|
W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Unspecified Infection (1930); Inflammation (1932)
|
| Event Date 02/02/2014 |
|
Event Type
Injury
|
|
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)].It should be noted that the gore® dualmesh® plus 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® plus 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.".
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, and (b)(6) 2014, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions to bowel, seroma, adhesions, open draining wound, surgery to remove mesh, bowel resection, inflammation, necrosis, adhesions to bowel, and infection.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
Relevant medical information: (b)(6) 2009: (b)(6) medical center.(b)(6) md.History and physical.Presents for surgical evaluation of a herniated colostomy.Status post abdominoperineal resection for rectal cancer in 2006.States the onset of pain, a bulge at the ostomy site, and cramping began about one year after the above procedure.Bulge is enlarging, becoming more difficult to reduce, increasing in discomfort and interfering with bowel function.Intermittent constipation.When constipated, hernia becomes much larger and painful.He eventually gets impacted and must flush the ostomy site in the shower to relieve the pressure from the hernia and constipation.Reports ct and pet scan within the past year which revealed no signs of recurrent/metastatic cancer.History of hepatitis c; last dose of interferon was about 3 weeks ago.Medical history: rectal cancer, inguinal and umbilical hernia.Surgical history: inguinal and umbilical hernia repair with colostomy placement.Medications: metformin, oxycodone.Abdomen: non-tender to palpation.Non-reducible parastomal hernia present left lower quadrant.Impression: colostomy complication, abdominal pain, parastomal hernia.Plan: has symptomatic parastomal hernia; recommend repair.Repair would require moving colostomy to the right side of abdomen.Repair will be scheduled after we obtain clearance from dr.(b)(6) based on hepatitis c levels/treatment.(b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.First assistant: dr.(b)(6) do.Preoperative diagnosis: paracolostomy hernia.Procedure: repair of paracolostomy hernia by relocation of the colostomy.Takedown of splenic flexure.Indications: the patient is a 58-year-old man, 3 years status post colostomy formation for rectal cancer.After the first year, he began to develop an increasingly troublesome paracolostomy hernia which interfered with his ostomy function.The risks, benefits, and alternatives were explained in detail to the patient.He expresses understanding and would like to proceed.Description of procedure: ¿the patient was brought to the operating room and placed in a supine position.A foley catheter was placed.His abdomen was shaved.The ostomy was oversewn with a running prolene suture.The abdomen was then prepped and draped in a sterile fashion.An _____ [sic] incision was then made transversely in the skin around the left lower quadrant ostomy.The subcutaneous tissue were divided until the ostomy was dissected away from its surrounding subcutaneous tissues down to the fascial level.There was a hernia sac located lateral to the ostomy site.The colon was dissected free of all of the fascial attachments and dunked into the abdominal cavity.There were adhesions noted medially towards the midline, and these were taken down through the ostomy site.The patient wanted a colostomy site which was just above the level of the umbilicus.I therefore placed the new ostomy site over the right rectus muscle just superior to the umbilical level.A quarter-sized piece of skin was removed.A plug of subcutaneous tissue was excised.A cruciate incision was made in the anterior rectus sheath.The rectus muscle was bluntly split and a cruciate incision was made in the posterior rectus sheath.The opening was sized so that two fingers could be placed through the ostomy site.Through the left lower quadrant ostomy site, the colon was mobilized from its surrounding attachments.It should be noted that a gia-75 was used towards the beginning of the case to remove the end of the ostomy with its attached skin.Through this left-sided ostomy site, the splenic flexure was able to be taken down to provide further length to the colon.This was performed with blunt dissection, as well as cautery on the peritoneal attachments.With this maneuver, there was enough mobility of the colon to bring it over to the right side without any tension and, therefore, a midline laparotomy was not necessary.Using a babcock, the colon was brought up through the new right-sided colostomy site.The old left-sided ostomy site was closed in a transverse fashion with loop #1 pds.Full-thickness bites were obtained for this closure and the edges came together without a lot of tension.The subcutaneous tissues were approximated and finally 3-4 clips were placed to loosely approximate the skin.A sterile dressing was applied followed by benzoin and tegaderm.The new ostomy was then matured by excising the staple line.Four corner sutures were placed in a book fashion.The remainder were placed between full-thickness edge of colon and dermis in the usual fashion.This was done with vicryl.A colostomy bag was applied.The patient tolerated this procedure well.He was withdrawn from general anesthesia, extubated and brought to recovery in good condition.¿ (b)(6) 2009: (b)(6) medical center.(b)(6) md.Discharge summary.Procedure: repair of parastomal hernia by relocation of the colostomy with take-down of splenic flexure.Began having increasing parastomal hernia formation which interfered with ostomy function.Elected to undergo repair for this.Postoperatively, did well.Did have an ileus postoperatively.Developed a small cellulitis around the incision site; given bactrim for this.This was converted to ciprofloxacin.Had stool in ostomy bag on (b)(6) 2009.On (b)(6) 2009, stable for discharge.Discharged home.No heavy lifting for 6 weeks.Diet as tolerated.Follow up with dr.(b)(6) one to two weeks.(b)(6) 2014: (b)(6) medical center.(b)(6) md.History and physical.62-year-old white male status post abdominoperineal resection for rectal cancer, had parastomal hernia that underwent relocation in 2009.Now has recurrent hernia and is interested in repair, plan for colonoscopy to assess prior to hernia repair.Medical history: arthritis, diabetes mellitus, back pain (left leg shorter than right), hypertension, hepatitis c.Surgical history: left inguinal hernia repair 2006, colectomy with colostomy 2006, revision colostomy (b)(6) 2009, revision colostomy 2012.Wt.195 lbs., bmi 27.21.Abdomen: soft, ostomy right lower quadrant, parastomal hernia.Impression/plan: parastomal hernia, history of rectal cancer, risks/benefits/alternative of colonoscopy discussed with patient.(b)(6) 2014: (b)(6) medical center main.(b)(6) md.Procedure report.Preoperative diagnoses: parastomal hernia.History of rectal cancer.Poor prep.Postoperative diagnoses: parastomal hernia.History of rectal cancer.Poor prep.Pandiverticulosis.Procedure: colonoscopy.Complications: none.Findings: pandiverticulosis.No other gross abnormalities.End-colostomy.Indications: mr.(b)(6) is a 62-year-old male who has undergone an apr for rectal cancer.He developed a parastomal hernia and underwent a relocation of his ostomy to the right lower quadrant.He subsequently has developed another parastomal hernia, and has seen me for repair of this.Prior to doing this, the risks, benefits, and alternative of colonoscopy to rule out any colonic pathology prior to surgery were discussed in detail with the patient.He understood and wished to proceed.Implant procedure: laparoscopic repair of parastomal hernia with mesh (modified sugarbaker technique).Laparoscopic lysis of adhesions (90 minutes).Implant: gore® dualmesh® plus biomaterial [1dlmcp04/(b)(6), 15 x 19 cm].Implant date: (b)(6) 2014 (hospitalization b)(6) 2014).(b)(6) 2014: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: multiple recurrent parastomal hernia.Postoperative diagnosis: multiple recurrent parastomal hernia.Small bowel adhesions.Assistant: b)(6), md.Anesthesia: general.Blood loss: 30 ml.Fluids: two liters of crystalloid.Urine output: 500 ml.Complications: none.Specimens: none.Findings: a 7 x 9 cm parastomal defect with moderate small bowel adhesions.Hernia repaired with 15 x 19 cm dualmesh with protacks and 9 transfascial sutures.Primary closure of parastomal hernia with 0 ethibond figure-of-eight suture.Small bowel adhesions of the anterior abdominal wall completely lysed.Previous proceed mesh seen on the anterior abdominal wall, recurrence of hernia noted.Indication: the patient is a 62-year-old male who underwent abdominoperineal resection (apr) for rectal cancer.He had a left lower quadrant colostomy and developed a parastomal hernia.Another surgeon in town performed an exploratory laparotomy and move his colostomy from the left to the right side.He subsequently developed a parastomal hernia at this site and had a laparoscopic keyhole technique repair.It has subsequently recurred and is symptomatic.He underwent a preoperative colonoscopy showing no significant abnormalities.At this time the risks, benefits, and alternatives of laparoscopic repair were discussed in detail with the patient.He understood and wished to proceed.Procedure in detail: ¿after the patient was appropriately anesthetized, the abdomen was prepped and draped in normal sterile fashion.Small nick incision was made at the left subcostal region and a veress needle was inserted on the first attempt.At this time the abdomen was insufflated using a veress needle.Once pneumoperitoneum was established, a 5.0 mm trocar was placed in the left lateral abdomen using optical trocar technique.Once inside the abdomen, the veress needle was seen in a space in the left upper quadrant.There was no evidence of bowel injury or omental injury related to veress needle placement.At this time, a 5.0 mm trocar was placed at this site under direct vision and another 5.0 mm trocar.At this time the 11 mm trocar was placed in the left subcostal region.At this time, there was noted to be some mild nodularity of the liver.There was noted to be a large amount of midline adhesions.We began taking down the small bowel adhesions, the midline omental adhesions sharply.After approximately 90 minutes, we were able to clear the entire abdominal wall adhesions.We had placed a foley within the ostomy to delineate the colostomy and we were able to free the small bowel up surrounding the stoma.There were quite dense small bowel adhesions in the right lower quadrant.We carefully and meticulously took these down in two areas, having to cut into the abdominal wall secondary to the dense adhesions.The previous proceed mesh was able to be visualized.There was, however, a recurrence noted.The mesh was more visible in the upper and medial portion of the defect but the defect was still quite visible.At this time, once the entire abdominal wall was cleared of adhesions, the falciform ligament was taken down and the stoma was measured.The entire defect was noted to be 7 x 9 cm.At this time the fascial defect was closed above the stoma with a figure-of-eight 0 ethibond suture using a suture-passer.This closed the fascial defect quite nicely around the stoma.At this time, a 15 x 19 cm gore dualmesh and five transfascial sutures placed and rolled as a scroll and brought into the 11 mm trocar.At this time, it was unrolled and the transfascial sutures were brought up, lateralizing the stoma in a modified sugarbaker type technique with two sutures on the lateral portion on either side of the lateralized stoma.At this time the mesh was noted to be in good position, with wide overlap of the hernial defect and the stomal lateralized nicely.At this time the sutures were tied.At this time protacks were placed approximately 1.0 cm apart and 0.5 cm off the mesh circumferentially around the mesh for lateral fixation.Additional four #1 pds sutures were placed in the remaining portions of the mesh to allow for further suture fixation.At this time the mesh was noted to be in good position with wide overlap of the hernial defect.The stoma appeared viable and not obstructed.At this time everything appeared in good order.The needle, sponge, and instrument counts were reported to us as correct with no evidence of intra-abdominal foreign body.The abdomen was irrigated and suctioned.Please note that right after adhesiolysis, the abdomen was examined to make sure there was no occult bowel injury or omental bleeding.This was also done at the end of the case and there was no evidence of occult bowel injury or bleeding.Again everything appeared in good order.At this time the fascial defect at the 11 mm trocar in the left upper quadrant was closed with 0 vicryl figure-of-eight suture under direct vision using a suture-passer.The 5.0 mm trocars were removed under direct vision without evidence of bleeding and the abdomen desufflated.The skin was approximated with 4-0 monocryl subcuticular stitch and dermabond glue.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.¿ b)(6) 2014: b)(6) medical center.B)(6) md.Operative note.Preoperative diagnosis: recurrent parastomal hernia.Procedures: laparoscopic repair parastomal hernia with synthetic mesh.Laparoscopic (sugarbaker) repair of recurrent parastomal hernia with mesh (15x19cm dualmesh), laparoscopic lysis of small bowel adhesions (90 minutes).Implant record.Implant name: mesh dual plus 15x19cm-log85626.Type: mesh.Inv.Item: 1974.Lot no.9650980.No.Used: 1.Findings: recurrent defect with previous proceed mesh seen, recurrent hernia 7x9 cm repaired with 15x19 cm dualmesh with 9 transfascial sutures, protacks, moderate small bowel adhesions, primary defect closure with figure-of-8 0 ethibond.(b)(6) 2014: b)(6) medical center.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 9650980.W.L.Gore & associates.Relevant medical information: (b)(6) 2014: (b)(6) medical center.Lab.Wbc 14.2 h (4.0-10.0).(b)(6) 2014: (b)(6) medical center.(b)(6) md.Radiology ¿ acute abdominal series.Indication: evaluate whether there is truly free air or not.Findings: most likely just atelectasis rather than free air.Small bowel loops are dilated with distention up to 5.5 cm.Impression: small bowel obstruction.Atelectasis in lung bases.Given atelectasis, it is difficult to evaluate for free air.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Consultation.States initially after colon surgery, he had total urinary incontinence which sounds like overflow.Postoperative urinary retention.Stated he felt like he could void but sill having problems with prolonged ileus.Believe he has probably had some incomplete emptying since original surgery by history.Will give voiding trial in morning, but will probably need foley until bowel function returns.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Discharge summary.Admission diagnosis: recurrent hernia parastomal.Discharge diagnosis: urinary retention.Presented for elective repair of a parastomal hernia.Underwent laparoscopic sugarbaker repair with mesh without complication.Did well after surgery and admission to surgical floor.Had very slow return of bowel function.Also had issues early on with urinary retention for which foley catheterization was used.Ultimately able to void spontaneously prior to discharge.Require nasogastric tube decompression for delayed post operative ileus.Ultimately had return of good ostomy function.Activity was advanced early as could tolerate.With return of spontaneous bowel function, diet appropriately advanced.Ambulated safely and pain controlled with oral medications.Discharged home in stable condition, tolerating regular diet, on oral analgesics and antiemetics.Activity: no heavy lifting over 15 lbs.For 6 weeks following date of surgery.Otherwise, no activity restrictions.Follow up with dr.(b)(6) in 2 weeks.Medications: glucophage, zofran, oxycontin, roxicodone, miralax.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Discharge summary.Admission diagnoses: recurrent parastomal hernia.Discharge diagnoses: constipation, postoperative ileus, acute blood loss anemia.Consultants: physical therapy/occupational therapy.Procedures: laparoscopic parastomal hernia repair; sugarbaker repair with mesh.Laparoscopic lysis of adhesions (90 minutes).Presented for elective repair of parastomal hernia.Had a previous abdominoperineal resection with end colostomy for low rectal cancer.Did well after surgery and admission to surgical floor.Required placement of nasogastric tube for postoperative ileus, which was not unexpected given extent of dissection and adhesiolysis required to achieve repair.Also required foley for urinary retention; ultimately able to void spontaneously prior to discharge.Had a few subclinical fevers postoperatively that responded to tylenol and incentive spirometry when compliant.Wbc count remained stable and within normal limits throughout inpatient recovery.Activity advanced early as could tolerate.With return of spontaneous bowel function on postoperative day 6, diet was advanced.Tolerated regular foods prior to discharge and was having appropriate output from stoma.Discharged home in stable condition, tolerating regular diet, on oral analgesics and antiemetics.No heavy lifting over 15 lbs.For 6 weeks following date of surgery, otherwise no restrictions.Follow up with dr.(b)(6) in 1 to 2 weeks.Medications: glucophage, zofran, roxicodone, miralax.(b)(6) 2014: (b)(6) medical center.(b)(6) md.History & physical.Chief complaint: free air on abdominal x-ray with concern for perforation.Underwent a modified sugarbaker repair of parastomal hernia on (b)(6) 2014.Hospital course was complicated by postoperative ileus; on discharge (b)(6) 2014, was tolerating regular diet with ostomy function.That night he began to feel increasingly fatigued, with increased abdominal pain, fever to 102.8, chills and nausea, and was taken to onslow hospital where he had a systolic blood pressure in the 80s with tachycardia to 128.He was resuscitated, nasogastric tube placed with large amount output, started on antibiotics.Initial abdominal x-ray was suggestive of partial small bowel obstruction.Earlier today repeat abdominal x-ray showed free air under the left and right hemidiaphragms, and he was transferred to nhrmc with concern for perforation.Currently pain about the same on discharge, minimal nausea, no shortness of breath, no chest pain, ostomy bag with stool although he thinks it is all from two days ago.Social history: former smoker; 1.5 packs/day for 7 years.Quit (b)(6) 1969.Abdomen: soft, moderately tender to palpation around ostomy, not frankly peritoneal, ostomy slightly dusky with stool in bag, area around ostomy more protuberant than rest of abdomen, but unable to palpate discreet hernia.Impression: with complex abdominal surgical history, most recently parastomal hernia repair, now transferred from osh two days after discharge with abdominal x-ray indicating free air with concern for perforation.Exam, labs, and overall clinical appearance reassuring, although needs further workup to rule out surgical abdomen.Plan: admit, nothing by mouth, intravenous fluids, nasogastric tube, blood/urine cultures, check electrocardiogram (irregular rhythm), ct abdomen/pelvis, closely follow.Attending attestation: evaluated patient, agree with findings and proposed management/treatment plans.Dr.(b)(6) will place percutaneous drain in large anterior collection, broad spectrum antibiotics to be started.Ct findings reviewed with patient and wife.Potential for operative intervention in am discussed if symptoms do not resolve with initial plan.Both understand the nature of the problem and associated risks.Will review with dr.(b)(6) in the morning.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: small bowel obstruction.Findings: atelectasis both lung bases.Small amount of free intraperitoneal air in upper abdomen.Large amount of free fluid.Complex mixed density rim-enhancing fluid collection within the right upper quadrant mesentery measuring 7.5 x 4.7 cm.A subcutaneous rim-enhancing fluid collection which appears to communicate with the peritoneal cavity measuring 10.9 x 5.0 cm.In addition, there is a large air and fluid containing collection associated with mesh in the anterior abdominal wall.Collection measures 17 x 6.6 cm.Pelvis: large amount of free fluid.Appears to be a fluid collection in the central pelvis measuring 8.3 x 4.0 cm.The source of the obstruction is the large fluid collection associated with the mesh in the anterior abdomen.Impression: multiple intraperitoneal abscesses.Question recent mesh reconstruction of the anterior abdominal wall with associated infection.There is free intraperitoneal air.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Procedure report.Procedure: ct guided abscess drain placement.Indication: infected mesh after recent surgery.Intravenous conscious sedation.Under direct ct guidance, an 18-gauge needle was used to access a large collection in the midline.Using the seldinger technique, the tract was dilated to 11 french before placing a 12 french catheter.Findings: excellent catheter placement.No complications.There was immediate return of foul-smelling purulent fluid.Sample sent for analysis.Diagnosis: successful ct-guided abscess drain.(b)(6) 2014: (b)(6) medical center.Microbiology.Urine culture: no growth after 2 days.Aerobic/anaerobic culture.Source: abscess/abdominal.Culture result: growth.Gram stain: 3-5 wbc/hpf.Numerous gram-positive cocci in pairs, numerous gram-positive rods, numerous gram-negative rods.Isolate 1: heavy escherichia coli.Isolate 2: moderate staphylococcus haemolyticus.Isolate 3: moderate viridians streptococcus.Isolate 4: heavy bacteroides uniformans.Blood culture: no growth after 5 days.(b)(6) 2014: (b)(6) medical center.Microbiology.Vre culture.Specimen: swab.Result: negative for vancomycin resistant enterococci.Mrsa screen.Specimen: nares swab.Result: negative for methicillin-resistant staphylococcus aureus.(b)(6) 2014: (b)(6) medical center.Lab.Albumin 1.7 l (3.4-5.0).Explant procedure: insertion of right subclavian triple lumen catheter.Exploratory laparotomy, damage control.Abdominal washout.Explant of intra-abdominal dual mesh in its entirety.Colostomy takedown with bowel left in discontinuity.Abthera placement.Explant date: (b)(6) 2014 (hospitalization (b)(6) 2014).(b)(6) 2014: (b)(6) medical center.(b)(6) md.Operative report.Pre-operative diagnosis: pneumoperitoneum with intra-abdominal abscess status post laparoscopic parastomal hernia repair with 15 x 19 cm dual mesh (sugarbaker).Small bowel obstruction.Hepatitis c.History of rectal carcinoma with apr, previous colostomy site transposition to rlq.Post-operative diagnosis: pneumoperitoneum with intra-abdominal abscess status post laparoscopic parastomal hernia repair with 15 x 19 cm dual mesh (sugarbaker).Small bowel obstruction.Hepatitis c.History of rectal carcinoma with apr, previous colostomy site transposition to rlq.Colotomy in the peritoneal side of the descending colostomy.Abscess cavity in the ruq abutting the transverse colon.Pelvic abscess.Resident surgeon(s): (b)(6), md.Anesthesia: general.Fluids: 4,000 ml crystalloid, 25 g albumin, 200 ml urine output.Estimated blood loss: 75 ml.Specimens: colostomy.Findings: intra-abdominal abscess (ruq, pelvis) with feculent peritonitis.Colotomy in the peritoneal side of the descending colostomy.Dense adhesions between the descending colon, terminal ileum and right pelvic sidewall.Omental adhesions to the descending colostomy creating an internal hernia.Complications: serosal tear to the terminal ileum which was not repaired at this operation as the patient became hemodynamically unstable and was requiring the use of pressors intraoperatively.Indications for procedure: (b)(6) is a 62 y.O.Caucasian male who underwent a prolonged laparoscopic lysis of adhesions with subsequent repair of his parastomal hernia with a 15 x 19 cm dual mesh by dr.(b)(6) 2013.The patient was hospitalized for 10 days with a postoperative ileus and was ultimately discharged on (b)(6) 2013 tolerating a diet and having normal ostomy output.Per the patient¿s report, he returned to onslow memorial hospital with in approximately 4-6 hours after being discharged with complaints of shaking chills, nausea, vomiting, and abdominal pain.He was noted to be hypotensive on arrival and was resuscitated with 3 l of crystalloid and noted to have a small bowel obstruction on plain film x-ray.He was transferred to (b)(6) in the middle of the day on (b)(6) for further evaluation at which point he underwent a computed tomography scan of abdomen and pelvis with oral and iv contrast.This revealed a very large intra-abdominal abscess just beneath his mesh as well as areas of pneumoperitoneum; however, the patient did not have an elevated white blood cell count or signs of peritonitis, he was minimally tachycardic and was hemodynamically stable.He had a percutaneous drain placed in the anterior abdominal abscess which appeared to drain feculent material.Despite antibiotic therapy and a percutaneous drain, the patient began feeing worse and became tachypneic and tachycardic.Given his overall clinical picture and concern for intra-abdominal bowel perforation, the patient was taken to the operating room as a class a for exploratory laparotomy.The risks (including, but not limited to bleeding, infection, injury to surrounding organs including bowel, the need for bowel resection, the need for multiple trips to the operating room, prolonged intensive care unit stay with chemical ventilation), benefits and alternative were discussed with the patient and his wife.His questions were answered to his satisfaction.Description of procedure: ¿the patient was taken to the operating room and placed in the supine position.A left radial arterial line was placed prior to induction of general anesthesia and the patient was intubated without issue.No further preoperative antibiotics were given as the patient had received cefepime and flagyl on the floor as empiric treatment for his intra-abdominal abscess.The bed was placed in a slight trendelenburg position and the right chest and neck were prepped and draped in the usual sterile fashion using hand hygiene, antiseptics, cap, gown, mask, gloves, and sheet.A triple lumen catheter was flushed with sterile saline.Landmarks were identified and the skin anesthetized as above.The cook needle was inserted angled towards the sternal notch until the clavicle was reached.The needle was placed under the clavicle and aspirated while being advanced.The subclavian vein was accessed with brisk return of blood in the syringe after 1 stick(s).The needle was held in place and the syringe removed and the hub occluded with a finger to prevent air embolus.A guidewire was passed easily and the needle removed leaving the wire in place.A incision was made at the site of the wire.A dilator was passed over the wire to dilate the track.Direct pressure was held at the skin as the dilator was removed.The catheter was place over the wire to the desired depth and the wire removed.Each port was aspirated and flushed with saline.A sterile cap was placed on all ports.The catheter was sutured in place and a sterile dressing placed.The previously placed percutaneous drain was removed.The right lower quadrant ostomy was sewn shut with a running 2-0 prolene, and the ostomy covered with a tegaderm.The abdomen was then prepped and draped in the usual sterile fashion.A midline laparotomy incision was made in the upper abdomen with a 10 blade.Bovie cautery was used to dissect down to the level of the fascia which was then incised with a 10 blade.Upon entering the peritoneum, a rush of air was noted followed by a rush of stool.The edges of the fascia were grasped with coker clamps and elevated and a pool sucker was inserted into the abdomen.The incision was extended proximally and distally with bovie cautery over top of the surgeon¿s finger.A large amount of feculent material was removed from the abdomen.A seroma superior to the dualmesh was also drained.The incision was carried down to the infraumbilical position to fully expose the dualmesh.The mesh was then removed in its entirety and discarded.Once the mesh had been removed, the abdomen was thoroughly suctioned with multiple pockets of dark murky fluid suctioned free from the right upper quadrant and the pelvis.Once the abdomen been cleared of this fluid, it became apparent that there was an area of mesentery that was adherent to the descending colon as it stretched across the abdomen from the left to the right forming the descending colostomy in the right lower quadrant.This appeared to be creating an internal hernia with a portion of small bowel rotated on either side of this band of omentum.This omentum was released with bovie cautery and hemostasis was obtained by placing kelly clamps on the cut ends and securing this area with 0 silk ties.It then became apparent that there was a colotomy in the peritoneal side of the descending colostomy.A gia 60 stapler was used to transect the colostomy at the level of the peritoneum.The descending colon was then isolated and a second gia 60 stapler load was used to remove the injured portion of the descending colostomy and this was handed off as a specimen.At this point the small bowel was run from the ligament of treitz to the terminal ileum.It was noted that the terminal ileum appeared to be adhesed to the descending colon as well as the right pelvic sidewall and cecum.The remainder of the colon was identified and appeared normal.The appendix was identified and was normal.The abdomen was thoroughly irrigated with several liters of warm normal saline until the suctioned effluent was clear.We did note a serosal tear in the distal terminal ileum however, the patient became hypotensive and was requiring boluses of neo-synephrine to maintain his pressure, so this was not repaired.At this time we decided to place an abthera dressing and transfer the patient to the intensive care unit for further resuscitation.The right lower quadrant ostomy was removed from the skin and sent as a specimen.The visceral protective layer was placed around the abdominal contents.Blue foam was placed in the midline incision as well as in the previous right lower quadrant ostomy site.Tegaderm was placed between the ostomy site and the midline incision to protect underlying skin.Blue foam was used to bridge between the right lower quadrant ostomy and midline incision.An adequate seal was obtained on the abthera.All needle, instrument, and towel counts were correct times two.The patient remained intubated and was transferred to the intensive care unit in critical condition.Dr.(b)(6) was present for this entire procedure.¿.
|
| |
|
Manufacturer Narrative
|
|
H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus 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® plus 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.H6: updated investigation finding.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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus 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.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 and sterilization records verified that the lot met all pre-release specifications.C1: 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
|
|
|
