|
Model Number 1DLMC09 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Obstruction/Occlusion (2422)
|
Event Date 07/17/2017 |
Event Type
Injury
|
Event Description
|
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2011 whereby a gore® dualmesh® biomaterial was 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: abdominal pain, abscess, adhesions, bowel obstruction/problems, fistula, incision & drainage, infections, hernia recurrence, removal, and bowel involvement.Additional event specific information was not provided.
|
|
Manufacturer Narrative
|
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.".
|
|
Manufacturer Narrative
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: none provided.Implant procedure: laparoscopic incisional hernia repair with mesh.[implant gore® dualmesh® plus biomaterial, 1dlmc09/(b)(6), 12 cm x 12 cm x 1 mm].Implant date: (b)(6), 2011 [same day hospitalization].(b)(6) 2011: (b)(6) medical center (bcgmc).Same day surgery.(b)(6) md.Operative report.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.Wound classification: i [clean].Procedure: operative report not provided.(b)(6) 2011: (b)(6) medical center.Implant record.Description: gore dualmesh biomaterial 12.0 cm circle x 1.0 mm.Lot number: 8638322.Catalogue # ref #: 1dlmc09.Manufacturer: gore.Implant site: ventral incision site.Quantity: (b)(4).Revision preoperative complaints: not provided.Revision procedure: diagnostic laparoscopy, exploratory laparotomy, enterotomy repair, extensive lysis of adhesions.Revision date: (b)(6) 2017 [hospitalization dates unknown].[facility not indicated].(b)(6) md.Operative report.Preoperative and postoperative diagnosis: vomiting, small bowel obstruction due to adhesions, acute kidney injury.Indication: sbo [small bowel obstruction] anesthesia: general.Findings: ¿extensive interloop adhesions with transition point in ruq.¿ [right upper quadrant].Specimens: none.Procedure: ¿after informed consent had been freely obtained for the patient the patient was taken to the operating room and placed in the supine position.The patient received cipro and flagyl as a prophylactic antibiotic.General anesthesia was induced by iv and maintained via an oral endotracheal airway.After successful induction and maintenance of general anesthesia the patients (sic) abdomen was propped and draped usual sterile fashion.A surgical timeout was taken, and correct patient correct procedure were confirmed.An area just above the umbilicus was anesthetized using half percent marcaine with epinephrine.A 1 cm vertical incision was made at the top of the patients (sic) previous midline scar.The umbilicus was grasped and elevated and a veress needle was introduced into the abdomen.Proper position of the needle was confirmed by positive drop test.Abdomen was then insufflated to a pressure of 15 mmhg.The veress needle was removed, and a 5 mm optiview trocar was inserted.The abdomen was inspected, there was no evidence of injury from initial trocar placement.2 additional 5 mm ports were placed in the midline.Both port sites were anesthetized using 0.5% marcaine with epinephrine and both port sites were placed under direct visualization.There was no evidence of adhesions to the anterior abdominal wall.A previously placed hernia repair mesh was identified and appeared to be well incorporated.The small bowel was carefully inspected and there were multiple loops of dilated bowel with extensive interloop adhesions there were 2 areas that appeared to be a possible transition point.Both areas had extensive interloop adhesions that were not amenable to laparoscopic lysis.At this point i decided to convert to an open procedure.A vertical midline incision was made through the patient's previous midline scar.Dissection was carried out through the subcutaneous tissue until level the anterior rectus fascia.The fascia was incised and the abdomen entered bluntly.The fascial incision was extended the full length of skin incision.A bookwalter self -retaining retractor was placed and the abdominal contents inspected.Again noted was extensive interloop adhesions particularly right lower quadrant and right upper quadrant.I was able to identified (sic) a ileorectal anastomosis in the pelvis.Started this point i worked backward along the ileum and jejunum back to ligament of treitz.All adhesions between loops of bowel and between bowel and the retroperitoneum were lysed either using electrocautery or sharp dissection.In the right upper quadrant there was a knot of several loops of bowel that was turned in on itself was not obvious transition point.All of these adhesions were also lysed.There was a single enterotomy made during the course of adhesiolysis.This was recognized and repaired immediately with interrupted 3-0 vicryl stitches.The suture line was then imbricated using interrupted 3- 0 lembert type stitches.Once all adhesions had been lysed the bowel was carefully inspected from the ligament of treitz all way to the ileorectal anastomosis.The bowel was completely mobile at this point there is no evidence of any further enterotomies or serosal tears.At this point the fascia of the midline incision, including the previously placed mesh, was closed using a series of interrupted figure of 8, 0 ethibond sutures.The subcutaneous tissues were then irrigated with saline.The skin was closed with staples.The midline wound was dressed with telfa and sterile 4 x4's abds pads and tape.This concluded the procedure.At the end of the case all sponge, needle, and instrument counts were correct.The patient tolerated the procedure well.She was awakened, extubated, and transferred to pacu in stable condition.She will be returned to the floor for postoperative care.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® 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.
|
|
Manufacturer Narrative
|
H6: updated health effect - impact code.Updated investigation findings code.Conclusion 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.
|
|
Manufacturer Narrative
|
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: relevant medical information: on (b)(6) 2016: (b)(6), m.D.Operative report.Pre- and postoperative diagnosis: small bowel obstruction, not improving with conservative management.Anesthesia: general.Estimated blood loss: minimal.Specimens: none.Exploratory laparotomy and lysis of adhesions.Details of the procedure: patient admitted with a high-grade small bowel obstruction identified on computed axial tomography scan with a transition point near the abdominal wall mesh, she has had previous episodes in the past which have resolved conservatively and that was her gallbladder.However when i came in to see her this morning she was in significant abdominal pain which had increased from yesterday.No flatus.And abdominal exam more tender in the peri -umbilical region.Discussed the option of continued conservative management versus proceeding with laparoscopy possible laparotomy, because there had been worsening in no improvement i favored proceeding with surgical intervention, which she also favored.Findings: there was an adhesive band up to the hernia mesh which was causing a slight twist in the mesentery, and most likely the source of partial obstruction.Explant preoperative complaints: not provided.Explant procedure: robotic removal of infected abdominal wall mesh debridement of the abdominal wall ventral hernia defect with phasix mesh.Explant date: (b)(6) 2018 [hospitalization dates unknown].On (b)(6) 2018: (b)(6) operative report.Preoperative diagnosis: infected abdominal wall mesh with cutaneous fistula.Postoperative diagnosis: the same and multiple ventral hernias.Anesthesia: general.Estimated blood loss: minimal.Specimen: mesh removed.Robotic removal of infected abdominal wall mesh debridement of the abdominal wall ventral hernia defect with phasix mesh.Findings: significant amount of intra-abdominal adhesions to the abdominal wall and very dense adhesions to the mesh, mesh infection with purulent fluid collection and cutaneous fistula from this collection to the skin, multiple ventral hernia defects.Procedure: please refer to my preoperative consultation for discussion of risks benefits alternatives and indications for surgery, patient was brought to the or placed on the or table in the supine position, preoperative antibiotics were given plexipulse was replaced, general anesthesia was established by the anesthesia team foley catheter was placed by nursing her abdomen was prepped and draped in a sterile fashion.Veress needle was introduced into the left upper quadrant pneumoperitoneum was established using the 12 mm optiview trocar the abdomen was centered all the layers were well visualized.Additional 8 mm ports were placed along the left flank.The table was positioned.The robot was then docked and the instruments were advanced under direct vision.The anterior abdominal wall was completely covered by omentum and small bowel adhesions mostly small bowel.All this adhesions were taken down on a avascular plane until the mesh was reached.Adhesions were taken from the xiphoid down to the mesh and then from the symphysis pubis up to the mesh.Once all those adhesions were taken down then i had the area isolated where the fistula lead and where the mesh was seen.This dissection was a lot more difficult in terms that there was no true plane between the small bowel and the mesh there were some areas where i did find a plane and the mesh and those adhesions came down nicely but for the most part there were very dense adhesions but a stayed very close to the mesh avoiding any enterotomy.Once the mesh was completely cleared.I then proceeded to remove the mesh at the edge of the mesh was identified.And then proceeded to remove it from the anterior abdominal wall.In the area of the infection the mesh was crumbled up in this area and a fluid collection with a combination of purulence with chronically necrotic tissue was identified which was suctioned out and cleaned.Not enough to get a new culture.I then found the fistulous tract to the skin and this area was directly irrigated from the abdomen coming out through the skin until the return was clear.The abdominal wall was cleared from any obviously necrotic tissue any purulence, the mesh was cut into smaller pieces and removed through the 12 mm port site.Once the abdominal cavity was as clean as possible in terms of any debris mesh or necrotic tissue.I then proceeded to close the fascia, there were several defects above and below the old mesh in the area where the mesh was removed also left an abdominal wall defect.This were closed with a running 0v lock suture 3 total sutures were used.But the fascial edges came together nicely reapproximating the edge of the rectus.The hernia sacs were included within the repair.I did drop the down to 10 mmhg to do this.Then measurements were taken.And a 25 x 15 cm phasix mesh was chosen for the repair.This was tailored to the size and i put 3 stay sutures in it.All the needles were removed the mesh was then introduced.Using the endo close device the mesh was grasped through the anterior abdominal wall tenting the mesh nicely.I elected to tack the mesh additional ports were placed in the right flank and then the mesh was tacked using the captured tacks circumferentially the tacks were placed about a centimeter apart.All the counts were correct, the robot had been undocked the instruments have been removed under direct vision ports were removed incisions were irrigated infiltrated with marcaine and closed with interrupted 4-0 vicryl subcu.The cutaneous fistula was also debrided and packed with quarter inch iodoform packing.Dressing was applied.She was then extubated and brought to the recovery room in stable condition.On (b)(6) 2018: (b)(6).Implant information.Phasix mesh.Size: 25 x 15 cm.Expiration date: n/a.Quantity.1.Relevant medical information: on (b)(6) 2018: (b)(6), operative report.Preoperative diagnosis: abdominal wall abscess at site of surgical wound.Postoperative diagnosis: abdominal pain, abdominal wall abscess at site of surgical wound.Anesthesia: general.Estimated blood loss: 25 ml.Specimen; sent to pathology.Procedure: debridement of abdominal wall abscess, explantation of synthetic mesh, bilateral external oblique component separation, abdominal wall reconstruction with biologic mesh.Cholecystectomy.Indication: ¿¿history of multiple abdominal and abdominal wall surgical procedures and chronic abdominal pain, chronic cholecystitis.¿ findings: chronic abdominal wall abscess with purulent fluid involving the previously placed synthetic mesh.Cholelithiasis.Procedure: the patient's previous midline incision was reopened.The incision was extended cephalad and caudad to the initial hernia repair.The peritoneal cavity was entered cephalad to the prior repair.The abdominal wall abscess was then entered and purulent fluid aspirated.A culture was sent.The synthetic mesh was exposed and explanted using a combination of electrocautery and sharp scissor dissection.Multiple metal tacks were removed with the mesh.The abdominal sidewalls were then debrided of the chronic infection.The chronic inflammatory tissue at the base of the abscess was directly adherent to multiple loops of bowel.These were able to be excised without injury to the bowel except for one loop which required a small enterotomy which was then primarily repaired with a series of interrupted 3-0 vicryl sutures placed in lembert fashion without enteric spillage.Once the abdominal wall was fully debrided of the chronically inflamed and infected tissue the remaining fascia was examined.While this could be approximated primarily i felt that the tension was too great to perform a simple primary repair.Electrocautery and advanced energy dissection were then used to dissect along the anterior rectus sheath laterally beyond the lateral edge of the rectus sheath to the external oblique aponeurosis.This dissection was then tunneled inferiorly to the pubis and superiorly to above the costal margin.The external oblique aponeurosis was then released.Good hemostasis was maintained.A similar dissection was then performed on the contralateral side resulting in bilateral external oblique component separation.A 20 x 25 cm piece of biologic mesh was then prepared and positioned as an underlay.This was then sewn into place with a series of interrupted mattressed 0 pds sutures.The fascia was then approximated using a running 0 barbed pds suture.This suture incorporated bites of the mesh to minimize dead space.Approximation of the fascia completed reconstruction of the abdominal wall.Irrigation was then used and aspirated, 215 french blake drains were placed through separate inferolateral stab wound incisions and positioned in the subcutaneous tissues along the component separation dissections.Closure: the subcutaneous tissue was then approximated with a series of interrupted 3-0 vicryl suture and the skin approximated with a subcuticular 3 oh barbed monocryl suture.A clear sterile dressing was then applied.The patient tolerated the procedure well was extubated in the operating room and transferred to the recovery area in satisfactory condition.On (b)(6) 2018: (b)(6).Implant information.¿biologic mesh¿ [manufacturer not provided].Size: 20 x 25.Expiration date: n/a.Quantity.1.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® 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.
|
|
Search Alerts/Recalls
|
|
|