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| Device Problem
Insufficient Information (3190)
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| Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/19/2010 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore® dualmesh® 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.".
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Event Description
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It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: chronic pain, adhesion, hernia recurrence, mesh erosion and swelling abdomen.Additional event specific information was not provided.
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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: relevant medical information: (b)(6) 2008: (b)(6) center downtown.(b)(6).Operative report.Preoperative diagnosis: crohn disease with severe terminal ileitis.Postoperative diagnosis: crohn disease with severe terminal ileitis.Operation/procedure performed: resection of terminal ileum and cecum.Anesthesia: general.Anesthesiologist: dr.(b)(6).Operative indications: a 47-year-old man with severe crohn disease refractory to remicade and other modalities, presents for resection of his terminal ileal disease.Operative procedure in detail: ¿the patient was placed supine.After induction of suitable general anesthesia, the abdomen was prepped with chloraprep and draped in the sterile fashion.A midline incision was made beginning in the midupper abdomen and extended to the right of the umbilicus and down toward the pubis.The peritoneal cavity was entered.We immediately encountered a large mass of thickened grossly abnormal loops of terminal ileum forming an inflammatory mass of active crohn disease.Proximal to this mass, the ileum was divided with the gia stapler 55-mm regular.The cecum was mobilized.The right colon was divided midway between the cecum and hepatic flexure.The right colon mesentery was divided with harmonic scalpel very close to the bowel wall so as to minimize interference with blood supply.The small bowel mesentery was also taken relatively close to the bowel wall with the harmonic scalpel and the ileocolic vessels were divided between clamps and ties with 0 silk.The mesentery was thickened and edematous.After completion of the mesenteric division, the specimen was removed.The small bowel was approximated to the ascending colon in a side-to-side fashion.A side-to-side 55-mm stapled anastomosis was performed with a gia stapler.The enterotomies were closed with running full-thickness 3-0 vicryl and protected with an outer roll of interrupted 3-0 muscular 3-0 silk.The mesenteric defect was closed with interrupted 3-0 silk.The operative field was irrigated with antibiotic irrigating solution.The fascia was closed with running #1 pds.Skin was closed with staples.Sterile dressing was applied.The patient was transported to recovery in satisfactory condition.Needle, sponge, and instrument counts were correct.Specimens submitted: [blank].Estimated blood loss: about 250 ml.Condition/disposition upon completion: see above.¿ (b)(6) 2009: (b)(6) medical center.(b)(6).Radiology ¿ chest pa & lateral.Indication: high blood pressure, smoking history.Impression: no acute cardiopulmonary disease.Implant procedure: incisional ventral hernia repair using gore-tex dual mesh.Implant: [ni, not indicated].Implant date: (b)(6) 2010 (hospitalization (b)(6) 2010).(b)(6) 2010: (b)(6) medical center downtown.(b)(6).Operative report.Preoperative diagnosis: incisional ventral hernia.Postoperative diagnosis: incisional ventral hernia.Assistant: (b)(6).Anesthesia: general.Anesthesiologist: dr.(b)(6).Operative indications: a 48-year-old man underwent a right colon resection 2 years ago for crohn disease.Subsequently, he has gained over 130 pounds and has developed a complex incisional hernia beneath the umbilicus.It was our hope to achieve laparoscopic repair.Operative procedure in detail: ¿the patient was placed supine.After induction of suitable general anesthesia, the abdomen was prepped with chloraprep and draped in a sterile fashion.A 5-mm incision was made in the left upper lateral abdomen.A 5-mm 0-degree laparoscope was placed within a 5-mm bladeless trocar which was advanced under direct vision into the peritoneal cavity.A loop of small bowel was found densely adherent to the umbilicus region.The supraumbilical surgical scar area revealed no evidence of incisional hernia.A ventral hernia existed inferior to the umbilicus and had a very complex system of sacs and extended down to the pubis.At this point, i elected to convert to an open procedure out of concern for satisfactory fixation techniques beneath the pubis via the laparoscopic approach.The laparoscopic instrumentation was removed.An infraumbilical vertical incision was made and deepened into the subcutaneous plane.A complex hernia sac was identified and was dissected free of subcutaneous adhesions.The sac was dissected back to the fascial edges circumferentially, and skin flaps were then created defining the surrounding fascia for 3- to 4-cm area circumferentially.The incision did have to be extended into the supraumbilical area.The sac was then opened and fully debrided.The vertical length of the fascial defect was 27 cm.A 24 x 36 cm gore-tex dual mesh was selected and cut to appropriate length and width.The mesh was placed in an underlay position using #1 ethibond sutures placed through-and-through the anterior abdominal wall, 3 to 4 cm lateral to the fascial edge.The sutures were placed at 2 cm intervals with great care taken to protect underlying bowel.The mesh was cut to a width of about 10 cm.The fascial edges remained about 4 cm apart.A #10 flat jackson-pratt drain was placed over the mesh and brought up through an inferior stab incision.Subcutaneous scar tissue was closed with a running 2-0 vicryl.Skin was closed with staples.The drain was placed to bulb suction and secured to the skin with a silk suture.Sterile dressing was applied.The patient was transported to recovery in satisfactory condition.Needle, sponge, and instrument counts were correct.(b)(6) , provided the first assistant services throughout the entirety of the procedure.Specimens submitted: [blank].Estimated blood loss: minimal.Condition/disposition upon completion: see above.¿ records for the alleged ¿gore-tex dual mesh¿ were not provided.Relevant medical information: (b)(6) 2010: (b)(6) medical center.(b)(6).Pathology report.Specimen sources: hernia sac, herniorrhaphy.Diagnosis: fibroadipose tissue consistent with hernia sac.(b)(6) 2010: (b)(6) medical center downtown.(b)(6).Discharge summary.Admit date: (b)(6) 2020.Final diagnosis: complex incisional ventral hernia.Admission diagnosis: hypertension.Additional diagnoses: hypokalemia, crohn¿s.History: underwent right colon resection in (b)(6) 2008 for crohn¿s, gained substantial amount of weight and developed complex incisional hernia.Course: underwent open repair of ventral hernia utilizing gore-tex dual mesh.Postoperative course characterized by initial ileus as well as hypertension and hypokalemia.Ileus resolved by postop day 3, was started on liquid diet, tolerated well.Required adjustment of hypertensive medications and potassium replacement and was kept in hospital until 5th postop day, discharged doing well.(b)(6) 2010: (b)(6) medical center.(b)(6).Radiology ¿ ct abdomen/pelvis with contrast.Indication: patient with abdominal pain and ventral hernia repair.Findings: anterior abdominal wall mesh in place for hernia repair.No evidence for recurrent hernia.Small amount of fluid just superficial to inferior-most extent of the mesh within the abdominal wall.This likely represents a small seroma.Impression: mesh in place for anterior abdominal wall hernia repair without evidence for recurrent hernia.No abscess, obstruction or free air.There does appear to be a small seroma superficial to the inferior aspect of the mesh.(b)(6) 2010: (b)(6) medical center.(b)(4).Radiology ¿ ct abdomen with oral and iv contrast.Indication: recurrent ventral hernia.Patient states he had surgery to repair hernia in (b)(6) 2010 and had colon resection prior to that in (b)(6) 2009.There was a seroma fluid collection present after the surgery.Findings: evidence of anterior abdominal wall mesh from the prior hernia repair.There is a little more bulging anteriorly of the mesh particularly at the level of the umbilicus where the mesh now reaches 5-6 mm deep to the umbilicus at its closest point and previously was approximately 16 mm deep to the umbilicus.The mesh extends to the inferior extent of this examination.The previously described seroma ventral to the mesh is not included on this examination as that was technically over the pelvis.Along the right lateral side of the hernia mesh best visualized on axial image #53 of series #2, also coronal image #9 of series #300 at the level just below the umbilicus.There is some change in the appearance of the hernia mesh where there is now some fat in the beginning of a small bowl loop protruding lateral to the margin of the mesh.This is likely the early development of a recurrent hernia along the right lateral side of the mesh just below the level of the umbilicus.At this time, there is no evidence of bowel obstruction.Impression: while the hernia mesh appears intact centrally, there is no herniation of a small amount of mesenteric fat and the beginning of a small bowel loop protruding just to the right lateral side of the mesh at a level just below the umbilicus without bowel obstruction at this time.There is also less subcutaneous fat between the mesh and the deep surface of the umbilicus.Small 11 mm likely benign nodule left adrenal gland.Degenerative changes in the spine.(b)(6) 2010: (b)(6) medical center downtown.(b)(6).Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Operation/procedure performed: laparoscopic recurrent ventral hernia repair.Assistant: (b)(6).Anesthesia: general.Anesthesiologist: dr.(b)(6).Operative indications: a 49-year-old man who underwent resection for crohn disease, required a ventral hernia repair last year.We attempted to do this laparoscopically but the hernia extended well under the lower abdomen and because of his morbid obesity and difficulty with obtaining adequate fixation point in the lower abdomen, the procedure was converted to an open repair.He has developed a localized recurrence along the right upper edge of the mesh.Operative procedure in detail: ¿the patient was placed supine.After induction of suitable general anesthesia, the abdomen was prepped with chloraprep and draped in a sterile fashion.A 5-mm incision was made in the left upper abdomen.A 5-mm 0 degree laparoscope was placed within a 5-mm bladeless trocar which was advanced under direct vision into the peritoneal cavity.A co2 pneumoperitoneum was established.There were adhesions to the central mesh and hernia sac but the left abdomen was free allowing placement of a 5-mm trocar in the left lower abdomen and a 12-mm trocar placed in the left lateral abdomen.Dissecting instruments were introduced.We switched to an angled 5-mm scope.A 30-minute adhesiolysis was required to clear the omental adhesions from the mesh and hernia sac.The hernia sac along the right superolateral aspect of the previous mesh repair was studied and found to measure approximately 4 x 6 inches.A 20 x 25 cm mesh was selected and placed over the abdominal wall.The insufflation pressure was reduced to 8 mmhg.Marks were made at 90 degree intervals on the abdominal wall and mesh for fixation sutures of 0 gore-tex.The mesh was then tightly rolled and introduced through the 12-mm port.The mesh was then unfurled at the premarked site.Small incisions were passed and tied in the subcutaneous plane.Four additional fixation sutures were placed through small incision under direct vision using the disposable suture passer at 90 degree intervals.After placement of 8 fixation sutures, the fixation was then completed with absorbotack tacker with placement of tacks at 1 cm interval circumferentially.Hemostasis was intact.The fascia at the 12-mm port was closed with 0 gore-tex using the suture passer under video guidance.The remaining trocars were removed.The pneumoperitoneum was released.The skin incisions were closed with interrupted subcuticular 4-0 vicryl.An abdominal binder was placed.The patient was transported to recovery in satisfactory condition.Needle, sponge, and instrument counts were correct.(b)(6), provided first assistant services for the entire procedure.Specimens submitted: [blank].Estimated blood loss: minimal.Condition/disposition upon completion: see above.¿ (b)(6) 2018: (b)(6) medical center.(b)(6).History and physical.Presented with syncope, occurred this afternoon.Sudden and loss of consciousness.Endorses feeling lightheaded, sweaty and clammy prior to passing out.Has never passed out before.Had been a crack smoker for a few years but quit recently and smokes tobacco daily.History of crohn¿s, hernia, hypertension, polysubstance abuse, tobacco use.Denied alcohol use.Exam: abdomen; protruding hernia, soft, nontender, nondistended, positive bowel sounds all 4 quadrants, no organomegaly, no palpable or pulsatile abdominal masses, no bruits.Impression: chest pain, syncopal episode.Plan: likely secondary to vasovagal/neurocardiac syncope vs atypical angina.Trop negative, ecg no acute abnormalities.(b)(6) 2018: (b)(6) medical center.(b)(6).Discharge summary.Admit date: (b)(6) 2018.Course: history of hypertension and previous cocaine now in remission, presented to er after collapsing in jail.Had gone there to visit his girlfriend, while he was taking to her over the provided phone he felt dizzy, nauseated and that he was going to pass out.He left and walking towards the elevator collapsed and remember being surrounded by prison guards.Ruled out for myocardial infarction by negative x 3 cardiac enzymes, had exercise stress test, normal.Was previously homeless while on illicit drugs not that he is no longer doing it no employed.Still using sulzbacher and i have encouraged him to continue to abstain.Explant procedure: [ni] [not indicated].Explant date: [ni] (hospitalization [ni]).A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® dualmesh® 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.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.Through gore's investigation and based on the available information 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 were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® 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.¿ 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.Based upon the information received, the device remains in the patient and was not available for evaluation.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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