|
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)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant perioperative complaints: on (b)(4) ,2013: (b)(6).Indication: this patient presents with reducible ventral hernia and will undergo laparoscopic ventral hernia repair.The patient was seen again in the holding room.The risks and benefits, including but not limited to recurrence and mesh infection requiring removal were explained to the patient, who acknowledges these risks and wished to proceed.Implant procedure: laparoscopic ventral hernia repair.Implant: gore® dualmesh® plus biomaterial [1dlmcp03/(b)(4) , 10cm x 15cm x 1mm, thick, oval] implant date: on (b)(6) ,2013 (same day surgery).On (b)(6), 2013: (b)(6): operative report.Pre-operative diagnosis: epigastric and umbilical hernias.Post-operative diagnosis: same.Anesthesia: general endotracheal anesthesia.Procedure details: ¿the patient was taken to operating room, identified as (b)(6) and the procedure verified as laparoscopic ventral hernia repair.A time out was held and the above information confirmed.Prior to the induction of general anesthesia, antibiotic prophylaxis was administered.General endotracheal anesthesia was then administered and tolerated well.After the induction, the abdomen was prepped in the usual sterile fashion.The patient was positioned in the supine position with the arm extended.All ports were injected with a combination of short and long acting local anesthetic prior to incision.An incision was made in the right upper quadrant, just off the coastal margin.Access to the abdomen was obtained using an optical viewing 11 mm trochar with a 0 degree laparoscope.A pneumoperitoneum to 15 mm hg was obtained.The underlying bowel was inspected and found to be free of injury.A 5 mm port was placed in the right lateral abdomen to facilitate dissection.The ventral hernias were identified and measured to be approximately 5 x 8 cm in aggregate dimension.A combination of blunt dissection and electrocautery were used to reduce the hernia contents back into the abdomen.The defect was measured and a 10 x 15 cm piece of gore dualmesh was chosen to cover the defect.Gore sutures were placed at the superior and inferior margins of the mesh, as well as the right and left lateral edges of the mesh.The mesh was rolled up and inserted through the 11 mm trochar, then unrolled within the abdomen.Stab incisions were made on the anterior wall corresponding to the suture on the mesh.A gore suture passer was used to grasp the loose ends of the sutures and pull them through the abdominal wall.Once all of the sutures were brought through, they were tied down.The mesh was inspected and found to lie flush with the abdominal wall, and under no tension.The securestrap was used to place tacks at 1 to 1.5 cm intervals around the circumference of the mesh.The insufflation was then expelled from the abdomen, and all ports were removed.The skin over all incisions were closed using 4-0 monocryl deep dermal sutures.Dermabond was applied and the patient was aroused and transferred to the recovery room in stable condition.Instruments, sponge, and needle counts were correct at closure and at the conclusion of the case.There were no immediate complications.¿ findings: 2 ventral defects.Estimated blood loss: minimal.Drains: none.Total iv fluids: see anesthesia records.Specimens: none.Complications: none; patient tolerated the procedure well.Disposition: pacu- hemodynamically stable.Condition: stable.On (b)(6), 2013: (b)(6).Implant record.Implant name: (b)(6).Pls.Model no: 1dlmcp03.Lot no: 10497717.Site: abdomen.Expiration date: (b)(6), 2015.Size: 10 cm x 15 cm x 1 mm.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/(b(4) was implanted during the procedure.On (b)(6), 2013: (b)(6) discharge summary.Admit date: (b)(6), 2013.Discharge date: no discharge date for patient encounter.Final diagnosis: no post-op diagnosis entered.Discharged home or self care.Discharge medication list: aspirin 81 mg.No lifting greater than 10 pounds for 6 weeks.Explant preoperative complaints: on (b)(4), 2015: (b)(6), abdomen/pelvis: findings: the stomach is moderately well distended.Evidence of prior mesh ventral abdominal hernia repair is noted.Again noted are 3, midline ventral supraumbilical hernias.The two cephalad hernias contain fat only.The one just above the umbilicus contains a short segment of small bowel which represents an interval change compared to on (b)(6), 2014.This hernia is located along the right lateral margin of ventral abdominal mesh.A portion of the hernia is excluded secondary to patient body habitus.There is also limitation secondary to artifact in this location.Mild stranding is present within the hernia sac.Impression: three, ventral, midline supraumbilical hernias are noted, the most inferior of which contains a short segment of nonobstructed small bowel.Correlation for reducibility recommended.No definite ct signs of strangulation at this time.Diffuse hepatic steatosis, small adrenal adenoma and splenomegaly also noted.On (b)(6), 2015: (b)(6) history and physical.Presented with severe abdominal pain.History of previous ventral hernia repair.Done well until 2 months ago when he noticed pain and pressure around his umbilicus.Was told to follow up with me and didn¿t for some reason.Returns with worsening pain.+ nausea.History of hypertension, gout.Surgical history abdominal hernia repair.Never smoker; current smokeless tobacco user.Exam: abdominal tenderness.There is no rebound.Nonreducible, tender hernia in epigastric area.Impression/plan: recurrent ventral hernia with incarceration, morbid obesity.Or for emergent repair, likely removal of old mesh.On (b)(6), 2015: (b)(6).(b)(6) indications: this patient presents with reducible ventral hernia and will undergo laparoscopic ventral hernia repair.The patient was seen again in the holding room.The risks and benefits, including but not limited to recurrence and mesh infection requiring removal were explained to the patient, who acknowledges these risks and wishes to proceed.Explant procedure: laparoscopic ventral hernia repair explant date: on (b)(6), 2015 (hospitalization on (b)(6), 2015).On (b)(6), 2015: (b)(6).(b)(6), operative report.Pre-operative diagnosis: recurrent incarcerated ventral hernia.Post-operative diagnosis: same.Anesthesia: general endotracheal anesthesia.Asa class: 2.¿ procedure details: ¿the patient was taken to operating room, identified as (b)(6) and the procedure verified as laparoscopic ventral hernia repair.A time out was held and the above information confirmed.Prior to the induction of general anesthesia, antibiotics prophylaxis was administered.General endotracheal anesthesia was then administered and tolerated well.After the induction, the abdomen was prepped in the usual sterile fashion.The patient was positioned in the supine position with the arms extended.All port were injected with a combination of short and long acting local anesthetic prior to incision.An incision was made in right upper quadrant, just off the costal margin.Access to the abdomen was obtained using an optical viewing 11 mm trochar with a 0 degree laparoscope.A pneumoperitoneum to 15 mm hg was obtained.The underlying bowel was inspected and found to be free of injury.A 5 mm port was placed in the right lateral abdomen to facilitate dissection.The ventral hernia was identified and measured to be approximately 4 cm in greatest dimension.A combination of blunt dissection and electrocautery were used to reduce the hernia contents back into the abdomen.The previous mesh was found to be retracted in this area.It is impossible to say whether this is a new defect forming lateral to the mesh or the previous mesh retracting, exposing an old defect.There were several other defects identified when the old mesh was removed.The fascia was reapproximated in the midline using 0 vicryl interrupted sutures.A 10 x 16 piece of strattice was chosen to cover the defect.Gore sutures were placed at the superior and inferior margins of the mesh, as well as the right and left lateral edges of the mesh.The mesh was rolled up and inserted through the 11 mm trochar, then unrolled within the abdomen.Stab incisions were made on the anterior abdominal wall corresponding to the sutures on the mesh.A gore suture passer was used to grasp the loose ends of the sutures on the mesh and pull them through the abdominal wall.Once all of the sutures were brought through, they were tied down.The mesh was inspected and found to lie flush with the abdominal wall, and under no tension.The sorbafix was used to place tacks at 1 to 1.5 cm intervals around the circumference of the mesh.The insufflation was then expelled from the abdomen, and all ports were removed.The skin over all incision were closed using 4-0 monocryl deep dermal sutures.Dermabond was applied and the patient was aroused and transferred to the recovery room in stable condition.Instrument, sponge, and needle counts were correct at closure and at the conclusion of the case.There were no immediate complications.¿ findings: recurrent ventral hernia, no bowel found in defect.All bowel viable.Incarcerated omentum.Estimated blood loss: minimal.Specimen: none.Complications: none; patient tolerated the procedure well.Disposition: pacu- hemodynamically stable.On (b)(6), 2015: (b)(6) implant record.Laparoscopic strattice reconstructive tissue matrix.On (b)(6),2015: (b)(6).(b)(6).Clinical diagnosis/information: 37 year old male with past medical history of hypertension and abdominal hernia, to emergency department complaining of severe on and off abdominal pain worsening about 45 min ago.Preoperative diagnosis: ventral hernia.Post-operative diagnosis: same.Specimen: removed mesh.Final pathologic diagnosis: segment of mesh accompanied by fibrosis and foreign body granulomatous inflammation.Gross description: specimen is labeled removed mesh.Received in formalin is a piece of synthetic mesh with adherent fibrous, white tissue.The mesh is a yellowish tan color and measures 10 x 6 x 0.2 cm.Some of the tissue is more friable in appearance and fibrous.¿ (b)(6), 2015 [assigned]: on (b)(6).(b)(6) discharge summary.Admit date: (b)(6), 2015.Principle problem: recurrent ventral hernia with incarceration.Hospital course: admitted with severe abdominal pain, found to have recurrent hernia with incarceration, small bowel found in defect by ct.Taken to operating room for repair.Postoperatively his bowel function took several days to return, and pain control was a problem.By time of discharge he was tolerating regular diet with normal bowel function, pain well controlled on oral meds.Discharged in good condition.Discharged home or self care.Follow up with (b)(6) on (b)(6),2015.Relevant medical information: (b)(6), 2016:(b)(6), abdomen/pelvis.Findings: there are at least 3 right paramedian small supraumbilical fat containing ventral hernias (2 of which are new), interval left paramedian supraumbilical small ventral hernia containing mesenteric fat and small portion of a single normal caliber small bowel loop, and 1 chronic periumbilical small ventral hernia containing a single loop of mildly dilated small bowel.There are a few noncontiguous prominent and also mildly dilated small bowel within the midline mid to upper abdomen without abrupt transition, but could be related to partial small bowel incarceration.Impression: findings concerning for partial small bowel obstruction, probably secondary to partial small bowel incarceration within a periumbilical hernia, as above.No abrupt transition identified.No definite ct signs of strangulation at this time.Surgical consultation may be warranted.3 additional small fat containing ventral hernias, and 1 supraumbilical left paramedian small ventral hernia which contains minimal portion of a normal caliber small bowel loop, as above.Splenomegaly.Grossly stable small right adrenal nodule.(b)(6), 2016: (b)(6).History and physical.History of ventral hernia repair x 2.Has been trying to lose weight, but is unable to exercise due to pain from hernia.Now with acute worsening of pain, no bowel movement for 2 days and minimal flatus.History of sleep apnea.Exam: abdominal tenderness.A hernia (multiple reducible hernias around umbilicus) is present.Impression/plan: hernia, small bowel obstruction, morbid obesity.Recurrent hernias secondary to morbid obesity.High likelihood for recurrence until he can lose weight.Lost about 15 pounds since this time last year.Small bowel not very dilated proximal to hernia.Will check small bowel follow-through to see if he is truly obstructed.If he is, will need repair this admit.If not, will try to begin workup for bariatric surgery prior to repair.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.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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as 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.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 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.
|
