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| Model Number 1DLMC08 |
| Device Problems
Contamination (1120); Use of Device Problem (1670); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Pain (1994); Seroma (2069); Discharge (2225)
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| Event Date 06/23/2010 |
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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 ventral hernia repair on (b)(6) 2007 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, seroma, fullness of abdominal wall, open draining wound, abdominal wall debridement, mesh infection, mesh removal.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Added patient medical history.Corrected results code.Code 3233 - sterilization results pending completion of the evaluation.Corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated on (b)(6) 2007 indicate the patient underwent laparoscopic ventral hernia repair with mesh.The records state: ¿the patient is a very pleasant 77-year-old male with a previous history of crohn's disease requiring resection times two, one in 1961 and one in 2005.Following the surgeries, the patient ended up developing a midline incisional hernia that causes him pain and discomfort.On physical exam, the patient has a fairly large midline incisional hernia extending above and below the umbilicus.After discussion with the patient regarding risks and benefits, the patient decided for a laparoscopic ventral hernia repair with mesh.¿ on (b)(6) 2007 records state: ¿inspection of the intra-abdominal cavity noted no injuries or bleeding.There was a large midline ventral hernia with adhesions to omentum.There did not appear to be any bowel in the hernia.A second left lower quadrant and two right lateral quadrant 5-mm trocars were placed under direct visualization.Adhesions were taken down bluntly and with cautery.The hernia was completely dissected around its edge.The peritoneum was taken off superiorly, and the falciform was taken down using cautery.The peritoneum was dissected inferiorly down to the pubic tubercle.At this time, the hernia was measured and found to be 15 x 16 cm.At this time, it was decided to place a gore dualmesh 34 x 26 cm.This was brought onto the field and marked appropriately, and four-quadrant stay sutures were placed using 0 gore-tex suture.It was rolled and placed into the intra-abdominal cavity and then unrolled.Stay sutures were brought out superior and laterally first and then inferiorly.There was noted to be good adequate coverage of the hernia.Sutures were tied.Tacks were placed around the circumference of the mesh, approximately 1 cm apart.¿ on (b)(6) 2007 records state: ¿additional transfascial sutures were then placed using 0 gore-tex using the suture passer.This was performed by making a small incision through the skin, using the suture passer to place the gore-tex suture through the abdominal wall, through the mesh, into the abdominal cavity, grasped with the grasper, and then the suture passer was passed again at a slightly different angle, taking a small bite of fascia and mesh and grasping the gore-tex suture and bringing it back out and then tying it.A total of 14 additional transfascial sutures were placed around the circumference of the mesh.The 11-mm balloon-tipped trocar site fascia was then closed with a 0 gore-tex suture, incorporating some of the mesh, under direct visualization using the suture passer was well.The abdomen was inspected, and hemostasis was assured.The trocars were then removed under direct visualization, and hemostasis was again assured.¿ the records confirm a gore dualmesh® biomaterial (1dlmc08/05050577) was used during the procedure.Records between 9/20/2007 and 6/23/2010 were not provided.Operative records dated on (b)(6) 2010 indicate the patient underwent exploratory laparotomy, excision of infected mesh, debridement of abdominal wall, and placement of vac dressing.Postoperative diagnosis is noted as ¿infected polytetrafluoroethylene mesh.¿ on (b)(6) 2010 records provide the following indication for procedure: ¿the patient is a 79-year-old gentleman who underwent a laparoscopic ventral incisional hernia repair mesh at the (b)(4) columbia for a ventral incision hernia that occurred after a intestinal resection for crohn's disease.The patient had a previous history of fascial dehiscence.In the extended postoperative period, the patient developed fullness of his abdominal wall.There were concerns he had a recurrent hernia.Imaging was obtained which demonstrated a large seroma both anterior and posterior to the polytetrafluoroethylene mesh.This was managed by percutaneous drainage through interventional radiology.Unfortunately the patient's fluid collection returned and was therefore managed in an open approach in the operating room.He had this opened and drained at an outside institution.The patient's fluid collection returned.It was drained on an additional occasion.¿ on (b)(6) 2010 indication for procedure notes continue: ¿unfortunately after this drainage procedure, the patient developed purulent fluid drain from the previous incisions.He also developed several sinus tracts that had some purulent drainage.The patient underwent imaging of his abdominal wall which demonstrated that the previous fluid anterior and posterior to the mesh had been adequately drained.The patient was placed on oral antibiotics.Consultation was obtained through cardiology regarding his preoperative risks and anticoagulation management for his mitral valve.Our recommendation was that the patient go to the operating room and have excision of his mesh, abdominal wall debridement, possible ventral incisional hernia repair with absorbable or biologic mesh upon separation release of myofascial advancement of rectus abdominis muscle." records detailing the patient¿s history of fascial dehiscence were not provided to gore.Additionally, records for the aforementioned fullness of the abdominal wall, follow up imaging, operative reports from the percutaneous drainage and multiple fluid collections, and development of purulent fluid and sinus tracts were not provided to gore.On (b)(6) 2010 records state: ¿midline laparotomy incision was made over his previous midline incision with a 15 blade scalpel.Electrocautery was used to dissect down to the subcutaneous tissues to the anterior fluid cavity.After this cavity was entered, the incision was extended to the superior and inferior extent of the mesh.The mesh was disrupted from the dowel wall and the right lateral side.The mesh was easy to remove by pulling the tacks from the abdominal wall and cutting the multiple sutures that were on the mesh circumferentially.This allowed for complete extraction of the mesh.Fluid within the infected cavity was sent for gram stain and culture and sensitivity.The patient had a large build up of granulation tissue within this cavity.It was debrided bluntly.The thick previous seroma cavity was debrided anteriorly.It was left intact posteriorly to act as a physical barrier between the placement of vac dressing and intestinal tract.There were no signs on inspection of wound of communication with the intestine.There was no exposed intestine circumferentially.The wound was irrigated with a pulse evacuation.Additional soft tissue debridement was performed of the anterior aspect of the cyst cavity and the multiple sinus tracts from the abdominal wall including two near the midline abdomen and one laterally.Some granulation tissue in these areas was also debrided.The wound was re-irrigated and hemostasis was reconfirmed.Vac dressing was then placed within the wound and it communicated anteriorly to the sinus tract that was debrided to the left inferior to the previous midline incision.The vac system was activated and seal was confirmed.Operative findings from on (b)(6) 2010 procedure state: ¿purulent fluid anterior and posterior to polytetrafluoroethylene mesh.Mature seroma cavity.Multiple sinus tracts with granulation tissue.¿ the records also indicate the following specimens were collected during the procedure: ¿debrided abdominal wall to include skin, subcutaneous fat, seroma, cavity.Polytetrafluoroethylene mesh.¿ pathology records describing the collected specimens were not provided to gore.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 date of birth.Updated sterilization evaluation results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records between (b)(6) 2007 and (b)(6) 2010 were not provided.A culture report dated (b)(6) 2010 regarding an abdominal wound specimen collected the same day states: ¿stain: few polymorphonuclear leukocytes seen.No organisms seen.¿ ¿no growth.¿ medical records pertaining to the (b)(6) 2010 visit were not provided.History and physical records dated (b)(6) 2010 state the patient was admitted for an abdominal wall infection.¿this is a 79-year-old male who has a history of undergoing a colon resection for crohn disease in 2005.Subsequently he developed a ventral hernia and underwent a laparoscopic ventral hernia repair with mesh in 2007.The patient's postoperative course from his ventral hernia repair was complicated with reoccurring seromas requiring multiple drainages including percutaneous drainage tube placement, however the patient denies any problems with an infectious process prior to four weeks ago.Approximately four weeks ago the patient was admitted to an outside hospital with complaints of abdominal pain and fever and worsening redness of his abdominal wall.During his admission cultures of his blood as well as abdominal wound and abdominal seroma drainage were all negative for bacterial growth.However, a white blood cell scan was ordered and the findings were consistent with an active infection in the central abdominal wall seroma with the main focus on the superolateral right corner of the fluid collection.¿ medical records for the ¿reoccurring seromas requiring multiple drainages including percutaneous drainage tube placement¿ after the (b)(6) 2007 procedure were not provided.Records for the visit and admission ¿four weeks ago¿, in addition to cultures and labs during this visit, were not provided.The (b)(6) 2010 records state: ¿the patient was treated with antibiotics during his admission and was discharged home on keflex 500 milligrams by mouth four times daily for management of his infectious process.The patient was then referred to dr.Matthew's office for further assessment and evaluation of his abdominal wall seroma for possible surgical management of his infected abdominal wall and possible surgical intervention.The patient was evaluated in dr.Matthew's clinic last week and after review of films, the patient was directly admitted to the general medical surgical floor today for further management and evaluation of his infected seroma.¿ the(b)(6) 2010 records continue: ¿this is a 79-year-old gentleman status post laparoscopic ventral hernia repair now with recurrent seroma and abdominal wound infection, currently on keflex.Will continue the patient on keflex.Will consult interventional radiology for placement of percutaneous drainage to drain infected seroma.Will consult cardiology for preoperative evaluation for surgery for anticipated removal of infected mesh.Will obtain baseline lab work and hold coumadin at this time.¿ ct records dated (b)(6) 2010 state: ¿again seen are postsurgical changes consistent with ventral hernia repair with a ventral mesh in place.In comparison to the prior examination, there has been marked interval decrease in the large fluid collection surrounding the ventral abdominal mesh material.It currently measures 14 cm transverse and 2.7 cm anteroposterior and contains a small amount of gas.Again seen is some soft tissue stranding within the anterior abdominal wall consistent with post operative changes.Bilateral inguinal lymphadenopathy is likely reactive in nature.Postsurgical changes of prior ileocolectomy with anastomosis are again noted within the right lower quadrant.There is no evidence of bowel obstruction or inflammation.Again noted are surgical clips along the right psoas muscle.¿ ¿impression: 1.Marked interval decrease in fluid collection surrounding the ventral abdominal mesh material.¿ discharge summary records dated (b)(6) 2010 state: ¿hospital course: the patient was admitted from dr.Matthews clinic with a seroma.Abdominal ct scan showed a marked decrease in the size of the fluid collection surrounding the abdominal mesh.Therefore, no surgical intervention was required.However, because the patient had been off his coumadin and required a heparin drip, he had to stay in the hospital until his inr was therapeutic because the patient has a st.Jude's mitral valve.The patient's inr became therapeutic today on the date of discharge to greater than 2, and he was deemed ready to go home.¿ history and physical records dated (b)(6) 2010 state: ¿the patient states that he has had this abdominal wound infection which consists of two open areas that are draining purulent pus since early may of this year, since he had his surgery.He had a hernia repair in early may of this year, and since then the infection and the patient also had a hematoma at that time as well.¿ ¿abdomen: is round and soft.The patient does in fact have two open sores that are present with purulent discharge.He has to change his dressings twice a day.The patient has been doing so since may of this year, since he had his surgery.¿ operative records for a procedure performed in early (b)(6) 2010 were not provided.Records detailing the patient¿s history of fascial dehiscence were not provided to gore.Additionally, records for the aforementioned operative reports from the percutaneous drainage were not provided to gore.An abdominal wound mycology culture dated (b)(6) 2010 regarding specimens collected the same day state: ¿no growth of fungus.¿ pathology records dated (b)(6) 2010 regarding specimens collected (b)(6) 2010 state: ¿specimen(s) received: a.Infected abdominal mesh.B.Abscessed cavity.Gross description: the first specimen is labeled "infected abdominal mesh." it holds a single circular tan to light brown portion of mesh materia.It is circular and has a diameter of 24 cm and a thickness of 0.3 cm.There are scattered adherent blood clots and tan-pink tissue.A few fragments of tissue are submitted.¿ ¿the second specimen is labeled "abscessed cavity." it holds three irregularly-shaped portions of pale tan to pink red rough surfaced rubbery fibrous tissues measuring in aggregate 11.0 x 8.5 x 1.0 cm.¿ ¿final diagnosis: soft tissue and medical device, ¿infected abdominal mass,¿ hernia repair (a) ¿ acute and chronic inflammation, granulation tissue, foreign body giant cell reason.¿ foreign material, grossly consistent with mesh.Soft tissue, ¿abscess cavity,¿ hernia repair (b) ¿ chronic inflammation, granulation tissue, foreign body giant cell reaction and foreign material.¿ a culture report dated 6/26/2010 regarding abdominal wound specimens collected (b)(6) 2010 state: ¿stain: rare polymorphonuclear leukocytes seen.No organisms seen.¿ ¿no growth.¿ records between (b)(6) 2010 and (b)(6) 2011 were not provided.History and physical records dated (b)(6) 2011 state the patient was admitted for ¿a chronic abdominal wound with open areas.¿ ¿[the patient] is an 80-year-old, white male patient of dr.Brent matthews who comes to the service with a chief complaint of a chronic abdominal wound infection, which consists of open areas that are draining purulent drainage since may of last year after he had surgery.The patient has had a hernia repair in (b)(6) 2010 and since then has had an infection, and the patient had also previously developed a hematoma at that site as well.He comes in today for preop for anticoagulation for surgery preparation on (b)(6).¿ operative records for the (b)(6) 2010 hernia repair were not provided.The (b)(6) 2011 records state: ¿the patient¿s belly is obese, round, and soft.Primarily nontender and nondistended.The patient has an obvious open wound.It seems somewhat superficial at this time; however, it is erythematous with some clear drainage in the mid region near the umbilicus.Bowel sounds are present in all four quadrants.¿ operative records dated (b)(6) 2011 indicate the patient underwent ¿ventral incisional hernia repair with 600 sq cm piece of bio-a mesh, bilateral component separation release with mild fascial advancement of the rectus abdominus muscles.Posterior rectus fascial release with bilateral release of the rectus abdominus muscle over the posterior rectus sheath.This constitutes four separate musculofascial flaps in a pedicle fashion for abdominal wall reconstruction.Excision of atrophic and nonhealing abdominal wall scar, measuring 25 cm x 10 cm with adjacent tissue transfer of abdominal skin and soft tissue.¿ postoperative diagnosis states: ¿chronic nonhealing abdominal wound, recurrent ventral incisional hernia.¿ indications for the (b)(6) 2011 procedure state: ¿the patient is a 79-year-old gentleman who i have been actively following since excision of infected mesh from previous abdominal wall hernia repair.The patient had a ventral incisional hernia repair with ptfe mesh at an outside institution.He developed a subcutaneous and mesh infection that was treated conservatively with incision and drainage and percutaneous drain.This did not definitively treat the infectious problem, and i took him to the operating room and performed excision of infected mesh.His wound healed by secondary intention, using a vac dressing.The patient developed a nonhealing chronic abdominal wound due to the pressure effects from his recurrent hernia that developed in interval time period after excision of the infected mesh.The hernia grew at an exponential rate, and he had some mild discomfort from it.He denied any obstructive symptoms.He and i had multiple long discussions regarding the risks and benefits of repair.He wore an abdominal wall binder to help with stabilizing his abdominal wall.He wanted a more definitive solution.¿ the (b)(6) 2011 operative report states: ¿midline incision was made with a 15 blade scalpel.Electrocautery was used to dissect down through the subcutaneous tissues to the hernia sac.The hernia sac was quite thick.The hernia sac was opened with sharp dissection.An entrance to the abdomen was performed superiorly above the hernia sac.The patient had adhesions of the small bowel, colon and omentum within the hernia sac.These were taken down with sharp dissection.A couple of serosal tears occurred during adhesiolysis, and these were repaired with lemberted 3-0 vicryl sutures.The area of adhesiolysis was inspected both during and immediately following and at the conclusion of the procedure prior to mesh placement and there no concerns regarding the integrity of the bowel.The inferior aspect of the hernia was above the pubis.Therefore, the bladder was mobilized by entering the preperitoneal space transversely and pushing the bladder inferiorly.¿ the (b)(6) 2011 operative report continues: ¿after the entire adhesiolysis was performed, the abdomen was packed with towels.The patient had approximately a 14 cm gap between his rectus abdominus muscles.Flaps were made anterior to the rectus sheath and lateral to the semilunaris line, first on the left side and then on the right side.Bilateral component separation release was performed by incision the aponeurosis of the external oblique lateral to the semilunaris line, first on the right side and then on the left side.Avascular plane between the internal oblique and external oblique was developed with sharp dissection to allow for sliding of the external oblique on the internal oblique bilaterally.The hernia sac was then excised from the subcutaneous space.¿ the (b)(6) 2011 operative report states: ¿there was still approximately a 3 cm gap and not allowing for closure.Therefore, posterior rectus sheath release was performed, incision on the rectus sheath posteriorly in a vertical fashion.This allowed for sliding of the rectus abdominal muscle over the top of the posterior rectus sheath.This was first done on the right side and then on the left side.This allowed for primary closure.Because of the chronic wound, a sublay repair with bio-a absorbable mesh was performed.A 20 x 30 cm piece of mesh was utilized for repair.It was placed in a sublay fashion and secured with interrupted #1 pds sutures, allowing for over 10 cm overlap in all directions.After the mesh was placed, the towels removed.All counts were correct times two.Inspection of the abdominal cavity was performed prior to parachuting the mesh in the anterior abdominal space.All stitches were tied.¿ the (b)(6) 2011 operative report continues: ¿the midline was then closed with a running #1 pds sutures.The wound was irrigated and hemostasis was confirmed.Approximately 300 sq cm of atrophic skin as well as chronic scar was then excised without bleeding from the wound vac'd areas, where there bleeding from the wound edge.This allowed for adjacent tissue transfer of the abdominal skin for closure after placement of three additional 19-french blake drains in the subcutaneous space.They were secured to the skin with 2-0 nylon sutures.The midline was closed with a series of interrupted 2-0 vicryl sutures on the dermis and 2-0 nylon stitches on the skin.Staples were placed between the stitches.¿ the records confirm a gore® bio-a tissue reinforcement biomaterial (lot number 7829589) was implanted during the procedure.Discharge summary records dated (b)(6) 2011 state: ¿hospital course: [the patient] was admitted on (b)(6) 2011 preoperatively to bridge with anticoagulation for surgery as he came off of his coumadin which he takes for mitral valve.On (b)(6) 2011, he went to the operating room where he underwent a ventral incisional hernia repair with bio a mesh and bilateral component separation release with fascial advancement of the rectus abdominus muscles.This was performed for his chronic non-healing abdominal wound and recurrent ventral incisional hernia.¿ records dated (b)(6) 2011 state the patient was seen ¿¿after hernia surgery on (b)(6) 2011, c/o swelling to bilateral ankles and ¿yellow pus¿ coming from incision.Pt with c/d/i dressing in place after triage.¿ ¿pt reports having surgery recently to repair a hernia.Pt was supposed to get his sutures out tomorrow.About a week ago, pt started having 4+pitting edema in his ble and scrotum.Pt had a foley placed by his surgeon to assist with urine flow due to the swelling.Pt also reports having increased drainage and a foul odor from his incision site.Upon exam, pt has purulent drainage from the incision with erythema noted.The area around the incision is firm and warm.¿ ¿surgery has been at bedside completing a washout of the incision site.¿ records dated (b)(6) 2011 state: ¿midline hernia incision with staples.Noted to be erythematous, puss on abd dressing.¿ ¿not soaked through pad.Non-tender.Two jp drains in place with sero-sanguinous fluid in both drains.Abdomen distended, no rebound.¿ ¿some scrotal edem, foley in place.¿ ¿pus and redness to abdominal incision as noted.¿ ¿rle lle bilaterally to level of knees, skin tight, somewhat erythematous secondary to swelling.¿ cultures from (b)(6) 2011 states regarding a urine culture: ¿greater than or equal to 50,000 colonies/ml of lactobacillus species.Isolate of questionable significance.¿ blood culture results state: ¿no growth.¿ a ct dated (b)(6) 2011 states: ¿history: 80 year old male with crohn¿s disease and recent hernia repair with purulent discharge from wound and abdominal pain.¿ ¿there is a large ventral abdominal wall repair mesh extending from the level of the diaphragm to the anterior iliac spines.Anterior to this, there is prominent, heterogeneous soft tissue thickening, and obscuration of the superficial fascia planes.An open skin defect with a small amount of internal debris is noted.Two surgical drains are also present within this collection.Near the anterior abdominal midline, adjacent to the open abdominal wound, three is a small collection of fluid and phlegmon measuring approximately 2.5 x 6.0 cm.This collection contains a small punctate focus of gas, which may be present from the neighboring open wound.More lateral and deep to the course of the left-sided anterior abdominal wall drain, just above the level of the left anterior iliac spine, is an additional lobulated collection of fluid, measuring 4.6 x 2.4 cm x 5.5 cm.¿ ¿impression: postsurgical change of large ventral abdominal wall mesh repair, with large inflammatory mass anterior to this mesh, which contains several loculated fluid collections and phlegmonous material.No fluid or phlegmon deep to the mesh.No additional acute intra-abdominal or intrapelvic process.¿ radiology records dated (b)(6) 2011 state: ¿impression: there is no free intraperitoneal gas.There are scattered air-fluid levels and mildly dilated loops of small bowel and colon, suggestive of postoperative ileus.There are skin staples, multiple surgical clips, and two drains overlying the pelvis.¿ a discharge summary dated 3/11/2011 states: ¿laboratory diagnostics demonstrate a normal white count of 9.3 and a normal creatinine of 1.0.¿ ¿he also had a ct scan that evaluated the state of his abdomen and intra-abdominal contents that demonstrated no deep abdominal infection.¿ ¿hospital course: the patient had the wound opened and packed.He was started on intravenous antibiotics.A picc was placed for long-term antibiotic treatment.He was discharged on intravenous antibiotics.¿ 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2007 state the patient was seen for follow up after his (b)(6) 2007 hernia repair.¿postoperatively, he was discharged without complication.He states that he continues to have mid epigastric pain with movement or sneezing at a suture site.He is also complaining of continued peripheral edema in bilateral lower extremities.¿ abdominal exam notes state: ¿soft, nontender to palpation.There were multiple well-healed laparoscopic incisions and suture sites noted to be approximated without evidence of erythema, induration, or drainage.There is a large seroma noted.¿ 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.H6: additional conclusion codes: 4311; 4315.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes (1994, 2225, 3191: used for ¿fullness of abdominal wall¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: ¿ known medical records span from september 20, 2007 through march 11, 2011 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial and therefore not described in the summary.¿ records from october 24, 2007 through may 24, 2010; june 26, 2010 through february 15, 2011 were not provided.Patient information: medical history: ¿ crohn¿s disease; ¿ hypothyroidism; ¿ arthritis; ¿ gastroesophageal reflux disease (gerd); ¿ congestive heart failure ;¿ prior smoker.Prior surgical procedures: ¿ mitral valve replacement [unknown date]; ¿ 1961, 2000: colon resection; ¿ 1980, 1982: kidney stone surgery; ¿ 2000: right ventral hernia repair; ¿ 2005: colon resection for crohn¿s disease.Implant preoperative complaints: ¿ (b)(6) 2007: ¿the patient is a very pleasant 77-year-old male with a previous history of crohn's disease requiring resection times two, one in 1961 and one in 2005.Following the surgeries, the patient ended up developing a midline incisional hernia that causes him pain and discomfort.On physical exam, the patient has a fairly large midline incisional hernia extending above and below the umbilicus.After discussion with the patient regarding risks and benefits, the patient decided for a laparoscopic ventral hernia repair with mesh.¿.Implant procedure: laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial (1dlmc08/05050577) 26cm x 34cm.Implant date: (b)(6) 2007 [unknown hospitalization dates]: ¿ description of hernia being treated: ¿on physical exam, the patient has a fairly large midline incisional hernia extending above and below the umbilicus.¿; ¿ implant size and fixation: ¿at this time, it was decided to place a gore dualmesh 34 x 26 cm.This was brought onto the field and marked appropriately, and four-quadrant stay sutures were placed using 0 gore-tex suture.It was rolled and placed into the intra-abdominal cavity and then unrolled.Stay sutures were brought out superior and laterally first and then inferiorly.There was noted to be good adequate coverage of the hernia.Sutures were tied.Tacks were placed around the circumference of the mesh, approximately 1 cm apart.Additional transfascial sutures were then placed using 0 gore-tex using the suture passer.This was performed by making a small incision through the skin, using the suture passer to place the gore-tex suture through the abdominal wall, through the mesh, into the abdominal cavity, grasped with the grasper, and then the suture passer was passed again at a slightly different angle, taking a small bite of fascia and mesh and grasping the gore-tex suture and bringing it back out and then tying it.A total of 14 additional transfascial sutures were placed around the circumference of the mesh.The 11-mm balloon-tipped trocar site fascia was then closed with a 0 gore-tex suture, incorporating some of the mesh, under direct visualization using the suture passer was well.¿; ¿ post-operative period: [one month]. (b)(6) 2007: ¿postoperatively, he was discharged without complication.He states that he continues to have mid epigastric pain with movement or sneezing at a suture site.He is also complaining of continued peripheral edema in bilateral lower extremities.¿ ¿soft, nontender to palpation.There were multiple well-healed laparoscopic incisions and suture sites noted to be approximated without evidence of erythema, induration, or drainage.There is a large seroma noted.¿.Relevant medical information: ¿ (b)(6) 2010: abdominal wound specimen ¿stain: few polymorphonuclear leukocytes seen.No organisms seen.¿ ¿no growth.¿.¿ (b)(6) 2010: ¿the patient's postoperative course from his ventral hernia repair was complicated with reoccurring seromas requiring multiple drainages including percutaneous drainage tube placement, however the patient denies any problems with an infectious process prior to four weeks ago.Approximately four weeks ago the patient was admitted to an outside hospital with complaints of abdominal pain and fever and worsening redness of his abdominal wall.During his admission cultures of his blood as well as abdominal wound and abdominal seroma drainage were all negative for bacterial growth.However, a white blood cell scan was ordered and the findings were consistent with an active infection in the central abdominal wall seroma with the main focus on the superolateral right corner of the fluid collection.¿.¿ (b)(6) 2010: ¿the patient was treated with antibiotics during his admission and was discharged home on keflex 500 milligrams by mouth four times daily for management of his infectious process.The patient was then referred to dr.Matthew's office for further assessment and evaluation of his abdominal wall seroma for possible surgical management of his infected abdominal wall and possible surgical intervention.The patient was evaluated in dr.Matthew's clinic last week and after review of films, the patient was directly admitted to the general medical surgical floor today for further management and evaluation of his infected seroma.¿.¿ (b)(6) 2010: ¿status post laparoscopic ventral hernia repair now with recurrent seroma and abdominal wound infection, currently on keflex.Will continue the patient on keflex.Will consult interventional radiology for placement of percutaneous drainage to drain infected seroma.Will consult cardiology for preoperative evaluation for surgery for anticipated removal of infected mesh.Will obtain baseline lab work and hold coumadin at this time.¿.¿ (b)(6) 2010: ct abdomen ¿impression: marked interval decrease in fluid collection surrounding the ventral abdominal mesh material.¿.¿ (b)(6) 2010: ¿hospital course: the patient was admitted from dr.Matthew¿s clinic with a seroma.Abdominal ct scan showed a marked decrease in the size of the fluid collection surrounding the abdominal mesh.Therefore, no surgical intervention was required.However, because the patient had been off his coumadin and required a heparin drip, he had to stay in the hospital until his inr was therapeutic because the patient has a st.Jude's mitral valve.The patient's inr became therapeutic today on the date of discharge to greater than 2, and he was deemed ready to go home.¿.¿ (b)(6) 2010: ¿the patient states that he has had this abdominal wound infection which consists of two open areas that are draining purulent pus since early may of this year, since he had his surgery.He had a hernia repair in early may of this year, and since then the infection and the patient also had a hematoma at that time as well.¿ ¿the patient does in fact have two open sores that are present with purulent discharge.He has to change his dressings twice a day.The patient has been doing so since may of this year, since he had his surgery.¿.¿ operative records for a procedure performed in ¿early may¿ of 2010 were not provided.Explant preoperative complaints: ¿ (b)(6) 2010: [the patient] ¿underwent a laparoscopic ventral incisional hernia repair mesh at the university of missouri columbia for a ventral incision hernia that occurred after a intestinal resection for crohn's disease.The patient had a previous history of fascial dehiscence.In the extended postoperative period, the patient developed fullness of his abdominal wall.There were concerns he had a recurrent hernia.Imaging was obtained which demonstrated a large seroma both anterior and posterior to the polytetrafluoroethylene mesh.This was managed by percutaneous drainage through interventional radiology.Unfortunately the patient's fluid collection returned and was therefore managed in an open approach in the operating room.He had this opened and drained at an outside institution.The patient's fluid collection returned.It was drained on an additional occasion.¿ ¿unfortunately after this drainage procedure, the patient developed purulent fluid drain from the previous incisions.He also developed several sinus tracts that had some purulent drainage.The patient underwent imaging of his abdominal wall which demonstrated that the previous fluid anterior and posterior to the mesh had been adequately drained.The patient was placed on oral antibiotics.Consultation was obtained through cardiology regarding his preoperative risks and anticoagulation management for his mitral valve.Our recommendation was that the patient go to the operating room and have excision of his mesh, abdominal wall debridement, possible ventral incisional hernia repair with absorbable or biologic mesh upon separation release of myofascial advancement of rectus abdominis muscle.¿.¿ records detailing the patient¿s history of fascial dehiscence were not provided.Additionally, records for the aforementioned operative reports from the percutaneous drainage were not provided.Explant procedure: exploratory laparotomy, excision of infected mesh, debridement of abdominal wall, and placement of vac dressing explant date: (b)(6) 2010 [unknown hospitalization dates].¿ (b)(6) 2010: ¿midline laparotomy incision was made over his previous midline incision with a 15 blade scalpel.Electrocautery was used to dissect down to the subcutaneous tissues to the anterior fluid cavity.After this cavity was entered, the incision was extended to the superior and inferior extent of the mesh.The mesh was disrupted from the dowel [sic] wall and the right lateral side.The mesh was easy to remove by pulling the tacks from the abdominal wall and cutting the multiple sutures that were on the mesh circumferentially.This allowed for complete extraction of the mesh.Fluid within the infected cavity was sent for gram stain and culture and sensitivity.The patient had a large build up of granulation tissue within this cavity.It was debrided bluntly.The thick previous seroma cavity was debrided anteriorly.It was left intact posteriorly to act as a physical barrier between the placement of vac dressing and intestinal tract.There were no signs on inspection of wound of communication with the intestine.There was no exposed intestine circumferentially.The wound was irrigated with a pulse evacuation.Additional soft tissue debridement was performed of the anterior aspect of the cyst cavity and the multiple sinus tracts from the abdominal wall including two near the midline abdomen and one laterally.Some granulation tissue in these areas was also debrided.The wound was re-irrigated and hemostasis was reconfirmed.Vac dressing was then placed within the wound and it communicated anteriorly to the sinus tract that was debrided to the left inferior to the previous midline incision.The vac system was activated and seal was confirmed.¿.¿ (b)(6) 2010: ¿purulent fluid anterior and posterior to polytetrafluoroethylene mesh.Mature seroma cavity.Multiple sinus tracts with granulation tissue.¿.Relevant medical information: ¿ (b)(6) 2010: abdominal wound specimens collected (b)(6) 2010 ¿stain: rare polymorphonucelar leukocytes seen.No organisms seen.¿ ¿no growth.¿ ¿no growth of fungus.¿.¿ (b)(6) 2011: ¿chief complaint of a chronic abdominal wound infection, which consists of open areas that are draining purulent drainage since (b)(6) of last year after he had had surgery.The patient has had a hernia repair in (b)(6) 2010 and since then has had an infection, and the patient had also previously developed a hematoma at that site as well.He comes in today for preop for anticoagulation for surgery preparation on (b)(6).¿ ¿ (b)(6) 2011: ¿ventral incisional hernia repair with 600 sq cm piece of bio-a mesh, bilateral component separation release with mild fascial advancement of the rectus abdominus muscles¿ hospitalization (b)(6) 2011 to (b)(6) 20/11.¿the patient had a ventral incisional hernia repair with ptfe mesh at an outside institution.He developed a subcutaneous and mesh infection that was treated conservatively with incision and drainage and percutaneous drain.This did not definitively treat the infectious problem, and i took him to the operating room and performed excision of infected mesh.His wound healed by secondary intention, using a vac dressing.The patient developed a nonhealing chronic abdominal wound due to the pressure effects from his recurrent hernia that developed in interval time period after excision of the infected mesh.¿.¿ (b)(6) 2011: ¿hospital course: [the patient] was admitted on (b)(6) 2011 preoperatively to bridge with anticoagulation for surgery as he came off of his coumadin which he takes for mitral valve.On (b)(6) 2011, he went to the operating room where he underwent a ventral incisional hernia repair with bio a mesh and bilateral component separation release with fascial advancement of the rectus abdominus muscles.This was performed for his chronic non-healing abdominal wound and recurrent ventral incisional hernia.¿.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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 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 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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