|
W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Catalog Number 1DLMPH03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
|
| Patient Problems
Adhesion(s) (1695); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 11/16/2005 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).It should be noted that the gore® dualmesh® plus biomaterial with holes 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.¿.
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2001 whereby a gore dualmesh® plus biomaterial with holes was implanted.It was reported the patient was additionally implanted with a gore® dualmesh® plus biomaterial on (b)(6) 2003.The complaint alleges that on (b)(6) 2005, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of meshes, additional surgery, lysis of adhesions.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
Updated results code.Conclusion code remains unchanged.
|
| |
|
Manufacturer Narrative
|
|
B5: corrected implant dates in event description.B7: added medical history.D4: added device lot# d6: corrected implant date.H6: updated methods and results codes.Conclusion remains unchanged.Operative records dated 2/22/1999 indicate the patient underwent ¿hernia repair with mesh¿ preoperative diagnosis ¿recurrent ventral hernia.¿ postoperative diagnosis ¿recurrent multiple hernias.Repaired with an inlay of marlex.¿ operative records dated (b)(6) 1999 state: ¿an incision was made down to the old incision.Part of the incision felt to be pretty solid, but once we found hernia in the upper portion of the incision, we cleaned that up.There was a hernia lateral to that area.We were feeling around and there was a hernia of the inferior portion and then laterally on the left side.Therefore, the whole area was carefully opened and cleaned to the fascia.The hernias were closed with a distal small vicryl suture.¿ operative records dated (b)(6) 1999 state: ¿then an inlay of 3 x 6 marlex mesh was sutured into place, covering the entire area of the old incision.Once it was sewn in to placed 360 degrees, we used some bacitracin to try to hold down any infection.We used marlex mesh and we used 0 mersilene for a suture.A #10 jackson-pratt drain was placed.The wound was closed.Sterile dressings were placed.¿ records between (b)(6) 1999 and (b)(6) 2001 were not provided.Operative records dated (b)(6) 2001 indicates patient underwent ¿repair of recurrent ventral hernia using dual-sided mesh.¿ preoperative diagnosis ¿recurrent ventral hernia.¿ the records state: ¿an incision was made down to the hernia sac.There were multiple sacs coming off of multiple defects, but in the lower end of the old incision.Once we were able to dissect away all the sacs back to the area of the abdominal wall, we were then able to take a piece of dual-sided mesh and using 360 degree sutures; we tacked the mesh to the underside of the abdominal wall.Once this was done in a 360-degree manner, a jackson-pratt drain was placed and the skin was stapled.Sterile dressings were placed.¿ the records confirm a gore® dualmesh® with holes antimicrobial (1dlmph03/p17023-068) was used during the procedure.Medical records dated (b)(6) 2003 state the patient was seen for chief complaint of ¿abdominal pain, hernia.¿ the records state: ¿onset yesterday evening of left lower quadrant pain with nausea and vomiting.Patient feels that his abdominal wall hernia is protruding abnormally.Patient has had 3 surgeries on his hernia; last was last year, stools normal.Surgeries: only for hernia.No fever.¿ diagnosis: ¿incarcerated ventral hernia.¿ history and physical dated (b)(6) 2003 states: ¿physical examination: abdomen: soft marked tenderness to the left of the incision, above the level of the umbilicus.There appears to be some slight erythema here also.A palpable 20 cm mass is present and is tender.With careful manipulation, this was eventually reduced and the patient had some relief of his pain.¿ operative records dated (b)(6) 2003 indicates the patient underwent repair of incisional hernia with implantation of mesh.¿ the records states ¿the patient is a 34-year-old 1na11 with three previous incisional hernia repairs.Following his last repair dual mesh goretex was used.He developed onset of severe abdominal pain last night and tenderness over an area of incarcerated hernia.This was partially reduced in the emergency room and he was taken to the operating room for surgical repair.¿ operative records dated (b)(6) 2003 state: ¿tl1e previous midline incision was opened over the area of the bulge and down to the umbilicus where a second defect could be felt.Dissection was carried down to the underlying hernia.The hernia sac was dissected back to the fascia at one point superiorly.The peritoneal cavity was entered.There were extensive defects with dense adhesions and these were gradually and carefully taken down.¿ operative records dated (b)(6) 2003 state: ¿there was no apparent injury to the bowel in the process.Eventually the entire anterior abdominal wall was cleared of adhesions.____[sic]were present scattered around the fascial edges and in order to encompass all these in the closure the largest dual mesh goretex was used.Approximately 4 cm was cut off the bottom and the edges were rounded.It was then secured using tacking sutures placed through stab incisions lateral to all the defects with #1 nylon sutures to tack it to the anterior abdomninal wall circumferentially.Four sutures were initially placed and then to make sure the mesh covered two of the more lateral defects, two more were placed on the left.The remainder of the mesh was secured to the anterior abdominal wall using a tacker.Subcutaneous tissue was closed with interrupted 3-0 vicryl and the skin and stab incisions were closed with staples.¿ the records confirm a gore® dualmesh® plus antimicrobial (1dlmcph07/01291815) was used during the procedure.A pathology report dated (b)(6) 2003 for a specimen collected (b)(6) 2003 states: ¿specimen: hernia sac and mesh.¿ ¿gross description: hernia sacs and mesh: in formalin are two portions of membranous tissue which are thick and fibrotic.A mass lesion is not identified.The serosal surface is trabeculated.They have an aggregate dimension of 12.5 x 7 x 2 cm.Sections of each, blocks 1 and 2~ remainder in stock.¿ ¿microscopic description: the two block show reactive fibrous tissue surrounding portions of foreign body mesh material.¿ discharge summary dated (b)(6) 2003 indicates the patient was admitted to the hospital on (b)(6) 2003 for ¿incarcerated and recurrent incisional hernia.¿ the records state: ¿the patient underwent a laparotomy with the finding of multiple defects and hernias.A large dual mesh gore-tex was secured using traction sutures laterally, and packed around the edges with a tacker.Postoperatively, he was fairly comfortable on the first postoperative morning and preliminary arrangements were 1nade for discharge.Developed nausea and increasing pain.However, eventually this was controlled by the third postoperative day.He did take a regular diet and was passing flatus at the time of discharge.¿ records between (b)(6) 2003 and (b)(6) 2005 were not provided.Operative records dated (b)(6) 2005 indicate the patient underwent ¿1.Laparotomy.2.Lysis of adhesions.3.Removal of intraperitoneal foreign body.4.Repair of multiple incarcerated recurrent ventral incisional hernia.5.Umbilectomy.6.Insertion of on-q pain buster pump.¿ preoperative/postoperative diagnosis ¿multiple recurrent incarcerated ventral incisional hernia.¿ operative records dated (b)(6) 2005 state: ¿findings: multiple ventral incisional hernia from above his umbilicus to /his pubic symphysis.There was a retained foreign body.¿ the records state: ¿a midline incision was made directly in the old scar.Taken down through skin and subcutaneous tissue with scalpel.Cautery was used for hemostasis.The hernia sacs were dissected out and at the base of this was an old piece of mesh with hernias around multiple portions of this.¿ operative records dated (b)(6) 2005 state: ¿there were multiple hernias up and down the whole entire abdominal wall requiring a full laparotomy.There were numerous adhesions, which took an extensive amount of time, over an hour, to lyse all the adhesions and remove the intra peritoneal foreign body.Due to the excess skin flap created, it was felt that umbilectomy was necessary and, therefore, this was all excised as part of the old scar.¿ operative records dated (b)(6) 2005 state: ¿we then repaired the defect of the ventral fascia using a bard composix ex mesh size 6 x 8 inches.This was done by tacking the mesh with horizontal li-stitches all the way full thickness through the entire fascia.This was able to be accomplished because the subcutaneous flaps were fairly extensive from the large hernia sac.This was done completely all the way around the entire mesh.We then place an on-q pain buster pump on top of the mesh.We placed 2 jackson-pratt drains on either side of the flaps, brought out through separate stab wounds anchored these to the skin with silk sutures.The skin was closed in layers using a running vicryl in deep subcutaneous layer and staples on the skin.Neosporin and sterile dressing were-applied.¿ a pathology report dated (b)(6) 2005 for a specimen received (b)(6) 2005 states: ¿final diagnosis: umbilicus and adjacent skin with underlying soft tissues and surgical mesh (incisional herniorrhaphy): hernia sac with fibrosis.Portion of'surgical mesh.¿ the report states: ¿gross description- received in formalin labeled "abdominal wall, umbilicus, peritoneal foreign body, incisional hernia sac are multiple fibrofatty tissues with adherent membrane aggregating 15.D x-15.0 x 6.0 cm.The largest portion is surfaced with a 40.0 x 4.5 cm tan white strip of skin with a central irregular scar.Towards one end of the ellipse is a 2.5 x 1.0 cm umbilicus.On the posterior surface, within the attached soft tissue is a portion of surgical mesh material measuring approximately 16.0 x 10.0 cm.The remaining membranous tissue resembling a hernia sac aggregates approximately 15.0 x 15.0 cm.Representative sections are submitted in two blocks.¿ 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® plus biomaterial with holes 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.
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2001 whereby a gore® dualmesh® plus biomaterial with holes was implanted.It was reported the patient was additionally implanted with a gore® dualmesh® plus biomaterial with holes on (b)(6) 2003.
|
| |
|
Manufacturer Narrative
|
|
H6: health effect impact code: f26: no health consequences or impact.H6: additional investigation conclusion code: d17: appropriate term/code not available for "withdrawn complaint¿.Previous patient code (1695) was reported based on the original complaint and is 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.Medical records: the known medical records span february 22, 1999 through november 18, 2005, and not all records received in this time span are relevant to the two gore® dualmesh® plus biomaterial devices.Patient information: medical history: gout and hypertension.Prior surgical procedures: (b)(6) 1999 : hernia repair with mesh.[marlex].Relevant medical information: (b)(6) 1999: hernia repair with mesh¿ preoperative diagnosis ¿recurrent ventral hernia.¿ postoperative diagnosis ¿recurrent multiple hernias.¿ repaired with an inlay of marlex.¿ ¿an incision was made down to the old incision.Part of the incision felt to be pretty solid, but once we found hernia in the upper portion of the incision, we cleaned that up.There was a hernia lateral to that area.We were feeling around and there was a hernia of the inferior portion and then laterally on the left side.Therefore, the whole area was carefully opened and cleaned to the fascia.The hernias were closed with a distal small vicryl suture.¿ ¿then an inlay of 3 x 6 marlex mesh was sutured into place, covering the entire area of the old incision.Once it was sewn in to placed 360 degrees, we used some bacitracin to try to hold down any infection.We used marlex mesh and we used 0 mersilene for a suture.A #10 jackson-pratt drain was placed.The wound was closed.Sterile dressings were placed.¿ implant #1 preoperative complaints: (b)(6) 2001: ¿repair of recurrent ventral hernia using dual-sided mesh.¿ (b)(6) 2001: preoperative diagnosis ¿recurrent ventral hernia.¿ implant #1 procedure: hernia repair with mesh.Implant: gore® dualmesh® biomaterial with holes (1dlmph03/p17023-068) [based on manufacture date of device, product tracking unavailable] 10 cm x 15 cm, oval.Implant #1 date: (b)(6) 2001.Description of hernia being treated: ¿an incision was made down to the hernia sac.There were multiple sacs coming off of multiple defects, but in the lower end of the old incision.¿ implant size and fixation: ¿once we were able to dissect away all the sacs back to the area of the abdominal wall, we were then able to take a piece of dual-sided mesh and using 360 degree sutures; we tacked the mesh to the underside of the abdominal wall.Once this was done in a 360-degree manner, a jackson-pratt drain was placed and the skin was stapled.Sterile dressings were placed.¿ no postoperative records.Implant #2 preoperative complaints: (b)(6) 2003: ¿abdominal pain, hernia.¿ ¿onset yesterday evening of left lower quadrant pain with nausea and vomiting.Patient feels that his abdominal wall hernia is protruding abnormally.Patient has had 3 surgeries on his hernia; last was last year, stools normal.Surgeries: only for hernia.No fever.¿ diagnosis: ¿incarcerated ventral hernia.¿ (b)(6) 2003: ¿physical examination: abdomen: soft marked tenderness to the left of the incision, above the level of the umbilicus.There appears to be some slight erythema here also.A palpable 20 cm mass is present and is tender.With careful manipulation, this was eventually reduced and the patient had some relief of his pain.¿ ¿three previous incisional hernia repairs.Following his last repair dual mesh goretex was used.He developed onset of severe abdominal pain last night and tenderness over an area of incarcerated hernia.This was partially reduced in the emergency room and he was taken to the operating room for surgical repair.¿ implant #2/explant #1 procedure: repair of incisional hernia with implantation of mesh.Implant: gore® dualmesh® plus biomaterial with holes (1dlmcph07/01291815) 20 cm x 30 cm.Implant #2/explant #1 date: (b)(6) 2003 [hospitalization (b)(6) 2003].Description of hernia being treated: ¿the previous midline incision was opened over the area of the bulge and down to the umbilicus where a second defect could be felt.Dissection was carried down to the underlying hernia.The hernia sac was dissected back to the fascia at one point superiorly.The peritoneal cavity was entered.There were extensive defects with dense adhesions and these were gradually and carefully taken down.¿ ¿there was no apparent injury to the bowel in the process.Eventually the entire anterior abdominal wall was cleared of adhesions.¿ implant size and fixation: ¿____ [sic] were present scattered around the fascial edges and in order to encompass all these in the closure the largest dual mesh goretex was used.Approximately 4 cm was cut off the bottom and the edges were rounded.It was then secured using tacking sutures placed through stab incisions lateral to all the defects with #1 nylon sutures to tack it to the anterior abdominal wall circumferentially.Four sutures were initially placed and then to make sure the mesh covered two of the more lateral defects, two more were placed on the left.The remainder of the mesh was secured to the anterior abdominal wall using a tacker.Subcutaneous tissue was closed with interrupted 3-0 vicryl and the skin and stab incisions were closed with staples.¿ relevant medical information: (b)(6) 2003: collected (b)(6) 2003 ¿specimen: hernia sac and mesh.¿ ¿the serosal surface is trabeculated.They have an aggregate dimension of 12.5 x 7 x 2 cm.¿ ¿microscopic description: the two block show reactive fibrous tissue surrounding portions of foreign body mesh material.¿ (b)(6) 2003: discharge summary: ¿incarcerated and recurrent incisional hernia.¿ the records state: ¿the patient underwent a laparotomy with the finding of multiple defects and hernias.A large dual mesh gore-tex was secured using traction sutures laterally, and packed around the edges with a tacker.Postoperatively, he was fairly comfortable on the first postoperative morning and preliminary arrangements were made for discharge.Developed nausea and increasing pain.However, eventually this was controlled by the third postoperative day.He did take a regular diet and was passing flatus at the time of discharge.¿ explant #2 preoperative complaints: (b)(6) 2005: preoperative/postoperative diagnosis ¿multiple recurrent incarcerated ventral incisional hernia.¿ explant #2 procedure: ¿1.Laparotomy.2.Lysis of adhesions.3.Removal of intraperitoneal foreign body.4.Repair of multiple incarcerated recurrent ventral incisional hernia.5.Umbilectomy.6.Insertion of on-q pain buster pump.¿ explant #2 date: (b)(6) 2005 ¿findings: multiple ventral incisional hernia from above his umbilicus to /his pubic symphysis.There was a retained foreign body.¿ ¿a midline incision was made directly in the old scar.Taken down through skin and subcutaneous tissue with scalpel.Cautery was used for hemostasis.The hernia sacs were dissected out and at the base of this was an old piece of mesh with hernias around multiple portions of this.¿ ¿there were multiple hernias up and down the whole entire abdominal wall requiring a full laparotomy.There were numerous adhesions, which took an extensive amount of time, over an hour, to lyse all the adhesions and remove the intra peritoneal foreign body.Due to the excess skin flap created, it was felt that umbilectomy was necessary and, therefore, this was all excised as part of the old scar.¿ ¿we then repaired the defect of the ventral fascia using a bard composix ex mesh size 6 x 8 inches.This was done by tacking the mesh with horizontal li-stitches all the way full thickness through the entire fascia.This was able to be accomplished because the subcutaneous flaps were fairly extensive from the large hernia sac.This was done completely all the way around the entire mesh.We then place an on-q pain buster pump on top of the mesh.We placed 2 jackson-pratt drains on either side of the flaps, brought out through separate stab wounds anchored these to the skin with silk sutures.The skin was closed in layers using a running vicryl in deep subcutaneous layer and staples on the skin.Neosporin and sterile dressing were-applied.¿ no postoperative records were provided.Relevant medical information: (b)(6) 2005: pathology: specimen received (b)(6) 2005 states: ¿final diagnosis: umbilicus and adjacent skin with underlying soft tissues and surgical mesh (incisional herniorrhaphy): hernia sac with fibrosis.Portion of'surgical mesh.¿ ¿multiple fibrofatty tissues with adherent membrane aggregating 15.0 x-15.0 x 6.0 cm.The largest portion is surfaced with a 40.0 x 4.5 cm tan white strip of skin with a central irregular scar.Towards one end of the ellipse is a 2.5 x 1.0 cm umbilicus.On the posterior surface, within the attached soft tissue is a portion of surgical mesh material measuring approximately 16.0 x 10.0 cm.The remaining membranous tissue resembling a hernia sac aggregates approximately 15.0 x 15.0 cm¿.Conclusion: it should be noted that the gore® dualmesh® plus biomaterial with holes 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 devices were 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.The devices were 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.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: p17023-068.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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.
|
| |
|
Search Alerts/Recalls
|
|
|
