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Model Number 1DLMC03 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Not Applicable (3189); No Information (3190)
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Event Date 02/03/2009 |
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: ¿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 umbilical hernia repair on (b)(6) 2005 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: mesh removal, revision surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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A2: added date of birth.H6: corrected results code.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: operative records dated 5/22/2002 indicate the patient underwent open repair of a symptomatic indirect left inguinal hernia.Indications state the patient ¿¿is a 26-year-old gentleman with a one-year history of an intermittent painful left groin bulge.Examination revealed a left inguinal hernia.He was advised to undergo repair.¿ findings from the procedure state: ¿a moderate sized indirect left inguinal hernia was present and associated moderate cord lipoma was noted.There was no evidence of direct or femoral hernia.¿ the 5/22/2002 records state: ¿a transverse incision was made in the left groin just above the pubic tubercle and extending laterally approximately 6 cm in length.Hemostasis was achieved with electrocautery and #2-0 vicryl ties.The incision was carried down through the subcutaneous tissues until the external oblique aponeurosis was identified and was incised along the lines of its fibers in such a manner in which to open the external ring and expose the internal ring.Two nerves were identified along side the spermatic cord.One, the larger of which was preserved, and the smaller which was sacrificed to facilitate the repair.The spermatic cord was mobilized and encircled with a penrose drain.The cord was then carefully dissected isolating the hernia sac and cord lipoma, both of which were dissected free of the surrounding cord structures and the internal ring.The cord lipoma was ligated with #2-0 vicryl, amputated and sent to pathology.The hernia sac was opened and finger inserted into the peritoneal cavity where search for direct and femoral hernia was made and none were identified.The hernia sac was twisted and doubly suture ligated with #2-0 silk.The excess hernia sac was amputated and sent to pathology.¿ the 5/22/2002 operative report states: ¿imbrication repair was then performed securing the transversalis fascia securely to the shelving edge of poupart's ligament inferiorly with interrupted #0 tevdek sutures in such a manner as to reconstruct the inguinal floor and the internal ring so that just the tip of the little finger could be inserted along side the cord.A relaxing incision was then made in the anterior rectus sheath deep to the external oblique aponeurosis beginning just below the pubic tubercle and extending superolaterally approximately 5 cm in length in hockey stick fashion.This provided significant relaxation so that the repair was under minimal tension.After careful hemostasis had been assured, the wound was irrigated with sterile saline following which the external oblique aponeurosis closed overlying the cord with cutaneous #2-0 vicryl with care being taken to avoid entrapment of the ilioinguinal nerve.The scarpa's fascia was reapproximated with continuous #3-0 vicryl, the superficial subcutaneous tissues with a similar suture and the skin with a #4-0 vicryl subcuticular skin closure followed by steri-strips and dry sterile dressing.¿ records between 2002 and 2005 were not provided.Operative records dated 5/2/2005 indicate the patient underwent umbilical hernia repair with mesh.Findings from the procedure state: ¿reducible supraumbilical hernia through approximately a 3 cm diameter fascial defect.¿ the records state: ¿a short midline incision was made from just below the umbilicus to approximately 4 cm above the umbilicus.The hernia sac was encountered directly beneath the skin.The sac was then dissected free from the surrounding subcutaneous tissue down to its base.The fascia edge was then cleared for several centimeters around the sac and the sac was dissected free from the fascial edge.The sac was then reduced back into the abdominal cavity and the peritoneum was mobilized for several centimeters from underneath the fascia circumferentially.The fascial defect measured approximately 3 cm in diameter.¿ the 5/2/2005 records state: ¿approximately a 9 cm gore-tex dualmesh patch was then fashioned and sewn to the undersurface of the fascia with interrupted horizontal mattress sutures.Half the repair was performed with 0 prolene suture.These were no longer were available so the second half of the repair was performed with a 0 gore-tex suture.Approximately 1 cm spacing was used between each suture.The patch was then tied in place and found to be tension free.The wound was then irrigated with saline and suctioned dry.Meticulous hemostasis was achieved.The fascial edges were then loosely approximated over the patch using 0 vicryl interrupted figure-of-eight sutures.The deep subcutaneous space was then closed with a running 3-0 vicryl suture.The umbilicus was tacked back to the fascia during this closure.The superficial subcutaneous space was closed with a 3-0 running vicryl suture.Interrupted intradermal sutures of 4-0 vicryl were then placed approximating the skin.Skin staples were then placed.A wad of cotton was then placed on the umbilicus followed by a dry sterile gauze dressing covered by a large tegaderm.¿ the records confirm a gore dualmesh® biomaterial (1dlmc03/02879509) was implanted during the procedure.Records between 2005 and 2009 were not provided.Operative records dated 2/3/2009 indicate the patient underwent repair of multiple ventral incisional hernias in the periumbilical area.Findings from the procedure state: ¿multiple midline repair of midline defects measuring a cm or 2 cm in size, the largest opening measured 3 cm across.¿ the records state: ¿the old wide scar on the right side of the umbilicus was excised.This was gradually extended approximately 10-12 cm to fully dissect the multiple hernias, which were mostly incarcerated with omentum.These were gradually connected in a step-wise fashion to the midline incision.The old mesh was freed up and a new piece of kugel 11.4 cm circular mesh patch was then placed and sutured in place with double stranded #1 pds suture material, as the fascia was closed partially vertically and partially horizontally overlying the mesh.The fat was approximated with 2-0 vicryl, skin clips utilized on the wound edge and dry sterile dressings applied.¿ the records indicate a bard composix device (non-gore device) was used during the procedure.There was no mention of infection and no mention of gore device removal.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: ¿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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Previous patient code (3190) was reported based on the original complaint and are no longer applicable per gore¿s investigation.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.This event will be closed as no problem detected.The following information was determined from the medical records.Medical records: ¿ the known medical records span (b)(6) 2002 through (b)(6) 2009 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.¿ records from (b)(6) 2005 through (b)(6) 2009 were not provided.Patient information: medical history: ¿ left inguinal hernia with associated moderate cord lipoma.Prior surgical procedures: ¿ open repair of left inguinal hernia.Implant preoperative complaints: ¿ [none provided].Implant procedure: open umbilical hernia repair with mesh.Implant: gore® dualmesh® biomaterial (02879509/1dlmc03) 10cm x 15cm, oval.Implant date: (b)(6) 2005 [hospitalization dates unknown].¿ description of hernia being treated: ¿a short midline incision was made from just below the umbilicus to approximately 4 cm above the umbilicus.The hernia sac was encountered directly beneath the skin.The sac was then dissected free from the surrounding subcutaneous tissue down to its base.The fascia edge was then cleared for several centimeters around the sac and the sac was dissected free from the fascial edge.The sac was then reduced back into the abdominal cavity and the peritoneum was mobilized for several centimeters from underneath the fascia circumferentially.The fascial defect measured approximately 3 cm in diameter.¿ ¿ implant size and fixation: ¿approximately a 9 cm gore-tex dualmesh patch was then fashioned and sewn to the undersurface of the fascia with interrupted horizontal mattress sutures.Half the repair was performed with 0prolene suture.These were no longer were available so the second half of the repair was performed with a 0 gore-tex suture.Approximately 1 cm spacing was used between each suture.The patch was then tied in place and found to be tension free.The wound was then irrigated with saline and suctioned dry.Meticulous hemostasis was achieved.The fascial edges were then loosely approximated over the patch using 0 vicryl interrupted figure-of-eight sutures.The deep subcutaneous space was then closed with a running 3-0 vicryl suture.The umbilicus was tacked back to the fascia during this closure.The superficial subcutaneous space was closed with a 3-0 running vicryl suture.Interrupted intradermal sutures of 4-0 vicryl were then placed approximating the skin.Skin staples were then placed.¿ ¿ no post-operative records were provided.Explant preoperative complaints: [none provided].Explant procedure: repair of multiple ventral incisional hernias in the periumbilical area.Explant date: (b)(6) 2009 [hospitalization dates unknown].¿ ¿multiple midline repair of midline defects measuring a cm or 2 cm in size, the largest opening measured 3 cm across.¿ ¿ ¿the old wide scar on the right side of the umbilicus was excised.This was gradually extended approximately 10-12 cm to fully dissect the multiple hernias, which were mostly incarcerated with omentum.These were gradually connected in a step-wise fashion to the midline incision.The old mesh was freed up and a new piece of kugel 11.4 cm circular mesh patch was then placed and sutured in place with double stranded #1 pds suture material, as the fascia was closed partially vertically and partially horizontally overlying the mesh.The fat was approximated with 2-0 vicryl, skin clips utilized on the wound edge and dry sterile dressings applied.¿ ¿ records indicate a non-gore device was implanted during the (b)(6) 2009 procedure.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.¿ 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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