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| Model Number 1DLMCP04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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| Event Date 08/03/2009 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2008, whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: recurrent hernia, additional surgery, pain, removal of mesh, extensive adhesions.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: records dated on (b)(6) 2008, state the patient was seen for ¿protrusion from incision.¿ ¿this is a 57-year-old male who underwent left colectomy about a year ago has developed swelling in his incision.¿ pathology records dated on (b)(6) 2008, regarding a specimen collected on (b)(6) 2008 states: ¿specimen(s) submitted: a.Hernia sac.Diagnosis: hernia sac: benign hernia sac admixed with reactive chronic inflammation.¿ ¿gross description: received in formalin labeled ¿hernia sac¿ are sac-shaped pieces of membrane-like tissues measuring 22 x 6.5 x 0.5 cm.The wall is thin, last, gray, glistening and measures 0.1 cm or less in thickness.There is attached grossly unremarkable adipose tissue.¿ ¿sections of hernia sac demonstrate normal-appearing fibroadipose tissue.There are congested vessels admixed with chronic inflammation and reactive fibroblasts.No malignancy is identified.¿ consultation records dated on (b)(6) 2009 state: ¿58 years old male with a history of colon resection in 2007 by dr.(b)(6).The patient developed a hernia and underwent ventral hernia repair with dual mesh on (b)(6) 2008 by dr.(b)(6).I did review that operative note.The patient has developed a recurrent herniation.He currently denies any diffuse abdominal pain, nausea or vomiting.He does feel herniation has gotten larger overtime.¿ abdominal exam notes state: ¿obsese, soft, nontender, nondistended.No guarding, rebound or peritoneal signs.No organomegaly.Upper midline abdominal scars.There is an obvious very large herniation with significant separation of the rectus muscles.This is easily reducible and soft.¿ ¿multiple bilateral inguinal scars.¿ ¿assessment: large recurrent incisional hernia.I do think this needs to be repaired to prevent problems in the future.¿ ¿because of the size of the herniation i do feel the patient would benefit from abdominal wall component separation and mesh placement.¿ pathology records dated on (b)(6) 2009 regarding a specimen collected on (b)(6) 2009 state: ¿specimen(s) submitted: a.Incisional hernia sac.¿ ¿gross description: in formalin labeled ¿incisional hernia sac and old mesh¿ is a 14.0 x 12.5 x 1.7 cm piece of rubbery pink-white to tan membranous tissue, yellow to orange abundant adipose tissue and a synthetic mesh.¿ ¿the sections exhibit segments of membrane-like, dense, regular, fibrous connective tissue.There is a marked extensive fibrosis.There is foreign material consistent with mesh surrounded by foreign body giant cell reaction, chronic inflammation, and marked fibrosis there is no atypia and no neoplasm.¿ ¿diagnosis: abdominal wall, history of incisional hernia, herniorrhaphy ¿ hernia sac, mesh, marked fibrosis, and foreign body giant cell reaction.¿ records dated on (b)(6) 2009 indicate abdominal x-rays were taken.¿history: small bowel obstruction, follow up.There are multiple loops of dilated small bowel.The largest loop is in the left lower quadrant and measures at least 5 cm across.Impression: persistent small bowel dilatation, though appearance is somewhat improved since last exam.¿ discharge summary records dated on (b)(6) 2009 state: ¿procedure: recurrent incisional hernia repair with component separation and removal of old mess [sic] as well aslysis of adhesion on (b)(6) 2009.Hospital course: the patient is a 58-year-old male who came in the day of his operation and underwent the above procedure.The patient had done fairly well postoperatively and was actually to be discharged home on (b)(6) 2009.However at the day of discharge he had significant nausea and vomiting and was found to have significant ileus and he had an ng tube placed.Eventually this ileus resolved.At the time of discharge he was tolerating a regular diet.He did have multiple bowel movements.His incision was clean and dry and he was subsequently discharged home.¿ records dated on (b)(6) 2018 indicate the patient was seen for ¿intermittent ruq abdominal pain.It started about 2 months ago.The pain is described as sharp and burning.There is radiation to the right side and back.It is associated with eating.The patient has nausea; denies vomiting.The patient denies fevers, denies chills and denies jaundice.The pain is relieved by nothing in particular.¿ on (b)(6) 2018 records continue: ¿the patient does have a history of colon resection for a benign colon polyp by dr.(b)(6).He then underwent an incisional hernia repair on (b)(6) 2008.The patient developed an early recurrent hernia and on (b)(6) 2009 i performed a recurrent incisional hernia repair with component separation, removal of old mesh, and extensive lysis of adhesions.A 10 x 13¿ proceed mesh was placed in the underlay position.The patient has been doing fairly well from that standpoint but did develop a small bulge in the epigastric region that has not changed in size.¿ the records indicate an abdominal ultrasound dated on (b)(6) 2018 notes the following: ¿impression: gallstones without evidence of acute cholecystitis.¿ on (b)(6) 2018 records state: ¿abdomen: inspection and palpation: no tenderness, guarding, masses, rebound tenderness, or cva tenderness and soft and non-distended; large midline abdominal scar.At the superior aspect of the scar is a small herniation with an approximate 3 cm defect that is easily reducible and not tender.¿ ¿assessment/plan: 1.Calculus of gallbladder with cholecystitis¿2.Recurrent ventral incisional hernia ¿ the recurrent incisional hernia is small and asymptomatic.¿ operative records dated on (b)(6) 2018, indicate the patient underwent laparoscopic cholecystectomy for a postoperative diagnosis of chronic cholecystitis and cholelithiasis.¿this 66-year-old male developed some right-sided abdominal pain, was found by ultrasound to have cholelithiasis.Liver function tests were normal.¿ ¿the patient had also had multiple previous abdominal surgeries and had been noted to have a small incisional hernia in the epigastric region.¿ ¿gross operative findings: the patient did have extensive intra-abdominal adhesions from previous hernia repairs, but the right upper quadrant was relatively free of adhesions.There were chronic adhesions around the gallbladder.I was able to remove the gallbladder laparoscopically.The incisional hernia was not repaired.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Please note the initial medwatch indicates an incorrect date gore aware of 11/12/2018.The date gore aware of information for the initial report is 11/10/2018.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) 2007, including records regarding the appendectomy and previous herniorrhaphy procedures, were not provided.Operative records dated (b)(6) 2007 state the patient underwent colonoscopy with snare polypectomy x1, multiple cold biopsies and egd with multiple biopsies.Operative records dated (b)(6) 2007 state the patient underwent endoscopic tattooing and resection of the hepatic flexure.¿a midline skin incision was made, and the abdomen was opened there.A thorough exploration was performed.Numerous adhesions between the omentum and the right lower quadrant anterior abdominal wall were carefully taken down.The dye was noted at the hepatic flexure.¿ the operative records dated (b)(6) 2007 continue: ¿the hepatic flexure was then mobilized from the mid transverse colon all the way up to the mid ascending colon.Following this, 2 suitable points for resection were found.The mesentery between these 2 points was divided between hemostats and tied with 2-0 silk suture.The bowel was then divided proximally and distally between atraumatic clamps.A 2-layer anastomosis was performed using alternating 3-0 silk and interrupted 3-0 chromic running-locking suture which was carried anteriorly in the canal fashion.The outermost layer was then placed with interrupted 3-0 silk suture.¿ the records dated (b)(6) 2007 state: ¿the mesenteric defect was then closed using interrupted 3-0 silk suture.The omentum was anchored on top of the anastomosis.The defect in the omentum was then carefully closed.At this point, the bowel was allowed to return to the abdomen in anatomic fashion.The anastomosis appeared to be satisfactory with no tension.Color [sic] to be good.There was no bleeding noted.¿ operative records dated (b)(6) 2007 continue: ¿at this point, the abdominal cavity was irrigated with normal saline solution.Following this, the fascia was reapproximated using #1 double-strength pds suture which was started inferiorly and tied at the apex.The subcutaneous tissue was irrigated.The skin was approximated with wide staples.Penrose wics were left in between.Sterile dressings were applied.¿ operative records dated 9/5/2008 state the patient underwent repair of ventral hernia.The patient ¿is a 57-year-old male who underwent left colectomy about a year ago has developed swelling in his incision.¿ the operative records dated 9/5/2008 state: ¿old incision was opened and hernia sac was completely dissected out, following which the sac was entered.The edges of the sac were trimmed, and the fascial edges were then then grasped with the help of kocher clamps.After subsequent mobilization, the defect was measured to be about 10 cm x 12 cm.A 15 x 18 dual mesh was obtained and was anchored with the help of 0 prolene suture.¿ the records dated (b)(6) 2008 continue: ¿caudal and cephalolateral stitch were placed, which were initially held long; and then 5 stitches were placed on each side , which were initially held long and then tied.Satisfactory repair was noted.There was no tension.All the fascial defects were covered.Following this, the fascia was then reapproximated using 0 prolene running locking sutures.Adequate hemostasis was obtained.A #7 jp drain was left in the subcutaneous tissue and anchored with the help of 3-0 nylon.The skin was approximated with wide staples.Sterile pressure dressings were applied, following which abdominal binder was applied.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmc04/04498514) was used during the procedure.Operative report dated (b)(6) 2009 states the patient underwent flexible colonoscopy up to cecum.Findings: minimal diverticulosis, normal anastomosis.Operative records dated (b)(6) 2009 state the patient underwent recurrent incisional hernia repair with component separation, removal of old mesh and extensive lysis of adhesions.The ¿patient is a 58-year-old male who had undergone a colon resection and developed incisional hernia after that.He underwent an incision hernia repair.He developed recurrence around that mesh and he comes in now for repair of the recurrent incisional hernia.¿ the operative records dated (b)(6) 2009 continue: ¿a midline abdominal incision was made through the old scar.It was extended a little bit further superiorly and inferiorly around the umbilicus.I came down upon the hernia sac and then the subcutaneous tissue was dissected off the hernia sac laterally and circumferentially.I came down upon native abdominal wall fascia and continued that dissection out further laterally passed the rectus sheath border.¿ the records dated (b)(6) 2009 continue: ¿once that dissection was completed, i then entered into the hernia sac at its base and very carefully began removing the hernia sac off the edge of the fascia defect.I continued this around circumferentially and some mild omental adhesions were taken down using cautery dissection.The hernia occurred around previously placed gore-tex dual mesh.¿ operative records dated (b)(6) 2009 state: ¿once i had this freed up, there was small bowel that was very densely adherent to the gore mesh and about 50% of the operation was simply carefully lysing these adhesions and carefully teasing that bowel off of that mesh.This actually went quite well and i did not get into any of the bowel at all but a couple of small serosal tears were reinforced then with 3-0 silk in lembert fashion.Thus the hernia sac and mesh were removed together and sent off the table to pathology.¿ records dated (b)(6) 2009 continue: ¿then i continued some adhesion lysis intra-abdominally in order to facilitate placement of the new mesh.Once this was all freed up, the fascial edges tried to be approximated but clearly the rectus sheath muscles could not get back toward the midline without very significant tension and i felt that component separation would be needed.I had my dissection then out laterally and just lateral to the rectus sheath.I then divided the anterior aspect of the external oblique aponeurosis and continued this superiorly and inferiorly for the length of the incision and also carried this up onto the ribs slightly.¿ operative records dated (b)(6) 2009 state: ¿once the component separation was done i was able to get the fascia reapproximated in the midline much better.Still a little bit of tension but it was clearly much better than before.I then selected a piece of mesh that was proceed mesh, 10 x 13 inches in size.It was placed in the intraabdominal position and clearly overlapped the entire defect by at least 6 cm.¿ the records dated (b)(6) 2009 continue: ¿i sutured the mesh circumferentially to the anterior abdominal wall using interrupted 0 prolene.Superiorly the mesh went up underneath the rib cage.I was able to place a single suture just below the xiphoid process to hold the mesh in place but then more superiorly under the ribs i used the laparoscopic tacker and tacked the mesh to the anterior abdominal wall above the rib cage.¿ the operative records dated (b)(6) 2009 state: ¿with the mesh in good location, i then was able to reapproximate the anterior abdominal wall over the mesh using a running #1 pds two-loop suture.I then placed two #10 jp drains in the subcutaneous tissue along both flanks and exited out through separate stab incisions in the skin and sutured to the skin with a 2-0 nylon.The subcutaneous tissue was closed using running 2-0 vicryl.The skin was approximated with staples.Jp drains were hooked up to bulb suction.Sterile dressings were applied.¿ records confirm a proceed mesh was used during the procedure.¿ pathology records dated (b)(6) 2009 state: ¿a 14.0 x 12.5 x 1.7 cm piece of rubbery pink-white to tan membranous tissue, yellow to orange abundant adipose tissue and a synthetic mesh.The sections exhibit segments of membrane-like, dense, regular, fibrous connective tissue.There is a marked extensive fibrosis.There is foreign material consistent with mesh surrounded by foreign body giant cell reaction, chronic inflammation, and marked fibrosis there is no atypia and no neoplasm.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (2240, 1994, 1695) 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 (b)(6) 2007 through (b)(6) 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records prior to (b)(6) 2007 including operative records for the appendectomy and previous herniorrhaphy procedures were not provided.Patient information: medical history: hypertension.Hyperlipidemia.Arthritis.¿prostate problems.¿ hepatitis a.Moderate alcohol use.Previous smoker.2 pack/day x30 years.Prior surgical procedures: bilateral inguinal herniorrhaphy [1959, 1967, 1970, 1971, 1999, 2008].2007: colon resection.Appendectomy.Relevant medical information: (b)(6) 2007: colonoscopy with snare polyectomy x1, multiple cold biopsies and egd with multiple biopsies.(b)(6) 2007: endoscopic tattooing and resection of the hepatic flexure ¿a midline skin incision was made, and the abdomen was opened there.A thorough exploration was performed.Numerous adhesions between the omentum and the right lower quadrant anterior abdominal wall were carefully taken down.The dye was noted at the hepatic flexure.¿ implant preoperative complaints: (b)(6) 2008: ¿protrusion from incision.¿ ¿this is a 57-year-old male who underwent left colectomy about a year ago has developed swelling in his incision.¿ implant procedure: repair of ventral hernia.Implant: gore® dualmesh® plus biomaterial (04498514/1dlmcp04) 15 x 19cm, oval.Implant date: (b)(6) 2008.Description of hernia being treated: ¿old incision was opened and hernia sac was completely dissected out, following which the sac was entered.The edges of the sac were trimmed, and the fascial edges were then grasped with the help of kocher clamps.After subsequent mobilization, the defect was measured to be about 10 cm x 12 cm.Implant size and fixation: ¿a 15 x 18 dual mesh was obtained and was anchored with the help of 0 prolene suture.¿caudal and cephalolateral stitch were placed, which were initially held long; and then 5 stitches were placed on each side, which were initially held long and then tied.Satisfactory repair was noted.There was no tension.All the fascial defects were covered.Following this, the fascia was then reapproximated using 0 prolene running locking sutures.Adequate hemostasis was obtained.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2009: flexible colonoscopy up to the cecum.Findings: ¿minimal diverticulosis, normal anastomosis.¿ explant preoperative complaints: (b)(6) 2009: ¿58 years old male with a history of colon resection in 2007 by dr.(b)(6).The patient developed a hernia and underwent ventral hernia repair with dual mesh on (b)(6) 2008 by dr.(b)(6)i.I did review that operative note.The patient has developed a recurrent herniation.He currently denies any diffuse abdominal pain, nausea or vomiting.He does feel herniation has gotten larger overtime.¿ abdominal exam: ¿obese, soft, nontender, nondistended.No guarding, rebound or peritoneal signs.No organomegaly.Upper midline abdominal scars.There is an obvious very large herniation with significant separation of the rectus muscles.This is easily reducible and soft.¿ ¿assessment: large recurrent incisional hernia.I do think this needs to be repaired to prevent problems in the future.¿ ¿because of the size of the herniation i do feel the patient would benefit from abdominal wall component separation and mesh placement.¿ explant procedure: recurrent incisional hernia repair with component separation, removal of old mesh and extensive lysis of adhesions.¿ explant date: (b)(6) 2009; hospitalized (b)(6) 2009.¿recurrent incisional hernia repair with component separation, removal of old mesh and extensive lysis of adhesions.¿ indications state: ¿the patient is a 58-year-old male who had undergone a colon resection and developed incisional hernia after that.He underwent an incision hernia repair.He developed recurrence around that mesh and he comes in now for repair of the recurrent incisional hernia.¿ findings from the procedure state: ¿the patient had previous mesh.The herniation occurred around the mesh.He did have some small bowel that was extensive adherent to the mesh.The component separation needed to be done and new mesh was placed with an underlay technique.¿ ¿a midline abdominal incision was made through the old scar.It was extended a little bit further superiorly and inferiorly around the umbilicus.I came down upon the hernia sac and then the subcutaneous tissue was dissected off the hernia sac laterally and circumferentially.I came down upon native abdominal wall fascia and continued that dissection out further laterally passed [sic] the rectus sheath border.Once that dissection was completed, i then entered into the hernia sac at its base and very carefully began removing the hernia sac off the edge of the fascia defect.I continued this around circumferentially and some mild omental adhesions were taken down using cautery dissection.The hernia occurred around previously placed gore-tex dual mesh.Once i had this freed up, there was small bowel that was very densely adherent to the gore mesh and about 50% of the operation was simply carefully lysing these adhesions and carefully teasing that bowel off of that mesh.This actually went quite well and i did not get into any of the bowel at all but a couple of small serosal tears were reinforced then with 3-0 silk in lembert fashion.Thus the hernia sac and mesh were removed together and sent off the table to pathology.Then i continued some adhesion lysis intra-abdominally in order to facilitate placement of the new mesh.Once this was all freed up, the fascial edges tried to be approximated but clearly the rectus sheath muscles could not get back toward the midline without very significant tension and i felt that component separation would be needed.I had my dissection then out laterally and just lateral to the rectus sheath.I then divided the anterior aspect of the external oblique aponeurosis and continued this superiorly and inferiorly for the length of the incision and also carried this up onto the ribs slightly.Once the component separation was done i was able to get the fascia reapproximated in the midline much better.Still a little bit of tension but it was clearly much better than before.I then selected a piece of mesh that was proceed mesh, 10 x 13 inches in size.It was placed in the intraabdominal position and clearly overlapped the entire defect by at least 6 cm.I sutured the mesh circumferentially to the anterior abdominal wall using interrupted 0 prolene.Superiorly the mesh went up underneath the rib cage.I was able to place a single suture just below the xiphoid process to hold the mesh in place but then more superiorly under the ribs i used the laparoscopic tacker and tacked the mesh to the anterior abdominal wall above the rib cage.¿ records indicate a non-gore device was implanted during the (b)(6) 2009 procedure.Relevant medical information: (b)(6) 2009: x-ray abdomen: ¿history: small bowel obstruction, follow up.There are multiple loops of dilated small bowel.The largest loop is in the left lower quadrant and measures at least 5 cm across.Impression: persistent small bowel dilatation, though appearance is somewhat improved since last exam.¿ (b)(6) 2009: discharge summary: ¿hospital course: the patient is a 58-year-old male who came in the day of his operation and underwent the above procedure.The patient had done fairly well postoperatively and was actually to be discharged home on (b)(6) 2009.However at the day of discharge he had significant nausea and vomiting and was found to have significant ileus and he had an ng tube placed.Eventually this ileus resolved.At the time of discharge he was tolerating a regular diet.He did have multiple bowel movements.His incision was clean and dry and he was subsequently discharged home.¿ conclusion: 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 gore® dualmesh® plus biomaterial instructions for use also state: ¿when suturing gore® dualmesh® plus biomaterial to the host tissue, a bite and spacing ratio of 1:1 in both gore® dualmesh® plus biomaterial and the host tissue is recommended.The same ratio applies when suturing two pieces of gore® dualmesh® plus biomaterial together.Follow the curve of the needle when piercing the device and pierce through the full thickness of the device to ensure adequate mechanical strength of the device.Interrupted sutures can provide additional security against recurrence due to suture failure.Mattress suturing can provide additional strength to the suture line.¿ 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.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.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 04498514.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate approximately 800 micrograms per cubic centimeter of product (g/cm3), and chlorhexidine diacetate approximately 1600 micrograms per cubic centimeter of product (g/cm3).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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