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| Model Number 1DLMC203 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 08/21/2017 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® 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 open chest wall hernia and diaphragmatic hernia repair on (b)(6) 2017 whereby a two gore® dualmesh® biomaterials were 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: seroma, infected mesh, lysis of adhesions, scarring, resection of the affected gallbladder, repair recurrent hernia, abscess, wound vac.Additional event specific information was not provided.
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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 procedure: right exploratory thoracotomy; reduction of giant chest wall and diaphragmatic hernia; repair of diaphragm using 10 x 20 cm dualmesh; chest was reconstruction was 20 x 30 cm dualmesh.Implant: gore® dualmesh® biomaterial (1dlmc203/10563885 and 1dlmc203/11969261; 20 cm x 30 cm) implant date: (b)(6) 2017 (hospitalization unknown).On (b)(6) 2017: [facility not indicated].(b)(6).Operative report.Preoperative diagnosis: giant chest wall hernia and diaphragmatic hernia.Postoperative diagnosis: giant chest wall hernia and diaphragmatic hernia.Attending: dr.(b)(6).Resident: dr.(b)(6).Anesthesia: general endotracheal.Indication for procedure: the patient is a 60-year-old gentleman who was referred on account of a right chest wall hernia.Upon further examination with ct imaging, it was clear that this was a diaphragmatic hernia that also was herniating through the 9th interspace.The hernia involved the stomach, small bowel, right and transverse colon, which was in the chest and also subsequently outside of the chest wall.The patient is being taken to the operating room for reduction of repair.Description of procedure: ¿the patient underwent preoperative screening and informed consent was obtained.He was subsequently taken to the operating room, was placed on the operating room table in a supine position.Upon induction of general endotracheal anesthesia, he was placed in left lateral decubitus position.His right chest was prepped and draped in a sterile fashion.Using a #10 blade, a low posterior lateral thoracotomy incision was made.The subcutaneous tissue was transected and electrocautery was used to ensure hemostasis.The incision was at the lower edge of the 9th interspace and this was carried down across the serratus muscle, which was transected using electrocautery and hemostasis was assured.This was carried anteriorly and part of the rectus muscle was also incised for exposure using electrocautery.Part of the latissimus dorsi muscle was also transected.Upon carrying the dissection down to the level of the chest wall, a large chronic hernia sac was visualized.The contents had reduced from the exterior to the chest wall into the right hemithorax with relations positioning.This was explored and it was clear that the hernia contained distal stomach and almost all of the small bowel, the right colon, transverse colon.Further exploration demonstrated that this was herniating through a diaphragmatic hernia that was located medially and anteriorly consistent with a morgagni hernia.There were minimal adhesions from the intestines to the intrathoracic cavity.This was then manually reduced into the abdominal cavity paying particular attention to respect the natural direction of the mesentery of each intestinal structure.Upon near complete reduction, the diaphragmatic hernia was measured and it was noted be 12 x 15 cm in diameter.The decision was then made to repair this with a 10 cm x 20 cm dualmesh with the smooth side towards the abdominal cavity.This was placed in a overlay position on the diaphragm and secured in place along the rim of the diaphragmatic defect using interrupted #1 prolene in horizontal mattress sutures.Medially and superiorly, this was secured to a very thin rim of diaphragmatic muscle as well as to the fascia of the rectus muscle.Upon completion of the diaphragmatic hernia repair, the chest wall defect was inspected and noted to be approximately 15 cm in length and at least 12 cm wide.Once again, a 20 cm x 30 cm dualmesh was used to reconstruct the chest wall.This was secured to the ribs in an overlaying fashion using interrupted #1 prolene sutures.A drill was used to drill the 9th rib superiorly and the 10th rib inferiorly in order to place the sutures.Several interrupted sutures were used to secure the mesh in place.Anteriorly, this was secured to the rectus fascia.Prior to placement of the mesh, a 28-french straight chest tube was introduced via separate stab incision directed towards the apex laterally.A 24-french blake drain was introduced via separate stab incision and placed along the diaphragm.These were secured in place using 0 prolene sutures.Two 19-french blake drains were then placed superior to the mass inferior to the muscle in the previous chest wall hernia cavity.The 19-french blake drains were secured in place using 2-0 nylon suture.The serratus fascia and rectus fascia and latissimus dorsi muscle were reapproximated using #1 vicryl in a running stitch.The deep dermal layer was reapproximated using 2-0 vicryl in a running stitch.The skin was reapproximated using 4-0 vicryl in a running subcuticular stitch.All wounds were then cleaned and dressed with steri-strips and a sterile dressing.The patient was then extubated.Due to the large size of the diaphragmatic hernia, the amount of herniated tissue (distal stomach and almost all of the small bowel, the right colon, transverse colon), as well as the large size of the chest wall hernia, this operation took a total of 4 hours for completion (approximately 1.5-2hrs of additional time).¿ drains: a 28-french straight chest tube, 24-french blake drain, 19-french blake drains x2.Condition: critical.Disposition: to pacu and surgical icu.On (b)(6) 2017: [facility not indicated].Implant record.Implant: mesh dualmesh 20 cm x 30 cm.Lot number: 10563885.Manufacturer: wl gore- medical products.Expiration date: 6/2017.Catalog #: 1dlmc203.Implant site: right chest.Quantity: 1.On (b)(6) 2017: [facility not indicated].Implant record.Implant: mesh dualmesh 20 cm x 30 cm.Lot number: 11969261.Manufacturer: wl gore- medical products.Expiration date: (b)(6) 2018.Catalog #: 1dlmc203.Implant site: right chest.Quantity: 1.The records confirm a gore® dualmesh® biomaterial (1dlmc203/10563885 and 1dlmc203/11969261) was implanted during the procedure.Explant procedure: diagnostic laparoscopy.Lap enterolysis last approximately 1 hrs.Lap cholecystectomy.Laparoscopic repair recurrent incarcerated ventral/spigelian hernia.Explant date: (b)(6) 2017 (hospitalization unknown).On (b)(6) 2017: (b)(6) hospital.(b)(6) , md, facs.Operative report.Preoperative diagnosis: infected mesh status post previous mesh placement for right flank and diaphragmatic hernia repair.Cholelithiasis.Recurrent flank hernia status post previous repair.Postoperative diagnosis: infected mesh status post previous mesh placement for right flank and diaphragmatic hernia repair.Cholelithiasis.Recurrent flank hernia status post previous repair.Anesthesia: general endotracheal anesthesia.Bupivacaine/experel tap black intra-op open.Estimated blood loss: 150 ml.Specimens: subcutaneous tissue, skin, muscle and attenuated fascia for permanent pathology.Indications for procedure: the patient is a 60-year-old who is well known to me and presented for evaluation of recurrent fluid collections after repair of right flank and chest wall hernia in january.I was preparing the patient for surgery with medical weight loss while on staff at (b)(6) hospital.I subsequently left employment with iu health and the patient was referred by iu health to another surgeon who performed a repair goretex mesh in january.The patient subsequently developed erythema and concern for infection with swelling per his report and was found to have what was thought to be a seroma which was aspirated and drained.Ultimately the drain was removed and the swelling and pain returned.At this point he contacted me for assistance.I reviewed his records and saw him in the office.We decided that the mesh was likely infected and would need to come out.In addition we noted that his gallbladder was full of stones and discussion of his pain symptoms could not rule out symptomatic cholelithiasis.We discussed performing a diagnostic lap to assess the recurrent hernia from the inside and removing his gallbladder if it appeared chronically inflamed.He awoke this past sunday in the middle of the night with a coughing spell and felt a ¿pop¿ and a warm sensation over the anterior abdominal wall followed by pain and discomfort.At this time he contacted me and we immediately had him evaluated with ct scan demonstrating similar hernia, possibly slightly worse.We admitted him for pain control and evaluation.The pain continued and we discussed proceeding with our original plan to excise his mesh in a hybrid fashion with diagnostic lap and lap cholecystectomy.He agreed to proceed with this plan.I explained the risks, benefits, complications, and procedures associated with abdominal wall reconstruction, mesh removal, and laparoscopic cholecystectomy.Informed consent was obtained.He was scheduled for or on today¿s date.Description of procedure: ¿the patient was brought to the operating room and placed on the table in the supine position.General anesthesia was induced and an endotracheal tube was placed.Thrombogaurds were placed on his lower extremities, and monitors were placed.Preoperative clindamycin antibiotics were given.A foley catheter was anchored in the bladder.The patient was rotated right side up with a bean bag.Care was taken to position his arm appropriately above his head.At this time the abdomen was prepped and draped in the usual sterile fashion.Finally, a pre-operative time out was performed by myself and all the other staff participating in the case in the room.All elements of the timeout were confirmed.The operation began by making approximately a 2 cm curvilinear supraumbilical incision.Subcutaneous tissue was dissected down to the base of the umbilicus.The baseof [sic] the umbilicus was grasped and elevated.The bovie electrocautery was used to enter the base of the umbilicus.The veress needle was inserted to insufflate the abdomen without difficulty.The abdomen was insufflated with 15 mm hg without difficulty.A 12 mm bladeless trocar was inserted under direct visualization without difficulty or evidence of underlying injury.The patient was placed in the reverse trendelenburg left lateral position.A 5 mm port was placed in the epigastrium.We immediately had to take down adhesions from his previous hernia repair to make space for additional trocar placement.Two right upper quadrant 5mm ports were placed at this time.We immediately had to take down multiple adhesions from the liver edge and the omentum was significantly scarred into the hiatus and around the gallbladder from what appeared to be chronic cholecystitis.The liver was fatty and soft.The gallbladder was distended and ruptured when grasped.The suction irrigator was used to clean up the spilled bile.The gallbladder was grasped and we slowly dissected out the fundus of the gallbladder which was incased in tough scar tissue.We ultimately were able to expose the end and work our way around until we found the cystic duct.At this point we were able to bluntly dissect out calot¿s triangle with a kitner and blunt grasper.After clear identification of the cystic duct, the cystic artery was dissected completely and the critical view was obtained visualizing one duct and the liver through calot¿s triangle.The clip applier was then used to place 3 clips down, 2 clips up on the cystic duct.Care was taken to ensure that each clip reached completely across the duct.The cystic artery was then clipped using the clip applier.The cystic duct was taken using the laparoscopic metzenbaum scissors.The distal portion of the cystic artery was taken using the harmonic scalpel by first bipolar cautery of the artery distal to the clip and then cutting the artery distally with the harmonic scalpel.The gallbladder was then dissected free form the gallbladder fossa using the harmonic scalpel with some difficulty as it was an intrahepatic gallbladder.There was edema in at the cystic plate consistent with chronic and acute inflammation.There was no evidence of bleeding, bile duct injury, bile leakage or duct of luschka leaking bile upon completion of the removal from the gallbladder fossa.The gallbladder fossa and the right upper quadrant was suctioned dry.At this time, the gallbladder was grasped and placed in the endocatch bag.This was done using a 5 mm scope in the epigastrium in the endocatch bag and the umbilicus.The endocatch bag was closed without difficulty.The patient was returned to the supine position.The right upper quadrant was once again suctioned and irrigated.At this point we turned to reducing the incarcerated omentum and pre-peritoneal fat from the spigelian hernia that had formed between the oblique complex and the previously placed mesh.In order to do this we put an additional 5mm port on the right side of the abdomen to aide in dissection.The harmonic scalpel was then used to completely reduce the incarcerated fate and omentum.Once this was completely reduced we turned to removing the infected mesh.A 5 cm incision was made in the right flank and carried down to identify the infected seroma cavity.Approximately 1 liter of pus was extruded and cultured.The first piece of goretex mesh was easily removed.Since the mesh tracked all the way to almost the spine i then inserted the gelport and performed a single incision laparoscopic evaluation of the cavity and remaining mesh.The prolene sutures were removed in this manner and then when complete the gelport was removed and the mesh was removed and passed off to pathology.At this point the wound cavity was pulse lavaged and hemostasis was obtained.This was a large cavity about 20cm long x 6cm wide x 5 cm deep.At this point we returned laparoscopically and we imbricated the fascia to close the spigelian hernia primarily using #1 pds and the carter-thompson by several figure-of-eight sutures.The intra-abdominal pressure was lowered to 8mmhg and the sutures were tied.At this time, the three 5 mm ports were removed under direct visualization without port site bleeding.Subsequently, the abdomen was completely deflated and the gallbladder was removed from the umbilicus.The gallbladder was then passed off for pathological examination.We then returned to the right flank abscess cavity.A 19fr jp drain was placed in the infected seroma space where the mesh had been removed.#1 pds was then used to close the hernia in the external oblique muscle while imbricating the external oblique.2-0 v-lock suture was then used to run serial progressive tension suture to close down the subq dead space.A second 19fr drain was then placed in the subq space.The subq was approximated using interrupted 3-0 monocryl sutures.The total wound size below the skin prior to closure was 20cm l x 5cm d and the skin incision was about 5cm in length.An incisional wound vac using a cork medical vac was then placed over adaptec in the standard fashion.A seal was confirmed.The jps were placed to bulb suction.The jps were sutured and dermabonded in place.This completed the operation.All sponge, needle, and instrument counts were correct.The patient was transferred to the pacu in stable condition.Specimens are skin and subcutaneous tissue with hernia sac, mesh, and skin tag resected during resection of excess skin to pathology.I was present and scrubbed for the entire operation.¿ 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." 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.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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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.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.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.No further investigation is required at this time.Through 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim and no problem detected.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.¿ the instructions for use further warn: ¿as with any implantable surgical device, 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.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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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