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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/06/2018 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic umbilical hernia repair on (b)(6) 2008 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: recurrence.Additional event specific information was not provided.
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Manufacturer Narrative
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(b)(4).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) 2003: (b)(6) preoperative diagnosis: ¿umbilical hernia.¿ implant procedure: laparoscopic umbilical hernia repair with mesh.[implant: ¿bilayer gore-tex mesh¿].Implant date: (b)(6) 2008 [hospitalization dates march 18 ¿ 19, 2008].On (b)(6) 2003: (b)(6) operative report.Preoperative and postoperative diagnosis: umbilical hernia.Anesthesia: general.Estimated blood loss: less than 50 cc.Complications: none.Wound classification: not provided.Findings: ¿approximately 3 cm supraumbilical hernia.¿ procedure: ¿the patient is brought to the operating room and placed on the table in supine position.After induction of general anesthesia without difficulty the patient¿s abdomen was prepped with betadine solution and the patient was draped in the usual sterile fashion.A transverse skin incision was made in the left upper quadrant.The anterior and posterior rectus fascia were incised with scissors.The peritoneum was opened and a 10 mm port was placed.A pneumoperitoneum was then created.The laparoscope was placed into the abdomen under direct vision two 5 mm ports were placed in the left abdomen and two 5 mm ports in the right abdomen.At this point we inspected the anterior abdominal wall.There was an obvious hernia defect at approximately 3 cm.This started just above the umbilicus.The falciform ligament superiorly was partially taken down to make room for the mesh.There was [sic] no contents in the hernia sac.At this point a piece of bilayer gore-tex mesh was selected that was 10 x 15 cm.Sutures were placed at the 12, 3 6, and 9 o'clock position.The mesh was then placed into the abdomen.The sutures were then brought out through a stab incision at the 12, 3, 6 and 9 o'clock position in the anterior abdominal wait the sutures were then tied to situation [sic] the mesh so that it completely covered the hernia defect the tacker was then used to tack the edges of the mesh to the anterior abdominal wall.The area was inspected and there was no bleeding.The 5 mm ports were removed.There was no bleeding from the abdominal wall.The laparoscope and upper left quadrant port were removed and the pneumoperitoneum was released.The fascia of the 10 mm port site in the upper left quadrant was closed with 0 vicryl suture.We then infiltrated all the wounds with 2% marcaine.The skin incisions were then closed with interrupted 4-0 vicryl suture.The abdomen was cleansed.Mastisol and steri-strips were applied as well as sterile dressings.The patient tolerated the procedure well and there were no complications.Sponge and needle counts were correct x2.The patient is extubated in the operative room and taken to the recovery room in good condition.¿ implant sticker: not provided.Partial explant preoperative complaints: on (b)(6) 2018: (b)(6) preoperative diagnosis: ¿incisional hernia.¿ partial explant procedure: repair hernia incisional, hernia incisional repair with mesh partial explant date: (b)(6) 2018 [same day surgery].On (b)(6) 2018: (b)(6) operative note.Assistant: (b)(6).Postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: 50 ml.Complications: none.Specimens: pathology surgical specimen (incarcerated omentum and hernia sac, ap specimen).Wound classification: not provided findings: ¿old mesh had actually rolled up creating the new defect.¿ procedure: ¿patient was brought to the operating suite, given general anesthetic, and intubated.He then had his abdomen prepped and draped sterilely.I could palpate the hernia just to the right of the midline.A midline incision was then made and dissection taken down to the hernia sac.The hernia sac was opened with some difficulty a portion of the omentum was able to be mobilized and transected with the bovie.After quite a bit of dissection the fascia was finally encountered and dissection carried around the fascia so that the omental stump could be reduced.It became obvious that the recurrence had occurred as a result of the mesh on the right side having rolled up creating an area to allow for herniation.There were adhesions to the mesh that had been placed previously that were dissected free and in order to actually repair the defect a portion of the old mesh had to be excised.Fascia was grasped on all 4 sides and the defect measured 7 x 4 cm.An 11 x 8 cm piece of oval-shaped mesh was placed through the defect and pulled up against the abdominal wall.It was then sutured to the fascial [sic] with interrupted 0 pds sutures in a horizontal mattress fashion.This left a lip of fascia that was closed over the repair with interrupted 0 pds sutures as well.Wound was irrigated and subcutaneous tissue closed with a running 2-0 vicryl suture and the skin stapled shut followed by placement of a sterile dressing.Patient tolerated the procedure well and went to pacu in stable condition.¿ on (b)(6) 2018: (b)(6) pathology: final diagnosis: ¿omentum and hernia sac.¿ specimen source: ¿incarcerated omentum and hernia sac.¿ gross description: ¿specimen received in formalin and labeled ¿harouff, incarcerated omentum and hernia sac¿ consists of multiple yellow lobulated fragments of soft tissue that measure 9.0 x 6.0 x 2.2 cm in aggregate.Most of the specimen consists of adipose tissue with a single triangular fragment of flat fibrous tissue with clips and possible mesh that measures 4.0 x 3.3 x 0.5 cm in size.The specimen is sectioned to reveal a firm white cut surface in the area of the fibrous tissue/hernia sac and uniform yellow soft adipose cut surface in the area of the fat.The adipose tissue has focal areas of hemorrhage.Multiple representative sections of the adipose tissue with possible hemorrhage and the firm fibrous tissue are submitted in a single cassette.¿ no date provided.Implant sticker: ¿ventrio st hernia patch.¿ 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.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.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) 2003: integris bass baptist health center.Edwin cole, md.Preoperative diagnosis: ¿umbilical hernia.¿ implant procedure: laparoscopic umbilical hernia repair with mesh.[implant: ¿bilayer gore-tex mesh¿] implant date: (b)(6) 2008 [hospitalization dates (b)(6) 2008] (b)(6) 2003: (b)(6) md.Operative report.Preoperative and postoperative diagnosis: umbilical hernia.Anesthesia: general.Estimated blood loss: less than 50 cc.Complications: none.Wound classification: not provided.Findings: ¿approximately 3 cm supraumbilical hernia.¿ procedure: ¿the patient is brought to the operating room and placed on the table in supine position.After induction of general anesthesia without difficulty the patient¿s abdomen was prepped with betadine solution and the patient was draped in the usual sterile fashion.A transverse skin incision was made in the left upper quadrant.The anterior and posterior rectus fascia were incised with scissors.The peritoneum was opened and a 10 mm port was placed.A pneumoperitoneum was then created.The laparoscope was placed into the abdomen under direct vision two 5 mm ports were placed in the left abdomen and two 5 mm ports in the right abdomen.At this point we inspected the anterior abdominal wall.There was an obvious hernia defect at approximately 3 cm.This started just above the umbilicus.The falciform ligament superiorly was partially taken down to make room for the mesh.There was [sic] no contents in the hernia sac.At this point a piece of bilayer gore-tex mesh was selected that was 10 x 15 cm.Sutures were placed at the 12, 3 6, and 9 o'clock position.The mesh was then placed into the abdomen.The sutures were then brought out through a stab incision at the 12, 3, 6 and 9 o'clock position in the anterior abdominal wait the sutures were then tied to situation [sic] the mesh so that it completely covered the hernia defect the tacker was then used to tack the edges of the mesh to the anterior abdominal wall.The area was inspected and there was no bleeding.The 5 mm ports were removed.There was no bleeding from the abdominal wall.The laparoscope and upper left quadrant port were removed and the pneumoperitoneum was released.The fascia of the 10 mm port site in the upper left quadrant was closed with 0 vicryl suture.We then infiltrated all the wounds with 2% marcaine.The skin incisions were then closed with interrupted 4-0 vicryl suture.The abdomen was cleansed.Mastisol and steri-strips were applied as well as sterile dressings.The patient tolerated the procedure well and there were no complications.Sponge and needle counts were correct x2.The patient is extubated in the operative room and taken to the recovery room in good condition.¿ implant sticker: not provided.Partial explant preoperative complaints: (b)(6) 2018: (b)(6) md.Preoperative diagnosis: ¿incisional hernia.¿ partial explant procedure: repair hernia incisional, hernia incisional repair with mesh partial explant date: december 6, 2018 [same day surgery] (b)(6) 2018: (b)(6) md.Operative note.Assistant: (b)(6).Postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: 50 ml.Complications: none.Specimens: pathology surgical specimen (incarcerated omentum and hernia sac, ap specimen).Wound classification: not provided.Findings: ¿old mesh had actually rolled up creating the new defect.¿ procedure: ¿patient was brought to the operating suite, given general anesthetic, and intubated.He then had his abdomen prepped and draped sterilely.I could palpate the hernia just to the right of the midline.A midline incision was then made and dissection taken down to the hernia sac.The hernia sac was opened with some difficulty a portion of the omentum was able to be mobilized and transected with the bovie.After quite a bit of dissection the fascia was finally encountered and dissection carried around the fascia so that the omental stump could be reduced.It became obvious that the recurrence had occurred as a result of the mesh on the right side having rolled up creating an area to allow for herniation.There were adhesions to the mesh that had been placed previously that were dissected free and in order to actually repair the defect a portion of the old mesh had to be excised.Fascia was grasped on all 4 sides and the defect measured 7 x 4 cm.An 11 x 8 cm piece of oval-shaped mesh was placed through the defect and pulled up against the abdominal wall.It was then sutured to the fascial [sic] with interrupted 0 pds sutures in a horizontal mattress fashion.This left a lip of fascia that was closed over the repair with interrupted 0 pds sutures as well.Wound was irrigated and subcutaneous tissue closed with a running 2-0 vicryl suture and the skin stapled shut followed by placement of a sterile dressing.Patient tolerated the procedure well and went to pacu in stable condition.¿ (b)(6) 2018: md.Pathology: final diagnosis: ¿omentum and hernia sac.¿ specimen source: ¿incarcerated omentum and hernia sac.¿ gross description: ¿specimen received in formalin and labeled ¿harouff, incarcerated omentum and hernia sac¿ consists of multiple yellow lobulated fragments of soft tissue that measure 9.0 x 6.0 x 2.2 cm in aggregate.Most of the specimen consists of adipose tissue with a single triangular fragment of flat fibrous tissue with clips and possible mesh that measures 4.0 x 3.3 x 0.5 cm in size.The specimen is sectioned to reveal a firm white cut surface in the area of the fibrous tissue/hernia sac and uniform yellow soft adipose cut surface in the area of the fat.The adipose tissue has focal areas of hemorrhage.Multiple representative sections of the adipose tissue with possible hemorrhage and the firm fibrous tissue are submitted in a single cassette.¿ no date provided.Implant sticker: ¿ventrio st hernia patch.¿ 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.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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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.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 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.Through gore's investigation and based on the available information 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 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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