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| Model Number 1DLMC200 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Pain (1994); Discharge (2225); Not Applicable (3189)
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| Event Date 07/13/2010 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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 open chest wall reconstruction on (b)(6) 2010 and (b)(6) 2010 whereby gore dualmesh® plus biomaterial devices were implanted.The complaint alleges that on (b)(6) 2010, the gore devices were explanted.It was reported the patient alleges the following injuries: pain, open draining wound, infection, and mesh removal.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Corrected date.Updated results code for the sterilization evaluation.Conclusion code remains unchanged.
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Manufacturer Narrative
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H6: corrected results code.Code 3233 - sterilization results pending completion of the evaluation.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2010 indicate the patient underwent ¿repair of left 8th rib fracture (rezorb bar), reconstruction of chest wall dehiscence (2 mm soft gore-tex patch -10/15 cm in size).¿ postoperative diagnoses state: ¿nonpathologic fracture of 8th rib, left chest wall dehiscence, lung herniation.¿ the (b)(6) 2010 operative report states: ¿left chest draped and prepped in the usual sterile fashion.I was able to easily palpate the area of separation within his chest wall.An incision was made over that area for a low anterior lateral thoracotomy incision.Dissection was carried through the latissimus serratus muscle.Upon dividing the serratus muscle, the pleura was noted and the lung was herniated through the chest wall.Opened up the pleura without difficulty.I was able to mobilize the soft tissue away from the rib and on inspection the 8th rib was fractured but there was no evidence of malignancy.The separation between the 8th and 9th rib was approximately 6 cm.Flaps were mobilized on the chest wall to allow facilitation.At the lower portion, down onto the diaphragm, this was reapproximated with interrupted #1 vicryl sutures.The rib fracture was then placed in normal position and an 8 cm rezorb bar was then placed with interrupted 0 ethibond sutures to stabilize the rib fracture.Because of the wide separation, i could not bring the intercostal space together, therefore the decision was to place the gore -tex patch.A 10 x 15 cm gore -tex patch to 2 mm gore -tex patch was then sutured with interrupted 0 prolene suture.This was done in the fashion to place the patch taught so there was no evidence of paradoxical motion.Through a separate stab incision inferiorly, a 28 straight chest tube was placed posteriorly and secured with an 0 silk.The final sutures were tied and there was no paradoxical motion of the chest wall and there was stabilization of the rib fracture.The gore -tex was irrigated with antibiotic solution.The incision was closed in routine fashion with running vicryl in the muscular, subcutaneous and subcuticular layers and dermabond was applied.¿ the records confirm a gore dualmesh® biomaterial (1dlmc200/06740609) was used during the procedure.Operative records dated (b)(6) 2010 indicate the patient underwent ¿stabilization of anterior costal arch with 2 -mm soft tissue gore -tex patch (8 x 12 cm in size).¿ preoperative diagnosis states: ¿history of spontaneous dehiscence of left lower chest wall, status post gore -tex patch repair, increasing pain to left lower lobe chest wall.¿ postoperative diagnosis states: ¿no evidence of patch dehiscence, further disruption of anterior chest wall (costal arch).¿ the (b)(6) 2010 records state: ¿the patient was placed in the right lateral decubitus position and the left chest was draped and prepped in the usual sterile fashion.The anterior portion of the previous incision was opened, it was carried out more toward the costal arch.Dissection was carried down through the chest wall.Inspection of the patch revealed that it was intact and there were no abnormalities.However, anteriorly the costal arch had separated further and warranted repair.On inspection, the 6th, 7th and 8th costal cartilage was intact, but he had had separation of the 9th and 10th.The defect measured approximately 8 x 10 cm.In size.To reinforce this area, a 2 -mm soft tissue gore -tex patch measuring 10 x 12 cm was in place within the defect area with interrupted 0-prolene.These were tied and secured to the costal cartilage and also to the anterior abdominal wall.These were placed and were taut and there was no paradoxical motion and laterally it was adhered to the old patch.The abdominal or chest cavity were not entered.After sutures were tied, the patch was in good position and was under good tension to prevent paradoxical motion.Positive pressure of 50 mmhg was carried out and there was no evidence of disruption.The incision was irrigated with antibiotic solution and the incision was closed in a routine fashion with running vicryl in the muscular, subcutaneous and subcuticular layers.¿ the records confirm a gore dualmesh® biomaterial (1dlmc200/06428652) was used during the procedure.Pathology records dated (b)(6) 2010regarding a specimen collected (b)(6) 2010 states as the diagnosis: ¿skin, chest wall, reconstruction: - skin with acute and chronic inflammation, granulation tissue and ulceration.¿ operative records dated (b)(6) 2010 indicate the patient underwent incision and drainage of left thoracotomy with washout and removal of mesh.Postoperative diagnosis states: ¿infected left thoracotomy.¿ the records state: ¿the patient is a 47 -year -old gentleman who previously has undergone 2 left thoracotomies by dr.Daniel miller for repair of a left chest wall defect.The patient was admitted to the hospital through the emergency room over the weekend with fevers 102, cellulitis around his wound, and drainage of pus from the wound.The patient had a ct scan, which showed a large fluid collection, and the wound was opened slightly in the emergency room to allow drainage of pus.The wound is currently growing staph, and the patient has been on iv antibiotics.The patient now comes to the operating room for incision and drainage of the wound as well as removal of the gore -tex.¿ the (b)(6) 2010 records state: ¿following this, the patient's previous thoracotomy incision was then opened with a #10 -blade scalpel.Electrocautery was then used to divide the subcutaneous tissue, and all sutures closing the subcutaneous tissue were removed with metzenbaum scissors.The tissue underneath was fairly edematous, but there was no gross pus seen.Once i opened the incision, i could see a large gore -tex patch that was sewn to the chest wall with interrupted prolene sutures.These sutures were cut and removed, and the gore -tex mesh patch was then removed.I then explored the incision, and more posteriorly, there was another smaller gore -tex patch that was also sewn to the chest wall with interrupted prolene suture, and the gore -tex patch was once again removed.Following this, i then irrigated the wound with a liter of normal saline with a gram of vancomycin in it and debrided the soft tissue using a curet.I did this until there was healthy tissue left and there was no more purulence.Following this, i then packed the wound with 2 vaginal packings soaked in saline.A dressing was applied.¿ operative records dated (b)(6) 2010 indicate the patient underwent primary closure of previous open thoracotomy incision and antibiotic irrigation left thoracotomy incision.Postoperative diagnoses state: ¿1.Status post lower chest wall reconstruction.2.Removal of infected material secondary to infection.3.Open thoracotomy incision.¿ the (b)(6) 2010 records state: ¿previous packing was removed and left chest was draped and prepped in usual sterile fashion.On inspection there was no evidence of gross infection within the thoracotomy incision and there was no foreign body remaining.The area was irrigated with antibiotic solution, 1000 ml with 1 g of vancomycin.After this was carried out the tissue was closed with running vicryl in the muscular, subcutaneous and subcuticular layers.I mobilized the subcutaneous and muscular tissue with electrocautery to allow a tension free closure.The skin was closed with skin staples and sterile dressings were applied.¿ operative records dated (b)(6) 2010 indicate the patient underwent primary closure of chest wall dehiscence and chest wall reinforcement with synthes titanium plates x 4.Postoperative diagnoses state: ¿1.History of spontaneous dehiscence of left lower chest wall, status post 2 previous repairs complicated by disruption and infection.2.Recurrence of old chest wall dehiscence.¿ the (b)(6) 2010 records state: ¿previous lower thoracotomy incision was reexcised, and dissection was carried down to the dehiscence.The dehiscence between the 10th and the 11th ribs was approximately 4 fingerbreadths.I mobilized the rib above and below not to get into the chest cavity.Because of the muscle relaxant and weight loss.I was able to bring the chest wall back together with 4 #2 interrupted pericostal sutures.After this was carried out, i remodeled the cartilage entirely, saw there was no rubbing.To prevent any disruption at that point, i decided to place 4 synthes titanium plates which were 6 screw holes long.They were placed at 9 degrees to the 10th and 11th ribs.These were secured with a total of 19 #14 screws.After this was carried out, positive pressure ventilation of 15 mmhg was carried out by the anesthesiologist and there was no paradoxical motion of the chest wall.The area was irrigated with antibiotic solution.Through a separate stab incision inferiorly, a 10 flat jackson-pratt drain was placed over the repair site.The musculature, skin and subcutaneous tissues were then closed with running vicryl, and dermabond was applied.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record summary.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2017 indicate the patient was seen for diagnosis ¿chest wall pain, fracture four ribs-closed, left, with delayed healing, subsequent encounter.¿ the records state: ¿54 yo wm current smoker (1.5 ppd) complaining of significant left lower chest wall pain.M [sic] s/p repair (b)(6) and (b)(6).Point tenderness.No fever or chills or night sweats.On significant narcs for pain.Has never seen pian [sic] specialist.Also complains of light headiness related to n [sic] pain.¿ medical records dated (b)(6) 2017 states: ¿respiratory: positive for chest tightness (left sided stabbing pain at previous repair of pulmonary hernia, spontaneous costal cartilage separation).Negative for cough (no recent pneumonia) and shortness of breath.Cardiovascular: positive for chest pain (progressively worse over three to four weeks).4 coronary stents recently replaced, total of 8.¿ ¿on pavix and asa.¿ medical records dated (b)(6) 2017 state: ¿physical exam: pulmonary/chest: effort normal and breath sounds normal.No stridor.No respiratory distress.He exhibits tenderness.Healed lower anterior thoracic incision no lung herniation.No paradoxical motion.Point tenderness posterior to repair (ribs 8 -10).¿ medical records dated (b)(6) 2017 state: ¿ct chest: there are atheromatous calcifications.There are coronary calcifications.There is no evidence of adenopathy.There are fractures of the left seventh eighth and ninth ribs with hardware.There is close approximation of the left eighth and ninth ribs laterally.There is some herniation through the chest wall best seen on image 220 of series 4.There are centrilobular emphysematous changes.There is no evidence of pneumothorax, consolidation or effusion.There is atelectasis in both lower lobes.Volume rendered imaging was performed demonstrating compression plates and screws.No acute fractures are seen.¿ medical records dated (b)(6) 2017 state: ¿impression: posttraumatic pain syndrome with possible nerve entrapment or neuroma formation of left lower chest wall (7- 10).¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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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The investigation has been completed.Based upon gore¿s investigation 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.Previous patient codes (1930, 1994, 2225) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: ¿ the known medical records span march 17, 2010 through february 8, 2017 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Patient information: medical history: ¿ smoker ¿ 1.5 pack/day x 35 years ¿ cancer ¿ hypertension ¿ coronary artery disease ¿ myocardial infarction prior surgical procedures: [unknown dates] ¿ cholecystectomy ¿ nephrectomy ¿ lymph node removal ¿ chest wall reconstruction implant #1 preoperative complaints: ¿ [none provided] implant #1 procedure: repair of left 8th rib fracture (rezorb bar), reconstruction of chest wall dehiscence (2mm soft ¿gore-tex patch¿ -10/15 cm in size).Implant: gore® dualmesh® biomaterial (06740609/1dlmc200) 10cm x 15cm.Implant #1 date: (b)(6) 2010 [hospitalization dates unknown] ¿ description of hernia being treated: ¿i was able to easily palpate the area of separation within his chest wall.An incision was made over that area for a low anterior lateral thoracotomy incision.Dissection was carried through the latissimus serratus muscle.Upon dividing the serratus muscle, the pleura was noted and the lung was herniated through the chest wall.Opened up the pleura without difficulty.I was able to mobilize the soft tissue away from the rib and on inspection the 8th rib was fractured but there was no evidence of malignancy.The separation between the 8th and 9th rib was approximately 6 cm.Flaps were mobilized on the chest wall to allow facilitation.At the lower portion, down onto the diaphragm, this was reapproximated with interrupted #1 vicryl sutures.The rib fracture was then placed in normal position and an 8 cm rezorb bar was then placed with interrupted 0 ethibond sutures to stabilize the rib fracture.Because of the wide separation, i could not bring the intercostal space together, therefore the decision was to place the gore-tex patch.¿ ¿ implant size and fixation: ¿a 10 x 15 cm gore-tex patch to 2 mm gore-tex patch was then sutured with interrupted 0 prolene suture.This was done in the fashion to place the patch taught so there was no evidence of paradoxical motion.Through a separate stab incision inferiorly, a 28 straight chest tube was placed posteriorly and secured with an 0 silk.The final sutures were tied and there was no paradoxical motion of the chest wall and there was stabilization of the rib fracture.The gore-tex was irrigated with antibiotic solution.The incision was closed in routine fashion with running vicryl in the muscular, subcutaneous and subcuticular layers and dermabond was applied.¿ ¿ no post-operative records were provided.Implant #2 preoperative complaints: ¿ preoperative diagnosis states: ¿history of spontaneous dehiscence of left lower chest wall, status post gore -tex patch repair, increasing pain to left lower lobe chest wall.¿ implant #2 procedure: stabilization of anterior costal arch with 2 ¿mm soft tissue ¿gore-tex patch¿ (8 x 12 cm in size).Implant: gore® dualmesh® biomaterial (06428652/1dlmc200) 10cm x 15cm.Implant #2 date: (b)(6) 2010 [hospitalization dates unknown] ¿ description of hernia being treated: ¿the anterior portion of the previous incision was opened, it was carried out more toward the costal arch.Dissection was carried down through the chest wall.Inspection of the patch revealed that it was intact and there were no abnormalities.However, anteriorly the costal arch had separated further and warranted repair.On inspection, the 6th, 7th and 8th costal cartilage was intact, but he had had separation of the 9th and10th.The defect measured approximately 8 x 10 cm.In size¿ ¿ implant size and fixation: ¿.To reinforce this area, a 2 -mm soft tissue gore-tex patch measuring 10 x 12 cm was in place within the defect area with interrupted 0-prolene.These were tied and secured to the costal cartilage and also to the anterior abdominal wall.These were placed and were taut and there was no paradoxical motion and laterally it was adhered to the old patch.The abdominal or chest cavity were not entered.After sutures were tied, the patch was in good position and was under good tension to prevent paradoxical motion.Positive pressure of 50 mmhg was carried out and there was no evidence of disruption.The incision was irrigated with antibiotic solution and the incision was closed in a routine fashion with running vicryl in the muscular, subcutaneous and subcuticular layers.¿ ¿ no post-operative records were provided.Explant preoperative complaints: ¿ (b)(6) 2010: ¿the patient is a 47 -year -old gentleman who previously has undergone 2 left thoracotomies by (b)(6) for repair of a left chest wall defect.The patient was admitted to the hospital through the emergency room over the weekend with fevers 102, cellulitis around his wound, and drainage of pus from the wound.The patient had a ct scan, which showed a large fluid collection, and the wound was opened slightly in the emergency room to allow drainage of pus.The wound is currently growing staph, and the patient has been on iv antibiotics.The patient now comes to the operating room for incision and drainage of the wound as well as removal of the ¿gore-tex¿.¿ explant procedure: left thoracotomy with washout and removal of mesh.Explant date: (b)(6) 2010 [hospitalization dates unknown] ¿ ¿the patient's previous thoracotomy incision was then opened with a #10 -blade scalpel.Electrocautery was then used to divide the subcutaneous tissue, and all sutures closing the subcutaneous tissue were removed with metzenbaum scissors.The tissue underneath was fairly edematous, but there was no gross pus seen.Once i opened the incision, i could see a large gore-tex patch that was sewn to the chest wall with interrupted prolene sutures.These sutures were cut and removed, and the gore-tex mesh patch was then removed.I then explored the incision, and more posteriorly, there was another smaller gore-tex patch that was also sewn to the chest wall with interrupted prolene suture, and the gore-tex patch was once again removed.Following this, i then irrigated the wound with a liter of normal saline with a gram of vancomycin in it and debrided the soft tissue using a curet [sic].I did this until there was healthy tissue left and there was no more purulence.Following this, i then packed the wound with 2 vaginal packings soaked in saline.A dressing was applied.¿ ¿ postoperative diagnosis states: ¿infected left thoracotomy.¿ relevant medical information: ¿ (b)(6) 2010: primary closure of previous open thoracotomy incision and antibiotic irrigation left thoracotomy incision. ¿previous packing was removed and left chest was draped and prepped in usual sterile fashion.On inspection there was no evidence of gross infection within the thoracotomy incision and there was no foreign body remaining.The area was irrigated with antibiotic solution, 1000 ml with 1 g of vancomycin.After this was carried out the tissue was closed with running vicryl in the muscular, subcutaneous and subcuticular layers.I mobilized the subcutaneous and muscular tissue with electrocautery to allow a tension free closure.The skin was closed with skin staples and sterile dressings were applied.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes 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.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿when operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the material.When using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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