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W.L. GORE & ASSOCIATES GORE SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFV1520 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Hernia (2240); Not Applicable (3189); No Code Available (3191)
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| Event Date 11/30/2016 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the gore® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2015, whereby a gore dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2016, whereby a gore® synecor biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure was performed whereby explant of the gore device was performed.The complaint alleges that on (b)(6) 2018, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: additional surgery, extensive lysis of adhesions, recurrent hernia, mesh failure, mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated on (b)(6) 2014 states ¿abdomen soft, + drainage from wound with mild erythema.Staples removed, wound spread with q-tip.Fluid drained-sent for culture.Irrigated with saline, packed with iodoform packing.Home care¿.Wound culture reports for specimen from abdomen obtained on (b)(6) 2014 states: ¿gram stain-occ/few wbc, moderate gram pos cocci in clusters, moderate gram neg bacilli.Culture- heavy growth escherichia coli extended spectrum beta lactamase producer, heavy growth methicillin resistant staphylococcus aureus (mrsa).¿ medical records dated on (b)(6) 2014 state: ¿s/p [status post] left colectomy, i+d [incision and drainage] abdominal abscess.¿ records also state ¿mrsa.E.Coli.¿ plan ¿packing of wound, hold antibiotic, multi drug resistance, if not healing with need [illegible] antibiotics.[followup] 1-2 weeks.¿ medical records dated on (b)(6) 2014 states: ¿s/p [status post] left colectomy/lar, + wound infected with mrsa; residual e.Coli.Now wound healed and weight gain.¿ also states: ¿c/o [complains of] pain around umbilicus rest [sic] pain with defecation.¿ the records also state: ¿schedule for laparoscopic/possible open inc{incisional] hernia repair with mesh.¿ history and physical records for hospital admission on (b)(6) 2015 to on (b)(6) 2015 states: ¿this is a 58-year-old african-american male who had a laparoscopic repair of ventral hernia by dr.(b)(6).Patient came to the emergency room complaining of swelling and abdominal pain.Patient had a ct scan of the abdomen and pelvis that shows fluid above and below the mesh which is not abnormal, however, patient also shows what appears to be dilated small bowel, possible partial small bowel obstruction.¿ the medical records for hospital admission on (b)(6) 2015 to on (b)(6) 2015 also state: ¿abdomen is soft.There is some tenderness in the epigastric area where the hernia is.No guarding, rigidity or rebound.Patient having bowel habits.Ct scan is concerning for small bowel obstruction.There also is a fluid collection.There may be an inadvertent injury to the small bowel.Will take the liberty of observing him.Get serial complete blood counts, abdomen complete, clinical evaluation.¿ radiology records dated on (b)(6) 2015 indicate the patient had an abdominal obstruction series for abdominal pain.Impression: ¿nonspecific and nonobstructive bowel gas pattern.No radiographic evidence of small bowel obstruction.¿ medical records dated on (b)(6) 2015 states: ¿s/p [status post] inc vhr [incarcerated ventral hernia repair] with mesh.Readmitted-seroma, psbo [possible small bowel obstruction]in ct but pt [patient] asymptomatic¿ records also state: ¿impression-seroma/vhr [ventral hernia repair] s/p, abdominal binder, no heavy lifting, f/u [follow up] 3 weeks, renal cyst-mon[day} followup urology.¿ medical records dated on (b)(6) 2015 states: ¿s/p [status post] lap [laparoscopic vhr [ventral hernia repair] with mesh.Post op seroma.Doing well.Abdomen [sic] [illegible] swelling, non-tender.Plan ¿no heavy lifting, improved seroma, f/u [follow up] prn.¿ medical record dated on (b)(6) 2015 states: ¿patient experiencing pain from previous surgery.¿patient is out of his post op [operative] period and we do not participate with his insurance so he would have to see a doctor in his network.¿ 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® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia 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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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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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: records dated (b)(6) 2017 state the patient was seen for follow up.¿he still has tenderness in the mid to left abdominal area.¿ abdominal exam notes state: ¿epigastric tenderness; multiple healed scars from surgeries.¿ consultation records dated (b)(6) 2017 state the patient was seen for complaints of acid reflux.¿he underwent colonic resection, although the area or section of colon that was removed is unknown.¿ ¿since then, he has undergone 2 additional surgeries for incisional hernia repair.He states mesh was placed with both of these surgeries.The most recent surgery was in (b)(6) 2016 [sic unfortunately, the hernia has again returned which causes him periodic abdominal pain in the llq.¿ abdominal exam notes state: ¿soft mid rlq and llq tenderness, non-distended with normal bowel sounds.No masses or hepatosplenomegaly noted.There is no guarding or rebound.Large incisional hernia noted.Midline incisional scar noted.¿ records dated (b)(6) 2017 state the patient was seen for follow up: ¿he underwent both an upper endoscopy and colonoscopy with dr.Shah on 9/28.The egd was remarkable for a mild to moderate hiatal hernia and moderate erosive gastritis.Biopsies were remarkable for barrett¿s esophagus without dysplasia, and h.Pylori, but were negative for celiac disease.¿ records dated (b)(6) 2017 state the patient was seen for follow up regarding an h.Pylori infection and gerd.¿he is currently feeling well.¿ ¿he denies abdominal pain, nausea or vomiting.¿ 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® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia 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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Please note the initial medwatch indicates an incorrect date gore aware of (b)(6) 2018.The date gore aware of information for the initial report is(b)(6) 2018.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: records prior to (b)(6) 2014 were not provided.Operative records dated (b)(6) 2014 state the patient underwent sigmoid colectomy with primary anastomosis and rigid procto-sigmoidoscopy.Right and left tap intercostal nerve block with long-acting marcaine/exparel.Lysis of adhesions.The ¿57-year-old male came to the hospital with complaint of having left lower abdominal pain.Patient had an outpatient colonoscopy done on (b)(6) saw internal hemorrhoid and 5 cm sigmoid mass.¿ the (b)(6) 2014records continue: ¿a lower midline laparotomy skin incision was given, extended through subcutaneous tissue.Fascia and peritoneum opened in the midline.Upon entering the peritoneal cavity, a buckwalter retractor was placed and small bowel was retracted proximally with large lap pads and retractor.Because of the patient's large amount of tinea and it was densely plastered in the pelvic wall, it required extensive enterolysis to free up this part of the colon from the pelvic wall.¿ the operative records dated (b)(6) 2014state: ¿a mass was palpated into the proximal sigmoid colon.It was a large-sized soft mass.After extensive lysis of adhesions, we were able to free up the sigmoid colon and mobilize it from the retroperitoneum.We also freed the part of the descending colon.A window was made in the mesentery of the proximal colon, proximal to the tumor, and colon was divided with a contour ta stapler.After that, mesentery of the colon was divided with the enseal device.One major pedicle was clamped and ligated with 0 vicryl ties.¿ the (b)(6) 2014 records continue: ¿distally, at the level of the rectum, a window was made into the mesentery and proximal rectum was divided with another load of contour ta stapler.The remaining mesentery was divided with enseal device.Hemostatic 2-0 vicryl sutures were placed close to the staple line.Thorough irrigation with saline was performed.After that, a purse string device was placed into the proximal colon and staple line was removed.A 29-size anvil was passed and purse string sutures were tied.Another layer of 3-0 vicryl was placed around the anvil for further security, and we did divide part of the mucosa to free up the staple line with low voltage bovie cautery.¿ records dated (b)(6) 2014 continue: ¿an end-to-end anastomosis between the distal rectum and proximal colon was performed with the eea staple.Two complete donuts were removed.Air and suppression gas was performed.There was no evidence of any air leak.We covered the anastomosis with the evicel fibrin glue.Some irrigation with saline was performed.All the fluid was aspirated and omentum was brought in to cover the rest of the bowel face.After that we performed right and left tap intercostal nerve block by injecting 20 ml of exparel diluted with 20 ml of saline, injected into both right and left sides.After that fascia was closed with running 1-0 looped pds sutures.Skin was irrigated with saline and the skin was closed with staples.¿ medical records dated (b)(6) 2015 state: ¿this patient is a 58-year-old male who is complaining of abdominal pain and swelling patient [sic].Physical examination states: abdomen with lower midline scar with positive swelling in the epigastric and suprapubic area with the hernia.Patient with abdominal pain, incisional ventral hernia.We will obtain cat scan.Apparently, the patient had a previous cat scan in the october, at that time, he was diagnosed with some renal mass and was supposed to follow up with urology.We will evaluate residual mass again with ct scan, and if there is no evidence of any other pathology, we will reschedule him for laparoscopy, possible open repair of incisional ventral hernia with mesh.¿ the records indicate a consultation for the left renal mass was performed and an mri was ordered.¿of note, the renal mass in a way prohibits the patient from undergoing treatment for the hernia for which he is scheduled.¿ the records provided do not further address this and surgery was performed on (b)(6) 2015 with a gore dualmesh® plus biomaterial as noted.Radiology results dated (b)(6) 2015 state: ¿the examination demonstrates air within nondilated colon from the cecum to the rectum.The examination is negative for a normal small bowel distention or pneumoperitoneum.¿ operative records dated (b)(6) 2015 state the patient underwent "laparoscopic extensive lysis of adhesions for about one and half hours.Laparoscopic repair of incisional ventral hernia with gore dual plus 19 x 15cm mesh.¿ the operative records dated (b)(6) 2015 state: ¿a veress needle was placed in the left upper quadrant and pneumoperitoneum often and a skin incision was given in the right upper quadrant and under optiview, a 5mrn port was placed.Under direct vision, three more ports were placed, one 11 mm in the left upper quadrant, two 5 mm ports in the right and left lower quadrant.After entering the peritoneal cavity, noticed there was a large defect in the midline with extensive and firm adhesions of the omentum to the hernial sac.With the help of harmonic scalpel, all these adhesions with hernial sac was dissected down and gradually released.¿ the (b)(6) 2015 records continue: ¿it took significant time to release all these adhesions, which were very dense and part of the hernial sac was also lysed down.Also part of the falciform ligament was released to expose the abdominal wall.After that, the defect was measured and a 19 x 15 cm gore dual plus was used.Four corners were sutured with gore sutures and the mesh was rolled and rolled into the abdominal cavity through the 11 mm port, after that with the above carter thomason suture passer and the stab incisions all the 4 quadrant sutures were pulled out of the 4 quadrants and all 4 sutures were tied.¿ records dated (b)(6) 2015 continue: ¿after that, the mesh was secured to all periphery with the help of protack device and all the edges were stapled to the abdominal wall.After that, the repair was inspected.It was good.Peritoneal cavity was inspected.There was no active bleeding.After that, under direct vision the above carter thomason, 11 mm port was sutured with the help of 0 vicryl suture.After that, pneumoperitoneum completely evacuated.All the ports were removed.The fascia was closed with 0 vicryl suture.Skin incisions were closed with 4"0 monocryl.Steri-strips and dressings were placed.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmc04/12791786) was used during the procedure.Operative records dated (b)(6) 2016 state the patient underwent laparoscopic extensive lysis of adhesions, recurrent incisional hernia repair with mesh, explantation of old mesh, and bilateral rectus sheath blocks.The ¿patient is a 60-year-old gentleman who developed an incisional hernia that was repaired with mesh some years ago.He developed a recurrence of this site and says that it is causing a lot of discomfort and disfigurement.¿ the records dated (b)(6) 2016 state: ¿using a #11 blade, we made a small stab incision in the left upper quadrant.The veress needle was inserted and connected to insufflation.The opening pressures upon insufflating the abdomen were approximately 3 mm hg.The abdomen was insufflated to 15 mm hg.Using a #11 blade, we went in the right lower quadrant and made a 5-mm incision.Using the optiview technique, a trocar and laparoscopic camera were inserted into the abdomen.The veress needle site was inspected.There was no damage to the adjacent organs.The 0-degree scope was switched out for a 30-degree scope.We noted that there were extensive adhesions on the anterior abdominal wall.¿ operative records dated(b)(6) 2016 continue: ¿we planned our next laparoscopic port site which was in the left lower quadrant.We used a #11 blade and made a 5-mm incision with obturator was inserted under direct visualization.We then placed another laparoscopic trocar in the right upper quadrant.Using a #11 blade, a 5-mm incision was made in the right upper quadrant.All trocars were inserted under direct visualization.At this point we began to take down all of the prior adhesions to the mesh and anterior abdominal wall.The adhesions were dense and vascular.¿ records dated (b)(6) 2016state: ¿a combination of harmonic and sharp dissection was used.The adhesiolysis portion took two hours.Once the adhesions were taken down we were able to place another 5-mm trocar into the left upper quadrant of the abdomen.At this time, we identified that the prior ventral hernia repair had failed.There was evidence of old mesh present; however, the inferior portion of this mesh was detached from the fascia and curled up.We decided that in order to perform a formal repair that was adequate, we had to explant the old mesh.We then grasped the old mesh and dissected it off the anterior abdominal wall.Once the mesh was removed, we extracted it through the left upper quadrant port.The left upper quadrant port was up sized to a 12-mm trocar.Once the mesh was removed, we then planned our repair.¿ operative records dated (b)(6) 2016 continue: ¿there was a large midline defect and diastasis rectus that was reapproximated using 0 ethibond sutures.We used tiny stab incisions along the midline and an endo pass suture to insert 0 ethibond sutures as interrupted fashion going from one lateral aspect of the fascia to the other aspect and reapproximating them.Approximately six of these sutures were placed along the anterior midline defect.This brought the lateral edges of the defect closer.Afterwards we then planned to place our mesh.¿ the (b)(6) 2016 records state: ¿a 15 x 20 mm mesh was gore synecor.The mesh was soaked in saline.It was placed on the anterior abdominal wall underneath the blue towel.We used 0 ethibond sutures around the four corners of the mesh and placed it through the mesh.The mesh was then rolled up and inserted into the abdomen.It was placed in appropriate position.Using the endo pass suture, the transfascial sutures were brought through the abdominal wall.The sutures were then tied.We then tacked the mesh up to the anterior abdominal wall going in a circumferential fashion using the reliatacker device.The mesh was well placed without wrinkles or tears.¿ records dated (b)(6) 2016 continue: ¿we then infiltrated the bilateral rectus sheaths with approximately 80 ml of exparel under direct visualization.We subsequently closed the left upper quadrant 10-mm incision with an 0 vicryl suture on an endo pass needle.The abdomen was then desufflated and the trocars were removed under direct visualization.The wounds were then washed, dried, and closed with 4-0 monocryl sutures.The abdomen was then subsequently again washed and dried.The wounds were dressed with dermabond.The abdomen was also dressed with abo pads, foam tape, and an abdominal binder.¿ the records confirm a gore® synecor biomaterial (gkfv1520/15186757) was used during the procedure.Operative records dated (b)(6) 2018 state the patient underwent ¿robotic-assisted laparoscopic lysis of adhesions extensive, robotic-assisted laparoscopic left renal cyst decortication.Robotic-assisted laparoscopic left partial nephrectomy with intraoperative renal ultrasound.¿ the records also state the patient underwent ¿repair of recurrent chronically incarcerated incisional hernia, lysis of adhesions, explanation of unincorporated mesh, implanation of hernia mesh.¿ the patient ¿is a 61-year-old male with a history of colon resection and 2 failed incisional herniorrhaphy (1 laparoscopic and 1 robotic) with a large recurrent incisional hernia, with newly diagnosed renal cell carcinoma.He was taken to the operative room for combined partial nephrectomy and recurrent incisional herniorrhaphy.¿ the operative records dated (b)(6) 2018 continue: ¿a veress needle technique was used to insufflate the abdomen to 15 mmhg, at which point port site markings were created and placed in standard position for a robotic-assisted surgery with a 12 mm assistant.It is important to note that the patient had significant amount of adhesions requiring a significant amount of lysis greater than 45 minutes simply to allow placement of the ports.With all ports in position, position was returned to the steep right tilt position.The robot was docked.The white line of toldt was mobilized all the way up to the spleen which was mobilized medially and all the way down to the lower pole of the kidney, the lower pole of the kidney was elevated.¿ records dated (b)(6) 2018 continue: ¿the ureter was identified and the plane towards psoas muscle and its fascia were identified.The kidney with its ureter was elevated.The gonadal vessel remained medially.Dissection ensued in this plane up towards the hilum where renal artery and vein were identified.The renal artery and vein were isolated, skeletonized nicely.We then identified the left renal mass which is rather exophytic and anterior and easy to identify, advanced a bk ultrasound probe into the patient's abdomen and performed a renal ultrasound, identifying the renal cyst, which was also anterior though more cephalad than the complex renal mass on the lower pole.¿ operative records dated (b)(6) 2018 continue: ¿the renal cyst was punctured and a large portion of the renal cyst wall was removed and then at this point, the perinephric fat overlying the interface to the kidney tumor and normal renal capsule was removed, the renal capsule was scored.The renal artery was clamped with two clamps.The renal vein was clamped singly and extirpation of the renal mass ensued.We did enter the collecting system.Upon extirpation, the tumor was excised and the margin was sent off.This was negative for any tumor.¿ records dated (b)(6) 2018 state: ¿running 3-0 v-loc sutures x2 were used to perform the deep renorrhaphy ensuring that all blood vessels and collecting system defects were closed.This was followed by a 0 v-loc capsular renorrhaphy using a sliding weck clip technique.Upon completion, the bulldogs were removed.We identified there to be adequate hemostasis from the renorrhaphy and the specimen was then placed into an endocatch bag.Some fibrillar was placed into the hilum and surgiflo was placed over the renorrhaphy site.It is important to note that we did have anesthesia administer mannitol 25 grams just prior to clamping the renal hilum.¿ the(b)(6) 2018 records continue: ¿the case was then turned over to dr.(b)(6) who then extracted the specimen through an extended skin incision overlying the 12mm assistant port site and through this he performed a complex repair of the fascia using a mesh.¿ operative records dated (b)(6) 2018 continue that following completion of the partial nephrectomy procedure, ¿a horizontal extraction port through the hernia defect approximately 10 cm above the umbilicus was extended in a horizontal fashion.There was a larqe recurrent incisional hernia defect containing intraabdominal omentum there were significant adhesions to the undersurface of the abdominal wall, especially inferiorly extending to the umbilicus and inferiorly from the patient's prior to [sic] failed incisional hernia repairs.There appeared to be coated mesh from 2 prior ipom (intraperitoneal onlay meshes, with what appeared to be metallic protacks).At this point, the defect measured approximately 8 x 8cm in size.¿ records dated (b)(6) 2018 state: ¿at this point, lysis of adhesion was performed taking down the omentum, small bowel and other adhesions of the anterior abdominal wall.Hemostasis on the omentum was obtained using the ligasure as well as kelly clamps and 0 vicryl ties.The segments of the omentum.Were excised along with attenuated fascia and large hernia sac, which i would estimate measured approximately 15 x 15 cm in size.The entirety of the hernia sac was removed to reduce risk of seroma.¿ the (b)(6) 2018 records continue: ¿there was significant attenuated fascia and the fascial edges were debrided to allow for adequate primary.Reapproximation.There was a defect at the base of the umbilicus.An additional fascial tissue needed to be excised.Local flaps were raised in order to allow for primary closure at the midline.At this point, 266 mg of exparel liposoma.L bupivacaine was infiltrated in the transverse abdominus plane bilaterally for postoperative pain relief.¿ operative records dated (b)(6) 2018 state: ¿on the inferior margin of the fascia, there was approximately a 5 x 10 cm segment of unincorporated mesh, which was excised and passed off to pathology.At this point, the repair was performed by primarily closing the fascia in a horizontal t fashion using #1 pds suture anchored on both sides and tied in the center.At this point, a 15 x 15 segment of light weight polypropylene in the form of bard soft mesh was trimmed to size and anchored down over the primary closure site providing for circumferential overlap over the entirety of the primarily repaired defect.This was performed using running 0 vicryl suture.Additional vicryl sutures were placed in the center to allow for better mesh tissue contact and better incorporation.¿ records dated (b)(6) 2018 continue: ¿at this point, the umbilicus was re-anchored down to the abdominal fascia using 0 vicryl suture.3-0 vicryl suture placed in scarpa's fascia.3-0 vicryl deep dermal sutures were then placed and the skin of all the incisions was closed with 4-0 monocryl subcuticular suture.Dermabond was applied.¿ there was no mention of infection in the records.Pathology report dated (b)(6) 2018 regarding a specimen collected (b)(6) 2018 states the following specimens were received: ¿left renal mass, left renal cyst wall, left renal mass, left renal deep margin, hernia sac and attenuated fascia, segment of mesh.¿ specimens a-d pertain to the patient¿s renal specimens and will not be included in the summary.¿specimen e is received fresh labeled ¿hernia sac and attenuated fascia" and consists of three fragments of adipose tissue, two of which are partially covered by a red-purple, glistening, congested and trabeculated membranous tissue.The three fragments in aggregate measure 14 x 7 x 1.5 cm.There is a blue-green suture embedded in the largest fragment of tissue.¿ ¿specimen f is received fresh labeled "segment of.Rnesh and consists of two fragments of a mesh material that in aggregate measure 7 x 4.5 cm ranging from 0.3 cm up to 1.5 cm with areas of a red-purple fibrous tissue and adipose tissue attached.No sections are taken.Gross only.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® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2016 state: ¿first noticed hernia after colon surgery over 2 years ago.After 4 months it was repaired.Seven to nine months after the repair it was noticed to re-occur.¿ physical examination: ¿gastrointestional:.Reducible incisional recurrent hernia in midline.¿ impression and plan: ¿herniorrhaphy: laparoscopic incisional, with mesh.¿ medical records dated (b)(6) 2016 state: ¿problems (active): bacterial infection of skin, hernia, mrsa, soft tissue mass.¿ a pathology report dated (b)(6) 2016 regarding a specimen collected (b)(6) 2016 states: ¿specimen source: a.Hernia sac.B.Old mesh.¿ ¿gross description: a) the specimen is received in formalin, labeled with the patient¿s name and designated ¿hernia sac¿ and consists of two irregular fragments of pink-tan to pink-red fibrofatty tissue measuring 3.5 x 1.5 x 0.3 cm in aggregate.The specimen is sectioned and representative sections are submitted for permanent microscopic examination in one cassette.B) the specimen is received in formalin, labeled with the patient's name and designated ¿old mesh" and consists of two irregular fragments of pink-tan to pink-red fibrofatty tissue surrounding a metallic mesh measuring 8 x 8 x 3 cm in aggregate, representative sections are peeled off the mesh and submitted for permanent microscopic examination in one cassette.Diagnosis: a) inguinal hernia sac with prominent reactive changes.B) dense fibrous tissues with chronic reactive changes.Fragments of mesh.¿ 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® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical record dated (b)(6) 2017 indicate the patient was seen for gastroenterology consult for complaint of acid reflux.The records state: ¿of note, he was diagnosed with colon cancer in (b)(6) 2015.He states a colonic mass was seen on diagnostic colonoscopy in evaluation for rectal bleeding.He underwent colonic resection, although the area or section of colon that was removed is unknown.¿ ¿since he has undergone 2 additional surgeries for incisional hernia repair.He states mesh was placed with both of these surgeries.The most recent surgery was (b)(6) 2019.The records state past medical history ¿atrial fibrillation on coumadin¿ medical records dated (b)(6) 2018 state ¿he presents today for follow up from hospitalization x 5 days for cellulitis.He was placed on antibiotic therapy and on discharge was given 5 days of antibiotics.The areas are still a little swollen.He also has been recently diagnosed with renal cancer and will be scheduling a nephrectomy in the near future.¿ medical records dated (b)(6) 2018 indicate the patient was seen for follow-up, urology referral.The records state: ¿he presents today for follow up after 2 surgical procedures.Since his last visit he has a partial left nephrectomy at rwj, and abdominal hernia repair.Both procedures done on may 1st.He is feeling well.Urination and defecation wnl.He denies any pain.¿ ¿abdomen: bowel sounds: normal.Inspection and palpation: no tenderness, guarding, masses, rebound tenderness, or cva tenderness and soft and non-distended; abdominal scar- transverse- healing well and multiple stab wounds also healed.¿ 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® synecor intraperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia 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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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient code / codes (1695, 2240, 3191: appropriate term / code not available for ¿mesh failure¿) was / were 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.Medical records: the known medical records span july 9, 2014 to june 12, 2018 and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial and gore® synecor biomaterial.Patient information: medical history: hypertension, right bundle branch block, coronary artery disease, atrial fibrillation, depression, insomnia, anxiety, neuropathy of unknown etiology, methicillin resistant staphylococcus aureus [mrsa], hypercholesterolemia, acid reflux, villous adenoma with infiltration cancer of the colon, left renal mass, obesity, bmi 30+, 2013: symptomatic bradycardia.Prior surgical procedures: 2013: permanent pacemaker, on (b)(6) 2014: sigmoid colectomy, lipoma resection, partial removal left kidney.Relevant medical information: on (b)(6) 2014: sigmoid colectomy with primary anastomosis and rigid procto-sigmoidoscopy.Right and left tap intercostal nerve block with long-acting marcaine / exparel.Lysis of adhesions.¿5 cm sigmoid mass.¿ ¿a mass was palpated into the proximal sigmoid colon.It was a large-sized soft mass.After extensive lysis of adhesions, we were able to free up the sigmoid colon and mobilize it from the retroperitoneum.¿ on (b)(6) 2014: ¿abdomen soft, + drainage from wound with mild erythema.Staples removed, wound spread with q-tip.Fluid drained-sent for culture.¿ on (b)(6) 2014: wound culture, abdomen: ¿culture- heavy growth escherichia coli extended spectrum beta lactamase producer, heavy growth methicillin resistant staphylococcus aureus (mrsa).¿ on (b)(6) 2014: i+d [incision and drainage] abdominal abscess.Implant #1 preoperative complaints: on (b)(6) 2014: ¿wound infected with mrsa; residual e.Coli.Now wound healed and weight gain.¿ ¿c/o [complains of] pain around umbilicus rest [sic] pain with defecation.¿ on (b)(6) 2015: ¿complaining of abdominal pain and swelling patient [sic].¿ ¿abdomen with lower midline scar with positive swelling in the epigastric and suprapubic area with the hernia.Patient with abdominal pain, incisional ventral hernia.¿ [previous ct on (b)(6), not in records] "he was diagnosed with some renal mass and was supposed to follow up with urology.We will evaluate residual mass again with ct scan, and if there is no evidence of any other pathology, we will reschedule him for laparoscopy, possible open repair of incisional ventral hernia with mesh.¿ ¿of note, the renal mass in a way prohibits the patient from undergoing treatment for the hernia for which he is scheduled.¿ implant #1 procedure: laparoscopic extensive lysis of adhesions ¿for about one and half hours.¿ laparoscopic repair of incisional ventral hernia with gore dual plus 19 x 15cm mesh.¿ implant: gore® dualmesh® plus biomaterial (1dlmcp04/12791786) 15 cm x 19 cm, oval.Implant #1 date: on (b)(6) 2015 [hospitalization unknown.] description of hernia being treated: ¿after entering the peritoneal cavity, noticed there was a large defect in the midline with extensive and firm adhesions of the omentum to the hernial sac.With the help of harmonic scalpel, all these adhesions with hernial sac was dissected down and gradually released.¿ ¿it took significant time to release all these adhesions, which were very dense and part of the hernial sac was also lysed down.Also part of the falciform ligament was released to expose the abdominal wall.¿ implant size and fixation: ¿after that, the defect was measured and a 19 x 15 cm gore dual plus was used.Four corners were sutured with gore sutures and the mesh was rolled and rolled into the abdominal cavity through the 11 mm port, after that with the above carter thomason suture passer and the stab incisions all the 4 quadrant sutures were pulled out of the 4 quadrants and all 4 sutures were tied.¿ ¿after that, the mesh was secured to all periphery with the help of protack device and all the edges were stapled to the abdominal wall.After that, the repair was inspected.It was good.Peritoneal cavity was inspected.There was no active bleeding.After that, under direct vision the above (b)(6), 11 mm port was sutured with the help of 0 vicryl suture.After that, pneumoperitoneum completely evacuated.All the ports were removed.The fascia was closed with 0 vicryl suture.Skin incisions were closed with 4"0 monocryl.Steri-strips and dressings were placed.¿ no immediate postoperative records.Relevant medical information: on (b)(6) 2015: emergency visit: swelling and abdominal pain.Ct abdomen / pelvis: ¿fluid above and below the mesh which is not abnormal, however, patient also shows what appears to be dilated small bowel, possible partial small bowel obstruction.¿ ¿abdomen is soft.There is some tenderness in the epigastric area where the hernia is.No guarding, rigidity or rebound.Patient having bowel habits.Ct scan is concerning for small bowel obstruction.¿ hospital admission: on (b)(6) 2015.On (b)(6) 2015: abdominal xr: ¿nonspecific and nonobstructive bowel gas pattern.No radiographic evidence of small bowel obstruction.¿ on (b)(6) 2015: ¿s/p [status post] inc vhr [incarcerated ventral hernia repair] with mesh.Readmitted-seroma, psbo [possible small bowel obstruction] in ct but pt [patient] asymptomatic¿ ¿impression-seroma / vhr [ventral hernia repair] s/p, abdominal binder, no heavy lifting, f/u [follow up] 3 weeks, renal cyst-mon[day] [followup] urology.¿ on (b)(6) 2015: ¿s/p [status post] lap [laparoscopic vhr [ventral hernia repair] with mesh.Post op seroma.Doing well.Abdomen [sic] [illegible] swelling, non-tender.Plan ¿no heavy lifting, improved seroma, f/u [follow up] prn.¿ on (b)(6) 2015: ¿patient experiencing pain from previous surgery." implant #2 / explant #1 preoperative complaints: on (b)(6) 2016: ¿first noticed hernia after colon surgery over 2 years ago.After 4 months it was repaired.Seven to nine months after the repair it was noticed to re-occur.¿ ¿reducible incisional recurrent hernia in midline.¿ plan: ¿herniorrhaphy: laparoscopic incisional, with mesh.¿ on (b)(6) 2016: ¿problems (active): bacterial infection of skin, hernia, mrsa, soft tissue mass.¿ ¿patient is a 60-year-old gentleman who developed an incisional hernia that was repaired with mesh some years ago.He developed a recurrence, of this site and says that it is causing a lot of discomfort and disfigurement.¿ implant #2 / explant #1 procedure: laparoscopic extensive lysis of adhesions, recurrent incisional hernia repair with mesh, explantation of old mesh, and bilateral rectus sheath blocks.Implant: gore® synecor biomaterial (gkfv1520/15186757) 15 cm x 20 cm, oval.Implant #2 / explant #1 date: on (b)(6) 2016.Description of hernia being treated: ¿we noted that there were extensive adhesions, on the anterior abdominal wall.¿ ¿we planned our next laparoscopic port site which was in the left lower quadrant.We used a #11 blade and made a 5-mm incision with obturator was inserted under direct visualization.We then placed another laparoscopic trocar in the right upper quadrant.Using a #11 blade, a 5-mm incision was made in the right upper quadrant.All trocars were inserted under direct visualization.At this point we began to take down all of the prior adhesions to the mesh and anterior abdominal wall.The adhesions were dense and vascular.¿ ¿a combination of harmonic and sharp dissection was used.The adhesiolysis portion took two hours.Once the adhesions were taken down we were able to place another 5-mm trocar into the left upper quadrant of the abdomen.At this time, we identified that the prior ventral hernia repair had failed.There was evidence of old mesh present; however, the inferior portion of this mesh was detached from the fascia and curled up.We decided that in order to perform a formal repair that was adequate, we had to explant the old mesh.We then grasped the old mesh and dissected it off the anterior abdominal wall.Once the mesh was removed, we extracted it through the left upper quadrant port.The left upper quadrant port was up sized to a 12-mm trocar.Once the mesh was removed, we then planned our repair.¿ implant size and fixation: ¿there was a large midline defect and diastasis rectus that was reapproximated using 0 ethibond sutures.We used tiny stab incisions along the midline and an endo pass suture to insert 0 ethibond sutures as interrupted fashion going from one lateral aspect of the fascia to the other aspect and reapproximating them.Approximately six of these sutures were placed along the anterior midline defect.This brought the lateral edges of the defect closer.Afterwards we then planned to place our mesh.¿ ¿a 15 x 20 mm mesh was gore synecor.The mesh was soaked in saline.It was placed on the anterior abdominal wall underneath the blue towel.We used 0 ethibond sutures around the four corners of the mesh and placed it through the mesh.The mesh was then rolled up and inserted into the abdomen.It was placed in appropriate position.Using the endo pass suture, the transfascial sutures were brought through the abdominal wall.The sutures were then tied.We then tacked the mesh up to the anterior abdominal wall going in a circumferential fashion using the reliatacker device.The mesh was well placed without wrinkles or tears.¿ ¿we then infiltrated the bilateral rectus sheaths with approximately 80 ml of exparel under direct visualization.We subsequently closed the left upper quadrant 10-mm incision with an 0 vicryl suture on an endo pass needle.The abdomen was then desufflated and the trocars were removed under direct visualization.The wounds were then washed, dried, and closed with 4-0 monocryl sutures.The abdomen was then subsequently again washed and dried.The wounds were dressed with dermabond.The abdomen was also dressed with abo pads, foam tape, and an abdominal binder.¿ no immediate post-operative period: on (b)(6) 2016: pathology: ¿specimen source: a.Hernia sac.B.Old mesh.¿ ¿inguinal hernia sac with prominent reactive changes.Dense fibrous tissues with chronic reactive changes, fragments of mesh.¿ relevant medical information: on (b)(6) 2017: ¿he still has tenderness in the mid to left abdominal area.¿ "epigastric tenderness; multiple healed scars from surgeries.¿ on (b)(6) 2017: complains of acid reflux.¿he underwent colonic resection, although the area or section of colon that was removed is unknown.¿ ¿since then, he has undergone 2 additional surgeries for incisional hernia repair.He [patient] states mesh was placed with both of these surgeries.The most recent surgery was on (b)(6) 2016 unfortunately, the hernia has again returned which causes him periodic abdominal pain in the llq.¿ ¿soft mid rlq and llq tenderness, non-distended with normal bowel sounds.No masses or hepatosplenomegaly noted.There is no guarding or rebound.Large incisional hernia noted.Midline incisional scar noted.¿ ¿of note, he was diagnosed with colon cancer on (b)(6) 2015.He states a colonic mass was seen on diagnostic colonoscopy in evaluation for rectal bleeding.He underwent colonic resection, although the area or section of colon that was removed is unknown.¿ explant #2 preoperative complaints: on (b)(6) 2018: ¿he presents today for follow up from hospitalization x 5 days for cellulitis.He was placed on antibiotic therapy and on discharge was given 5 days of antibiotics.The areas are still a little swollen.He also has been recently diagnosed with renal cancer and will be scheduling a nephrectomy in the near future.¿ on (b)(6) 2018: [the patient] ¿is a 61-year-old male with a history of colon resection and 2 failed incisional herniorrhaphy (1 laparoscopic and 1 robotic) with a large recurrent incisional hernia, with newly diagnosed renal cell carcinoma.He was taken to the operative room for combined partial nephrectomy and recurrent incisional herniorrhaphy.¿ explant #2 procedure: robotic-assisted laparoscopic lysis of adhesions extensive, robotic-assisted laparoscopic left renal cyst decortication.Robotic-assisted laparoscopic left partial nephrectomy with intraoperative renal ultrasound.Repair of recurrent chronically incarcerated incisional hernia, lysis of adhesions, explanation of unincorporated mesh, implantation of hernia mesh.Explant #2 date: on (b)(6) 2018.¿the case was then turned over to dr.(b)(6) [after nephrectomy] who then extracted the specimen through an extended skin incision overlying the 12mm assistant port site and through this he performed a complex repair of the fascia using a mesh.¿ ¿a horizontal extraction port through the hernia defect approximately 10 cm above the umbilicus was extended in a horizontal fashion.There was a large recurrent incisional hernia defect containing intraabdominal omentum.There were significant adhesions to the undersurface of the abdominal wall, especially inferiorly extending to the umbilicus and inferiorly from the patient's prior to [sic] failed incisional hernia repairs.There appeared to be coated mesh from 2 prior ipom (intraperitoneal onlay meshes, with what appeared to be metallic protacks).At this point, the defect measured approximately 8 x 8cm in size.¿ ¿at this point, lysis of adhesion was performed taking down the omentum, small bowel and other adhesions of the anterior abdominal wall.Hemostasis on the omentum was obtained using the ligasure as well as kelly clamps and 0 vicryl ties.The segments of the omentum.Were excised along with attenuated fascia and large hernia sac, which i would estimate measured approximately 15 x 15 cm in size.The entirety of the hernia sac was removed to reduce risk of seroma.¿ ¿there was significant attenuated fascia and the fascial edges were debrided to allow for adequate primary reapproximation.There was a defect at the base of the umbilicus.An additional fascial tissue needed to be excised.Local flaps were raised in order to allow for primary closure at the midline.At this point, 266 mg of exparel liposoma.Bupivacaine was infiltrated in the transverse abdominus plane bilaterally for postoperative pain relief.¿ ¿on the inferior margin of the fascia, there was approximately a 5 x 10 cm segment of unincorporated mesh, which was excised and passed off to pathology.At this point, the repair was performed by primarily closing the fascia in a horizontal t fashion using #1 pds suture anchored on both sides and tied in the center.At this point, a 15 x 15 segment of light weight polypropylene in the form of bard soft mesh was trimmed to size and anchored down over the primary closure site providing for circumferential overlap over the entirety of the primarily repaired defect.This was performed using running 0 vicryl suture.Additional vicryl sutures were placed in the center to allow for better mesh tissue contact and better incorporation.¿ ¿at this point, the umbilicus was re-anchored down to the abdominal fascia using 0 vicryl suture.3-0 vicryl suture placed in scarpa's fascia.3-0 vicryl deep dermal sutures were then placed and the skin of all the incisions was closed with 4-0 monocryl subcuticular suture.Dermabond was applied.¿ records do not indicate.No immediate post-operative records.Relevant medical information: on (b)(6) 2018: pathology: ¿specimen e is received fresh labeled ¿hernia sac and attenuated fascia" and consists of three fragments of adipose tissue, two of which are partially covered by a red-purple, glistening, congested and trabeculated membranous tissue.The three fragments in aggregate measure 14 x 7 x 1.5 cm.There is a blue-green suture embedded in the largest fragment of tissue.¿ ¿specimen f is received fresh labeled ¿segment of nesh [sic] and consists of two fragments of a mesh material that in aggregate measure 7 x 4.5 cm ranging from 0.3 cm up to 1.5 cm with areas of a red-purple fibrous tissue and adipose tissue attached.¿¿ on (b)(6) 2018: ¿he is feeling well.¿ ¿abdominal scar- transverse- healing well and multiple stab wounds also healed.¿ conclusion: it should be noted that the gore® synecor 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, pain, exposure (extrusion), bowel obstruction and recurrence.¿ the gore® synecor biomaterial instructions for use states, ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.When suturing gore® synecor biomaterial to the host tissue, the mesh should be sutured a minimum distance of 1 cm (0.4¿) from the edge of the device.Interrupted sutures can provide additional security against recurrence due to suture failure.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 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.The investigation concluded that there is no relationship between the device history record findings and the event.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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Search Alerts/Recalls
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