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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/11/2014 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel obstruction, breakdown of the ventral hernia, mesh unraveled, dense adhesions, explant, sepsis, death related to mesh failure and injury.Additional event specific information was not provided.
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Manufacturer Narrative
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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: relevant medical information: ¿ (b)(6) 2014 (b)(6) hospital.Richard bessette.History and physical.Patient well known to me, approximately 2 years ago underwent mesh repair of ventral hernia.Ten weeks postoperatively, developed wound infection.Ultimately, mesh was removed.Now presents with recurrent hernia and here for laparoscopic repair.Surgical history cholecystectomy, hysterectomy.Weighs 250 pounds.Abdomen soft, non-tender, without hepatosplenomegaly or masses.Recommended laparoscopic repair of hernia.Patient does have some misconceptions with regard to body habitus.Large adipose rolls on either side, which she thinks is a hernia.I explained the hernia is more central and much smaller than that, and the only thing that will change after surgery is the hernia will be repaired and her pannus will not change.Implant procedure: attempted laparoscopy, followed by open herniorrhaphy with small bowel resection.Implant: gore dualmesh® plus biomaterial [1dlmcp04/11148528].Implant date: (b)(6) 2014 (hospitalization february (b)(6) 2014) ¿ (b)(6) 2014: (b)(6) hospital in partnership with (b)(6).Richard a.Bessette, md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Anesthesia: general endotracheal.Description of procedure: ¿under general anesthesia, the patient was prepped and draped in the usual fashion.Incision was made in the right mid abdomen, anterior to the anterior axillary line in the midclavicular line.This extended down to the fascia.Veress needle was then placed.Fluid did not flow easily under gravity.The veress needle transgressed the bowel.It was therefore decided to open the old incision.Once the old incision was opened and extended, there were multiple subcutaneous hernia sacs that had extended significantly lateral from the fascial defect and within this sac was a loop of bowel that had been transgressed.This was inspected.There was a small needle stick there.There was also a clamp mark.There was no evidence of spillage.A small bowel resection was then done by dividing the bowel proximal and distal to the clamp mark and the needle stick area.Gia staplers were fired in these spots and ligasure was used to take down the mesentery.The antimesenteric corner of each staple line was then excised.Gia staple fire with an endo-gia stapler with 3.5 staples was used to close remaining artery.The rent in mesentery was closed with running 3-0 vicryl.There had been no spillage of succuss and gloves were then changed.The preperitoneal space was then entered.The hernia sac and the preperitoneal space was then imbricated over the bowel in order to separate the bowel from the dualmesh.A piece of dualmesh was brought onto the field, fashioned to appropriate shape and size and sutured in position using a running #1 prolene and a horizontal mattress in running fashion.A portion of the fascia was able to be approximated over the mesh.It should be noted then the subcutaneous layer was closed with a running 2-0 vicryl.Skin was closed with staples.The patient tolerated the procedure well without problems.Sponge and instrument counts were correct.Estimated blood loss was nil.¿ ¿ (b)(6) 2014 [assigned, record states (b)(6) 2014]: (b)(6) hospital.Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number 1dlmcp04.Lot batch code 11148528.Exp: 112016.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/11148528) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2014: (b)(6) md.Radiology ¿ abdomen x-ray.Clinical history: instrument count, rule out surgical foreign body.Midline staples in place, right lateral staples.No radiopaque foreign bodies identified.¿ (b)(6) 2014: carson tahoe regional healthcare.(b)(6).Consultation.For opinion on following issues: abdominal sepsis, hyponatremia, hypertension, insulin-dependent diabetes, acute on chronic kidney disease, stage iii.Patient is postoperative day 3 status post abdominal hernia repair, complicated by small nick to bowel.Since then had very poor oral intake, multiple episodes of nausea and vomiting.Nasogastric tube placed, only took out 75 ml then she did pull that refusing to put it back in and only taking ice chips.Blood work today showed acute on chronic kidney disease, leukocytosis with white count 18,000.Having abdominal pain.Gastrointestinal distended, no bowel sounds, tenderness in all four quadrants.Status post hernia repair complicated by abdominal sepsis.Recommend continuing antibiotic therapy with rocephin and flagyl, continue intravenous fluids.Check electrolytes, feeling [sic] secondary to poor oral intake, albumin that she may start third spacing.¿ (b)(6) 2014: (b)(6) hospital.(b)(6) md.Radiology ¿ abdomen 4 views, portable ap chest.Clinical indication: five days post abdominal surgery with shortness of breath and abdominal distention.Compared to (b)(6) 2014, midline abdominal staples noted and nasogastric tube in stomach.Stomach decompressed but now air-filled dilated loops of small bowel within mid to left upper quadrant of abdomen measuring 5 cm in maximum diameter.Paucity of air within non-dilated loops of colon and small bowel loops in right lower quadrant.Possibility of underlying ascites.Impression abnormal bowel gas pattern suspicious for developing mechanical small bowel obstruction.Shallow lung volumes with bilateral perihilar and basilar discoid atelectasis.Developing right pleural effusion not excluded.Successful placement of nasogastric tube into and decompressing stomach.¿ (b)(6) 2014: (b)(6) hospital.(b)(6) md.Radiology ¿ ct abdomen/pelvis.Clinical indication: post-operative complications.Status post abdominal surgery six days ago with increasing abdominal distention.Recent laparotomy and periumbilical herniorrhaphy.Disrupted graft tethered to abdominal wall superiorly with recurrent 8-cm wide periumbilical hernia containing small bowel and peritoneal fat.Dilated small bowel loops proximal to hernia measuring 4.5 cm in maximum dimension containing contrast and air-fluid levels.Consider delayed phase scanning, allow for transit of contrast to determine whether this represents mechanical small bowel obstruction or ileus from recent surgery.Suture line noted within segment of small bowel within hernia sac.Pleural-based consolidation within lower lobes surrounding by small pleural effusions consistent with atelectasis/infiltrate.¿ (b)(6) 2014: (b)(6) hospital.(b)(6) md.Radiology ¿ ct abdomen/pelvis.Clinical indication: concern for small bowel obstruction versus ileus.Comparison abdominal ct (b)(6) 2014.Again seen enlarged anterior abdominal wall defect containing multiple loops of small bowel.Oral contrast seen within multiple dilated small bowel loops proximal to hernia.Proximal small bowel loops remain dilated, up to 4 cm.Oral contrast has not significantly progressed.Remaining intra-abdominal findings unchanged.Small bilateral pleural effusions and adjacent consolidation stable.Findings suspicious for mechanical small bowel obstruction.Explant procedure: removal of gore-tex mesh, adhesiolysis, placement of central line.Explant date: (b)(6) 2014 (hospitalization (b)(6), 2014) ¿ (b)(6) 2014: (b)(6) hospital in partnership with (b)(6), md.Operative report.Preoperative diagnosis: small bowel obstruction, breakdown of ventral herniorrhaphy.Postoperative diagnosis: small bowel obstruction, breakdown of ventral herniorrhaphy.Anesthesia: endotracheal by (b)(6) description of procedure: ¿under general anesthesia, the patient was prepped and draped in the usual fashion.The right subclavian vein was cannulated.Wire was placed through the needle and the needle removed.Next dilator was then placed over the wire and the dilator was removed.The catheter was then placed over the wire.The wire was removed.The tip of the catheter was placed at 15 cm.It was sutured in position.X-ray will be taken in the recovery room.All port sites aspirated easily and were then flushed.Next the abdomen was prepped.The staples were removed.The wound was opened.There were multiple loops of small bowel that were in the subcutaneous position.The mesh had essentially unraveled due to a fracture in the suture line, which was obvious.The fascial tissues themselves were intact.There were dense adhesions involving one margin of the fascia and gore-tex.These were taken down.The bowel was then run from ligament of treitz to the ileocecal valve.The succus entericus and air were then milked retrograde through the ng tube.The bowel was then returned to the abdominal cavity.Alloderm was then used to close the defect.The dermal layer was placed on the underside of the muscle and fascia.It was sewn into position using a #1 prolene suture.Two pieces of the 6 x 16 mesh had to be used and will be sewn in the midline with a running prolene suture.Two jackson-pratt drains were placed.The subcutaneous fat was then approximated with 2-0 vicryl and skin was closed with a smead-jones running 2-0 nylon.The patient tolerated the procedure without problems.Sponge, needle, and instrument counts were correct.Estimated blood loss was approximately 100 ml.¿ (b)(6) 2014: sierra surgery hospital.Implant sticker.Alloderm® ready to use.Lifecell corp.¿ 2/11/14: sierra surgery hospital.Implant sticker.Alloderm® ready to use.Lifecell corp.Relevant medical information: ¿ (b)(6) 2014: carson tahoe regional healthcare.(b)(6).Discharge summary/history and physical for ltach.Admission: (b)(6) 2014 at (b)(6) center.Discharge diagnoses: 1) abdominal abscess.2) hyponatremia.3) postoperative ileus.4) small bowel obstruction.5) hypertension.6) protein-calorie malnutrition with edema.7) insulin-dependent diabetes.8) acute on chronic kidney disease, stage iii.9) status post hernia repair, complications with bowel injury.Procedures: hernia repair (b)(6) 2014, exploratory laparotomy (b)(6) 2014.Hospital course: had incisional hernia repair (b)(6) 2014 complicated with small nick to bowel.Since then, having abdominal pain, nausea, vomiting and leukocytosis of 18,000, medicine team consulted for possible abdominal sepsis, started on vancomycin and fortaz (b)(6) 2014, and nasogastric tube due to abdominal incision, nausea and vomiting, and started on total parenteral nutrition and undergone exploratory laparotomy on (b)(6) 2014.Since then, not having bowel movements but started having bowel sounds today, till poor oral intake, discharge to long-term (b)(6) hospital for one more week of intravenous vancomycin and fortaz and continue total parenteral nutrition until takes good oral intake.Albumin 1.6, leukocytosis down to 11 today.Had nasogastric tube, please continue that.Needs physical therapy, occupational therapy and wound care for postoperative abdominal wound, please follow up with (b)(6)if any acute issues.¿ (b)(6) 2014: (b)(6) hospital.(b)(6) md.Radiology ¿ abdomen x-ray.History: abdominal pain after hernia surgery.Two jackson-pratt drains within right and mid-abdomen.Gaseous (b)(6)(hospital.(b)(6).Radiology ¿ abdomen x-ray.Clinical history: abdominal pain.Two drains over abdomen.Air-filled loops of non-dilated small bowel in central abdomen.Less stool within colon.Little interval change.¿ (b)(6) 2014: (b)(6) health.[illegible signature].Progress note.Icu hospitalist.Hypercarbic respiratory failure requiring intubation.[illegible] with bilateral effusions.Low fever 100.7.Abdomen with drain in place.[illegible].Respiratory failure: bilateral thoracentesis.[illegible].¿ (b)(6) 2014: carson tahoe regional healthcare.(b)(6), md.Radiology ¿ abdomen x-ray.Clinical history: orogastric tube placement.Study limited, motion artifact and pelvis cut off.Nasogastric/orogastric tube present within stomach.Nonobstructive bowel gas pattern.Opacities within lung bases.One of surgical drains has been removed.¿ (b)(6) 2014: (b)(6) healthcare [assigned].(b)(6), md.Progress note.Critical care.Abdomen positive bowel sounds, soft, tender, non-distended.Acute respiratory failure.Continue diuresis.Wean to extubate once awake.Intraabdominal sepsis.Continue vancomycin and zosyn.¿ (b)(6) 2014: (b)(6) healthcare [assigned].(b)(6) md.Progress note.Critical care.Extubated yesterday, on bi-level positive airway pressure.White blood cells 12.60.Abdomen positive bowel sounds, soft, tender, non-distended.Acute respiratory failure.Extubated yesterday.Still with respiratory issues.Thoracentesis today and increase lasix dose.Intraabdominal sepsis.Continue vancomycin and zosyn.¿ (b)(6) 2014: (b)(6) health.[illegible signature].Progress note.Patient was emergently intubated for respiratory distress and altered level of consciousness.¿ (b)(6) 2014: (b)(6) healthcare [assigned].Kameron ferdowsali, md.Progress note.Acute respiratory failure.Reintubated overnight.Possible thrush.Start fluconazole.Thoracentesis right lung today and attempt extubation tomorrow.If fails will require tracheostomy for long-term weaning from ventilator.Intraabdominal sepsis.Continue vancomycin and zosyn.¿ (b)(6) 2014: carson tahoe regional healthcare.(b)(6) , md.Radiology ¿ abdomen x-ray.Interval placement of gastric feeding tube.Bowel gas pattern non-specific.No gross free air.¿ (b)(6) 2014: (b)(60 health.[illegible] bartlett, pa-c.[illegible signature].Consultation.Asked to place percutaneous endoscopic gastrostomy tube to meet nutritional needs.Plan for percutaneous endoscopic gastrostomy tube placement tomorrow.May not be successful due to body habitus.¿ (b)(6) 2014: carson tahoe regional healthcare [assigned].Kameron ferdowsali, md.Progress notes.Not enough fluid for thoracentesis.Family want tracheostomy.Difficult to wean off vent due to morbid obesity, intensive care unit myopathy and continued fluid overload.Trach monday.Intraabdominal sepsis.Continue vancomycin and zosyn.¿ (b)(6) 2014: carlson tahoe regional healthcare.Hong gao.Procedure report.Procedure performed: esophagogastroduodenoscopy with peg tube placement.Indication: acute respiratory failure, ventilator dependency.Procedure: site of peg placement identified by excellent transillumination and 1:1 indentation.Skin marked.Local anesthetic applied.Small incision made.Catheter introduced into stomach through skin incision.Guidewire introduced to stomach through catheter and grabbed with polypectomy snare.Scope withdrawn.20-french peg tube placed using pull method.Antibiotic ointment applied to skin incision site.Endoscope reintroduced into stomach.Location and position of peg verified.Tolerated well.No immediate complications.¿ (b)(6) 2014: carson tahoe regional healthcare.(b)(6) md.Discharge summary.Date of admission: (b)(6) 2014.Diagnoses on admission: 1) respiratory failure.2) hypercarbic respiratory failure.3) obesity hypoventilation syndrome.4) chronic kidney disease.5) recent intra-abdominal abscess.Diagnoses on discharge: 1) intra-abdominal sepsis secondary to bowel laceration secondary to hernia repair.2) hyponatremia.3) prolonged ileus.4) small bowel obstruction.5) hypertension.6) protein-calorie malnutrition.7) insulin-dependent diabetes.8) chronic kidney disease with acute renal failure.Procedures: thoracentesis, picc line insertion, percutaneous endoscopic gastrostomy tube placement, tracheostomy.Surgeon: (b)(6) md.Hospital course: transferred from the long-term (b)(6) hospital with respiratory failure.Partial pressure of carbon dioxide around 100.Considered to be multifactorial secondary to morbid obesity, obesity hypoventilation syndrome, with component chronic obstructive pulmonary disease, questionable medications.Intubated in the long-term acute care hospital and transferred.Aggressively diuresed and had bilateral thoracentesis, planning for extubation when successfully weaned off ventilator.During hospitalization had worsening acute renal failure and suspected acute tubular necrosis secondary to sepsis.She was extubated and on bridge therapy with bi-level positive airway pressure, however, due to fatigue and carbon dioxide retention, required to be reintubated (b)(6) 2014.Had respiratory distress as well as encephalopathy.Underwent percutaneous endoscopic gastrostomy tube placement, tracheostomy and will be transferred to long-term acute care hospital for definitive care.Abdomen with percutaneous endoscopic gastrostomy tube in site, well-healed surgical scar consistent with previous laparotomy, abdomen soft, non-tender, non-distended, no organomegaly.White blood cell count 10.9.Respiratory failure.Complete antibiotics, questionable component of pneumonia, never confirmed.Thoracentesis unsuccessful in past but did not provide any significant impact of respiratory failure.¿ (b)(6) 2014: (b)(6) healthcare.Kameron ferdowsali.Discharge summary.Admitted (b)(6) 2014 and passed away (b)(6) 2014 at approximately 1:00 pm.Admission diagnoses: respiratory failure, hypercapnic respiratory failure, obesity hypoventilation syndrome, intra-abdominal sepsis secondary to bowel laceration secondary to hernia repair, prolonged ileus, severe protein-calorie malnutrition, diabetes, chronic kidney disease.Discharge diagnoses: chronic ventilator-dependent respiratory failure, intensive care unit myopathy, chronic kidney disease leading to end-stage renal disease, acute renal failure, insulin-dependent diabetes, severe protein-calorie malnutrition, small bowel obstruction, intra-abdominal sepsis.Transferred (b)(6) 2014 for very complicated course.Transferred for ventilator weaning management, antibiotics, physical therapy, occupational therapy.Despite very aggressive physical therapy and occupational therapy, failed to gain much strength, and despite aggressive diuretics remained 40 liters positive.Nephrology gave option of dialysis to remove fluid which she denied and stated that was against her wishes.Thoracenteses were done at main hospital, again she developed pleural effusions and she refused any further aggressive measures for this.Long discussions held with family due to poor prognosis without aggressive treatment with dialysis or thoracenteses that likelihood of being extubated and fluid-free was very low, and family discussed this with patient who was awake and aware, and she agreed she was okay to pass away peacefully.Made comfort care (b)(6) 2014 and passed away peacefully.¿ (b)(6) 2014: state of nevada.(b)(6) md.(b)(6).Certificate of death.Deceased name:(b)(6).Date of death: (b)(6) 2014.Hospital: continuecare hospital of (b)(6), inc.Inpatient.Age at death: 80.Date of birth: (b)(6) 1934.Usual occupation (even if retired): l.V.N.Certifier: (b)(6) md.Date signed: (b)(6) 2014.Hour of death: 13:00.Cause of death: cardiopulmonary arrest due to hypercapnic respiratory failure due to abdominal sepsis due to bowel laceration.Autopsy: no.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.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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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.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 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.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® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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, 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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