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W.L. GORE & ASSOCIATES GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFR2030 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930); Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/28/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).It should be noted that the gore® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ the gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.When operative infection is suspected, dissection of involved tissues should be considered.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 laparoscopic incisional hernia repair on (b)(6) 2017 whereby a gore® synecor intraperitoneal was implanted.The complaint alleges that on (b)(6) 2017, the patient developed wound infection with dehiscence.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby excisional debridement of wound edges with fasciocutaneous flap creation occurred.The complaint alleges that on (b)(6) 2018, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: wound infection, wound dehiscence, wound vac, additional surgical procedure, mesh removal, chronic open wound, scar, purulent drainage, inflamed soft tissue with associated mesh, mesh contraction.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records for the surgical procedure completed on (b)(6)15 exploratory laparotomy, open sigmoid olectomy, olostomy were not provided.(b)(6)17: (b)(6).Operative report.Surgeon: surgeon(s) and role: (b)(6)- resident- assisting.Level of involvement of attending surgeon: attending was present and scrubbed for the entirety of his portion of his procedure.Anesthesia type: general.Case length: 4 hr 19 min 0 sec.Pre-operative diagnosis: incarcerated ventral incisional hernia.Post-operative diagnosis: incarcerated ventral incisional hernia without bowel compromise, two additional non-incarcerated ventral hernias.Operation performed: dr.Solomon: exploratory laparotomy.Lysis of adhesions x2 hours.Dr.(b)(6) (see separate operative report for further details): ventral incisional hernia repair with overlay gore synecor preperitoneal mesh 20x30cm.Anterior component separation.Findings (normal + abnormal): moderate adhesions throughout bowel.Three ventral hernias in series, 3-5cm in diameter.Bowel adhered within the superior most hernia.No compromise, ischemia, or perforation of small or large bowel.Midline fascia easily approximated after anterior component separation.Procedure in detail: ¿(b)(6) was brought to the operating theater and placed in the supine position.General anesthesia was induced and an endotracheal tube placed.Her abdomen was prepped and draped in the normal sterile fashion.Antibiotics were given.A time out was performed to ensure the correct patient, procedure, and laterality.A midline incision was made superior to the umbilicus, in an area with no prior surgical scar.This was carried down to the level of the fascia.The peritoneal lining was visualized and entered with sharp dissection.There was no observed injury to the bowel.The incision was carried inferior until the first hernia was encountered.There was noted to be bowel adherent to the hernia sac inside of the hernia but it was not strangulated.It was delivered into the peritoneal cavity and the adhesions were lysed.Two additional ventral incisional hernias were encountered and the adhesions were taken down sharply and without injury to the bowel.Lysis of adhesions was performed for 2 hours.This allowed the bowel to run in its entirety.There was no noted edema, erythema, ischemia, or perforation of the bowel.There was no free fluid noted within the peritoneal cavity.The hernia sacs were excised from the fascial defects and sent to pathology.At this point, the case was turned over to dr.(b)(6) for hernia repair and abdominal closure.Please see her operative note for further details.¿ rapid frozen section telephone diagnosis: n/a.Specimens removed: hernia sac x 3.Wound classifications: clean.Skin closure: primary closure.Drains/packs: #19 round black drains, llq [left lower quadrant] draining deep to mesh, rlq [right lower quadrant] draining superficial to mesh.Estimated blood loss: 100 ml.Blood products administered: none.Attending attestation: i was present for the entire procedure which was performed under my personal supervision.I reviewed and edited the resident¿s note and agree with the documented findings except as noted here: none.(b)(6)17: (b)(6).Operative report.Surgeon: surgeon(s) and role: (b)(6).Level of involvement of attending surgeon: attending was present and scrubbed for the entirety of her portion of the procedure.Anesthesia type: general.Case length: 4 hr 19 min 0 sec.Pre-operative diagnosis: incarcerated ventral incisional hernia.Post-operative diagnosis: incarcerated ventral incisional hernia without bowel compromise, two additional non-incarcerated ventral hernias.Operation performed: dr.(b)(6) (see separate dictation for further details): exploratory laparotomy.Lysis of adhesions x2 hours.Dr.(b)(6): ventral incisional hernia repair with overlay gore synecor preperitoneal mesh 20x30cm.Anterior component separation.Procedure in detail: ¿ms.(b)(6) was on the operating room table in the supine position with the endotracheal tube in place when dr.(b)(6) began her portion of the procedure.The lysis of adhesions was complete.There was no evidence of bowel compromise or peritoneal infection.Please see dr.(b)(6) operative report for further details.The abdominal wall was noted to not re-approximate.Flaps were raised between the anterior abdominal wall fascia and the subcutaneous tissue.This was done on both sides, but still the fascia did not re-approximate in a tension-free manner.Anterior rectus sheath component separations were performed with electrocautery.Just lateral to the rectus abdominal muscle, the fascia was scored until the tension released.This was performed on the entire length of the muscle on either side of the incision.The fascia then easily approximated.Figure-of-8 0 pds sutures were used to close the midline fascia.A gore synecor mesh, 20cm x 30cm, was then placed in an overlay fashion.It was trimmed to fit, being sure to cover the anterior rectus sheath component separation lines.0 vicryl was run to anchor the mesh to the anterior abdominal wall fascia on all four sides.Two 19fr jp [jackson-pratt] drains were placed, the llq [left lower quadrant] drain positioned to drain just deep to the mesh, and the rlq [right lower quadrant] drain positioned to drain superficial [sic] to the mesh.The subcutaneous tissue was closed using figure-of-8 3-0 vicryl sutures.The wound was irrigated and skin staples used to close the skin.The drains were anchored at the skin with 2-0 nylon sutures.Sterile dressings were applied.The patient was awakened, extubated, and taken to the pacu for further care.¿ rapid frozen section telephone diagnosis: n/a.Specimens removed: none.Wound classification: clean.Skin closure: primary closure.Drains/packs: #19 round blake drains, left drain deep to mesh, right drain superficial to mesh.Estimated blood loss: 100 ml.Blood products administered: none.Attending addendum: i was present for the entire procedure which was supervised under my personal supervision.I reviewed and edited the resident¿s note and agree with the documented findings and plan of care.(b)(6)17: (b)(6).Implant sticker.Item type: gore® synecor biomaterial.Ref: (b)(4).Sn: (b)(6).Expiration: 2019-11-07.Quantity implanted: 1.The records confirm a gore® synecor intraperitoneal biomaterial (gkfr2030/15690535) was implanted during the procedure.(b)(6)17: [missing records: a culture report which showed ¿pseudomonas and e-coli¿ was not provided.] (b)(6)17: [missing records: records for the ¿in-office debridement¿ were not provided.] (b)(6)18: (b)(6).History and physical.History of crohn¿s disease status post sigmoidectomy with colostomy on (b)(6) and status post colostomy reversal and complex parastomal and ventral hernia repair on (b)(6)17.Transferred from (b)(6) hospital for exploratory laparotomy, lysis of adhesions, ventral incisional hernia repair with overlay mesh, and anterior component separation.Subsequently had a wound infection with dehiscence noted in clinic on (b)(6) and referred for abdominal wall management with recommendations to place a wound vac.Interval: upper abdominal pain x 1 week; worse when flexes abdominal muscles getting out of bed or chair.Constant cough x 2 weeks that has not improved.Denies fever, chills, issues with bowel movements.Wound nurse removed wound vac yesterday due to pain and has managed the wound with wet-to-dry dressings.Had appointment with primary care provider for management of cough but canceled due to fear of infection to the abdomen.Past medical/surgical/social history: anemia, obesity, perforation of colon (b)(6)2015), ulcerative colitis (2007).Exploratory laparotomy, open sigmoid colectomy, colostomy (b)(6)15); exploratory laparotomy, incisional or ventral hernia repair, ileoanal anastomosis, sigmoidoscopy, parastomal hernia repair (b)(6)17); exploratory laparotomy (b)(6)17).Never smoked, does not drink.Exam: 174 lbs, bmi 35.38.Mild tenderness to deep palpation of upper abdomen.Midline wound measuring 7.5cm long, 3cm wide, and 1cm deep with appropriate granulation tissue; no signs of infection, cellulitis or surrounding erythema.Assessment: abdominal pain possible associated with prolonged cough.Wound is healing appropriately; reapply wet-to-dry dressing with instructions to reapply wound vac today.Instructed patient to make appointment with primary care provider regarding prolonged cough.Plan: irrigation and debridement of abdominal wound, possible wound vac placement, possible closure.(b)(6)18: (b)(6).Operative report.Surgeon: surgeon(s) and role: (b)(6).Level of involvement of attending surgeon: attending was present and scrubbed for the entire procedure.Anesthesia type: general.Case length: 0 hr 55 min 8 sec.Indications: the pt [patient] is a 50 y/o f [year old female] with a non healing chronic abdominal wall wound now requiring debridement.After discussing the risks and benefits of the procedure the patient agreed to proceed with the procedure.Pre-operative diagnosis: abdominal wall wound.Post-operative diagnosis: same.Operation performed: excisional debridement of wound edges with fasciocutaneous flap creation.Procedure details: ¿the patient was brought into the operating room and placed on the table in the supine position.General anesthesia was administered.A time-out was completed verifying correct patient, procedure, site, positioning, implant(s) and/or special equipment prior to beginning this procedure.All bony prominences were padded.The abdomen was prepped and draped in the usual sterile fashion.The wound edges were debrided and excised with metz and electrocautery to healthy tissue.Fasciocutaneous flaps were created.The wound was washed and cleaned.Hemostasis was ensured.The wound was then packed with wet to dry kerlix.The wound was then anesthetized with marcaine.Counts were done and correct at the end of the case.The patient was then extubated and taken to the pacu in stable condition.¿ findings (normal + abnormal): non healing skin edges.Exposed mesh on the superior left aspect of the wound.Good hemostasis at the end of the case.Rapid frozen section telephone diagnosis: none.Specimens removed: none.Wound classifications: contaminated.Drains/packs: none.Estimated blood loss: 5ml.Blood products administered: none.Implants: none.Complications: none.Disposition: pacu- hemodynamically stable.Condition: stable.Attending addendum: i was present for the entire procedure which was supervised under my personal supervision.I reviewed and edited the resident¿s note and agree with the documented findings and plan of care.(b)(6)18: (b)(6).Radiology- ct abdomen/pelvis.History: abdominal pain; crohn¿s disease.Impression: interval postsurgical changes related to ventral abdominal wall hernia repair with a soft tissue defect.There is ill-defined ventral abdominal wall stranding and fluid with a tiny 9 mm collection with an apparent tract extending to the skin surface to the left of midline.Findings may be related to post surgical change.Correlate clinically with superimposed infection.Loops of nondilated small bowel are seen extending through an apparent defect in the linea alba abutting the ventral abdominal wall mesh material.No ct evidence of acute inflammatory bowel disease.Prominent fatty infiltration of the submucosa involving the ascending colon and the rectum which may represent sequelae of prior inflammatory bowel disease.(b)(6)18: (b)(6).Radiology- ct abdomen/pelvis.History: history of crohn¿s disease being evaluated for ventral hernia with mesh and nonhealing wound over mesh.Impression: redemonstration of postsurgical changes related to ventral abdominal wall hernia repair with a soft tissue defect.There is increased stranding with ill-defined fluid and scattered foci of air superficial to the mesh material when compared to the prior examination.Loops of nondilated small bowel are seen extending through an apparent defect in the linea alba abutting the ventral abdominal wall mesh material.Enterocutaneous fistulas are not excluded.There is new focal bowel wall thickening and adjacent stranding near the prior colocolonic anastomosis site, which may represent active inflammatory bowel disease or infectious colitis.Neoplastic etiologies are not entirely excluded.Interval increase in size of multiple pericentimeter and subcentimeter short axis mesenteric, retroperitoneal and perirectal lymph nodes.Prominent fatty infiltration of the submucosa involving the ascending colon and the rectum which may represent sequelae of prior inflammatory bowel disease.(b)(6)18: (b)(6).History and physical.History of present illness: poor wound healing over ventral incisional hernia repair.Wound cultures on (b)(6)17 positive for pseudomonas and e-coli, treated with cipro x 7 days.Mesh noted as exposed during an in-office debridement on (b)(6)17 and augmentin started after positive enterococcus cultures.Wound vac placed on (b)(6)17; discontinued on (b)(6)18.Returns today for pre-operative appointment.Continues to have moderate drainage from her midline wound.Denies fever, chills.Endorses diarrhea, no blood, and abdominal pain.Ready to have wound exploration.Exam: 175 lbs, 3.2 oz, bmi 33.10.Abdomen: approximately 5cm x 1cm x 0.5 cm wound oriented vertically.It contains a mix of granulation and gelatinous tissue.Mesh is visible at the base of the wound.A small (0.5cm) sinus is noted inferior to the wound.Active drainage, fibrinous exudate and purulent fluid expressed.Rubber band setons in place.Assessment/plan: non healing midline abdominal wound with underlying mesh infection and non incorporation.Failed attempts at local wound care.Wound exploration, possible explantation of infected mesh, possible ventral hernia repair with mesh, possible wound vac placement.[missing records: a culture report which showed ¿enterococcus¿ was not provided.] (b)(6)18: (b)(6).Operative report.Surgeon: surgeon(s) and role: (b)(6).Medicare regulations generally require that a gme resident serve as the first assistant for all operative cases.However, in this case, no qualified resident was available.Dr.(b)(6)therefore served as the first assistant.Level of involvement of attending surgeon: attending was present and scrubbed for the entire procedure.Anesthesia type: general.Case length: 2 hr 37 min 12 sec.Pre-operative diagnosis: mesh infection, chronic wound.Post-operative diagnosis: same.Operation performed: wound exploration, explantation of infected mesh.Wound vac placement.Findings (normal + abnormal): 1.Mesh with chronic wound and scar, purulent to draining skin wounds, all removed in entirety and mesh also removed in entirety.Large skin defect remained at conclusion 15 x 20 cm, partially closed, vac applied to wound and undermined area.Indication: 50 y.O.[year old] female with crohn's disease s/p [status post] multiple abdominal operations, complicated by ventral hernias, parastomal hernia, and currently a non-healing midline abdominal wound with underlying mesh infection and non incorporation.She has failed attempts at local wound care.Operative details: ¿the patient was brought to the operating suite and placed supine on the operating room table.General anesthesia was achieved.The patient's abdomen was prepped and draped in the usual sterile surgical fashion.A timeout was performed according to standard protocol and preoperative antibiotics were administered, ancef.A #15 blade was then used to circumscribe the abdominal wound complex and electrocautery was used to divide tissues to the level of the external aponeurosis.The total skin defect measuring appx 15x20cm in size.A tissue plane was developed anterior to the aponeurosis and continued bilaterally as well as cranial/caudally, identifying the extent of the underlying mesh.Using kocher clamps to retract, the extent of the mesh was removed with the incorporated aponeurosis with sharp dissection using a curved mayo scissors.Two underlying defects were then identified, one measuring appx 1 x2cm in the left upper region of the wound, just lateral to the rectus, the second noted in the superior midline measuring 2cm x 5cm.A loop of bowel was palpated deep to the midline wound.The defects were closed primarily with interrupted 1-0 prolene suture, with care not injure underlying structures/bowel.The lower 1/3 portion of the wound was reapproximated with 2-0 vicryl suture, with the upper 2/3 of the wound loosely approximated with 2-0 vicryl placed at 2cm intervals leaving a gap of 3 cm between skin edges.A large wound vac sponge was placed within the wound, through the gap, undermining the skin, placed to -125 mmhg.¿ rapid frozen section telephone diagnosis: none.Specimens removed: mesh and chronic wound.Wound classifications: dirty.Skin closure: other than primary.Drains/packs: neg [negative] pressure wound therapy.Estimated blood loss: 35 ml.Blood products administered: none.Attending attestation: i was present for the entire procedure which was performed under my personal supervision.I reviewed and edited the resident¿s note and agree with the documented findings except as noted here: none.(b)(6)18: (b)(6).Pathology report.Accession #: ms-18-0015761.Diagnosis: a.Ulcerated and inflamed soft tissue with associated mesh, removed clinically secondary to mesh infection and chronic wound.Clinical information: mesh infection, chronic wound.Specimens: a.Infected mesh.Gross description: a.(labeled: (b)(6); a.Infected mesh).Received fresh is a 134 gram, 16.2 x 6 cm strip of mesh which is surmounted by an 8.2 x 2 cm irregular excision of gray and brown skin.(representative sections, 1 cap).Microscopic description: __ [sic].(b)(6)18: (b)(6).Discharge summary.Diagnosis: chronic mesh infection status post hernia repair.Discharge exam: abdomen soft, non-tender, non-distended.No rebound tenderness.Incisional wounds are clean, dry, intact with skin glue.Wound vac in place with serosanguinous output.Discharge home.Activity: no strenuous exercise, ambulation as tolerated, no lifting greater than 10 lbs.Wound care as directed with home health nurse managing wound vac.(b)(6)18: (b)(6).Emergency room visit.Wound dehiscence x 1 day.Home nurse was changing surgical bandages and noted purulent drainage from left lower region of surgical site and dehiscence of vicryl sutures.Difficulty eating because of pain at surgical site, denies worsening pain.Passing flatus, regular bowel movements.Social history: former smoker/3 years; quit 1985.Exam: 176 lbs.Abdomen: tenderness.There is a large open wound with purulent drainage, granulation tissue, and dehiscence.Plan: surgery consult.(b)(6)18: (b)(6).Consultation.Presents after her wound nurse removed wound vac due to being concerned about dehiscence and purulent drainage.No increased pain, no fever, chills, vomiting, change in bowel habits.Has intermittent nausea.In the emergency department had wet to dry dressing over her wound.Exam: large open abdominal wound with inferior portion sutured closed, rest of incision is open with evidence of good granulation tissue, no purulent drainage, has some fibrinous exudate.Has noted vicryl sutures that have torn free from deep dermal closures.No evidence of fascial dehiscence.Assessment/plan: no evidence of fascial dehiscence.Wound appears to be healing well.Okay to continue with wound vac and follow up in general surgery clinic next week.Wound was packed with wet to dry until am when wound nurse comes and can reapply wound vac.(b)(6)19: (b)(6).Radiology- ct abdomen/pelvis.History: evaluated for abdominal pain.Findings: bowel: evaluation of the gastrointestinal tract is limited by nondistention and stool.Abdominal wall: post surgical changes also seen related to intra-abdominal wall hernia repair.No recurrent hernias are seen.Soft tissues: midline abdominal incision scarring is stable.No subcutaneous fluid collections.Impression: no acute ct abnormality of the abdomen or pelvis.Stable postsurgical changes related to prior colocolonic anastomosis near the rectosigmoid junction.Interval improvement of mild bowel wall thickening/inflammatory change at the anastomotic site with mild perirectal lymph node prominence.Fatty hypertrophy of the cecal wall suggesting chronic inflammation.Evolving expected postsurgical changes related to anterior abdominal wall ventral hernia repair.Cholelithiasis.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 gore® synecor intraperitoneal 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® synecor intraperitoneal 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 investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes (1154, 1930, 1932, 2061, 2225, 2446, 3191: ¿wound vac, chronic open wound and mesh contraction¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records: ¿ the known medical records span (b)(6), 2017 through (b)(6), 2018 and not all records received in this time span are relevant to the gore® synecor intraperitoneal biomaterial.¿ records from (b)(6), 2017 through (b)(6), 2018 were not provided.Patient information: medical history: ¿ obesity - (b)(6) 2018: obesity, weight 174 lbs., bmi 35.4 ¿ smoker - ¿former smoker/3 years; quit 1985.¿ ¿ crohn¿s disease ¿ (b)(6) 2017: ventral hernias and parastomal hernia ¿ 2007: ulcerative colitis.¿ 2009: anemia ¿ (b)(6) 2015: colon perforation.¿ v 2018: non-healing wound over mesh surgical procedures: ¿ unknown date: colostomy reversal.¿ (b)(6) 2015: exploratory laparotomy, open sigmoid colectomy, colostomy.¿ (b)(6) 2017: exploratory laparotomy, ventral incisional hernia repair, ileoanal anastomosis, sigmoidoscopy, parastomal hernia repair.¿ (b)(6) 2017: exploratory laparotomy.Lysis of adhesions x2 hours.Ventral incisional hernia repair with overlay ¿gore synecor preperitoneal mesh 20 x 30cm.¿ anterior component separation.Implant: gore® synecor intraperitoneal biomaterial.¿ (b)(6) 2017: debridement; mesh exposed.¿ (b)(6) 2018: excisional debridement of wound edges and fasciocutaneous flap creation; ¿exposed mesh on the superior left aspect of the wound.¿ ¿ (b)(6) 2018: wound exploration; explantation of infected mesh; wound vac placement.Implant preoperative complaints: ¿ (b)(6) 2017: preoperative diagnosis: ¿incarcerated ventral incisional hernia¿ implant procedure: exploratory laparotomy.Lysis of adhesions x 2 hours.Ventral incisional hernia repair with overlay ¿gore synecor preperitoneal mesh 20 x 30cm.¿ anterior component separation.[implant: gore® synecor intraperitoneal biomaterial, gkfr2030/15690535, 20cm x 30cm] implant date: (b)(6), 2017 ¿ wound classification: ¿clean¿ ¿ findings: ¿moderate adhesions throughout bowel.Three ventral hernias in series, 3-5cm in diameter.Bowel adhesed within the superior most hernia.No compromise, ischemia, or perforation of small or large bowel.Midline fascia easily approximated after anterior component separation.¿ ¿ description of hernia being treated [per dr.(b)(6)]: ¿a midline incision was made superior to the umbilicus, in an area with no prior surgical scar.This was carried down to the level of the fascia.The peritoneal lining was visualized and entered with sharp dissection.There was no observed injury to the bowel.The incision was carried inferior until the first hernia was encountered.There was noted to be bowel adherent to the hernia sac inside of the hernia but it was not strangulated.It was delivered into the peritoneal cavity and the adhesions were lysed.Two additional ventral incisional hernias were encountered and the adhesions were taken down sharply and without injury to the bowel.Lysis of adhesions was performed for 2 hours.This allowed the bowel to run in its entirety.There was no noted edema, erythema, ischemia, or perforation of the bowel.There was no free fluid noted within the peritoneal cavity.The hernia sacs were excised from the fascial defects and sent to pathology.¿ ¿at this point, the case was turned over to dr.(b)(6) for hernia repair and abdominal closure.Please see her operative note for further details.¿ ¿specimens removed: hernia sac x 3." ¿skin closure: primary closure.Drains/packs: #19 round black drains, llq [left lower quadrant] draining deep to mesh, rlq [right lower quadrant] draining superficial to mesh.¿ ¿ description of hernia being treated [per dr.(b)(6)]: ¿the lysis of adhesions was complete.There was no evidence of bowel compromise or peritoneal infection.The abdominal wall was noted to not re-approximate.Flaps were raised between the anterior abdominal wall fascia and the subcutaneous tissue.This was done on both sides, but still the fascia did not re-approximate in a tension-free manner.Anterior rectus sheath component separations were performed with electrocautery.Just lateral to the rectus abdominal muscle, the fascia was scored until the tension released.This was performed on the entire length of the muscle on either side of the incision.The fascia then easily approximated.Figure-of-8 0 pds sutures were used to close the midline fascia.¿ ¿ implant size and fixation [per dr.(b)(6).]: ¿a gore synecor mesh, 20cm x 30cm, was then placed in an overlay fashion.It was trimmed to fit, being sure to cover the anterior rectus sheath component separation lines.0 vicryl was run to anchor the mesh to the anterior abdominal wall fascia on all four sides.Two 19fr jp [jackson-pratt] drains were placed, the llq [left lower quadrant] drain positioned to drain just deep to the mesh, and the rlq [right lower quadrant] drain positioned to drain superificial [sic] to the mesh.The subcutaneous tissue was closed using figure-of-8 3-0 vicryl sutures.The wound was irrigated and skin staples used to close the skin.The drains were anchored at the skin with 2-0 nylon sutures.Sterile dressings were applied.¿ relevant medical information: ¿ wound cultures completed on (b)(6) 2017 were not provided for review.However, a history and physical dated 2/14/18 documented the following: ¿subsequently had a wound infection with dehiscence noted in clinic on (b)(6).¿ [2017] a history and physical dated (b)(6) 2018 documented the following: ¿wound cultures on (b)(6) 2017 positive for pseudomonas and e-coli, treated with cipro x 7 days.¿ ¿ documentation from (b)(6) 2017 office visit were not provided.However, a history and physical dated (b)(6) 2018 documented the following: ¿mesh noted as exposed during an in-office debridement on (b)(6) 2017 and augmentin started after positive enterococcus cultures.¿ ¿ (b)(6) 2018: history and physical.¿transferred from (b)(6) for exploratory laparotomy, lysis of adhesions, ventral incisional hernia repair with overlay mesh, and anterior component separation.Subsequently had a wound infection with dehiscence noted in clinic on (b)(6) and referred for abdominal wall management with recommendations to place a wound vac.¿ ¿interval: upper abdominal pain x 1 week; worse when flexes abdominal muscles getting out of bed or chair.Constant cough x 2 weeks that has not improved.¿ ¿wound nurse removed wound vac yesterday due to pain and has managed the wound with wet-to-dry dressings.Had appointment with primary care provider for management of cough but canceled due to fear of infection to the abdomen.¿ exam: ¿mild tenderness to deep palpation of upper abdomen.Midline wound measuring 7.5cm long, 3cm wide, and 1cm deep with appropriate granulation tissue; no signs of infection, cellulitis or surrounding erythema.Assessment: abdominal pain possible associated with prolonged cough.Wound is healing appropriately; reapply wet-to-dry dressing with instructions to reapply wound vac today.Instructed patient to make appointment with primary care provider regarding prolonged cough.Plan: irrigation and debridement of abdominal wound, possible wound vac placement, possible closure.¿ ¿ (b)(6) 2018: excisional debridement of wound edges with fasciocutaneous flap creation: - indication: ¿the pt [patient] is a 50 y/o f [year old female] with a non-healing chronic abdominal wall wound now requiring debridement.¿ - wound classifications: ¿contaminated¿ - findings: ¿non healing skin edges.Exposed mesh on the superior left aspect of the wound.¿ - ¿the wound edges were debrided and excised with metz and electrocautery to healthy tissue.Fasciocutaneous flaps were created.The wound was washed and cleaned.Hemostasis was ensured.The wound was then packed with wet to dry kerlix.The wound was then anesthetized with marcaine.¿ ¿ (b)(6) 2018: ct abdomen/pelvis [a/p]: ¿abdominal pain; crohn¿s disease.Impression: interval postsurgical changes related to ventral abdominal wall hernia repair with a soft tissue defect.There is ill-defined ventral abdominal wall stranding and fluid with a tiny 9 mm collection with an apparent tract extending to the skin surface to the left of midline.Findings may be related to post-surgical change.Correlate clinically with superimposed infection.Loops of nondilated small bowel are seen extending through an apparent defect in the linea alba abutting the ventral abdominal wall mesh material.No ct evidence of acute inflammatory bowel disease.Prominent fatty infiltration of the submucosa involving the ascending colon and the rectum which may represent sequelae of prior inflammatory bowel disease.¿ ¿ (b)(6) 2018: ct [a/p].¿history of crohn¿s disease being evaluated for ventral hernia with mesh and nonhealing wound over mesh.Impression: redemonstration of postsurgical changes related to ventral abdominal wall hernia repair with a soft tissue defect.There is increased stranding with ill-defined fluid and scattered foci of air superficial to the mesh material when compared to the prior examination.Loops of nondilated small bowel are seen extending through an apparent defect in the linea alba abutting the ventral abdominal wall mesh material.Enterocutaneous fistulas are not excluded.There is new focal bowel wall thickening and adjacent stranding near the prior colocolonic anastomosis site, which may represent active inflammatory bowel disease or infectious colitis.Neoplastic etiologies are not entirely excluded.Interval increase in size of multiple pericentimeter and subcentimeter short axis mesenteric, retroperitoneal and perirectal lymph nodes.Prominent fatty infiltration of the submucosa involving the ascending colon and the rectum which may represent sequelae of prior inflammatory bowel disease.¿ explant preoperative complaints: ¿ (b)(6) 2018: history and physical: ¿poor wound healing over ventral incisional hernia repair.Wound cultures on (b)(6) 2017 positive for pseudomonas and e-coli, treated with cipro x 7 days.Mesh noted as exposed during an in-office debridement on (b)(6) 2017 and augmentin started after positive enterococcus cultures.Wound vac placed on (b)(6) 2017; discontinued on (b)(6) 2018.Returns today for pre-operative appointment.Continues to have moderate drainage from her midline wound.Denies fever, chills.Endorses diarrhea, no blood, and abdominal pain.Ready to have wound exploration.Exam: abdomen: approximately 5cm x 1cm x 0.5 cm wound oriented vertically.It contains a mix of granulation and gelatinous tissue.Mesh is visible at the base of the wound.A small (0.5cm) sinus is noted inferior to the wound.Active drainage, fibrinous exudate and purulent fluid expressed.Rubber band setons in place.Assessment/plan: non healing midline abdominal wound with underlying mesh infection and non-incorporation.Failed attempts at local wound care.Wound exploration, possible explantation of infected mesh, possible ventral hernia repair with mesh, possible wound vac placement.¿ ¿ (b)(6) 2018: indication: ¿50 y.O.[year old] female with crohn's disease s/p [status post] multiple abdominal operations, complicated by ventral hernias, parastomal hernia, and currently a non-healing midline abdominal wound with underlying mesh infection and non-incorporation.She has failed attempts at local wound care." ¿ (b)(6) 2018: pre-operative diagnosis: ¿mesh infection, chronic wound.¿ explant procedure: wound exploration, explantation of infected mesh.Wound vac placement.Explant date: (b)(6), 2018 [hospitalization (b)(6), 2018] ¿ wound classification: ¿dirty¿ ¿ findings: ¿mesh with chronic wound and scar, purulent to draining skin wounds, all removed in entirety and mesh also removed in entirety.Large skin defect remained at conclusion 15 x 20 cm, partially closed, vac applied to wound and undermined area.¿ ¿ procedure: ¿a #15 blade was then used to circumscribe the abdominal wound complex and electrocautery was used to divide tissues to the level of the external aponeurosis.The total skin defect measuring appx 15x20cm in size.A tissue plane was developed anterior to the aponeurosis and continued bilaterally as well as cranial/caudally, identifying the extent of the underlying mesh.Using kocher clamps to retract, the extent of the mesh was removed with the incorporated aponeurosis with sharp dissection using a curved mayo scissors.Two underlying defects were then identified, one measuring appx 1 x2cm in the left upper region of the wound, just lateral to the rectus, the second noted in the superior midline measuring 2cm x 5cm.A loop of bowel was palpated deep to the midline wound.The defects were closed primarily with interrupted 1-0 prolene suture, with care not injure underlying structures/bowel.The lower 1/3 portion of the wound was reapproximated with 2-0 vicryl suture, with the upper 2/3 of the wound loosely approximated with 2-0 vicryl placed at 2cm intervals leaving a gap of 3 cm between skin edges.A large wound vac sponge was placed within the wound, through the gap, undermining the skin, placed to -125 mmhg.¿ ¿specimens removed: mesh and chronic wound¿ ¿ pathology: diagnosis: ¿ulcerated and inflamed soft tissue with associated mesh, removed clinically secondary to mesh infection and chronic wound.Clinical information: mesh infection, chronic wound.Specimens: infected mesh.¿ gross description:¿ ¿(¿ a.Infected mesh) received fresh is a 134 gram, 16.2 x 6 cm strip of mesh which is surmounted by an 8.2 x 2 cm irregular excision of gray and brown skin.¿ ¿ (b)(6) 2018: discharge summary: ¿diagnosis: chronic mesh infection status post hernia repair.¿ ¿exam: abdomen soft, non-tender, non-distended.No rebound tenderness.Incisional wounds are clean, dry, intact with skin glue.Wound vac in place with serosanguinous output.¿ ¿discharge home.Activity: no strenuous exercise, ambulation as tolerated, no lifting greater than 10 lbs.Wound care as directed with home health nurse managing wound vac.¿ relevant medical information: ¿ (b)(6) 2018: emergency room: ¿wound dehiscence x 1 day.Wound dehiscence x 1 day.Home nurse was changing surgical bandages and noted purulent drainage from left lower region of surgical site and dehiscence of vicryl sutures.Difficulty eating because of pain at surgical site, denies worsening pain.¿ ¿abdomen: tenderness.There is a large open wound with purulent drainage, granulation tissue, and dehiscence.Plan: surgery consult.¿ - (b)(6) 2018: consultation: ¿presents after her wound nurse removed wound vac due to being concerned about dehiscence and purulent drainage.No increased pain, no fever, chills, vomiting, change in bowel habits.Has intermittent nausea.In the emergency department had wet to dry dressing over her wound.Exam: large open abdominal wound with inferior portion sutured closed, rest of incision is open with evidence of good granulation tissue, no purulent drainage, has some fibrinous exudate.Has noted vicryl sutures that have torn free from deep dermal closures.No evidence of fascial dehiscence.Assessment/plan: no evidence of fascial dehiscence.Wound appears to be healing well.Okay to continue with wound vac and follow up in general surgery clinic next week.Wound was packed with wet to dry until am when wound nurse comes and can reapply wound vac.¿ conclusion: it should be noted that the gore® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.¿ the instructions for use warn: ¿incorrect positioning of the shiny film surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.When operative infection is suspected, dissection of involved tissues should be considered.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.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.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.Medical records that indicate mesh ¿movement¿ or that the device lost anchorage may be a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.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.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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