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B7: added medical history.H6: updated results code 1 for manufacturing evaluation.Conclusion code remains unchanged.H6: updated results code 2 for sterilization evaluation.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: ??/??/??: [missing records: records prior to (b)(6) 2007 including operative report for exploratory laparotomy, partial right colectomy with ileocolic anastomosis were not provided.] on (b)(6) 2007: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: incisional and umbilical hernia.Postoperative diagnosis: same.Operation: extensive lysis of adhesions and laparoscopic repair of incisional and umbilical hernia.Anesthesia: general.Complications: none.Estimated blood loss: minimal.Indications: this is a 70-year-old gentleman who was status post exploratory laparotomy who developed a symptomatic incisional hernia in the upper part of his abdomen.He also has a small umbilical hernia, presenting now for repair.Procedure: ¿the patient was brought to the operating room, placed in the supine position.Sequential teds were placed.The patient was placed under general anesthesia and intubated.The foley catheter was inserted.The entire abdomen was prepped and draped in the usual sterile fashion.In the left lower quadrant, local anesthesia was infiltrated.A small incision was made, carried down through the subcutaneous tissues.The external oblique was identified.Two lateral stay sutures were placed and the external oblique was opened in the direction of its fibers.The muscles were separated and the peritoneum opened.The hasson trocar was inserted in the abdomen.The abdomen was then inflated to a pressure of 15 mm.Of mercury with co2.Under direct visualization, two additional left lateral 5 mm.Trocars were inserted.The abdomen was inspected.The liver appeared normal.There were extensive adhesions essentially along the entire length of the incision, mainly the right hand side of the abdomen.The left hand side of the abdomen was clear.Using a grasper and sharp endo shears, meticulous careful lysis of adhesions was carried out, taking down the adhesions, well over to the right side of the abdominal wall.There was an incarcerated loop of intestine in the incisional hernia.This was grasped and carefully reduced and adhesions keeping this loop of intestine in the hernia were carefully lysed.This was fairly extensive in nature.Once all of the adhesions of the hernia had been reduced, there was approximately a 4 cm.Hernia defect in the upper part of his abdomen as well as a small umbilical hernia.Overlapping each by about 7 cm.In all directions, the area was marked out.The patch size selected was a 20 x 30 and cut to approximately 23 x 15 cm.This covered both defects again with approximately 3 cm.In all direction.Alternating between 0 prolene and gortex stitches, stitches were placed into the patch circumferentially.The patch was marked with the rough side wall and the smooth side bowel rolled up and placed into the abdominal cavity and unfurled.Starting on the right hand side in the right upper quadrant, about 2 cm.Outside the patch edge, a small incision was made.The suture passer was placed through the abdominal wall.Both arms of the stitch were brought out.Each was clamped with a mosquito.This process was carried out circumferentially, bringing all 13 anchoring stitches out through the anterior abdominal wall through 13 small separate incisions.Once this was accomplished, all stitches were tightened and tied.The mesh patch came up against the anterior abdominal wall, was smoothed and adequately covered both the defects very well.Confirmation was made that the smooth side was towards the peritoneal cavity and that the rough side was up against the anterior abdominal wall.Next, a tacker was used to circumferentially tack the rim of the patch to the anterior abdominal wall.When this was completed, the abdomen was inspected.All areas were noted to be hemostatic.The trocar was removed under direct visualization.The abdomen was deflated.The left lower quadrant fascial defect was closed with a figure of eight 0 dexon stitch with the previously placed lateral stay sutures tied on top of this.A 00 dexon stitch was used to reapproximate the subcutaneous tissues at this site and then the three trocar site incisions were closed with a 0000 dexon subcuticular stitch.Benzoin and steri strips were placed over all of the incisions as well as bandaids.At the end of the procedure, all needle, sponge and instrument counts were correct.The patient tolerated the procedure well and returned to the recovery room in stable condition.¿ on (b)(6) 2007: (b)(6) medical center.Implant sticker.Gore® dualmesh® biomaterial.Ref catalogue number: 1dlmc07.Lot batch code: 04771168.W.L.Gore & associates.On (b)(6) 2007: (b)(6) medical center.Intraoperative record.Asa: 2.Implants/explants.Manufacturer: gore w.L.Item number: 1dlmc07.Lot number: 04771168.Implant.Wound class: clean.The records confirm a gore® dualmesh® biomaterial (1dlmc07/04771168) was implanted during the procedure.??/??/??: [missing records: records from ¿outside hospital¿ and of abdominal ultrasound were not provided.] on (b)(6) 2018: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Operative report.Addendum by (b)(6) md, (b)(6).Late entry for (b)(6) 2018.Indications reviewed with resident.Present during entire procedure.Kocher clamps used to grasp the fascia initially.Multiple tacks were identified in the anterior abdominal wall placed to stabilize the goretex mesh.Aquacel surgical dressing 12 in (8 inner length) was used to cover the wound.Preoperative diagnosis: acute cholecystitis and cystic duct obstruction.Postoperative diagnosis: gangrenous cholecystitis and cystic duct obstruction, small bowel laceration x 2, contaminated ventral hernia mesh.Procedure performed: lap [laparoscopic] convert to open cholecystectomy, enterorrhaphy x 2, explantation of hernia mesh.Anesthesia: general, local.Indications: mr.Dowling is an 81-year-old male with pmh [past medical history] most significant for colon polyps (? cancer) s/p [status post] partial right colectomy with ileocolic anastomosis who presented to (b)(6) medical center from an outside hospital with concern for possible bowel perforation however was later identified to have cholecystitis.Patient with fevers, elevated glucose cytosis, direct bilirubinemia, lactic acidosis and transaminitis.Abdominal ultrasound revealed cholelithiasis with gallbladder wall thickening and mild intrahepatic ductal dilation but normal common bile duct.Gi was consulted and did not recommend an ercp [endoscopic retrograde cholangiopancreatography].With antibiotics and resuscitation, patient¿s leukocytosis were resolved and total bilirubin declined significantly.As such decision was made to take patient to the operating room for a laparoscopic possible open cholecystectomy.All risks and benefits discussed with the patient, consent obtained and patient wished to undergo procedure.Specimen: gallbladder, infected hernia mesh.Drains: gastrostomy.Estimated blood loss: 180 ml.Description of procedure: ¿the patient was brought to the operating room and transferred to the operating table.Patient was intubated and sedated by anesthesia without issue.Patient was kept in the supine position, was prepped and draped in the usual sterile fashion.Timeout was performed confirming the correct patient and procedure.Attention was then turned to accessing the abdomen for laparoscopic cholecystectomy.Quarter percent marcaine plain was infiltrated in the infraumbilical position and skin incision was made.Tissue was dissected down to the umbilical stalk and fascia was grasped with coker¿s and a fascial incision was made.Hassan port was then entered into the abdomen, insufflation was able to be achieved successfully.Upon entry into the abdomen with the camera, it was clear that there was extensive adhesions present from the right paramedian exploratory laparotomy incision from prior height right hemicolectomy.A small window into the right lower quadrant was able to be viewed with the camera from the umbilical port, and a 5 mm right lower quadrant port was inserted without issue under direct visualization.With graspers through the right lower quadrant port site, some of the dense omental adhesions were able to be teased down from the anterior abdominal wall.Tissues were clear enough to be able to place an additional two right upper quadrant sub costal ports to attempt further perform adhesiolysis.Numerous attempts were made to bluntly peel the large veil of omental adhesions off the anterior abdominal wall and while performing adhesiolysis, it became clear that these adhesions were quite dense and concerning to harbor small bowel and colon.As these lesions were dissected off the abdominal wall, we observe that there was mesh and tacks present to the abdominal wall revealing the patient had prior ventral hernia repair.While performing adhesiolysis and dissecting a loop of small bowel off the mid abdominal wall near the our [sic] umbilical port site, was clear that we observed to [sic] enterotomies that were made.It is unclear if these were made secondary to injury from the tacts [sic] from prior ventral hernia repair or from our own dissection.Enterotomies were planned to be dealt with later after evaluation of the gallbladder to determine whether or not procedure can move forward laparoscopically.Once we felt that the performed significant enough adhesiolysis to adequately evaluate the gallbladder, attention then turned to the right upper quadrant.Again significant adhesions were noted to be present with a significant inflamed appearing gallbladder.Upon attempts to dissect and free the gallbladder of adhesions, it became clear that we were causing injury to the surrounding liver.Given dense adhesions noted throughout the entire abdominal cavity including at her umbilicus, and gallbladder in the setting of the enterotomies that were also observed to require repair and the significantly inflamed gallbladder, became clear that laparoscopy would be challenging should we continue to pursue it and decision was made to convert to an open cholecystectomy.A right subcostal incision was then created connecting the 2 previously made subcostal 5 mm port incision sites.Tissue was dissected down to the fascia which was then incised and divided.The rectus muscle was then divided in which a ventral goretex mesh was again confirmed to be present.Balfour retractor was utilized to retract open the abdominal wall to inspect it [sic] abdominal contents.Small bowel was then again inspected, and adhesiolysis was performed in order to deliver the small bowel into operating view to identify our previously noted enterotomies.Once identified, there were noted to each be small approximately 1 cm, approximately 5 cm between each enterotomy and encompassing les than 50% of the circumference of the small bowel.Decision was made to primarily repair these enterotomies.3-0 silk interrupted lemberted sutures were used to primarily repair the enterotomies.They were repaired without issue.Our attention was then turned back to the gallbladder.Again the gallbladder was noted to be significantly inflamed and gangrenous.2 rolled to perihepatic lap pads were placed in order to deliver the liver and gallbladder into the field of view.Peritoneum over the gallbladder was bluntly dissected to mobilize the gallbladder.Kelly clamps x2 were then used to clamp the body and infundibulum of the gallbladder to allow for adequate retraction.Using direct palpation and visualization, the cystic duct was able to be identified and isolated with a right angle clamp.Once the gallbladder was dissected off the liver fossa using blunt and electrocautery dissection, the gallbladder was then transected off at the cystic duct.3-0 silk tie was then used to ligate the cystic artery/duct trunk.A single lumen was noted in the dissected gallbladder that was removed.Gallbladder sent for pathologic analysis.The abdominal cavity was then thoroughly irrigated with sterile saline.A latex glove was used with packing to achieve hemostasis.Once hemostasis was deemed to be successfully achieved, attention was then turned towards closing the abdominal wall.Patient is now noted to have enterotomies and required incision through the old hernia mesh site, decision was made to partially explant his previously placed mesh.Explanted mesh was sent for pathologic analysis.Abdomen was then inspected, felt that hemostasis was adequately achieved and decision was made to close the abdominal wall.A running #1 vicryl was utilized to close the posterior fascial suture sheath.The tissue was somewhat [illegible]enuded and tornwaldt running this layer.Following this a running looped #1 pds was utilized to close the anterior [illegible]ascial wall.This was closed without issue.Staples were then utilized to close the overlying skin and an aquasol [illegible]ressing was applied.Patient tolerated the procedure well all counts were correct x2.Patient was extubated and [illegible]ansported to the pacu in stable condition.Dr.(b)(6) present and scrubbed throughout the entire procedure.¿ on (b)(6) 2018: [missing records: pathology and culture reports detailing analysis of the device and specimen removed during the 07/05/18 procedure were not provided.] on (b)(6) 2018: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Operative report.Addendum by (b)(6) md, (b)(6).Late entry for 07/12/18.Indications reviewed with resident.Present during the entire procedure.Preoperative diagnosis: perforated bowel ¿ small bowel.Postoperative diagnosis: same as preoperative diagnosis.Procedure performed: exploratory laparotomy, enterorrhaphy, removal of infected hernia mesh, excision of necrotic fascia, temporary abdominal closure.Anesthesia type: general.Patient with worsening leukocytosis and bilious drainage from subcostal incision concerning for missed enterotomy.¿the patient was brought to the operating room and transferred to the operating room table.Patient was intubated and sedated by anesthesia without issue.Patient was kept in the supine position, was prepped and draped in the usual sterile fashion.Timeout was performed confirming the correct patient and procedure.Attention was then turned to open previous righ [sic] subcostal incision.Upon entering the abdomen, bile stained ascites was immediately encountered in the subhepatic space.Post operative adhesions were lysed with combination of careful blunt and sharp dissection.Fascial edges were noted to be frankly necrotic and debrided non viable tissue.Previously partially excised ventral mesh was noted to be grossly infected, thus explanted from abdominal wall along with associated tacks.After thororough [sic] irrigation, identified previous enterorrhaphies, which appeared to be intact, but additional enterotomy was noted in close proximity to prior repair.Enterotomy was less than 1 cm and repaired with 3-0 silk interrupted lemberted sutures.After repair, abdomen was again copiously irrigated and small bowel inspected.No other enterotomies or bile staining was found.Gallbladder fossa without bile staining.Of note, small bowel with significant interloop adhesions.Complete lysis of adhesions not possible without risk for further damage to already friable bowel.Decision was made to leave abdomen open with placement of abthera wound vac and planned re-look laparotomy in 48 hrs.Patient tolerated the procedure well all counts were correct x2.Patient was left intubated and transferred to the sicu in stable condition.Dr.(b)(6) present and scrubbed throughout the entire procedure.¿ on (b)(6) 2018: [missing records: pathology and culture reports detailing analysis of the device and specimen removed during the 07/12/18 procedure were not provided.] on (b)(6) 2018: (b)(6) medical center.(b)(6) , md.Operative note.Preoperative diagnosis: perforated viscus.Postoperative diagnosis: perforated small bowel, infected hernia mesh, necrotic fascia, intraabdominal abscess.Procedure performed: exploratory laparotomy, enterorrhaphy, removal of infected hernia mesh, excision of necrotic fascia, temporary abdominal closure.Assistants: (b)(6) md, (b)(6) wbc, draining abdominal wound, amylase in the drainage was 15k.Findings: small bowel perforation, likely mid jejunum, infected hernia mesh, necrotic fascia.Specimen: hernia mesh, necrotic fascia.Description of procedure: explore lap, suction bile-staine [sic] ascites from ruq, anterior abdomen, subhepatic space, extensive adhesions, irrigation of bile-stained ascites x 20 min\identify infected hernia mesh, explantation of mesh along with all associated tacks\identify previous enterorrhaphies, both intact\extensive lysis of adhesions x 20 min\identify small bowel perforation, etiology unclear, repair small bowel\excise necrotic fascia x 10 min\irrigation x 10 min\placement of abthera (26 x 8 cm ) 208 cm2).On (b)(6) 2018: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Operative report.Addendum by (b)(6) md, (b)(6).Indications reviewed with resident.Present during entire procedure.Preoperative diagnosis: open abdomen\intraabdominal abscess.Postoperative diagnosis: same\sb perforation.Procedure performed: 2nd look laparotomy\enterorrhaphy\replacement negative pressure dressing.Anesthesia: general.Intraabdominal infection.Patient is an 81-year-old man with past medical history of diverticulosis, hypertension, tia, right hemicolectomy with ileocolic anastomosis and colon polyps who underwent a laparoscopic converted to open cholecystectomy with enterorrhaphy and mesh explantation on 7/5 who experienced a cystic duct leak now status post ercp.Postoperatively he was found to have enteric leak on upper gi.He was taken to the operating room on 712 [sic] for exploratory laparotomy enterotomy repair, mesh explant and after placement.Patient returns today for relook laparotomy and washout and possible closure.Findings: minimal necrotic fascia, spontaneous sb perforation.Specimen: none.Estimated blood loss: 75 ml.Description of procedure: ¿patient was brought into the operating room and placed on the operating room table in the supine position.After induction of general endotracheal anesthesia, the patient¿s arms were tucked and the abdomen was prepped and draped in the usual sterile fashion.The patient had the abthera wound vac in place which was removed the abdomen was inspected and there was necrotic fascia that was noted in the abdominal wall along with necrotic adipose tissue.This was bluntly debrided using debakey forceps.The abdomen was irrigated with warm saline.We identified a small bowel leak adjacent to prior small bowel repair this was repaired with a 3-0 silk suture.We inspected the left upper quadrant which was found to be clean without any psychosis.Inspected the right upper quadrant and the suprahepatic and inferior hepatic space.The gallbladder fossa was noted to be clean without any bile.Due to the presence of the small bowel leak noted during our inspection today, the decision was made to replace abthera wound vac.The patient tolerated the procedure well, there were no immediate complications.The patient was transferred to the surgical icu in stable condition, intubated.All counts were correct x2.¿ other information: wound classification: contaminated.On (b)(6) 2018: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Operative report.Addendum by (b)(6) md, (b)(6).Indications reviewed with resident.Present during entire procedure.Preoperative diagnosis: intraabdominal abscess.Postoperative diagnosis: same as preoperative diagnosis.Procedure performed: 3rd look laparotomy, enterorrhaphy, replacement of negative pressure abdominal dressing.Anesthesia type: general.Operative note: ¿patient was brought into the operating room and placed on the operating room table in the supine position.After induction of general anesthesia, the patient¿s arms were tucked and the abdomen was prepped and draped in the usual sterile fashion.The previous abthera wound vac was removed and the abdomen was inspected.Again noted to have some necrotic fascia, which was sharply debrided, but much improved from previous re-looks.Small amount of bile stained ascites again noted.The abdomen was irrigated with warm saline.A small bowel leak adjacent to prior small bowel repair was again repaired with a 3-0 silk suture.Gallbladder fossa was noted to be clean without bile.Additional thorough irrigation without any bile staining.Due to the presence of the small bowel leak noted during our inspection today, the decision was made to replace abthera wound vac.The patient tolerated the procedure well, there were no immediate complications.The patient was transferred to the surgical icu in stable condition, intubated.All counts correct x2.Dr.(b)(6) was scrubbed and present for the entirety of the operation.¿ on (b)(6) 2018: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Operative report.Addendum by (b)(6) md, (b)(6).Late entry for (b)(6) 2018: indications reviewed with resident.Present during entire procedure.Preoperative diagnosis: perforated viscous, open abdomen.Postoperative diagnosis: same as preoperative diagnosis.Procedure performed: 4th look laparotomy, tiseel application, abdominal closure.Anesthesia type: general.Operative note: ¿patient was brought into the operating room and placed on the operating room table in the supine position.After induction of general anesthesia, the patient¿s arms were tucked and the abdomen was prepped and draped in the usual sterile fashion.The previous abthera wound vac was removed and the abdomen was inspected.Again noted to have some necrotic fascia, which was sharply debrided, but minimal debridement required.No immediate bile staining noted.The abdomen was irrigated with warm saline.Gallbladder fossa was noted to be clean without bile.Closely inspected loops of small bowel with previously noted enterotomies and very minimal bile staining noted at previous repair sites.Tiseel applied over entirety of previous enterorrhaphies.No additional bile staining noted.Due to previously required extensive debridement of necrotic fascia, abdomen was closed with interrupted full thickness #5 ethibond sutures with bolsters and skin closed with staples.Aquacel ag dressing then applied.Post operative xray without any retained foreign bodies from or.The patient was extubated and tolerated the procedure well, there were no immediate complications.The patient was transferred to the surgical icu in stable condition.All counts correct x2.Dr.(b)(6) was scrubbed and present for the entirety of the operation.¿ on (b)(6) 2018: (b)(6) surgical associates.(b)(6) , md.Office notes.Underwent open cholecystectomy, removal of infected hernia mesh in early july.Case was complicated because he had small bowel fistula at the site where small bowel attached to several tacks in previous hernia mesh.Portion of mesh removed.The fistulae were closed, belly closed; however, he developed small bowel leak, several days later required re-exploration and although repairs of small bowel were intact, he had 2 additional spontaneous small bowel holes in same segment of bowel more than 5 cm away from previous tacks.I do not think these were missed enterotomies at that time.These were repaired and abthera replaced in wound temporarily.Underwent re-exploration and this time all four holes were closed.He was placed, after washout, with abthera and we elected to keep belly closed temporarily, returned 2 days later for final closure after no additional holes found.Retention sutures placed.Extubated after each operation in surgical icu.Became nutritionally depleted, on tpn.Has since gone to nursing home at (b)(6).Has not had nausea, vomiting, abdominal pain.Feels he is getting stronger.Does not have drainage from chevron wound.Impression: overall, doing much better.Has regained some weight, nutritional status improving.Do not think he has intra-abdominal abscess at present time.Walking very little at nursing home and only with assistance.Malnutrition, venous insufficiency, deconditioning.Plan: gait training, compression stockings, protein supplements.Return (b)(6) 2018.On (b)(6) 2018: (b)(6) surgical associates.(b)(6) , md.Office notes.Has done extremely well since last visit.Continues to take eliquis for atrial fibrillation.Denies nausea, vomiting, abdominal pain.Biliary stent removed in interim.Abdominal chevron incision well healed without evidence of hernia or infection.Scars from retention sutures, but no drainage or erythema, abdomen benign.Impression: status post laparoscopic converted to open cholecystectomy complicated by hernia mesh removal and subsequent incidental enterorrhaphy, requiring multiple follow up procedures.Plan: routine activities; walk 15-20 minutes each day.Discharge from care.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® biomaterial 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.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.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.Through gore's investigation and based on the available information 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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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