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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP03 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Seroma (2069)
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| Event Date 11/11/2008 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence".The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2008 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: wound exploration, removal of infected mesh, drainage of seroma/abscess, repair of incisional hernia.Additional event specific information was not provided.
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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: relevant medical information: ¿ (b)(6) 2007: spectrum health, blodgett campus.Derek thomas nagle, md.Carlos h.Rodriguez, md.Operative/procedure report.Pre-operative diagnosis: 1) abdominal pain.2) abdominal wall endometrioma.Post-operative diagnosis: 1) abdominal pain.2) abdominal wall endometrioma.Operation performed: 1) excision of abdominal wall endometrioma.2) complex abdominal wall closure with 10 x 12 cm defect with mesh.Operative details: anesthesia: general.Estimated blood loss: less than 50 ml.Complications: none.Drains: one jackson-pratt drain.Condition of patient: good to recovery room.Findings: abdominal wall mass/endometrioma.Specimens removed inferior abdominal wall rectus muscle.Operative technique: ¿after informed consent was obtained, the patient was brought back to the operating room and placed supine on the operating table.The patient was prepped and draped in standard sterile surgical fashion.An incision was made along the previous lines of a cesarean scar in a transverse direction and dissected down to the abdominal fascia using bovie cautery.Once the fascia was encountered, we resected adipose tissue off it superiorly up to the point of the umbilicus and on the inferior side of the scar down to the area around the pubic symphysis.We then connected the dissection of the fascia circumferentially around the scar in a 360-degree fashion, leaving the scar tissue attached to the anterior fascia.Cautery was then used to excise the external fascia anteriorly above the rectus abdominis muscle superior of the scar tissue in an arc fashion, and then inferiorly from the pubic symphysis laterally connecting the lower incision to the upper incision and circling the scar tissue to the anterior abdominal wall.Finger dissection underneath first the left rectus muscle, isolating and bovie cauterizing through it, typing [sic] off the inferior epigastric muscles as we went.The inferior rectus muscle was also cauterized through and the inferior muscle ligated.The lower half of our arc was then cauterized through the anterior fascia also, from the lateral aspects of the arc dome and across the pubic symphysis.We then used debakey graspers and elevated the anterior abdominal tissues that were left, and dissected through until we were in the abdominal cavity.Finger-sweeping the bowel away, the finger was used to isolate the remaining pre-peritoneal tissues and incise them, first in the superior arc and then along the inferior arc just above the pubic tubercle, which left us with a freed-up subcutaneous tissue anterior abdominal wall rectus muscle containing an endometrioma that was palpable in pre-peritoneal tissues.This was removed as a specimen and taken back to the back table to be cut open and looked at.It was felt that the remaining tissue just superior of the pubic symphysis was still continuing some of our specimen, and the tissues were taken down right onto the tibial tubercle inferiorly removing the complete rectus muscle and anterior abdominal wall, and this was also passed off the field as a specimen to be looked at on the back table.The area of the defect was then measured and it was approximately 10 cm superior to inferior, and 12 cm laterally.A 10 x 15 piece of proceed mesh was then cut to 10 x 12 cm and will be used to close the complex defect.Dr.Rodriguez then opened the specimen on the back table, identifying the endometrioma.He then switched gloves and we began our placement of the mesh.Prolene sutures were then placed in the 6 o¿clock, 12 o¿clock, 3 o¿clock and 9 o¿clock positions in the fascial walls of the defect and interruptedly tied to the mesh securing it in place in 4 places, so it would not move when we sewed it in.We then sewed in a clockwise fashion, starting with the left lateral area with stitch in a running fashion, bites of the mesh and fascia were taken in a running fashion from the 3 o¿clock position to 12 o¿clock position.This stitch was then tied to the tail of the stitch at the 12 o¿clock position.The next stitch was then run in a running continuous fashion, taking the rectal fascia from the 12 o¿clock position to the 9 o¿clock position in a running fashion and tied to that stitch.The 9 o¿clock position was then run to the 6 o¿clock position and tied to it.The 6 o¿clock position was run to the 3 o¿clock position and tied to that stitch.Our mesh was completely intact.There were no gaps in the spaces along the side.It was not under excessive tension, but was under appropriate tension and not lose [sic]/floppy.We then irrigated the site with one liter of saline.There was no bleeding identified.Sutures of 3-0 vicryl were use in an interrupted fashion to close the scarpa fascia, and staples were then used to close the skin.An area was cleaned and dried.All needles, sponges and instrument counts were correct at the end of the case.Dr.Rodriguez was present the entire time.The patient was awakened from general anesthesia and transported to the recovery room in stable satisfactory condition." ¿ (b)(6) 2007: spectrum health.Implant sticker.Proceed surgical mesh.¿ (b)(6) 2007: blodgett campus.Implant record.Proceed surgical mesh, ethicon.Implant procedure: abdominoplasty and complex incisional hernia repair with mesh, lysis of adhesions, umbilical and bilateral inguinal herniorrhaphy.Implant: gore® dualmesh® plus biomaterial [1dlmcp03/04896333, 10 cm x 15 cm x 1 mm].Implant date: september 14, 2007 (hospitalization september 14-17, 2007) ¿ (b)(6) 2007: (b)(6) campus.(b)(6), md.(b)(6), md.Operative/procedure report.Pre-operative diagnosis: complex incisional hernia.Post-operative diagnosis: complex incisional hernia, umbilical hernia, bilateral inguinal hernias.Operative details: anesthesia: general endotracheal.Specimens: abdominal pannus 32-cm long x 10 cm wide x 4 cm thick.Drains: 2 gp [sic] drains.Instrument count: correct.Operative technique: ¿the patient was taken to the operating room and placed supine onto the operating table.After preoperative antibiotics were administered and the patient was intubated without difficulty, the abdomen was prepped and draped in a standard surgical fashion.Inspection of the abdomen was done in order to map out incision lines to provide an adequate abdominoplasty.An elliptical incision was then done inferior to the umbilicus in approximately a 3:1 ratio.This was done using sharp dissection and deepened using electrocautery.This was deepened down until abdominal wall fascia was identified.The ellipse of skin and subcutaneous tissue were then lifted from the fascias and electrocautery maintaining hemostasis until the ellipse was completely transected from the underlying fascia.This was then passed off the table as a surgical specimen and dimensions were 32 x 10 cm and it was 4-cm thick.The fascia was extremely tenuous and was incised using electrocautery revealing the abdominal contents.No injury to the bowel contents were confirmed.Flaps were then developed in a superior-inferior manner in order to provide adequate fascia edged until the flaps dimensions were approximately 20 cm superior-inferior and 24-cm wide.All portions of the overlying tenuous fascia was then removed using electrocautery in order to provide adequate edges for mesh placement.This was done surrounding the defect.At the superior portion of the defect, omentum was adhered to the mesh that had been placed in a previous procedure.This was divided using electrocautery in the left lateral portion of the defect.There were adhesions that were taken down using electrocautery.At this point, the bowel was completely free of the abdominal wall, and there was approximately 10 x 12 cm defect in the fascia with abdominal contents exposed.At this point, 2-0 prolene sutures were then placed in four corners to the fascia edges and to a dualmesh plus.The dualmesh plus piece that was used was approximately 12 x 10 cm and the edges of the dualmesh plus were sutured in place to the edges of the fascia.When this was completed, inspection of the fascia revealed that the patient had external ring defects which required primary repair using the 2-0 prolene.An umbilicus defect was also present, and this was closed primarily using 2-0 ethibond in a figure-of-eight and an interrupted suture were placed.Inspection of wound revealed that hemostasis was obtained.A large piece of ultrapro mesh was then placed approximately 24-cm wide and 20 cm superior-inferior.This was placed and trimmed to provide a perfect fit.This was then secured in place using an auto suture staple tacker.Multiple reloads were used until the mesh was secured firmly in place.The umbilicus was then secured in place using a 3-0 vicryl stitch.This was secured to the underlying fascia and mesh.Two drains were then placed in a standard fashion through stab incisions in the superior aspect of the incision using electrocautery.These were secured in place using 3-0 silk suture.The incision was closed in layers: first with multiple interrupted 3-0 vicryl sutures closing the subcutaneous tissue and then the skin was closed using staples.Telfa and gauze was then used for sterile dressing.Sponge and instrument counts were correct at the end of the case.The patient tolerated the procedure well and was transferred to the recovery room in good condition.Dr.Carlos rodriguez was scrubbed in and prepped through the entire case.¿ ¿ (b)(6) 2007: (b)(6) campus [assigned].Implant record.Dualmesh plus 10 cm x 15 cm x 1 mm.Cat # 1dlmcp03.Lot # 04896333.Ultrapro mesh.Ethicon.Complex hernia repair.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/04896333) was implanted during the procedure.Relevant medical information: [ni].Explant procedure: wound exploration, removal of infected mesh, drainage of seroma/abscess, and repair of incisional hernia.Explant date: (b)(6), 2008 (hospitalization unknown) ¿ (b)(6) 2008: (b)(6) campus.(b)(6), md.Operative/procedure report.Surgeon: (b)(6), md.Assistant: (b)(6), md.Pre-operative diagnosis: seroma, possible abscess, and infected mesh graft on the abdominal wall.Post-operative diagnosis: seroma, possible abscess, and infected mesh graft on the abdominal wall.Operative details: anesthesia: general.Estimated blood loss: less than 50 ml.Complications: none.Drains: one jackson-pratt drain.Condition of patient: good to recovery room.Technique: ¿the patient was taken to the operating room, where after a satisfactory induction of a general anesthetic, she was prepped and draped in the appropriate manner.The patient had a nickel-sized draining opening just below her lower abdominal transverse scar.Ct scanning prior to the procedure had shown the patient to have a fluid collection above and below mesh that had been placed in a repair of an abdominal wall defect in the past.An incision was made through the lower transverse scar above the above-mentioned opening.The incision was extended through the skin and subcutaneous tissue down to the mesh itself.The seroma cavity was entered and a fair amount of clear fluid was suctioned.The incision was extended laterally bilaterally and the cavity further opened.It became obvious that the patient had separated the ultrapro mesh from the dualmesh that had been placed in combination to repair her defects.The ultrapro mesh was incised and the area below it was suctioned.A more purulent-looking fluid was then noted to come from the upper edge of the dualmesh.The dualmesh was taken down completely.The dualmesh itself measured 10 x 12 cm and was shaped like a rectangle.Underneath this dualmesh, a fair amount of purulent material was removed.This fluid was sent for gram¿s stain.The gram¿s stain came back showing no organisms and a rare white cell.The dualmesh was removed as was the ultrapro mesh that was anterior to it.The area was irrigated with warm saline and hydrogen peroxide.Re-review of the patient¿s ct scan intraoperatively showed that the fluid collection was based above and below the dualmesh only.There was no fluid collection anywhere else on the ct scan of the abdominal wall that was anywhere above, lateral, or inferior to the mesh itself.The area was irrigated well.A jackson-pratt drain was then placed onto the granulation bed where the mesh had been and brought out through the inferior defect.The inferior incision/defect was created by making an elliptical incision around the patient¿s nickel-sized hole that had spontaneously drained the seroma.This was able to give an ability to freshen up the edges.It was through this incision that a jackson-pratt drain was placed onto the granulation bed.Over the granulation bed and the drain, the fascial edges were reapproximated using interrupted 0 vicryl suture ligatures.An absorbable suture was used because of the possibility of an infection.The skin wound was once again irrigated and was closed using staples.A penrose drain was placed between the fascia and the skin.The jackson-pratt drain which laid underneath the fascial repair was brought out through a separate incision as noted above.That incision was closed with staples and both drains were secured using 3-0 black nylon suture ligatures.The patient tolerated the procedure well.There were no complications encountered.She was taken to the recovery room in good condition.¿ relevant medical information: ¿ (b)(6) 20/09: healthquest surgical associates.Questionnaire.What is the reason for your appointment? abdominal mesh.Surgeries cesarean sections x 2.¿ (b)(6) 2010: (b)(6) campus.(b)(6), md.Operative report.Preoperative diagnosis: 1) recurrent ventral hernia.2) loss of anterior abdominal wall.Postoperative diagnosis: recurrent ventral hernia.2) loss of anterior abdominal wall.Procedure: 1) ventral herniorrhaphy with mesh.2) muscle advancement flaps via component separation times 2.3) placement of xenograft 300 cm squared.4) subcutaneous tissue advancement flap times 1.Operative details: anesthesia: general.Indications: the patient is a 37-year-old female who had a wide excision of endometrioma with loss of the lower right rectus muscle.She underwent a hernia repair and developed a recurrence.Underwent second hernia repair which developed infected mesh and this was removed.Now has recurrent hernia and undergoing hysterectomy by dr.Elizabeth luce and presents for repair of the recurrent ventral hernia.Findings: a 15 x 15 cm fascial defect.There was incorporation of the previous ultrapro mesh which extended the anterior wall coverage approximately 10 cm in a craniocaudal direction.This had a significant amount of overlap into the native tissue.There was a hernia that extended down into the left labial region.There were minimal intra-abdominal adhesions.Technique: ¿the patient was brought to the operating room and after induction of general anesthesia, dr.Luce and dr.Rodriguez proceeded with opening the incision and dr.Luce did a hysterectomy.Once she was completed, the case was turned over to myself and dr.Rodriguez.She had a transverse incision through her previous incision sites.There was, as noted, a 15 x 15 cm fascial defect.This went from just above the umbilicus to approximately 1 cm superior to the pubic tubercle.The previously-placed ultrapro mesh extended from above the umbilicus and laterally significantly.Dr.(b)(6) had to go through this mesh in order to obtain entrance for dr.Luce.Therefore, the fascial defect was 15 x 15 cm but the mesh incorporated into peritoneum allowed approximately 10 cm more of coverage.Therefore, it was about a 15 x 5 cm coverage gap that was missing.Because of this, and that this could not be closed without significant tension, a subcutaneous tissue advancement flap was developed superiorly.This was developed to about 6 cm above the umbilicus.This gave several centimeters of downward direction of the fascia release but there was still a significant amount of tension.Adhesiolysis was performed to remove a few adhesions laterally along the edge of the remnants of the proceed mesh that was intra-abdominal.Small pieces of this were removed and some of the staples were removed.The anatomy was defined down to the bladder, and all bowel was removed from the inferior fields.Because of the gap still present, a component separation was performed to allow for more medial and downward retraction of the midline tissue.A second counterincision was made in the left upper quadrant.This was carried down through subcutaneous tissue to the fascia.The fascia was grasped, elevated, and the external oblique muscle fibers were identified.This was followed medially until its junction with the rectus muscle on the left.Using electrocautery and a lighted retractor, this was split down to the level of the anterior superior iliac spine.At this point, some of the ultrapro mesh was encountered.This was carried up just over the rib margin.Because the mesh was inferiorly, this was not completed inferiorly with the intent to expose this inferiorly through the incision.Therefore, subcutaneous flaps were developed laterally until the edge of the rectus was identified inferiorly.This was from the anterior superior iliac spine down to the inguinal ligament.There were only several centimeters of fascia still intact above the inguinal ligaments on both sides.Once the left side was exposed, the component separation was carried down several more centimeters.This allowed for several more centimeters of medial and downward traction of the tissue.In exposing the right side inferiorly, it was easy to obtain a pocket at that point to use a lighted retractor and superiorly to do a component separation up to the level of the rib margin.This allowed again several centimeters of downward traction.Because of the small amount of tissue over the pubic tubercle, it was decided to place a xenograft intra-abdominally to overlap the pubic tubercle internally, close native tissue, and place ultrapro mesh overlapping the external portion of the pubic tubercle.In order to obtain this, the bladder needed to be removed from the undersurface of the pubis.The bladder was instilled with 90 ml of normal saline sterilely.This was clamped so that the bladder could easily be identified, its location and extent.Using electrocautery dissection, the bladder flap was developed for approximately 3 cm anteriorly.This allowed for good placement of the xenograft.A 15 x 20 piece of permacol was used.The edges were trimmed slightly to give a curvature to this.This was marked for orientation with a marking pen and using 2-0 prolene interrupted sutures, this was tacked to the undersurface of the pubis as well as cooper¿s ligament laterally as it was palpated.It was then sutured to the inguinal ligament as we came around the lateral edge and was placed superiorly through the true native fascia and not just the mesh/peritoneum coverage.These were slowly tightened in place to allow for complete closure of the fascia and tissue over this mesh and the mesh was lying very flat.The fascia and mesh tissue coverage was then closed with 0 prolene figure-of-eight sutures.Again, the mesh fascia bridge (from a previous surgery) extended well above our subcutaneous advancement flap.Therefore, there was probably at least 10 cm of overlap onto good tissue.This was well-incorporated and the strength was very good.This was sutured along the inguinal ligament and along the fascia margin along the pubic tubercle.This gave a nice flat surface, and a piece of ultrapro mesh was trimmed to fit the area.This was approximately 20 x 20 cm.This was tacked in place using a versatack stapler.This was sutured with 0 prolene all along the anterior pubic area.This was to decrease the chance of recurrence in the area of highest risk.The wound was irrigated and 2 drains were placed through separate stab incisions.The skin was closed with 3-0 vicryl deep dermal sutures and 4-0 monocryl subcuticular sutures.Dermabond was placed.A sterile dressing and abdominal binder were placed.The patient tolerated the procedure well and was transferred to the post-anesthesia care unit in stable condition.¿ ¿ (b)(6) 2010: (b)(6).Implant record.Permacol arrow.Percacol.Ultrapro mesh.Ethicon.¿ (b)(6) 2010 [assigned]: butterworth.Implant sticker.Permacol surgical implant.Manufactured by tissue science laboratories.¿ (b)(6) 2011: healthquest surgical associates, plc.[assigned].[illegible signature].Office notes.Recheck abdomen.[illegible].Prescription for ibuprofen as needed for pain.¿ (b)(6) 20/11: healthquest surgical associates, plc.[assigned].Sv.Office notes.Phone call, having problems with lower end of her incision.Feels a bump and incision seems to be pulling.Appointment made with dr.(b)(6).¿ (b)(6) 2011: healthquest surgical associates, plc [assigned].(b)(6), md.Letter.(b)(6) in office today.Formerly patient of dr.(b)(6) and i helped with some of complex abdominal wall reconstruction.In last week she noticed painful bulge over left side of pubic tubercule down into mons.Some nodular tenderness in this area and i cannot tell if this is small recurrence at edge of pubic tubercle or inflamed sebaceous cyst.I ordered ct scan for evaluation.¿ (b)(6) 2011: (b)(6).(b)(6), md.Radiology-ct pelvis.History of tightness at incision in lower abdomen.Comparison ct abdomen and pelvis (b)(6) 20/09.Findings multiple surgical clips over anterior abdominal wall.At midline anterior abdominal wall, oval fluid collection measuring approximately 4.5 cm across and 1.9 cm anterior-posterior dimension.May be tracking to skin surface where there is adjacent thickening, uncertain if this may relate to postoperative seroma or abscess.On sagittal reformats, length approximately 7.9 cm.Cystic collections in left ovary.Cyst measuring 4.5 cm.Large amount of fluid surrounding this, uncertain if may related to some layering fluid from hemorrhagic cyst.No definite wall associated with this.May be some loculated fluid or additional cystic component which measures 8.5 cm.Short-term pelvic ultrasound recommended for follow-up.Impression midline anterior abdominal wall fluid collection measuring approximately 4.5 x 1.9 x 7.9 cm.Large cyst and fluid in left adnexa/left ovary.Recommended short-term follow-up pelvic ultrasound.¿ (b)(6) 2011: (b)(6) associates, plc.[assigned].(b)(6).Office notes.Augmentin for 7 days, called to (b)(6).Still [illegible], no fever.Attempt at aspiration of fluid seen on ct.Despite needle in middle of collection on ultrasound, no aspirate.Start antibiotics for 1 week.Follow up next week.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Prescription re-called.Patient quite painful first few days.Antibiotics helped and much better now.Still no fever or chills.Hypertrophic scar, more distended? central area of questionable fluctuant area of firmness/erythema on labia much improved.Attempt at aspiration under scar with a few drops of clear.Continue antibiotics for 7 days.I suspect this may [illegible] be infection of chronic [illegible], but is resolving with antibiotics.Follow up in 2 weeks.¿ (b)(6) 2011: (b)(6) associates, plc.[ni].Office notes.Follow-up.Groin culture to lab.Doing ok, still draining.3 mm opening now draining purulent.Culture taken.Labial induration resolved.Depth of wound about 1.5 cm.Opened to about 5 mm.Packed with iodoform to allow drainage.Follow up in 2 weeks.Diflucan called to d&w caledonia.¿ (b)(6) 20/11: (b)(6).Lab.Culture, wound: bacteria not isolated.Anaerobic bacteria not isolated.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Follow-up.Incision feels good with [illegible].Last few days she has felt feverish and pain in left kidney area (¿punched¿) feeling.Strange urine smell.Area of incision and drainage with 3 mm granulation area, no drainage, no erythema.Healing well.No further treatment.If recurs recommend exploration in operating room for suture granuloma.Check urinalysis to rule out pyelonephritis.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Patient calls, ¿hole¿ still leaking, closes then leaks off and on.Dr.(b)(6) to see patient in office.¿ (b)(6) 20/11: (b)(6) associates, plc [assigned].(b)(6), md.Letter.(b)(6) in office today for continued drainage from suprapubic wound.Has very complex abdominal wall reconstruction history.More recently, having recurrent drainage from small sinus in suprapubic region.I suspect suture granuloma that continues to drain.I recommended exploration and debridement and she wishes this to be in operating room for her comfort.¿ (b)(6) 2011: (b)(6) associates.(b)(6), md.History and physical.Complaint chronic open wound suprapubic.We tried to incise and drain several times in office.It heals and recurs.Most recently [illegible] to drain small amount with chronic sinus to suprapubic.Slight tenderness at pubis, no fever or chills.Abdomen soft, non-distended, liver/spleen organomegaly none, 2 mm sinus suprapubic with brown drainage, no erythema, no mass.Impression chronic wound suprapubic.I suspect this is a suture granuloma.She has had ¿mac¿ before and was very uncomfortable.So, wishes general ¿ reasonable.Plan exploration and debridement.Augmentin for 5 days prior to operating room.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Patient calls, complaining of swollen abdomen and not feeling well, tired.Augmentin called in.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Patient calls, complaining of abdomen hard with increased [illegible], feels ¿full¿, pain into groin, antibiotics since (b)(6) 2011.To go to emergency room for evaluation at bl.¿ (b)(6) 20/11: (b)(6) associates.(b)(6), md.History and physical update.Exam healed sore.Impression chronic wound on pelvis.Plan debridement.¿ (b)(6) 2011: (b)(6) hospitals.[illegible signature].Anesthesia pre-operative evaluation.Surgical history cesarean section x 2, appendectomy, cholecystectomy, (b)(6)2006 diagnostic laparoscopy, (b)(6) 2010 excision of endometrioma with graft x 7.Rheumatoid arthritis onset age 7.Asa physical status 2.¿ (b)(6) 2011: (b)(6) campus.(b)(6), md.Operative/procedure report.Preoperative diagnosis: chronic wound in suprapubic region.Post-operative diagnosis: suture granuloma with chronic wound.Operative procedure: debridement of wound with removal of suture.Operative details.Anesthesia: general.Indications: the patient is a 39-year-old female who has had a complex abdominal wall history.Over the last several months, she developed a small abscess in the suprapubic region.This was then intermittently closed and drained despite several attempts at opening and debriding the area.Evaluation under anesthesia with full debridement was recommended.The patient agreed to proceed.Findings: the ultrapro mesh was in the base of the wound, and this tracked down to the suprapubic tubercle where a prolene stitch was identified at the base of the chronic cavity.The suture was removed.Technique: ¿the patient was brought to the operating room and placed on the operating table in a supine position.After induction of general anesthesia, her suprapubic and lower abdomen area was prepped and draped in standard surgical fashion.An elliptical incision was used to remove the chronic wound.This was carried down just through the subcutaneous tissue until the chronic wound track was identified.Electrocautery was used to follow this scar tissue down to its base.This then opened into an approximately 2 cm chronic wound tracking down towards the left labia.At the base of this, some ultrapro mesh could be identified.There was 1 small rolled edge and this was excised.The rest was flat and incorporated relatively well into the base.The chronic granulation tissue was removed from the inside of the cavity.The excess scar tissue was excised using electrocautery.At the base, a single prolene suture was identified and this was loose and not affording any support to the mesh and this was excised.The area over the mesh was relatively clear and this was left in the base because it was incorporated very well.The wound was irrigated, and the left lateral half was closed.The rest was packed with iodoform gauze.The patient tolerated the procedure well.A dressing was placed over the abdomen and an abdominal binder placed.She was transferred to postanesthesia unit in stable condition.¿ ¿ (b)(6) 2011 [assigned]: (b)(6) hospital.(b)(6).Discharge instructions.Change outer dressings as needed.Remove packing friday (if falls out sooner that¿s ok).Ok to shower.I would expect moderate amount of drainage the first few days.¿ (b)(6) 2011: (b)(6) associates, plc.(b)(6).Office notes.Postoperative visit.Abdomen sore but ok.Wound closed.Opened with q-tip with small [illegible].Packed with iodoform.Remove iodoform about 1 inch every 2 days.Follow up in 1-2 weeks.¿ (b)(6) 20/11: (b)(6) associates, plc.(b)(6).Office notes.Postoperative visit.Doing well, minimal drainage.Less than 1 cm area at skin with about 3 mm depth.Probed, no pocket of fluid.Should heal in next 2-3 weeks.Follow up as needed.¿ (b)(6) 20/12: (b)(6) associates, plc.(b)(6).Office notes.Still [illegible] small drainage.[illegible] mm opening.Q-tip on [illegible] < 5 mm (whole tip not in).[illegible] depth then test [illegible] visit and granulate tissue [illegible].Follow up if [illegible].[handwritten note, poor copy].¿ (b)(6) 2012: (b)(6) associates, plc.(b)(6).Office notes.Patient calls.Still same about incision with drainage; questions regarding methicillin-resistant staphylococcus aureus.Patient will make appointment.¿ (b)(6) 2012: (b)(6) associates, plc [assigned].(b)(6).History and physical.Complaint open suprapubic wound.Patient continues to have intermittent drainage.No fever or chills.Continues to have pain suprapubic, also about 4 cm below wound.Occasional purulent drainage.Abdomen soft, non-distended, incision healed on abdomen.Suprapubic wound 3 mm, cross-section 1 cm x 1.5 cm [includes drawing].Impression continued drainage from wound.Essentially unchanged from previous.No depth.We discussed re-exploration.She may have other stitch or mesh (unincorporated) at base.Would make counterincision lower.She will talk to husband and call.Culture sent to rule out methicillin-resistant staphylococcus aureus (patient concern).¿ (b)(6) 2012: (b)(6).Lab.Wound culture, abdominal wound: many staphylococcus aureus.Susceptible to oxacillin, clindamycin, daptomycin, linezolid, trimethoprim-sulfamethoxazole, tetracycline, vancomycin, cefazolin, inducible clindamycin resistance negative.¿ (b)(6) 2012: (b)(6) associates, plc.(b)(6).Office notes.Left message to call.Spoke with patient regarding culture.No methicillin-resistant staphylococcus aureus.Open, no sign of ¿infection.¿ most likely colonized with chronic open wound.She is getting second opinion and will let me know what she decides.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.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 were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿as with any implantable surgical device, 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: 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.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.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 and sterilization records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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