operative records dated (b)(6) 2010 indicate the patient underwent laparoscopic removal of previously placed mesh and drainage of an abscess.Post-operative diagnosis states: ¿postoperative abscess after mesh repair of parastomal hernia.¿ indications for the procedure state: ¿this patient is status post laparoscopic mesh repair of parastomal hernia and presents with abscess.Initially, the patient improved with abscess drainage but now is having ongoing symptoms consistent with untreated infection'.Due to the fact that this is a microporous synthetic mesh, resolution of the process without mesh excision is felt highly unlikely.Subsequently after discussing the various treatment options with the patient, plan has been made to proceed with laparoscopic mesh excision.The (b)(6) 2010 operative report states: ¿the anterior abdominal wall was visualized at the site of the prior hernia repair.There were multiple adhesions between the small bowel and the anterior abdominal wall as well as the small bowel and the previously placed mesh.Using sharp dissection without electrocautery, these adhesions were taken down.A "pseudocapsule" was then entered between the mesh and the peritoneum and dissection, of this plane allowed for the multiple loops of bowel to be safely dissected away from the mesh, by leaving these attached to the capsule.Following this, the mesh was then dissected away from the anterior abdominal wall.Dissection was begun medially, and using hook dissector with electrocautery, the mesh along with the previously placed packs and sutures were dissected away from the anterior abdominal wall.As this continued laterally, the loop of bowel and its mesentery going towards the stoma were encountered, and at this point, careful sharp and blunt dissection (without electrocautery) was used to dissect the mesh away from this bowel and mesentery in an atraumatic fashion.¿ the (b)(6) 2010 records state: ¿during the latter part of the procedure, the abscess cavity adjacent to the cephalad aspect of the mesh was entered resulting in return of purulent material which was rapidly suctioned in an effort to contain the process as best as possible.This area was later irrigated using antibiotic solution as was the entire right lower quadrant of the abdomen.In order to remove the mesh, the initial trocar was upsized to a 12-mm trocar.Endopouch bag was inserted via this trocar.The mesh was then placed in the bag, which was removed via the trocar site.¿ the (b)(6) 2010 records continue: ¿the previously placed drain in the right lateral abdomen was clearly clogged and this was removed and a new 19 blake drain was placed using laparoscopic assistance.The proximal portion of the drain was looped up in the abscess cavity and the distal part down into the right lower quadrant adjacent to the stoma.The abdomen' was surveyed.The bowel that had been taken down' from the mesh and the anterior abdominal wall was examined and was without evidence of injury/enterotomy.There was no bleeding.This 12-mm trocar was removed and this fascial defect was approximated with 0 vicryl placed with the gore suture passer in a figure-of-eight fashion.¿ operative records dated (b)(6) 2011 indicate the patient underwent exploratory laparotomy, extensive lysis of adhesions, takedown and resection of ileostomy, and alloderm mesh repair of parastomal hernia and brooke ileostomy for repair of a recurrent parastomal hernia.The records state: ¿this patient is a 51 - year- old very pleasant male who has a history of ulcerative colitis and had a total proctocolectomy with an end ileostomy site on the right side in maine medical center who subsequently then had to undergo an ileostomy revision for ischemia of his stoma and repair of a parastomal hernia last year which was then removed due to a mesh infection.The patient has been living with another parastomal hernia for about a 1- 1/2 years now and would like to have this removed.¿ the (b)(6) 2011 records state: ¿we were able to enter the peritoneal cavity in the very superior portion of his wound and did not encounter a significant amount of adhesions.The fascia and peritoneum were then entered and the incision carried down inferiorly.We did encounter extensive adhesions in the right abdomen where his stoma was.This was to be expected.We proceeded with an extensive lysis of adhesions using metzenbaum scissors and blunt dissection.At this point we could not proceed further with extensive lysis of adhesions, so we decided to move our attention to the old stoma site.An elliptical incision was made around the ileostomy with the longest dimension in a horizontal direction.This was performed using a 10 blade.This was then carried down through the subcutaneous tissue with bovie cautery.The ileostomy was sharply and bluntly freed up from the subcutaneous tissues and adhesions using metzenbaum scissors.Once the ostomy was freed up down to the fascia, fascial adhesions were divided.It was clear that there was a very large hernia sac which had bowel in it that was released.Once the entire end ileostomy was free, we were able to pass it back into the abdominal cavity.¿ the (b)(6) 2011 records state: ¿we then turned our attention to the excision of the hernia sac.This was excised in toto with full completion using sharp dissection as well as bovie electrocautery.This was then passed off as a specimen.We then turned our attention back to the abdomen and had to continue lysis of adhesions of the old ileostomy site and the loops of bowel that were contained in the parastomal hernia.Once this was completed, we identified a place to resect his bowel for his new stoma.A gia stapler was then used to divide the bowel and this was passed off as a second specimen.We then chose a place on the left side of the abdomen where the patient had been preoperatively marked for the new area of his end ileostomy.Using the bovie on the cut function, a nickel size hole was created over the padded area and carried down through the subcutaneous tissues.Once the fascia was encountered, a cruciate incision was then made over the fascia and muscle divided.¿ the (b)(6) 2011 records continue: ¿once this was enlarged so that three finger widths could be passed through the hole, the new stoma site was then passed through, taking care not to twist the bowel and the mesentery.This was then covered and our attention was turned to repair of the parastomal hernia.We irrigated the abdomen and the parastomal hernia cavity and ensured that there was adequate hemostasis.Once this was performed, we took a large 16 x 24 thick alloderm piece of mesh and placed it transversely as an underlay to repair the parastomal hernia and incorporated it into the final midline closure as well.Initially we used large 2- 0 prolene suture in a horizontal mattress to attach the fascial edges which were identified and cleared from the parastomal hernia to the alloderm mesh.This was then placed in all four corners and along both the medial and lateral sides.Each stitch was placed about 1 cm apart.¿ the (b)(6) 2011 records continue: ¿¿we then did the same on the medial side of the parastomal hernia repair.At this point, we then turned our attention to packing the alloderm mesh to the left lateral midline incision side which it did stretch across.The same maneuvers of 2- 0 prolene were then used 1 cm apart.Once this was performed, we then turned our attention to closing the midline with a #1 looped pds on both the superior and inferior sides and meeting in the middle which was then tied.The skin in the midline was then closed using skin staples.The old stoma site was then closed using 3- 0 vicryl in the subcutaneous tissues.After placement of a jp drain in that area and copious irrigation and adequate hemostasis control.Skin staples were also used on the skin for the old stoma site.Once this was performed, a clean towel was placed over the patient.We then turned our attention to the brooking of the ostomy.We placed two allis clamps on the old staple line from the new end ileostomy and removed the old staple line.We then placed four tacking 4- 0 vicryl sutures in each corner, which were then tied and then subsequent 4- 0 vicryl sutures were placed in between the four quadrants.Once this was performed, the patient's abdomen was then cleaned and dry sterile dressings were placed as well as a stoma bag on the patient.The patient tolerated the procedure well.¿ pathology report dated (b)(6) 2011 regarding a specimen collected (b)(6) 2011 indicate the following final diagnoses: ¿a.Abdominal scar: benign skin with dermal fibrosis consistent with scar.There is no evidence of malignancy.B.Parastomal hernia sac: benign fibrovascular tissue with focal chronic inflammation, foreign body giant cell reaction, and focal dystrophic calcification.There is no evidence of malignancy.C.Ileostomy: ileocutaneous anastomosis site with focal chronic inflammation and reparative changes.There is no evidence of malignancy.¿ operative records dated (b)(6) 2013 indicate the patient underwent repair of multiple recurrent hernias.The records state: ¿the patient is a 53-year-old male with multiple abdominal operations associated with ulcerative colitis.He originally had a proctocolectomy and ileostomy.He developed a large parasternal hernia and eventually had the ileostomy relocated to the left side.He subsequently developed a ventral hernia that was repaired at an outside hospital.He developed a wound infection and the mesh that was placed was removed.The patient then developed a large symptomatic ventral hernia in the upper midline of his abdomen as well as in the right lower abdomen at the old ileostomy site.¿ the (b)(6) 2013 records state: ¿the wide surgical scar was excised completely.Dissection was carried down to the hernia sac with electrocautery.The hernia sac was identified and was dissected free from surrounding scar tissue as well as subcutaneous tissue.Eventually the fascial edges were identified.The hernia sac was completely excised and sent to pathology.The defect was approximately 5 x 6 cm.It was elected to characterize the right lower abdominal hernia before repairing the midline hernia.A transverse incision was made over the hernia through the old ostomy closure scar.This was done with scalpel.Dissection was carried down to the hernia sac with electrocautery.Again, a very large hernia sac was identified.There were multiple loops of bowel within it.The hernia sac was opened and the bowel was carefully dissected free from the hernia sac using blunt and sharp dissection.This was done until all the bowel was returned to the abdomen.The large hernia sac was then excised.The fascial edges were identified.This was a somewhat larger defect, measuring approximately 8-10 x 7-8 cm.There was a very small fascial bridge between the midline defect and the right-sided defect.The (b)(6) 2013 records continue: ¿it was elected to perform the repair using a 20 x 30 em thick strattice biologic mesh.This was done in an underlay fashion.The lateral defect was closed initially.The mesh was secured to the undersurface of the fascia with multiple mattress sutures of #2 prolene suture material.This very effectively closed the defect.The mesh was brought under the fascial bridge.It was tacked to the fascial bridge again with mattress sutures of #2 prolene suture material.The midline defect was then closed with the remaining portion of the mesh.This again was done in an underlay fashion with interrupted mattress sutures of #2 prolene suture material circumferentially.With this done, both defects were securely closed.There was good hemostasis.The wounds were irrigated with a cefoxitin solution.Then 10 mm jackson-pratt drains were placed through stab wounds lateral to both of the defects and positioned over the mesh.In each case, the soft tissue was brought together over the mesh with interrupted 3-0 vicryl sutures.¿ the records confirm a strattice device (non-gore device) was used during the procedure.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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Added patient weight.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated on (b)(6) 2010 state: ¿he is also concerned about his abdominal wall incisional hernia that creates a significant protrusion in the abdominal wall that is mechanically problematic when it comes lo activities such as basketball.He continues to empty his bag about 6 times a day.He is having no ostomy site problems.His surgeon, dr.Sarah mayo, and her assistant, indicated to him that if he was going to have his hernia repaired he should be at an optimal weight.¿ records dated 2/18/2011 state: ¿[patient] reports he has a small nonhealing wound aprox[sic] 2cm in size next to his stoma.¿ dr.Wants him to see a wound specialist.Records dated on (b)(6) 2011 state: ¿patient status post cholecystectomy has an incisional hernia that he is very self-conscious about.It is currently not painful when wearing an abdominal binder.He is planning to have the colostomy site switched to the left side in november so that the hernia can be repaired.¿ the records state: ¿examination today finds evidence of the hernia.He is not tender in the area.There is no evidence of bowel strangulation.Colostomy seems to be functioning normally.¿ records dated on (b)(6) 2011 indicate patient was seen for complaint of suprapubic discomfort in wake of recent revision of his ileostomy site from the right lower abdominal wall to the left with biological mesh repair of a large abdominal wall defect in the peristomal region from its previous location.¿ records dated on (b)(6) 2011 state: ¿where the staples enter the skin, placement is seen as not optimal as for as promoting wound edge eversion.Some of the staples are not symmetrically placed, and it is in those locations that there seems to be drainage.The redness at the entry site is not that out of the ordinary.There is no associated induration or odor, although the drainage is cultured and sent for culture and sensitivity in the event that there is a significant change in the localized nature of the inflammation.He is having no constitutional symptoms of infection.¿ records dated on (b)(6) 2012 indicate patient was seen for right upper quadrant pain.¿this patient post abdominal wall hernia repair with mesh continues at times to wear an abdominal binder.He is been restricted from doing sit-ups and crunches but has been told that he can advance cardio-type exercise with intolerance.He continues to actively run up and down stairs at work which he feels does have a conditioning effect.He is uncertain as to the cause of the discomfort he has in his upper abdomen when he sneezes but worries that could be symptomatic of a repair that is not standing up to adls.He has not had any distention nausea or vomiting.He would be considered at risk for developing adhesions is extensive abdominal surgery in the past.Lleostomy function remains stable.¿ records dated on (b)(6) 2012 state: ¿the patient no longer has the large abdominal wall hernia that he had preoperatively.His wounds are well healed with minimal evidence of keloid formation.He's not acutely tender to deep palpation or release it is not tympanitic in the area.¿ records dated on (b)(6) 2018 indicate patient seen for annual exam.The records state: ¿he also would like to get a referral to a surgeon because of right abdominal hernia.¿ physical exam: ¿abdominal: bowel sounds are normal.There is no tenderness.There is no rebound.Colostomy bag on the left abdomen.Abdominal hernia on the right lower abdomen, bulging, reducible, non tender.¿ the records state: ¿i do not think he will benefit for repeat surgery.So he does not want to proceed with the referral.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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B7: updated 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 dated (b)(6) 2010 state the patient was seen for follow up regarding his parastomal hernia.¿he initially underwent a total proctocolectomy with end ileostomy for ulcerative colitis in 2006.He then had an early reexploration and revision of the stoma about a month later.He has had a known bulge at the site of the ileostomy for a number of years.He believes this has gotten larger, and he describes mild discomfort lateral to the stoma.He says at times he feels that the bulge makes it difficult to keep his appliance on.He does wear an abdominal binder, which he says helps with both issues.¿ abdominal exam states: ¿reveals a well-healed somewhat imbricated midline incision.There is a functional stoma in the right lower quadrant.There is a fullness surrounding the stoma which is firm and tender but partially reducible.¿ findings from the (b)(6) 2010 procedure state: ¿the patient had approximately 8 cm diameter fascial defect with the stoma sitting centrally within the defect.The defect was relatively empty at the time of initial laparoscopy, there were some small-bowel loops adherent to the lateral aspect of the defect.The patient also had a number of small ventral incisional hernias at the periumbilical aspect of the prior midline incision.The parastomal hernia measured approximately 8 cm in diameter.A 15 cm gore-tex dualmesh was used to repair the region as an intraperitoneal underlay in the modified sugarbaker fashion.This mesh also extended beyond the midline covering the midline hernia as well.This was secured with full-thickness 0 ethibond transfascial fixation sutures and 5-mm hernia tacks.¿ records dated (b)(6) 2010 state the patient was seen for nausea and peristomal erythema.¿this is a 50-year-old male status post laparoscopic hernia repair with mesh on (b)(6) 2010 who presents with fevers, nausea and peristomal erythema.He was seen in the office due to issues with ileostomy output and required position change in order to allow his ileostomy to properly empty.He has noticed that he has had progressive nausea since approximately four days ago, accompanied by erythema around his stoma.He has had minimal output from his stoma since the nausea has kept him from taking in a fair amount of p.O.He was seen in the office today and underwent a ct scan which indicated a right-sided fluid collection lateral to his stoma, which appeared to be a seroma, along with a medial phlegmon, which is distinctly separate from his mesh or his tacks, and relates to the symptomatic region.¿ the (b)(6) 2010 records state: ¿assessment: postoperative cellulitis versus abscess/phlegmon without overt involvement of mesh or bowel.Possibly at prior mesh fixation suture site.¿ ¿no plans for drainage of fluid collection at this point as the right lateral collection appears peripherally sterile and the medial collection is very small.¿ the records indicate the patient was admitted to the hospital for treatment.Findings from the (b)(6) 2010procedure state: ¿upon incision and drainage, a moderate amount of purulent material as well as what appeared to be old blood/hematoma was removed.This did appear to extend down to the muscle/fascia.There was no evidence that the process tracked deeper than the muscle/fascia or more laterally towards the other collection (that was seen on ct).¿ discharge summary records dated (b)(6) 2010 state: ¿the patient was admitted for a peristomal abscess and stoma and started on iv antibiotics.Initially, the patient noted improvement in erythema with starting iv antibiotics.The patient remained afebrile and pain was well-controlled.On hospital day #3, the patient was noted to have purulent drainage from the inferior portion of his wound.A bedside incision and drainage of peristomal abscess was performed.Procedure notes include no evidence of mesh involvement during bedside procedure.¿ ¿wound cultures from the inferior wound, staph gram-positive cocci pansensitive; second culture obtained with staph sensitive organism with some resistance to penicillin, otherwise pansensitive.¿ history and physical records dated (b)(6) 2010 state: ¿this patient is a 50-year-old man who was discharged from the hospital last week.He is now approximately 6 weeks status post parastomal hernia repair with mesh implantation.His course has been complicated by an abscess.Initially upon admission to the hospital, this appeared to be a superficial process, but it has now become clear that this is a deeper process and is contiguous with the mesh.The patient states that since discharge from the hospital, he has felt ¿lousy.¿ he said that when he first went home after drainage of the larger collection, he felt pretty well but that over the past couple of days, he has had increasing nausea and headache as well as weakness.He denies fever or chills.He says he thinks his symptoms may be secondary to the antibiotics.He has been monitoring [his] jackson-pratt drain output and had noted that over the past day and a half, the output dropped off significantly to less than 20 ml a day.Subsequently, he underwent a ct scan yesterday which revealed a residual collection with the drain centralized within it.¿ the (b)(6) 2010 records state: ¿there is a well-healed midline incision.There is a functional stoma in the right lower quadrant.Lateral to the stoma is a percutaneous drain which has purulent material in it and in the bulb.This initially appeared to be clogged but with ¿milking¿ of the drain and irrigation with sterile saline, the drain was unclogged, resulting in return of some more purulent fluid.Caudal to the stoma site is an approximately 6 mm incision from prior incision and drainage site.There is no erythema, discharge or pain or tenderness at this site.This was treated with a gauze wick and a dry gauze.¿ the (b)(6) 2010 records continue: ¿ct scan from yesterday is reviewed on the pacs system.This reveals a residual fluid collection adjacent to the mesh with the drain centralized within it.This is much smaller than the collection that had been seen on previous ct scan.The other region that had been seen on ct scan is markedly improved, and this corresponds to the previous incision and drainage site.¿ ¿he has an infection/abscess that is contiguous with the previously placed mesh.Subsequently, the viability of the mesh is felt to be questionable.It is unlikely that this process will be able to be resolved without mesh excision.Currently, the patient is not toxic and exhibits no evidence of peritonitis.Some of his current complaints may be secondary to antibiotics side effects or the result of ongoing undrained abscess.¿ the (b)(6) 2010 records state: ¿for now, we will change the patient¿s antibiotics.He has a pansensitive staphylococcus aureus and we will subsequently discontinue the bactrim and begin oral keflex.Additionally, now that the drain appears to be opened, we will continue with drainage.If the patient has had improvement of his symptoms, then we will continue with this current course in hopes of possibly sparing the patient mesh excision.I did express that i thought that this was unlikely with this type of micro-porous synthetic material and that ultimately mesh excision would be necessary.¿ findings from the (b)(6) 2010 procedure state: ¿the patient had extensive adhesions at the prior surgical site primarily between the small bowel and the anterior abdominal wall and the small bowel and the mesh.These were taken down carefully allowing for complete removal of the mesh and the previously placed sutures and tacks.An abscess cavity was identified between the mesh and the anterior abdominal wall to prior hernia space.This was drained.¿ abdominal x-ray records dated (b)(6) 2010 state: ¿indication: abdominal distention, question new abdominal distention and decreased ostomy out put.Question obstruction.¿ ¿findings: the bowel loops are dilated and thick walled throughout the abdomen.This would appear to be a change compared to recent ct scan.¿ additional findings state: ¿the right upper quadrant drain is unchanged in position.Bowel loops are virtually identical to the prior study demonstrating thickening and dilatation of proximal small bowel and slight tribulation of the distal small bowel suggesting bowel wall edema as well as fluid within bowel loops.A profound ileus could present this appearance.¿ abdominal x-ray records dated (b)(6) 2010 state: ¿there has been slight decompression of distal small bowel but no change proximally.As before, the bowel appears moderately edematous but the degree of edema appears to have improved also.Although this is likely localized ileus, a distal small bowel obstruction is difficult to exclude.¿ culture report dated (b)(6) 2010 regarding specimens collected (b)(6) 2010 state: ¿no recognizable bacteria seen.¿ ¿no growth at 48 hours.¿ ¿no mrsa isolated.¿ ¿no enterococci isolated.¿ discharge summary records around (b)(6) 2010 state: ¿infection/abscess contiguous with parasternal mesh with drainage of an abscess.The viability of the mesh was questionable and thought to unlikely resolve without mesh excision.Laparoscopic removal of previously placed mesh and draining of an abscess was done on 8/19.Patient was found to have pansensitive staphylococcus aureus for which oral keflex was started.Patient then developed a postoperative ileus which was monitored by serial abdominal exams and diagnostics that later resolved.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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B7: updated 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: ct abdomen/pelvis dated (b)(6) 2013 states: ¿the patient is status post a colectomy.There is a ventral hernia containing nondistended bowel loops.The maximum transverse dimension of the ventral hernia just above the umbilicus is 6 cm (image 32, series 2).The cephalocaudal span of this hernia is approximately 5.4 cm (image 17, coronal series).Inferior to the midline hernia there is a spigelian hernia containing multiple loops of nondistended bowel.The maximal transverse diameter of this hernia is approximately 5.2 cm (image 46, series 2).The cephalocaudal span of this hernia is approximately 7.2 cm (image 43, coronal series).There is a left lower quadrant ostomy.¿ discharge summary dated (b)(6) 2013 indicates the patient was admitted to the hospital on (b)(6) 2013 for ventral hernia repair with mesh.The records state: ¿he tolerated the procedure well and was transferred to the pacu in stable condition.¿ he was admitted to 6usen where she [sic] remained hemodynamically stable.The patient was planned to leave that day but was admitted due to trouble with pain control.¿ the records state: ¿pain was well controlled with pca dilaudid and the patient is now tolerating oral pain medications.¿ ¿patient is medically stable for discharge to home.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event will be closed with the information provided.Previous patient codes (1690, 1695, 1970, 1994 and 2422) were reported based on the original complaint and are not longer applicable and/or reportable per gore's investigation.The following information was determined from the medical records.Medical records: the known medical records span january 13, 2010 through december 8, 2013, and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Patient information: medical history: proctitis, ulcerative colitis on steroid therapy, obese, on (b)(6) 2006: 229 lbs.On (b)(6) 2010: ¿if he was going to have his hernia repaired he should be at an optimal weight.¿ prior surgical procedures: on (b)(6) 2006: total proctocolectomy with right lower quadrant end ileostomy for ulcerative colitis on (b)(6) 2006: exploratory laparotomy, ileal resection, drainage intra-abdominal abscess, end ileostomy.Implant preoperative complaints: on (b)(6) 2010: ¿he is also concerned about his abdominal wall incisional hernia that creates a significant protrusion in the abdominal wall that is mechanically problematic when it comes to activities such as basketball.He continues to empty his bag about 6 times a day.He is having no ostomy site problems.His surgeon, dr.(b)(6), and her assistant, indicated to him that if he was going to have his hernia repaired he should be at an optimal weight.¿ on (b)(6) 2010: ¿he initially underwent a total proctocolectomy with end ileostomy for ulcerative colitis in 2006.He then had an early reexploration and revision of the stoma about a month later.He has had a known bulge at the site of the ileostomy for a number of years.He believes this has gotten larger, and he describes mild discomfort lateral to the stoma.He says at times he feels that the bulge makes it difficult to keep his appliance on.He does wear an abdominal binder, which he says helps with both issues.¿ abdominal exam states: ¿reveals a well-healed somewhat imbricated midline incision.There is a functional stoma in the right lower quadrant.There is a fullness surrounding the stoma which is firm and tender but partially reducible.¿ on (b)(6) 2010: ¿this patient presents with an enlarging and increasingly uncomfortable mass at the site of a right lower quadrant ileostomy.Examination and history was suggestive of a peristomal hernia and this was confirmed on ct scan which revealed a large amount of bowel within the hernia.Subsequently, repair was felt appropriate.¿ implant procedure: laparoscopic repairs of a parastomal hernia and midline ventral/incisional hernias using mesh.Implant: gore® dualmesh® biomaterial (1dlmc04/7031671, 15cm x 19cm oval).Implant date: on (b)(6) 2010 [hospitalization dates unknown] description of hernia being treated: ¿the patient was noted to have a number of small fascial defects in the periumbilical region of the prior midline incision which were empty.He had a large defect at the stoma site in the right lower quadrant.¿ ¿the hernia sac was empty except for the ileostomy itself.There were some adherent loops of small-bowel along the inferolateral aspect of the defect which were taken down sharply.The mesentery of one of the loops was adherent to the mesentery of the bowel going to the ileostomy and these adhesions were taken down as well in preparation for repair.¿ implant size and fixation: ¿intracorporeal measurements were used to delineate the dimensions of the defect which was approximately 8 cm in diameter.Subsequently, a 15 x 19 cm gore-tex dualmesh was chosen and was tailored to creating [sic] a 15 cm diameter circle.Sutures of 0 ethibond were placed at the 12, 3, 6 and 9 o'clock positions with both tails left long for later retrieval.The original 5-mm trocar was upsized to a 12-mm and this trocar was then placed in the upper midline and the mesh was rolled up and inserted into the peritoneal cavity via the 12-mm trocar.Once positioned intraperitoneally, the mesh was unrolled and using the gore suture passer through small skin incisions, the four sutures were pulled up through the anterior abdominal wall with a fascial bridge of approximately 1 cm at each site thereby allowing for wide coverage of the defect with a margin of overlap of approximately 4 cm circumferentially of the parastomal defect and again extension beyond the midline in the periumbilical region to cover the hernias in this area as well.¿ ¿in the inferolateral aspect of the mesh a gap was left to allow ileum and the mesentery going to the ileostomy to travel between the mesh and the abdominal wall.Following this, three more additional transfascial fixation sutures were placed at equal distance from the 9 and 12, 12 and 3, and 3 and 6 o'clock sutures.One was not placed between the 6 and 9 o'clock suture again as this was where the bowel was positioned.All these sutures were then tied down extracorporeally burying the knots within the anterior abdominal wall within the subcutaneous tissue.Following this, the 5 mm hernia tacker was used to secure the mesh to the anterior abdominal wall circumferentially at intervals of approximately 8-10 mm and a distance of approximately 1-2 mm from the edge of the mesh.The tack and suture fixation sites were hemostatic.Survey was taken of the abdomen there was no bleeding.There was no enterotomy.Again, the bowel going to the ileostomy did not appear compromised.¿ relevant medical information: on (b)(6) 2010: hospitalization.¿status post laparoscopic hernia repair with mesh on (b)(6) 2010 who presents with fevers, nausea and peristomal erythema.Seen in the office due to issues with ileostomy output and required position change in order to allow his ileostomy to properly empty.¿ on (b)(6) 2010: ct abdomen: ¿right-sided fluid collection lateral to his stoma, which appeared to be a seroma, along with a medial phlegmon, which is distinctly separate from his mesh or his tacks, and relates to the symptomatic region.¿ on (b)(6) 2010: incision and drainage of a parastomal abscess.On (b)(6) 2010: discharge summary: ¿initially, the patient noted improvement in erythema with starting iv antibiotics.On hospital day #3, the patient was noted to have purulent drainage from the inferior portion of his wound.A bedside incision and drainage of peristomal abscess was performed.Procedure notes include no evidence of mesh involvement during bedside procedure.¿ ¿wound cultures from the inferior wound, staph gram-positive cocci pansensitive; second culture obtained with staph sensitive organism with some resistance to penicillin, otherwise pansensitive.¿ explant preoperative complaints: on (b)(6) 2010: ¿he is now approximately 6 weeks status post parastomal hernia repair with mesh implantation.His course has been complicated by an abscess.Initially upon admission to the hospital, this appeared to be a superficial process, but it has now become clear that this is a deeper process and is contiguous with the mesh.The patient states that since discharge from the hospital, he has felt ¿lousy.¿ he says he thinks his symptoms may be secondary to the antibiotics.Jackson-pratt drain output dropped off significantly to less than 20 ml a day.Subsequently, he underwent a ct scan yesterday which revealed a residual collection with the drain centralized within it.¿ ¿ct scan from yesterday is reviewed on the pacs system.This reveals a residual fluid collection adjacent to the mesh with the drain centralized within it.This is much smaller than the collection that had been seen on previous ct scan.The other region that had been seen on ct scan is markedly improved, and this corresponds to the previous incision and drainage site.¿ ¿he has an infection/abscess that is contiguous with the previously placed mesh.Subsequently, the viability of the mesh is felt to be questionable.It is unlikely that this process will be able to be resolved without mesh excision.¿ ¿this patient is status post laparoscopic mesh repair of parastomal hernia and presents with abscess.Initially, the patient improved with abscess drainage but now is having ongoing symptoms consistent with untreated infection.Due to the fact that this is a microporous synthetic mesh, resolution of the process without mesh excision is felt highly unlikely.Subsequently after discussing the various treatment options with the patient, plan has been made to proceed with laparoscopic mesh excision.¿ explant procedure: laparoscopic removal of previously placed mesh and drainage of an abscess.Explant date: on (b)(6) 2010 [hospitalization on (b)(6) 2010].¿the anterior abdominal wall was visualized at the site of the prior hernia repair.There were multiple adhesions between the small bowel and the anterior abdominal wall as well as the small bowel and the previously placed mesh.Using sharp dissection without electrocautery, these adhesions were taken down.A ¿pseudocapsule¿ was then entered between the mesh and the peritoneum and dissection, of this plane allowed for the multiple loops of bowel to be safely dissected away from the mesh, by leaving these attached to the capsule.Following this, the mesh was then dissected away from the anterior abdominal wall.Dissection was begun medially, and using hook dissector with electrocautery, the mesh along with the previously placed packs [sic] and sutures were dissected away from the anterior abdominal wall.As this continued laterally, the loop of bowel and its mesentery going towards the stoma were encountered, and at this point, careful sharp and blunt dissection (without electrocautery) was used to dissect the mesh away from this bowel and mesentery in an atraumatic fashion.¿ ¿during the latter part of the procedure, the abscess cavity adjacent to the cephalad aspect of the mesh was entered resulting in return of purulent material which was rapidly suctioned in an effort to contain the process as best as possible.This area was later irrigated using antibiotic solution as was the entire right lower quadrant of the abdomen.In order to remove the mesh, the initial trocar was upsized to a 12-mm trocar.Endopouch bag was inserted via this trocar.The mesh was then placed in the bag, which was removed via the trocar site.¿ ¿the previously placed drain in the right lateral abdomen was clearly clogged and this was removed and a new 19 blake drain was placed using laparoscopic assistance.The proximal portion of the drain was looped up in the abscess cavity and the distal part down into the right lower quadrant adjacent to the stoma.The abdomen was surveyed.The bowel that had been taken down from the mesh and the anterior abdominal wall was examined and was without evidence of injury / enterotomy.There was no bleeding.This 12-mm trocar was removed and this fascial defect was approximated with 0 vicryl placed with the gore suture passer in a figure-of-eight fashion.¿ post-operative period: on (b)(6) 2010: x-ray abdomen: ¿the right upper quadrant drain is unchanged in position.Bowel loops are virtually identical to the prior study demonstrating thickening and dilatation of proximal small bowel and slight tribulation of the distal small bowel suggesting bowel wall edema as well as fluid within bowel loops.A profound ileus could present this appearance.¿ on (b)(6) 2010: x-ray abdomen: ¿there has been slight decompression of distal small bowel but no change proximally.As before, the bowel appears moderately edematous but the degree of edema appears to have improved also.Although this is likely localized ileus, a distal small bowel obstruction is difficult to exclude.¿ on (b)(6) 2010: discharge summary: ¿patient was found to have pansensitive staphylococcus aureus for which oral keflex was started.Patient then developed a postoperative ileus which was monitored by serial abdominal exams and diagnostics that later resolved.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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