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| Model Number 1320030020 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Erosion (1750); Unspecified Infection (1930); Perforation (2001); Hernia (2240)
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| Event Date 10/12/2017 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material".
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Event Description
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It was reported to gore that the patient underwent open diaphragmatic hernia repair on (b)(6) 2014 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, infected mesh, bowel perforation, mesh migration, abscess, mesh erosion, removal of infected mesh and adhesions.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.It should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2014 : usaf (united states air force).(b)(6) md.Indications: ¿(b)(6) is a pleasant 64-year-old veteran who was being followed for what was apparently a benign pulmonary nodule but was discovered to have a giant diaphragmatic hernia on imaging studies.The patient has had some shortness of breath and inability to perform strenuous activity for quite some time and his pulmonary function test indicated some restrictive pattern.The patient had imaging which demonstrated a good portion of the colon as well as just about all the stomach in the patient's chest cavity in the hernia sac.As such, the patient and i along with his wife had a long discussion about the risks and benefits of proceeding with surgery compared to the risks of medical management.After careful thought, he elected to proceed with surgical correction of the defect.¿ implant procedure: endoscopic gastroduodenoscopy; left thoracotomy; reduction of diaphragmatic hernia and resection of hernia sac; collis gastroplasty; nissen fundoplication; repair of hernia defect with 2mm gore-tex mesh.[implant: gore-tex® soft tissue patch, 1320030020/12035444, 20cm x 30cm x 2mm thick] implant date: (b)(6) 2014 [hospitalization dates unknown] (b)(6) 2014: usaf.(b)(6), md.Operative report.Assistant: (b)(6).Pre and postoperative diagnoses: giant diaphragmatic hernia.Anesthesia: general.Estimated blood loss: 300 cc.Specimens: hernia sac.Drains: chest tube x 3.Complications: none.Wound classification: not provided.Procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating room table.After the successful induction of general endotracheal anesthesia, an egd [esophagogastroduodenoscopy] scope was passed down the esophagus.The ge [gastro-esophageal] junction was indeed measured at 41cm and there was no mucosal irregularities.The scope was withdrawn a double lumen endotracheal tube was placed.There was quite a bit of difficulty placing the double lumen endotracheal tube and there was quite a bit of edema at the end of this portion of the procedure.However, once we were satisfied with the position, the patient was positioned in the right lateral decubitus position and then prepped and draped in usual sterile fashion.A cervical [sic] timeout was performed.A thoracotomy incision was made over the 7th intercostal space.This was carried down through the latissimus dorsi muscle and through the intercostals to enter the pleural space.A rib spreader was then used to open the chest and expose the pleural cavity.There was a giant hernia defect that [sic] easily be seen upon entering the chest.We meticulously dissected the hernia sac off from the surrounding structures, which included along the pericardium, the left inferior pulmonary ligament, and some of the diaphragm.Once this was accomplished, we entered the hernia sac and transected it so as to resect the sac in preparation for repair of the hernia.Once this was accomplished, there were multiple adhesions inside the hernia sac that needed to be lysed in order to deliver the contents of the hernia sac back into the abdomen.There was some loss of domain apparent after this portion of the case.It became apparent that the esophagus was too short to deliver the eg [esophagogastric] junction back into the abdominal cavity.As such, the collis gastroplasty was then performed using a purple load endo gia stapler and using a #54 french bougie as a guide.After this was accomplished, a 360-degree nissen fundoplication posterior wrap was then performed with the part of the stomach that was used for the gastroplasty.After this was accomplished, the remaining portion of the abdominal contents were then delivered down into the abdominal cavity and interrupted #1 prolene sutures were placed around the entire ridge of the hernia defect.Once this was accomplished, these sutures were then placed through a 2mm gore-tex mesh which was fashioned to cover the defect and also was fashioned with a hole in the middle to allow the esophagus to enter the abdominal cavity through this portion of the mesh.Sutures were all tied down and the mesh was parachuted into the defect when we were quite pleased with the positioning of the mesh and the repair that this created.At this point, antibiotic irrigation was introduced into the pleural cavity and a blake chest drain was placed into the right pleural space which had been entered at one point during the dissection of the hernia sac.A right angle and a straight chest drain was [sic] then placed in the left pleural space.The ribs were reapproximated with monofilament suture and then the remaining portion of the wound was closed in layers.A dry sterile dressing was applied over the top of this and then the patient was taken to the cardiovascular intensive care unit in fair condition.The patient was taken over the [sic] icu intubated with the plan to keep him intubated overnight due to the fact that there was difficulty placing the double lumen endotracheal tube and there was edema of the airway that was seen after last placement.I was present for all critical portions of the procedure.¿ [date n/i.] (b)(6) medical center.Implant record: ¿soft tissue patch¿.Site.Manufacturer: gore.Cat#: 1320030020.Lot#: 12035444.Size: 20.0cm x 30.0cm x 2.0mm.Expiration date:10-2018.Quantity: 1.Explant preoperative complaints: (b)(6) 2017: (b)(6), md.Indications: ¿the patient is a 67-year-old man with history of prior paraesophageal hiatal hernia who underwent a prior left thoracotomy, combined collis gastroplasty, and nissen fundoplication, and placement mesh in the diaphragm in january of 2014.His postoperative course showed recurrence of the diaphragmatic hernia and mesh erosion into the distal esophagus.Biopsies of the tissue showed that he grew actinomyces and was treated for 1 year with antibiotics.Due to this chronic mesh erosion, he was referred to the (b)(6) hospital for further management.Our review of his chart showed the mesh was in the lumen of the distal esophagus with some extension into the proximal stomach.There was slow transit of contrast through the ge junction due an eccentric mass effect from the mesh and repeat endoscopy here confirmed the same findings as the prior endoscopy with the mesh erosion.Our evaluation showed he had a severe malnutrition and, therefore, had a laparoscopic feeding jejunostomy tube placed and received tube feeds in addition to oral nutrition preoperatively to help increase his nutrition status.His preoperative prealbumin normalized to 26 and albumin was 3.1.Due to this chronically infected mesh, he is consented to undergo mesh removal and possible distal esophagectomy and reconstruction to help with his problem.He consented for the procedure and we proceeded.¿ explant procedure: 1.Removal of infected mesh from the gastroesophageal junction.2.Gastrorrhaphy and esophageal repair.3.Gastrostomy tube placement.Explant date: (b)(6) 2007 [hospitalization dates unknown] (b)(6) 2017: (b)(6), md.Operative record.Assistant: (b)(6), md.Preoperative diagnosis: chronically eroded mesh at the gastroesophageal junction.Postoperative diagnosis: chronically eroded mesh in the gastroesophageal junction with chronic perforation.Anesthesia: general.Estimated blood loss: 300 ml.Wound classification: not provided.Findings: ¿the [sic] mesh had eroded into the esophagus and stomach at the ge junction, and it also had erroded [sic] through the nissen wrap and stomach in another location.There was a 100 cc abscess cavity around the mesh.The mesh erosion caused perforation at the ge junction (esophagus and stomach), the wrap, and another area of the stomach.With dissection this abscess cavity and the walled off perforations became evident.The fluid in the abscess cavity was sent for culture (as was a portion of the infected mesh).The esophagus was densely adherrant [sic] to the aorta, mediastinum, and posterior pericardium ¿ making mobilization to normal esophagus impossible.The patient also had several episodes of sbp [systolic blood pressure] to the 70sm, which was treated with pressors.Because of these findings [sic].We removed the mesh from the stomach /esophagus and closed the areas of perforation.We could not mobilize to healthy esophagus due to the findings noted above.We also placed a gastrostomy tube.The gallbladder was noninflamed and did not have palpable stones present (and was not removed).¿ procedure: ¿the patient was brought to the operating room and an epidural catheter was placed.He was then intubated and all pressure points were padded.His abdomen was prepped and draped in the usual sterile fashion.He had a foley catheter placed an attending [sic] time out was performed.He received preoperative antibiotics with ertapenem.We began with a midline incision from above the xiphoid down below the umbilicus.Dissection was taken down to the fascia and was entered in the midline.The abdomen was entered sharply and the round ligament was divided.We then placed omni retractor and retracted the bilateral upper abdominal walls laterally and retracted [sic].We took down the left triangular ligament to mobilize the left lobe of the liver and then retracted the liver cranially.We began to examine the whole abdomen and saw the gastrocolic ligament was very fused and the lesser sac was difficult to identify.We dissected in this plane and were able to enter the lesser sac with caution on the inferior edge of the stomach.This dissection was continued medially and laterally to expose the posterior aspect of the stomach and laterally towards the short gastrics, some of which were still there despite his prior operation and these were taken with a ligasure.Since the anterior portion of the stomach was involved in the mesh infection, we approached the area posteriorly using the less inflamed plane for our approach.After mobilizing much of the distal stomach, we moved up to the more proximal lateral stomach and took down some adhesions to the spleen.The spleen and retroperitoneal tissues were retracted laterally.We also worked at the pars flaccida, which appeared to be very chronically thickened and dissected in this plane to try to enter the lesser sac from this approach.Anteriorly the stomach, wrap, and esophagus were adherrant [sic] to the diaphragm.As we worked proximally and posteriorly we encountered a retrogastric chronic abscess cavity with prurient dark fluid (about 100 cc).This was sent for culture and suctioned out.There was an opening into the stomach at the base of this abscess and exposed mesh as well.The area was irrigated out, we could see that the mesh had eroded through the stomach in this location.We continued to work proximally and were able to identify a plane above this area and using blunt dissection, we were able to get around the whole stomach from the pars flaccida to the greater curvature and placed a penrose drain around the mid stomach.This was retracted caudally and dissection was continued along the more superior border of the stomach.This area was all very chronically inflated and stuck to the diaphragm.A lot of gentle blunt dissection as made along what appeared to be the right diaphragmatic crura in the anterior diaphragmatic hiatus.We were able to make some progress to define a plane between what looked like the herniated stomach along the right medial edge and gained some length and were able to pull down some of the stomach into the abdomen.We then worked on the lateral and posterior aspect to free up additional short gastric for additional tissue at the level of the fundus and found there was many chronic and hard adhesions around the ge junction.We could feel intraluminal mesh in the proximal stomach and distal esophagus and this was extremely hard.We continued to work circumferentially along the anterior border of the gastroesophageal junction to continue to try to define a plane from the diaphragm.We could feel the chronically eroded mesh underneath the soft tissue and this appeared to be eroding through as well.While dissecting the ge junction off of the diaphragm, chronic areas of erosion were exposed and we encountered mesh eroding through the ge junction (stomach and esophagus).We could see the intraluminal mucosa.The mesh also eroded through and through the wrap (and encircled a portion of it).In all there were a total of 3 areas of mesh erosion.One was on the right medial aspect, one on the left lateral aspect, and the previously mentioned posterior proximal gastric aspect.The esopahgus [sic] was denselly [sic] adherrent [sic] to the diaphragm and aorta, especially on the left side, and it was also friable, due to the mesh erosion, which made mobilization to normal esophageal tissue impossible.Even on the right, where there was no erosion, the esophagus was densely adherrent [sic], and we could not get up to normal esophagus.In addition, during the procedure the patient had several esisodes [sic] of hypotension during the case, with systolic pressures in the 70s.This responded to pressors, and he was being maintained on a neo [neo-synephrine] drip.At this point, given the chronic adhesions, the friability of the esophagus (preventing mobilization to normal esophagus), and his hemodynamic instability, it was clear that the patient would not tolerate a thoracotomy to help with further esophageal mobilization.Therefore, we proceeded to remove the mesh and repair the openings caused by the mesh erosion, and provide wide drainage to maximize the chance that he would heal by removing the infection source.We removed the infected mesh through the left lateral gastrotomy (caused by the mesh erosion) near the ge junction.We grasped the edge of the mesh that was already eroding through and gently followed it, pulling it out of the stomach and esophagus.We were able to pull this out of the hole and had to cut prolene sutures that had been keeping it in place.The mesh had appeared to chronically erode into the ge junction and was in the posterior aspect, encapsulated in a chronic abscess cavity, and it encircled portions of the wrap (which had eroded through and through).After removing the mesh, we then irrigated the upper abdomen and we assessed our ge junction.We passed an ng [nasogastric] tube through the esophagus into the stomach.We identified the openings caused by the mesh and closed these with interrupted 2-0 silk sutures.We also then placed interrupted 2-0 silks along the right lateral ge junction hole as well and also from the esophagus onto the stomach in a transverse fashion.After performing these 2 closures, we lifted the stomach to the right and exposed the posterior ge junction.Several interrupted 2-0 silk sutures were again placed transversally from the inferior edge of the stomach to the distal esophagus.These appeared to close all the holes visually.We used an endo stitch device to place some sutures posteriorly.We also closed the posterior gastrotomy, which was approximately 2 cm in length, which was where the mesh had eroded and caused [sic] an abscess cavity.This was closed using interrupted 2-0 silk sutures and additional 2-0 silk sutures used in a lembert fashion at 3 areas.At this point we noted that all the openings caused by the mesh erosion were repaired.We then irrigated the abdomen with warm saline, as well as antibiotic irrigation.There was adequate hemostasis in the whole area and we sprayed 20 ml of fibrin tissue sealant across all the areas that were repaired.We also placed a gastrostomy tube.A point along the anterior stomach along the mid body was selected.A 2-0 silk pursestring suture was placed and the stomach was entered using electrocautery.A spot along the left upper abdomen was chosen and the skin was incised.A 22 french malecot tube was inserted into the gastrotomy and the pursestring was tied.The drain was placed through the abdominal wall and secured in place.3 stamm sutures were placed to the posterior abdominal wall and onto the stomach to hold the ge tube in place.We then placed two #10 jp [jackson-pratt] drains, the drain on the right when anterior the ge junction and the one placed on the left was posterior to the ge junction and lateral to the ge tube.We checked our jejunostomy tube, which was in good position that had been placed the week prior.We then closed the abdomen using #1 pds sutures in a running fashion from the inferior and superior edges at 3 cm intervals, interrupted #1 pds sutures were additionally placed on the fascia for additional security.The sutures were tightened and tied in the middle of the abdomen.The soft tissue was irrigated [sic] antibiotic irrigation and the wound was closed using skin staplers.All instruments, laps, and needle counts were correct at the end of the case.He awoke from general anesthesia without any issues.¿ 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-tex® soft tissue patch 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-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following complications among others: ¿possible complications with the use of any tissue deficiency prosthesis: complications which may occur include, but are not limited to: infection, seroma formation, adhesions, hematomas, inflammation, fistula formation, and recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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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