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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: on (b)(6) 2013: (b)(6) md.Letter: ¿he has a history of nonhealing fractures of his right 7-8 ribs and an expanding chest wall mass.2 years ago, he had bronchitis and after a prolonged course of coughing, he developed right chest pain.He went into the emergency room and was found to have right rib fractures.He was discharged but 2 weeks later he sneezed, again developed this right chest pain, went to the emergency room, and was found to have another rib fracture.After discharge from the emergency room, he noticed swelling in his right lower chest and upper abdomen that has gradually, he tells us, increased in size over the past 2 years.The swelling is causing him a significant amount of pain, especially when lying on it and when coughing.This mass is not causing him any shortness of breath.He says that concern about the mass has prevented him from working.¿ ¿beneath what appears to be the 8th rib, there is about a 20-25 cm bulge that is on the anterolateral aspect of his thorax.When the patient is in the left lateral decubitus position, you can appreciate a widened intercostal space between ribs 8 and 9.He is tender to palpation along the superior and inferior aspects of the bulge.The bulge is reducible back into the thoracic and abdominal cavities when he is in the left lateral decubitus position.He has a floating 9th rib which appears to have come away from the costal cartilage anteriorly.¿ ¿imaging: mr.(b)(6) had a ct scan done in (b)(6) 2013; and in reviewing it, you can see a right 7th and 8th rib fracture.There is no union of those rib fractures.Below the 8th rib fracture, there is remarkable laxity of the right chest wall with a lateral bulge of the lung and right lobe of the liver.Impression: mr.(b)(6) is a 63-year-old with a right chest wall hernia.We believe that he is a fit for an operation, and without operation this will simply continue to grow until it is even more difficult to repair in the future.We have suggested that he have chest wall reconstruction with a gore-tex patch.And we have tentatively scheduled this for (b)(6) 2013.The risk and potential benefits of the procedure were discussed with the patient in detail.Dr.(b)(6) felt that there is a 90% chance that we will be able to fix the hernia.However, it was discussed at length with the patient that, with respect to his pain, we might not be able to improve his pain and, in fact, we could even make his pain worse with this operation.Additional risks discussed with the patient were risks of pneumonia, recurrent hernia, and infection, especially given that prosthetic material will be placed inside the body.He wishes to proceed.¿ on (b)(6) 2013: (b)(6) md.Indications: ¿mr.(b)(6) is a gentleman who had a bronchitis and severe coughing and spontaneously fractured at least 2 ribs and then developed a large lower chest wall and upper abdominal wall hernia.This progressively enlarged to the point that it was quite huge over 2 years.I recommended repair while it was at the size that at least had a substantial chance of success.He was aware of the risks and potential benefits, including the risk of infection of a prosthetic material that would be used, as well as the significant risk of recurrence.He was anxious to proceed.¿ implant procedure: right thoracotomy for repair of chest wall/intercostal hernia as well as diaphragmatic/upper abdominal wall hernia with gore-tex prosthetic.[implant: gore® dualmesh® biomaterial, 1dlmc07/(b)(6), 20cm x 30cm x 1mm thick.] implant date: (b)(6) 2013 [hospitalization dates (b)(6) 2013].On (b)(6) 2013: (b)(6) hospital.(b)(6) m.D.Postoperative diagnoses: ¿giant chest wall hernia with separation of the diaphragm medically, resulting essentially in a diaphragmatic/upper abdominal hernia as well, successfully repaired.¿ estimated blood loss: 150 ml.Drains: #20-french chest tube x1.Complications: none.Specimens: redundant hernia sac and excess serratus anterior muscle to pathology.Wound classification: not provided.Procedure: ¿mr.(b)(6) was placed supine on the operating table and general anesthesia was induced.A double-lumen endotracheal tube was placed in position without difficulty to allow single lung ventilation on the left side.He was placed on the left lateral decubitus thoracotomy position and the right chest was prepped and draped in the usual sterile fashion.He was given both kefzol and vancomycin antibiotic prophylaxis given the likelihood of using a prosthetic material.The hernia defect was easily visible and palpable, between the 8th and 9th ribs with complete loss of the costal margin anteriorly.The 9th rib could be felt with a floating anterior cartilaginous margin through the skin at the lower border of the defect.We made an incision extending essentially from the posterior aspect of the defect, along the 8th intercostal space over the center of the hernia, to the area anteriorly where the costal margin would normally be.We dissected down through the subcutaneous tissue until we came onto what was essentially the hernia sac, composed of stretched-out serratus anterior muscle extending anteriorly onto the rectus sheath and the transversus abdominis muscle.We entered the sac and resected approximately a 15 x 7 cm piece of the serratus muscle with the underlying sac and sent this to pathology.Fortunately, there were minimal adhesions between the underlying lung posteriorly and the diaphragm anteriorly to the hernia sac itself.Once the sac was opened, however, we could see that the diaphragm had completely separated from its anterior attachment to what would normally be in the area of the costal margin, and the costal margin as expected was completely absent with the floating 9th rib cartilage anteriorly.This left essentially naked peritoneum covering about the anterior 1/4 of the hernia, with abdominal contents between the peritoneum coming up into the hernia itself.We therefore conceptualized how we would repair the hernia, by reattaching the anterior margin of the diaphragm to what was left of the thinned-out transversus and rectus muscles anteriorly, and then placing a gore-tex patch to stabilize the separated ribs to each other and to essentially recreate the costal margin anteriorly with the anterior border of the patch.We separated the diaphragm from some minor adhesions to the undersurface of the 9th rib, which was very close to its insertion.We then cut the gore-tex patch to a size such that it would bring the ribs together under what we thought would be only mild tension, cutting it to about 3 cm wide at the posterior aspect, progressively widening to 7 cm wide at the most anterior aspect/costal margin location.There was a non-healed fracture in the 8th rib at the upper border of the hernia, far posteriorly, but the 8th rib behind this was quite thick and there were no other fractures within the rib, so we opted to use a mesh to sew to the rib just anterior to this fracture, leaving the more posterior ribs, which were not particularly separated, unfixed.The patch was sewn in with the interrupted #1 prolene sutures along the entire length of the 8th rib, taking the bites around the rib, and then through drill holes in the 9th rib at the lower border of the defect.Before completing the more anterior of these sutures, we reattached the separated anterior border of the diaphragm to the upper abdominal muscles with first 1 buttressed horizontal mattress suture, using a piece of gore-tex at the pledget, and then several other interrupted #1 vicryl sutures.We then placed a #28-french chest tube through the 9th interspace and tunneled it out the apex posteriorly and secured it to the skin with a silk suture.We then completed fixing the gore-tex patch with the anterior sutures to the ribs and then taking it to a more superficial layer of the soft tissue fascia anteriorly.The serratus muscle was then closed with running 0 vicryl over the gore-tex.The subcutaneous tissue was closed with running 2-0 vicryl followed by running 3-0 vicryl, and the skin was closed with running subcuticular 4-0 monocryl followed by steri-strips and dry sterile dressings.Mr.(b)(6) tolerated the procedure well.All sponge and needle counts were correct.He was extubated in the operating room and taken to the recovery room in stable condition.I should also mention that we placed a large binder with a moderate pressure dressing over the repair for the early postoperative period.¿ on (b)(6) 2013: (b)(6) hospital.Implant record: ¿gore® dualmesh® biomaterial.¿ ref catalogue number: 1dlmc07.Lot batch code: 10527572.W.L.Gore & associates.Pathology report was not provided.On (b)(6) 2013: (b)(6) np.Discharge summary.¿he was transferred to the thoracic surgery service postoperatively where he was given a pca for pain control and started on a regular diet.Once tolerating a regular diet, he was transitioned from iv to p0 [oral] medications.His chest tube, epidural and foley was discontinued on pod 2 [post-operative day 2] and serial cxrs revealed no clinically significant pneumothorax.He was discharged home in stable condition.¿ ¿wound care instructions: please do not submerge your wounds in water although you may shower.You may take your chest tube bandage off in 24 hours.Your steri-strips will fall off on their own; you do not need to re-bandage your surgical wounds once they do.¿ ¿other comments: stable exam today.Right thora [thoracic] incisions ss [soft, supple] ota [open to air], well approximated, mild erythema.No drainage.¿ partial explant preoperative complaints: on (b)(6) 2014: (b)(6) hospital, (b)(6) md.History and physical.History of present illness: ¿the patient reports a decrease in the bulge and pain until this past (b)(6) 2014 when the pain started again.He noticed and (sic) increase in the bulge and has been using norco, 1-2 tabs daily for the pain.The pain is unrelieved by wearing a belt and is affecting his sleep and activity markedly.Patient denies any fevers, chills, recent infections, cough, cold or changes in bowel or bladder habits.¿ physical examination: ¿abdomen: a large right sided bulge, worse with standing and lying on the right side.A defect between the ribs is palpable and pain overlying the inferior rib of the thoracoabdominal defect.¿ ¿ct scan (b)(6) 2014.Impression: increase laxity of the right lateral upper abdominal wall, with associated right lateral displacement of the liver, compared to prior examination on (b)(6) 2013.Hernia mesh remains in place.¿ assessment/plan: ¿mr.(b)(6) is a 64 yo m (year old male) with a history of a recurrent thoracoabdominal right sided hernia s/p repair in (b)(6) 2013.He has had increased pain and impact on quality of life, prompting presentation to the general surgery clinic.We reviewed his ct scan today and it appears as if his liver is contained in the hernia between his rib space.The hernia repair would require a complex procedure, possibly involving rib plating, with intervening struts and a patch underneath to help control the abdominal viscera.We discussed the potential procedure as well as the risk of recurrence of the hernia, which could be close to 20% given it is a recurrent hernia.We will discuss the case with dr.(b)(6) regarding timing of the procedure.In the meantime, he will see anesthesia pre op.The treatment alternatives, risks and benefits were reviewed and questions were answered.Potential complications were reviewed including wound infection, bleeding and recurrence and the patient stated he understands and consented to the procedure.The consent was signed.¿ on (b)(6) 2014: (b)(6) md.Indications: ¿mr.(b)(6) is an unfortunate 64-year-old male who had experienced several rib fractures including disruption of his right costal margin after a large coughing fit from bronchitis and had a resultant large hernia, consisting of parts of the right lower lobe of the lung and the liver, along with substantial laxity of his surrounding chest wall and upper abdominal musculature resulting in a massive bulge in this area.We had taken him to the operating room in (b)(6) 2013 for a complex repair of the diaphragm, chest wall and reapproximation of the ribs with a gore-tex prosthetic patch.He did very well initially after the procedure, but, after 3 months postoperatively, he had an episode where, after bending over to tie his shoes, he again noted increasing pain and progressive bulge in the area.We then obtained a ct scan of the chest that did not show any definite recurrence.However, several weeks ago, he again noted that the hernia was becoming substantially more of a problem for him with increasing pain and bulging and was beginning to experience quite a substantial amount of discomfort from the area.We saw him again in clinic and he had substantially increased bulging in the area along the site of the prior repair.It was unclear at the time whether the prior patch was actually separated and the repair had broken down or whether he had simply increasing weakness and bulging of his upper abdominal musculature in the area.He was consented for a redo right thoracotomy with repair of this intercostal hernia.In addition, dr.(b)(6) involved dr.(b)(6) of general surgery, who has substantial experience with complex ventral hernias, to assist with this difficult problem.¿ on (b)(6) 2014: (b)(6) hospital.(b)(6) md.Indications: ¿mr.(b)(6) is a 54 (sic)-year¿old gentleman with a history of a right-sided thoracic hernia as well as a diaphragmatic hernia, both of which were initially repaired with mesh in 2013.Unfortunately, mr.(b)(6) has experienced a recurrence of this hernia with symptoms that are significantly impacting his life.We were as ked by the thoracic surgery team lead by dr.(b)(6) to assist with the reconstruction of mr.(b)(6) thoracic and abdominal wall.¿ partial explant procedure: (b)(6), md.Redo right thoracotomy for complex repair of chest wall and intercostal hernia, as well as upper abdominal wall hernia with prolene mesh.[implant prolene] (b)(6), md.Repair of right chest wall hernia with mesh.Placation of right oblique muscles with mesh.Partial explant date: (b)(6) 2014 [hospitalization dates (b)(6) 2014].On (b)(6) 2014: (b)(6) md.¿dr.(b)(6) was a co-surgeon for dr.(b)(6) portion of the procedure, then he independently performed additional procedure as dictated by him separately.¿ assistant: (b)(6) md.Operative report.Preoperative diagnoses: recurrent lower thoracic and upper abdominal hernia of lung and liver (traumatic).Postoperative diagnoses: same.Estimated blood loss: 250ml.Drains: none.Specimens: none.Anesthesia: general.Wound classification: not provided.Procedure: ¿mr.(b)(6) was placed supine on the operating room table, and general anesthesia was induced.A double-lumen endotracheal tube was placed in position without difficulty to allow single lung ventilation on the left side.He was placed in the left lateral decubitus thoracotomy position, rotated slightly posteriorly, and the right chest was prepped and draped in the usual sterile fashion.He was given both kefzol and vancomycin antibiotic prophylaxis, given the likelihood of using additional prosthetic material.The prior right thoracotomy incision was easily visible and the defect between the involved ribs and absence of a costal margin at that location was also easily visible and palpable.I should mention that the hernia defect was easily visible and palpable prior to administration of anesthesia and, in particular, when he would cough or take a deep breath, it would protrude massively.The prior thoracotomy incision extending over the costal margin was then opened and electrocautery was used to dissect through the subcutaneous tissues and scar, and down in between the 8th and 9th ribs, and to a portion where the prior gore-tex patch was identified.A portion of the patch, perhaps 10% of it, was adherent to the caudal edge of the 8th rib, but most of the patch was still sutured to the cephalad aspect of the 9th rib, embedded in dense scar tissue.It appeared that most of the patch had pulled away from the upper rib via tearing of the sutures that held it in place, while anteriorly the patch itself tore , leaving a small portion still with the upper rib.Clearly there was full recurrence of the defect, with a large defect in between the 8th and 9th ribs.Unlike at the previous operation, the diaphragm was not separated from the general area where the costal margin would be (if present).We proceeded using bovie electrocautery to enter the pleural space through scar tissue.The lung was visible and adherent to the parietal pleura and was never disturbed.The diaphragm was intact.We next carefully dissected around the inferior and superior margins of the 8th rib, mobilizing the rib sufficiently from surround [sic] scar and muscle to be able to place sutures around it.Similarly, we dissected out the 9th rib, keeping the existing gortex patch with the rib, so that it could ultimately be used as a ¿buttress¿ to the sutures that were to be placed.Some existing prolene sutures from the prior repair were removed where they held in a small fragment of the patch along the inferior border of the 8th rib, along with that small piece of patch.Given the recurrence of this hernia after repair with gortex, we elected to use a couble (sic) layered prolene mesh for repair of this intercostal hernia.A large piece of prolene mesh was then measured appropriately and then cut to approximately 15 cm in length, with about 7 cm in width at the posteior (sic) end of the patch, and then approximately 9 cm at the anterior end, leaving sufficient width to leave in intercostal space slightly wider than the normal (hopefully reducing tension) and leaving about 2 cm on either side to overlap the undersurface of each rib.The patch was then carefully sutured with the interrupted pericostal sutures with #1 prolene, both to the 8th rib above and the 9th rib below.The sutures were brought through the patch such that when tied the patch would lie at the internal surface of the ribs.After we had placed circumferential interrupted sutures to secure the patch, we then elected to place 3 additional pericostal sutures with #1 prolene, connecting the 8th and 9th ribs, above the fascia and the patch, in order to try to further relieve tension on the patch.When the patch was complete, there remained an intercostal gap about 4cm posteriorly and 5cm anteriorly, as desired.The patch appeared to have good strength.At the anterior end of the patch, we placed 3 #1 prolened (sic) through the costal cartilages and through the patch, to try to create the most strength we possible (sic) could directly at the costal margin.Dr.(b)(6) initially felt that there was no need to further buttress and abdominal wall musculature anterior to the intercostal patch, so we then proceeded to close the wound in layers; first, with interrupted 0 vicryl suture on the deepest muscle later, followed by running 0 vicryl on a more superficial layer of scar tissue, followed by 2-0 vicryl on fat.The skin was closed with 4-0 monocryl.The wound was covered with a sterile dressing.It should then we [sic] noted that, upon emergence from anesthesia from this operation, the patients generate (sic) an enormous cough, and a pop was heard and a substantial bulge of the anterior portion of the hernia was seen.We felt that perhaps abdominal musculature required buttressing, so we called dr.(b)(6) and his general surgery team back into the operating room to assess the situation.The anesthesia was then lightened once again and the patient coughed again massively, and we heard another large pop.Our suspicion that the patch had broken down was very high.We then elected to reopen the incision and explore the wound again.This is a separate dictation that will be dictated by dr.(b)(6) team; however, in summary the existing excision was explored and was extended more medially toward the abdomen.The patch repair appeared to have failed superiorly with the interrupted prolene sutures holding it to the 8th rib and the intercostal prolenes have broken after he experienced coughing during emergence of anesthesia.We then elected to re-attach the superior portion of the patch using a running prolene suture to better distribute the tension.This was then reinforced with several pericostal sternal wires this time.A portion of the external oblique muscle was then also plicated and an additional prolene patch was fashioned on top of the external oblique and taken across the existing intercostal hernia repair.And this outer mesh was also tacked with interrupted #1 prolene sutures.Please see dr.(b)(6) operative report for additional details of this procedure.After the re-repair, it was decided to keep the patient intubated for a short time postoperatively and then do our best to have a slow, cough free emergence.¿ on (b)(6) 2014: (b)(6) md.Operative report.Preoperative diagnosis: large right thoracic hernia with abdominal wall hernia/diastasis.Post-operative diagnosis: right thoracic hernia with right oblique and rectus diastasis.Anesthesia: general endotracheal anesthesia.Estimated blood loss: 100 ml.Specimens: none.Drains: none.Complications: none.Findings: ¿large thoracic intercostal hernia on the right with significant abdominal wall diastasis including significant attenuation of both the oblique muscles and their aponeuroses on the right side.¿ procedure: ¿mr.(b)(6) was brought to the operating room and placed on the left lateral decubitus position on the operating table after general endotracheal anesthesia was induced a preoperative time-out was performed and the procedure was initiated by the thoracic surgery team led by dr.(b)(6).Please see their dictated operative report for details of the first portion of the procedure.Upon completion of the initial repair, it appeared as if the abdominal wall fascia was completely intact with no obvious hernia present, and the decision was made to close the skin and complete the operation.However, upon reversal of the paralytics, mr.(b)(6) coughed and was observed to have a very large bulge just anterior to the thoracic wall incision.There were also several popping noises consistent with disruption of the completed repair.At this point, the decision was made to reparalyze mr.(b)(6) and reopen the wound to address both any damage to the initial repair as well as the anterior abdominal wall bulging.After sterilely prepping mr.(b)(6) chest and abdomen, the previous incision was opened and extended approximately 6 cm anteriorly over the right lateral abdominal wall.It was immediately apparent that the superior sutures holding our initial gore-tex repair had all pulled through with the patient¿s coughing.We began the repair by resuturing the gore-tex patch to the superior rib using a running #1 prolene stitch with 3 interposed sternal wires to buttress the repair incorporating both the superior and inferior ribs spanning the hernia defect.This repair was performed without incident.We then turned our attention to the anterior abdominal wall and reinspected the fascia and musculature.The muscles did appear to be quite attenuated, but the fascia was indeed intact.Given the relatively profound bulging upon valsalva, we decided to plicate his right oblique muscle.We freed up the fascia by creating skin flaps using electrocautery.After ensuring hemostasis, we plicated the oblique muscles and upon aponeurosis using a running #1 pds suture.We then placed a 12 cm x 5 cm overlay gore-tex mesh over this repair and the anterior aspect of the thoracotomy repair.This mesh was sutured into place using interrupted #1 pds suture.After satisfactorily repairing both the thoracic hernia and the lateral abdominal wall diastasis, we closed the subcutaneous tissue with a running #1 vicryl followed by #2 running vicryl in the deep dermal layer, and the skin was closed with 4-0 monocryl.Mr.(b)(6) tolerated this procedure without incident.Given the fact that mr.(b)(6) required a 2nd dose of paralytics after reversing his 1st dose in the operating room, the decision was made to take him to the intensive care unit for extubation after a sufficient period of paralytic metabolism.He tolerated the procedure without difficulty and was transported to the icu without incident.¿ on (b)(6) 2014: (b)(6) hospital.(b)(6) md.Discharge summary: ¿at the time of discharge, he did exhibit a small amount of erythema around his surgical site.He was sent home on a seven-day course of keflex.He is to wear his binder at all times.He has been instructed to attempt to avoid constipation by following a strict bowel regiment.¿ wound care: ¿for the next 2-3 weeks, please keep incisions clean dry and open to air when possible.You are advised not to pick, scratch, or scrub the incisions.Light showers are fine 48 hours after surgery as long as the incision line remains dry and there is no prolonged water exposure.You may cover the incisions with gauze and tape while showering, change dressing following your shower.At all times keep all incisions clean and dry please do not bathe, or soak the wounds in a hot tub or a swimming pool for four to six weeks.If you have steri-strips (thin paper strips covering your incision), please do not remove them they will fall off by themselves.You should not replace the steri-strips if they fall off.¿ 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® 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.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.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.
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