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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Obstruction/Occlusion (2422)
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| Event Date 11/14/2018 |
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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.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopic lysis of adhesions requiring 2 hours of adhesiolysis and parastomal hernia repair with mesh.Implant: ¿gore dualmesh¿; [ni/ni, 15 x 19 cm].Implant date: (b)(6) 2015 (hospitalization [ni]) (b)(6) 2015: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: parastomal hernia with small-bowel obstruction.Postoperative diagnosis: parastomal hernia with small-bowel obstruction.Assistant: (b)(6), md.Indication: the patient is a (b)(6) male who previously underwent an abdominoperineal resection for rectal cancer.He developed a parastomal hernia, which was initially asymptomatic, but has become markedly symptomatic with bowel obstructive symptoms every week.We, therefore, elected to proceed with parastomal hernia repair despite the fact that he had not lost weight as was recommended.He understood risks, benefits, and alternatives as well as the risk of recurrent hernia with his morbid obesity.Intraoperative findings: 1) parastomal hernia with incarcerated small bowel, which was the site of the small-bowel obstruction.2) dense intraabdominal adhesions.Estimated blood loss: 2 ml.Attestation: i was present for the entire procedure.Procedure description: ¿following the induction of general anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion.A 5 mm incision was created in the right upper quadrant and an optical separator was used to gain an entry into the peritoneal cavity, there were no immediate injuries by circumferential inspection.Pneumoperitoneum was achieved.Additional 5 mm trocars were placed in the right lower abdomen, mid abdomen and further in the right upper quadrant.Inspection revealed dense intra-abdominal adhesions and an incarcerated parastomal hernia, numerous adhesions were taken down of the small intestine to the retroperitoneum abdominal wall and parastomal hernia sac.This was ultimately achieved and only the colon conduit was left in place traversing the ostomy site fascia.At this point, we had seen a transition point of the obstruction within the hernia sac.We ensured that interloop adhesions in this area were lysed.We attempted the lysis of small bowel adhesions in the left pericolic gutter and proceeded with this for over 1 hour, but encountered dense adhesions in an area where we could not visualize without proceeding in an open fashion.Because of the risks of recurrent hernia and others with an open surgery, we elected to leave this small intestine in this area.The colon conduit was freed from surrounding small bowel adhesions as well in order to repair this in a standard sugarbaker fashion with the colon conduit entering the mesh in the inferolateral approach.We measured the defect of the hernia itself, which was approximately 5 x 7 cm.A piece of gore dualmesh was selected, which was 15 x 19 cm.The stay sutures were placed at 4 quadrants and the mesh was placed within the abdominal cavity in a sterile fashion through a 15-mm trocar.A finder needle and carter-thomason was used to anchor the mesh with the 4-corner stay sutures, transfascial permanent tacks were placed for securing the mesh circumferentially again with the stoma exiting the mesh after tunneling along the abdominal wall in the inferolateral location.The 15 mm trocar site was closed with interrupted 0 vicryl sutures.The other sites were irrigated and closed with skin suture and/or skin glue.The stoma appliance was applied.The patient was awoken from anesthesia and transferred to recovery room in stable condition.¿ product identification records for the alleged ¿gore dualmesh¿ were not provided.Explant procedure: exploratory laparotomy, takedown of end colostomy, left hemicolectomy, creation end colostomy, lysis of adhesions for 2.5 hours, removal of mesh foreign body from intraluminal small bowel, splenic flexure mobilization, abdominal wall closure with plastic surgery.Explant date: (b)(6) 2018 (hospitalization [ni]).(b)(6) 2018: (b)(6).(b)(6) md.Operative report.Preoperative diagnoses: parastomal hernia, recurrent small-bowel obstruction.Postoperative diagnoses: parastomal hernia, recurrent small-bowel obstruction.Assistant: (b)(6), md.Indication: the patient is a (b)(6) male who previously underwent an abdominoperineal resection for locally advanced rectal cancer.He subsequently developed a parastomal hernia and had a laparoscopic mesh repair of his parastomal hernia several years ago.He has had recurrent small bowel obstructions, likely at the site of his hernia with sometimes almost daily symptoms of nausea and vomiting.He has attempted weight loss and smoking cessation with little success, but because of progression of his symptoms, we elected to proceed with hernia repair.Risks of recurrent hernia were clearly explained to the patient as well as other associated risks with the surgery.Intraoperative findings: 1) no residual mesh on the abdominal wall.2) mesh was entirely intraluminal within the ileum of the small intestine and was extracted from the jejunum in healthy proximal small bowel.3) numerous intra-abdominal adhesions with residual adhesions of the terminal ileum deep within the pelvis! which were not entirely lysed.4) left-sided parastomal hernia and a low midline hernia.Estimated blood loss: for my portion of procedure 350 ml.Attending statement: i was present for the entire portion of the procedure.Medicare statement: ¿i understand that section 1842 (b) (7) (d) of the social security act generally prohibits medicare physician fee schedule payment for the services of assistants at surgery in teaching hospitals when qualified residents are available to furnish such services.I certify that the services for which payment is claimed were medically necessary and that no qualified resident was available to perform the services.I further understand that these services are subject to post payment review by the medicare carrier.¿ procedure description: ¿following the induction of general anesthesia, the patient was positioned in the supine position on the operating room table.His abdomen was widely prepped and draped in the usual sterile fashion.A midline incision was created.Dissection was carried down to the fascia and the peritoneal cavity was entered sharply.There were no immediate adhesions in this location.Ultimately, the incision was extended inferiorly and cephalad in order to have full access to the abdominal cavity.There were adhesions of the small bowel to the anterior abdominal wall, especially denser than the pelvis and the terminal ileum was densely adherent within the pelvis and this was not fully mobilized.After we had taken down all small bowel adhesions to the anterior abdominal wall, we palpated the hernia defect.There was no incarcerated small bowel and in fact this pulled freely away.All small bowel, pulled freely away from the hernia defect.The only contents within the hernia itself was the descending colon approaching the colostomy which were adhesed within the hernia sac.Ultimately, after completely circumscribing the anterior abdominal wall in every direction, the residual adhesions deep in the pelvis were attempted, as there was a large palpable bezoar within the ileum and all the small bowel was dilated immediately proximal to this, but not necessarily distal to this, there was no transition point of small bowel, more proximal to this either.This large palpable bezoar was approximately 2.5 cm in diameter and 8 cm or so in length.Because of the location immediately at the adherent loops within the pelvis, we could not easily extract it in this location and the dilated bowel proximal to this was dilated and very thin walled.Therefore, this was milked back to the mid jejunum and a small enterotomy was created.The bezoar was extracted and placed on the back table and the defect was then closed with ta 60 blue staplers without narrowing the bowel lumen.The massively dilated bowel was also decompressed via this enterotomy and again this was closed with a ta 45 blue stapler.The specimen of the foreign body was then visualized and unfurled on the back table and this was noted to be the mesh which had been placed laparoscopically previously.All 4-corner tacking sutures were in place as well as numerous metal protacks.Likely there were no missing pieces of this mesh and it had been completely rolled as if a cinnamon roll, within the bowel lumen.There were no identifiable fistula between any portion of the colon and the small intestine and again the small bowel was not adherent anywhere near the colostomy site.At this point, we turned our attention to reciting of the colostomy given the giant hernia.Therefore, an incision was created at the mucocutaneous junction of the left-sided colostomy.The colon conduit was dissected free from the hernia sac until we had this within the abdominal cavity.The white line of toldt of the descending colon was scored and the mesentery was fully mobilized, the splenic flexure was mobilized.This was rather adherent in this location and because of breech in length, we ultimately performed essentially a left hemicolectomy in order to reach to the right side of the abdomen.The mesentery was divided with the ligasure device.The colon itself was transected with a gia 60 blue stapler.Once we had adequate reach, we created the right-sided colostomy site at the previously marked stoma site, a circle of cutaneous tissue was removed.Dissection was performed down to the level of the fascia.A circle of the anterior fascia was removed.The rectus was spread and the posterior sheath was opened.The colon was brought through this aperture ensuring viability.We then turned our attention in the abdominal cavity.It was hemostatic.Small bowel was ran.There were no other injuries.Again, there was no notable fistula or entered side of the mesh within the small intestine.We then matured the colostomy after amputation of the staple line and in a standard brooke fashion with 3-0 vicryl sutures.Plastic surgery then closed the abdominal cavity.The patient was then awoken from anesthesia and transferred to the recovery room in stable condition.¿ 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.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.
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Event Description
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It was reported to gore that the patient underwent laparoscopic parastomal hernia repair on (b)(6) 2015 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: lysis of dense adhesions, recurrence, bowel obstruction, removal of mesh, mesh shrinkage, and pain and suffering.Additional event specific information was not provided.
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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® 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.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.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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