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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Catalog Number 1DLMCP06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Code Available (3191)
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| Event Date 04/21/2016 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: previous gore mesh separated from the fascia allowing the small bowel to recur and create adhesions, loop of small bowel was wedged between the mesh and fascia, removal of gore mesh, recurrent incisional hernia repaired with placement of new mesh.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.C1: added serial # and udi #.D4: added serial #, expiration date, udi #.H4: added device manufacture date.H6: conclusion code remains unchanged.H6: updated method and results code.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: implant #1 preoperative complaints: (b)(6) 2011: (b)(6) medical center.(b)(6).Radiology.Acute abdomen series.History: 59-year-old male with given history of severe abdominal pain, history of hernias and resection.Impression: nonspecific abdominal gas pattern without obvious evidence suggesting acute abdominal or chest process as described.Please see dictated report of abdominal and pelvic ct performed this date (b)(6) 2011, for further descriptive details.¿ (b)(6)2011: (b)(6) medical center.(b)(6), md.Radiology.Ct scan abdomen and pelvis without contrast.History: unspecified abdominal pain.History of abdominal hernia repair.Findings: ¿there are 3 separate ventral abdominal wall defects in the lower abdomen which measure 5-7 cm in their transverse dimensions.The overall craniocaudad dimension of the abdominal wall pathology is approximately 14 cm.There is protrusion of unenhanced and nondilated viscera and omental fat into the defects with some mild stranding of this fat.¿ impression: ¿multiple ventral abdominal wall defects with protrusion of viscera and omental fat, but without overt evidence of visceral strangulation or obstruction.Subtle stranding opacity in the omental fat may reflect some compromise of blood flow.No other evidence of acute abdominal/pelvic pathology.(b)(6)2011: (b)(6) medical center.(b)(6) md.History and physical.Chief complaint: abdominal pain.¿the patient is a 59-year-old obese white male who presents with epigastric abdominal pain probably associated with abdominal wall hernias.He has had pain over an extended period of time.About 2 weeks ago, he came to my office with abdominal discomfort and chronic constipation.He had a ct scan that shows nonobstructive loop and an incisional hernia.He has a couple of other defects.After his previous surgery, despite multiple warnings, he had gone back to lifting heavy things within a week or 2 after hisprocedure.It has suggested that he is not able to eat, and yet his weight has gone up progressively, and he weighs at least 20 pounds more than what he did when he was operated on before.I do believe that these hernias are causing him discomfort, and that he definitely needs to have them repaired at some point, but i have quoted them a commented [rg3]: (b)(6)-1mrmc-ppr-jlg-00099-100commented [rba4]: note findings on ct.Commented [rg5]: (b)(6)-1mrmc-ppr-jlg-00101-102 privileged and confidentialevent (b)(6) received:(b)(6) 2020 significant risk of recurrence without him losing weight and stopping his smoking.I am going to admit him to the hospital and place an ng tube, examine him serially inhis abdomen.I would like him to have several days of bowel rest and decompression prior to a procedure.¿ impression: ¿small-bowel hernia, nonobstructive, does not appear to be incarcerated.I could reduce it.¿ plan: admit and repair.(b)(6)2011: (b)(6) medical center.(b)(6) md.Indications: ¿the patient is a 59-year-old white male who presents with painful incisional hernias, has a mild element of obstruction.It was scheduled for repair and was found to have some cardiac disease.He wasadmitted to the hospital and seen by dr.(b)(6), and was cleared for his cardiac disease.He presents at this time for incisional hernia repair.¿implant #1 procedure: incisional hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial [1dmlcp06/06854846].Implant#1 date: (b)(6) 2011(hospitalization (b)(6) 2011.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: incisional hernias, multiple.Anesthesia: general.Oprocedure: ¿after informed consent he was taken to the operating room, placed in a supine position under general endotracheal anesthesia.The abdomen was prepped and draped in the usual fashion using ioban and duraprep.The incision was taken down to the fascia.The fascia was then incised.There were multiple large hernias, one the size of a baseball and two size of a golf ball.These were all reduced, dissected free and the sacs removed.The fascial edges identified.A duramesh was then placed within the abdominal cavity, secured at its edges with multiple sutures, approximately 1 cm apart circumferentially around the mesh.The left side of the mesh was secured tothe anterior abdominal wall with protackers.The right side was secured with interrupted prolene and a running prolene along the inner edge.The fascia was almost brought completely to the middle so there was at least 4 or 5 cm on either side of overlap of mesh on the peritoneal surface.As much as the fascia could be closed over the mesh it was with multiple figure-of-eight prolene.The subcutaneous tissue was closed with interrupted 2-0 vicryl and the skin was closed with skin staples.The dressing was placed.The patient tolerated the procedure well without complications.(b)(6) 2011: (b)(6) medical center.Implant sticker.¿gore dualmesh® plus biomaterial.¿ref catalogue number: 1dmlcp06.Lotbatch code: 06854846.W.L.Gore & associates.(b)(6) 2011: (b)(6) medical center.(b)(6).Radiology.Ct abdomen and pelvis without contrast.History: history of recent exploratory laparoscopy, low h&h, multiple abdominal incisional hernias not otherwise specified.Findings: ¿there has been interval ventral herniorrhaphy with placement of laparoscopic spiral tacks along the left lateral abdominal wall with suggestion of mesh material paralleling the expected location of the mid abdominal peritoneum involving the mid abdomen centering about the umbilicus.Additionally, there are surgical skin clips overlying the midline of the mid abdomen centering about the umbilicus.There is new focal subcutaneous fluid collections scattered commented [rba6]: note history and non-compliance of patient.Commented [rg7]: dhapps-1mrmc-ppr-jlg-00007-8commented [rg8]: dhapps-1mrmc-ppr-jlg-00012commented [rba9]: note implant technique and use of prolene suture as well as tacks on the left.Commented [rg10]: dhapps-1mrmc-ppr-jlg-00012-13commented [rg11]: dhapps-1mrmc-ppr-jlg-00010 privileged and confidentialevent 1205donald happsmr received: 9/17/20within the generous subcutaneous tissue abutting the anterior aspect of the abdominal wall.There is a small focal area of fluid density abutting and blending with the mid upper abdomen which is ellipsoid in nature measuring roughly 5.4 cm in cc dimension by 2.9 cm in ap dimension by 2.8 cm in transverse dimension measuring roughly s hounsfield units in density with the inferior margin blending with a pocket of subcutaneous fluid density.This appears to lie in the preperitoneal space just superior to the peritoneum proper centering just right of midline.There are scattered air bubbles contained within the subcutaneous fluid collections and within the midline incision.¿ impression: ¿1.Interval ventral abdominal wall hernia with several mildly prominent fluid collections within the deep subcutaneous tissues of the midline of the mid and upper abdominal wall containing tiny pair of bubbles likely representing seromas with recent ventral abdominal wall surgical change as described.2.Remote right-sided hemicolectomy.3.Mildly enlarged fatty-replaced liver stable from comparison.¿ (b)(6) 2011: (b)(6) medical center.(b)(6), md.Discharge summary.¿because of his circumstance and the wayhe had presented, we had taken him to the operating room and he underwent open incisional hernia repair.It was an extensive procedure requiring mesh, had a difficult time.His postop course was slow.He had some hematoma that collected above the graft that drained.He had no fevers, no chills.He began eating and having bowel movements and he was discharged home on (b)(6)2011, in good condition to see me in the office on tuesday.¿relevant medical information: (b)(6) 2011: (b)(6) medical center.(b)(6)md.Radiology.Ct scan abdomen and pelvis without contrast.History: patient is status post ventral abdominal hernia repair with mesh.Postoperative incisional bleeding.Findings: ¿as on comparison, there are postop changes status post midline ventral abdominal hernia repair with mesh material in place spanning approximately 15 cm superior to inferior by 17 cm transverse with multiple metallic staples about the left side of the mesh material unchanged.There are multiple, loosely grouped, deep subcutaneous soft tissue collections superficial to the mesh along the incision site, the aggregate spanning approximately 28 cm superior to inferior corresponding to the length of the cutaneous staple line and spanning 12 cm in greatest transverse dimension and approximately 5 cm in greatest ap dimension with the overall contour, size, and morphology of the collections for the most part unchanged from comparison with the exception of the bulk of the gas bubbles within the prior collections have resolved in the interim.There is, however, marginal increased prominence of fluid attenuation material, collection immediately ventral to the mesh measuring approximately 2 cm in greatest thickness.There is a small ventral intraperitoneal collection just superior to the superior margin of the mesh similar to comparison, albeit marginally smaller spanning approximately 3 cm superior to inferior by 5 cm transverse by 1.5 cm anterior-posterior.There are no significant intraperitoneal collections otherwise.¿impression: persistent deep subcutaneous peri-incisional collections ventral to hernia mesh material of the anterior abdominal wall, albeit with resolution of the bulk of mottled gas within some of the collections.There is slight increased thickening of the low-attenuation fluid immediately adjacent to the midline and left paramedian aspect of the mesh whereas, the remainder of commented [rba12]: note ct findings.Commented [rg13]: dhapps-1mrmc-ppr-jlg-00016-18commented [rba14]: note post-op hematoma.Commented [rg15]: dhapps-1mrmc-ppr-jlg-00004-5commented [rba16]: note reference to post-op bleeding.Privileged and confidentialevent 1205donald happsmr received: (b)(6) 2020 the collections are unchanged.There is marginal decrease in size of the intraperitoneal collection superior to the superior margin of the mesh.(b)(6) 2012: (b)(6) medical center.(b)(6) md.Radiology.Abdomen series acute.History: abnormal pain.Findings: ¿new from comparison examination are postop changes abdominal hernia repair with corkscrew laparoscopic staples in the left lateral mid to lower abdomen.There is a nonspecific nonobstructive bowel gas pattern with gas, stool, and fluid amongst several segments of large bowel and paucity of small bowel gas.A portion of the bowel and abdomen extend beyond the lateral margins of the radiographs due to patient's large habitus.Abdominal hernia recurrence cannot be excluded.There is no pneumatosis or free intraperitoneal gas.¿ impression: nonspecific nonobstructive bowel gas pattern.No evidence of perforation.Stable chest x-ray.(b)(6) 2015: mat-su regional medical center.D.(b)(6) md.Radiology.Ct scan abdomen and pelvis with contrast.Findings: ¿as per the clinical history there is a large ventral periumbilical hernia.The maximum transverse dimension is approximately 17 cm.The maximum craniocaudad dimension is approximately 11 cm.There are multiple loops of small and large bowel and mesentery which have protruded through the defect, but there is no evidence of incarceration, strangulation or obstruction of the unenhanced hollow viscera.A surgical staple line is seen in the midline transverse colon in this patient who has apparently undergone right hemicolectomy.Man-made materials in the abdominal wall are believed to represent interval repair of this ventral hernia which has failed.¿ impression: failed repair of a large ventral periumbilical hernia.No evidence of incarceration or strangulation of the hollow viscera.Distended, if not hydropic, gallbladder.Explant#1, implant #2preoperative complaints: (b)(6) 2016: (b)(6) medical center.(b)(6), md.History and physical.¿the patient is a 64-year-old man, who has a recurrent ventral hernia.He has had this repaired previously.He previously underwent his repair when he had a significant degree of obesity.He now has lost weight secondary to a concentrated effort in anticipation of having the procedure performed.He has lost approximately 100 pounds.The patient has been working to give up his smoking.He is still smoking, however, he has decreased his smoking significantly, and he understands that he is not going to be able to smoke in the hospital.He presents now with a hernia that has a diameter of approximately 18 cm on his right side.He does have viable muscles, however, his rectus muscles are widely separated.He has a midline abdominal scar.He has a paramedian scar.Past history: ¿as mentioned, he did have his coronary artery bypass grafting in 2015.He has had a left internal mammary artery graft taken, and the impact that this has on the blood supply to the left rectus muscle has been reviewed with him.He and dr.(b)(6)and i have all discussed the fact that he may not be able to have full mobilization of his left rectus at the proximal most portion.¿ physical exam: abdomen: ¿he does have a healed median sternotomy incision.He has abdominal scars as noted.His hernia is as noted.Direct pressure on the hernia is quite tender for the patient.He has no inguinal adenopathy.He has no evidence of maceration, irritation, or infection in the skin fold at the pannus site.¿ (b)(6)16: (b)(6)medical center.(b)(6) md.History and physical.Chief complaint: recurrent incisional hernia.History: ¿in (b)(6)2009, he underwent a right commented [rg17]: (b)(6) [rba20]: now with periumbilical hernia.Commented [rba21]: note reference to failed hernia repair, now 4 years post repair.(b)(6).Privileged and confidentialevent (b)(6) received:(b)(6) 2020 hemicolectomy with primary ileocolic anastomosis to treat colonic inertia.Eight days later, he underwent an exploratory laparotomy for reduction of an incisional hernia.The incisional hernia was repaired primarily with sutures.He developed another incisional hernia and this was repaired in 2011 with proceed mesh.He then went on to develop a recurrent incisional hernia, which has bothered him since at least 2013.He made a concentrated effort to lose weight and has lost almost 100 pounds in preparationfor this recurrent hernia surgery repair.The abdomen was evaluated by a cat scan in (b)(6) 2015.A large incisional hernia was identified.Since then, the defect has increased a bit in size.However, he has lost a bit more weight since that cat scan in (b)(6) 2015.Because of the very large fascialdefect, the patient has also seen dr.(b)(6) who will be involved with his operative repair who will separate his abdominal muscle components to advance his rectus muscle to provide muscle coverage for the mesh.Dr.(b)(6) also planned to perform a panniculectomy in order to decrease the strain on the abdominal wall at the same time as the recurrent incisional hernia repair is accomplished.¿ physical exam: ¿abdomen: soft.He has a large ventral incisional hernia, which was not totally reduced.There is no associated erythema, fluctuance, or sign of infection.The hernia is mildly tender to palpation.There is a moderate-sized pannus present without skin breakdown.¿assessment: a 64-year-old male with recurrent incisional hernia with a wide fascial defect.Plan: repair of this recurrent incisional hernia with mesh and then dr.(b)(6) plans separation of abdominal muscle component and advancement of the rectus muscles to provide muscle coverage for the mesh and also panniculectomy to decrease the strain on the abdominal wall.(b)(6) 2016: (b)(6) medical center.(b)(6), md.Indications: ¿the patient is a 64-year-old man, who has previously undergone repair of a ventral incisional hernia.He had mesh placed.He has had a recurrence of his hernia.However, in between the patient's original hernia repair and now, he has lost approximately 100 pounds.With the weight loss that the patient has gone through, he has had significant decompression of the pressure on the intraabdominal contents.His weight loss has also caused him to have a significant and symptomatic pannus.This does pose some strain on his abdominal tissue and it does cause problems with skin irritation, skin infection, and balance and ambulation.¿ explant #1, implant #2 procedure:recurrent incisional hernia repair with mesh.Removal of previously implanted mesh.Implant: gore® dualmesh® plus biomaterial [1dmlcp06/14490165, 18cm x 24cm x 1cm]the hernia repair performed by dr.(b)(6)and assisted by dr.(b)(6), and repair of the abdominal wall defect using bilateral rectus abdominis muscle flaps and panniculectomy performed by dr.(b)(6) and assisted by dr.(b)(6).Explant #1, implant #2 date: (b)(6) 2016(hospitalization (b)(6) 2016.(b)(6) 2016: (b)(6) medical center.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: recurrent incisional hernia.Ofindings: ¿recurrent incisional hernia with mesh separated from the fascia.¿oprocedure: ¿an elliptical incision was made around his previous vertical midline incision and the scar was removed including the umbilicus.This allowed entry easily into the hernia sac and into the abdomen.Numerous adhesions between the hernia commented [rba26]: note review of history, assume reference to ¿proceed¿ is an error.(b)(6).Privileged and confidentialevent (b)(6) received: (b)(6) 2020 sac and the small bowel were divided with blunt and bovie dissection.The previously placed mesh was noted to be to the left of the midline rather than across the midline.There was a gap inferiorly too through which the loop of small bowel had become wedged.This bowel was wedged between the mesh and the fascia.This bowel was reduced back into the abdomen.The previously placed dualmesh was totally excised and it was separated from the overlying fascia and totally removed.The numerous pro tack clips were removed.The prolene suture was also removed.The undersurface of the abdominal wall was cleared of any adhesions to the intraabdominal contents.The fascial edges were then grasped on either side of midline, along this grasped the rectus muscle, and it could almost be pulled together in the midline.A piece of dualmesh plus was chosen to facilitate the closure.The mesh was soaked in antibiotic solution and then cut to size to be 10 cm wide and 22 cm long.O ethibond was used to secure the mesh circumferentially, 4 to 5 cm from the edge of the fascia, so that the mesh would lie beyond the fascia circumferentially.Dr.(b)(6) then assumed care of the patient and proceeded with her portion of the case with the component separation, rectus muscle advancement, and the panniculectomy.(b)(6) 2016: (b)(6) medical center.(b)(6) md.Operative report.Preoperative and postoperative diagnosis: recurrent incisional hernia with abdominal wall defect.Symptomatic pannus.Oprocedure:¿under general anesthetic, the patient was prepped and draped in a sterile fashion.The previously placed midline abdominal incision was used for entrance into the area of abdominal wall defect and hernia.A full operative note for the hernia repair portion of the procedure has been dictated by dr.(b)(6).After completion of the hernia repair, the rectus abdominis flaps, which had been elevated prior to the completion of the hernia repair, were advanced.The flaps had previously been elevated.The elevation of the flaps was performed in a staged fashion.Initially, the hernia was identified, reduced, and the old mesh was removed.This allowed direct visualization of the anchor points of the old mesh into the remnants of the original rectus muscle suture line.This was used as a landmark for identifying the posterior border of the rectus muscles bilaterally.With the posterior border identified, the anterior border was then approached using the electrocautery.The skin and scar tissue was elevated from the rectus muscles.The left rectus muscle was noted to be attenuated compared to the right.The right rectus muscle was robust, however, it was approximately 8 cm from the abdominal midline.The pan nus was approached prior to full repair of the hernia and prior to advancement of the rectus muscle flaps.The area to be excised from the pannus had been marked.The cranial border of the area to be excised was incised.The abdominal flap was elevated in a cranial to caudal fashion.The flap was elevated off the anterior rectus sheath.Perforating vessels were identified and it was noted that the perforating vessels on the right side were significantly larger than those on the left.The scarpa fasciallayer in this abdominal flap was noted to be rather thin and attenuated.There was no significant strength to the scarpa's.Because the scarpa's fascia was not noted to be a layer of rather strong thick fibrous tissue, it was not commented [rba30]: prior dlmcp is completely removed.No clear description of the prior repair having failed.Recall that the patient has lost 100 lbs.Commented [rg31]: (b)(6) 84commented [rba32]: dlmcp placed and secured with ethibond sutures.Privileged and confidentialevent (b)(6) received: (b)(6) 2020 salvaged as a reinforcing layer for closure over the hernia repair.The lines of preoperative marking were verified, and the caudal portion of the abdominal flap was advanced cranially.It was verified that this would allow a tension-free closure at the panniculectomy site.The caudal border to be excised was incised along the preoperative lines of marking.The excised pannus was discarded.The weight of the pannus that was excised is 1520g [3.35 lbs.].Hemostasis was achieved during this procedure using direct ligature with vessel clips, suture ligature, and electrocautery.With the rectus abdominis muscle flaps prepared, and the pannus excised, the completion of the hernia repair was performed.Upon completion of the hernia repair, the rectus abdominis muscle flaps were then advanced to the midline.This closure was completed using layers.0 ethibond sutures in a horizontal mattress fashion were used.This was followed with a running locking 0 prolene closure.The portion of the viable but fibrotic left rectus muscle that had been separated previously from the main belly of the rectus abdominis muscle, this was used as a reinforcing layer of closure over the mesh and muscle closure.This was sewn into place using a running 0 prolene suture.Attention was then focused on the closure of the vertical incision and the lower abdominal horizontal incision.The fascia layer was marked using methylene blue.Two 10 mm flat jackson-pratt drains were placed prior to closure of the abdominal skin flaps.One is exited through the left lower quadrant, and this drain drains the lower abdominal region.One is located through the stab incision at the right lower quadrant and this drain drains the abdominal flap overlying the hernia repair site.The drains were sewn into place using 2-0 nylon sutures.They were placed to bulb suction.The area of undermining and dissection was copiously irrigated with normal saline.Hemostasis was verified.The scarpa's fascia layer was closed using interrupted 2-0 ethibond sutures.The deep dermal layer was closed using interrupted 3-0 monocryl sutures.The intracuticular closure was then undertaken using 3-0 monocryl sutures.The skin was reinforced using widely spaced 4-0 nylon sutures.The skin flaps were cleaned of any prep solution and bloody debris.The suture lines were dressed with the kci vac sponge.Good suction was maintained, and the vac sponges weremaintained with suction to the vac machine.After placing an adequate suction dressing with the vac device, the skin flaps were reinforced using epifoam.This was then secured into place using an abdominal binder.¿ (b)(6) 2016: (b)(6) medical center.Implant sticker.¿mesh dual plus 18cmx24cmx1.Qty: 1.Catalog nbr: 1dlmcp06.Serial#: (b)(6) site: abdomen.Manufacturer: wl gore.(b)(6) 2016: (b)(6)medical center.(b)(6) md.Discharge summary.He had fairly uneventfulpostoperative course with gradual resumption of bowel function and transition to oral pain medication.He was up walking.He was using his incentive spirometry.He was wearing the binder.He was doing well enough, that on (b)(6) he was discharged to home.He was to lift nothing heavier than 10 pounds for 6 weeks.He could have a regular diet.He was to follow up in 1 week with me and in a few days with dr.(b)(6).¿relevant medical information: commented [rba33]: component separation done and vac placed.Commented [rg34]: (b)(6).Privileged and confidentialevent 1205donald happsmr received: (b)(6) 2020, (b)(6) 2016: (b)(6) medical center.(b)(6)md.Radiology.X-ray abdomen.Impression: nonspecific bowel gas pattern.No dilated loops of bowel are identified.Evidence for previous bowel surgery with staple line left abdomen.Findings of left ventral hernia repair.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." 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 results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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