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B7: added medical history.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) 2009: [facility ni].(b)(6), md; (b)(6), md.Operative report.Preoperative diagnosis: incarcerated umbilical hernia.Postoperative diagnosis: incarcerated umbilical hernia.Procedure: umbilical hernia repair.Chief resident: dr.(b)(6).Staff physician: dr.(b)(6).Anesthesia: mac anesthesia by dr.Laroe.Estimated blood loss: minimal.Complications: none.Indication: the patient is a 30-year-old male who began complaining of umbilical pain starting the evening prior to his admission to the hospital.The patient had noticed a bulge at his umbilicus, which was very tender to palpation.Upon evaluation in the er, the emergency room physician was able to reduce this hernia which appeared to be containing omental fat.The patient was then recommended to undergo an umbilical hernia repair which patient has consented for during this admission.Procedure: ¿the patient brought to the operating room and placed in supine position.The patient underwent mac anesthesia by dr.Laroe.Once the patient was sedated, the patient was prepped with duraprep solution and draped in sterile standard surgical fashion.A timeout was performed by the surgical team while all concerns and questions were addressed prior to making the incision.The patient did receive a dose of preoperative antibiotics and was placed on lovenox for dvt prophylaxis.An incision was made in elliptical fashion superior to the umbilicus.This incision was carried down using electrocautery until we could identify the hernia sac.Hernia sac was taken off the umbilicus and was cleared from the abdominal defect and was pushed back into the abdomen.At this point, the fascial defect was repaired using interrupted 0 ethibond sutures.Once the hernia was closed, the umbilicus was tacked back down to the abdominal fascia.The 3-0 vicryl sutures were used to approximate the subcutaneous fat.The skin was closed using 4-0 monocryl suture in running fashion.Steri-strips were applied to the incision.The patient was transferred to the pacu in good condition.One percent lidocaine mix with epinephrine was used [incomplete report].¿.(b)(6) 2009: [facility ni].(b)(6).Radiology-ct abdomen/pelvis.Indication: umbilical hernia.Findings: there is elevation of the left hemidiaphragm.There is no bowel wall thickening or obstruction.There is asymmetric unilateral atrophy of the rectus abdominis muscle on the left with atrophy of the oblique muscle on the [illegible] inferiorly.There is laxity of the anterior [illegible] at this level with bulging of fat in the left lower quadrant.There are small bilateral fat-containing inguinal hernias.Impression: [illegible] of the [illegible] on the left with atrophy and fatty infiltration of the rectus muscle as well as the oblique muscles.(b)(6) 2014: (b)(6).(b)(6), do.History and physical.Presents to grove city emergency room.Is on 3 liters nasal cannula around the clock and has been on oxygen for about 2 years.6 days ago started having productive cough, fevers.Past medical history: asthma/chronic obstructive pulmonary disease, hypertension, morbid obesity, and ¿borderline¿ diabetes.Current medications: metformin.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Emergency room visit.Presents for evaluation of acute respiratory distress.Admitted for pneumonia, left against medical advice today.Was receiving levaquin for pneumonia.Past medical history: essential hypertension, depressive disorder, gastroesophageal reflux disease, h1n1 influenza, liver disease liver laceration related to motor vehicle accident in 2004, obstructive sleep apnea, diaphragmatic paralysis, asthma, obesity, inguinal hernia, undescended testicle, dependency on alcohol, chronic bronchitis, elevated diaphragm, memory impairment, vascular insufficiency, acute kidney injury, lower extremity edema, cyst of pancreas, hemoptysis, hepatitis, alcoholic, hypertriglyceridemia, neck fracture, lung collapse.Past surgical history: hernia repair.Facial reconstruction surgery.Tracheal surgery.Ankle fracture surgery; right; (b)(6) 2013.Finger fracture surgery; left; 2005; pink finger.Social history: never smoker, smokeless tobacco never used.Alcohol use: 21.0 oz/week, 42 cans of beer per week.Drug use: no.Exam: unremarkable except; appears distressed.Morbidly obese, diaphoretic.In respiratory distress, has wheezes, rales.Abdominal: soft, bowel sound normal, no distention and no mass; no tenderness.Impression: acute respiratory failure, pneumonia.Plan: emergently intubate at bedside.Admit to intensive care unit.(b)(6) 2014 - (b)(6) 2014: (b)(6) medical center.Inpatient hospitalization.(b)(6) 2014: (b)(6) medical center.(b)(6), md.History and physical.Currently intubated.Exam: unremarkable except; obese, intubated.Decreased air entry on both lower lung fields.Gastrointestinal soft, obese, no tenderness.Impression/plan: acute hypercarbic respiratory failure; keep intubation and ventilator care; keep breathing treatment; consult pulmonology.Possible health care associated pneumonia from methicillin resistant or gram negative organism; started empiric antibiotics; will check blood culture.Hypertension, hold all blood pressure medications for now.Depression; keep home medications, on sedation now.Obstructive sleep apnea and left diaphragmatic paralysis, obesity.Alcohol abuse and dependency; on fentanyl and versed with adequate sedation.Gastroesophageal reflux disease; keep h2 blocker.Hypomagnesemia; replace with intravenous and recheck chemistry.(b)(6) 2014: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Consultation.Pulmonary.Pulmonary has been consulted for aid with management of respiratory failure.Has history of reported asthma.Last pulmonary function tests were completed in 2011 and revealed forced expiratory volume 1 38 (severe obstruction) severe restriction and decreased diffusion capacity.Exam: abdomen soft, non-tender, obese.Impression: acute hypoxemic respiratory failure secondary to healthcare-associated pneumonia in setting of obstructive lung disease.Obstructive lung disease, asthma.Elevated left diaphragm.Ethyl alcohol abuse.Obesity.Acute kidney injury, likely secondary to hemodynamic instability following intubation.Plan: continue ventilator support.Will require clinical institute withdrawal assessment for alcohol protocol.Obtain mini- bronchoalveolar lavage.Continue broad spectrum antibiotics.Continue scheduled nebulizers.Was given dose of steroids overnight; may consider restarting given severe obstruction on pulmonary function test.If unable to wean ventilator, consider ct pulmonary embolism versus empiric heparin tomorrow.Gentle hydration for acute kidney injury.(b)(6) 2014: (b)(6) medical center.(b)(6), do.Progress notes.Weight 349 lb 10.4 oz, bmi 48.79.(b)(6) 2014: (b)(6) medical center.(b)(6) , md, phd.Consultation.Nephrology.Blood pressure dropped after intubation and propofol, so sedation was changed to versed and blood pressure stabilized.Eventually placed on pressors, urine output dropped and creatinine increased.No history of kidney disease reported.Impression/plan: oliguric acute tubular necrosis with hyperkalemia.Hypotension.Sepsis, leukocytosis.Acute respiratory failure.Adult respiratory distress syndrome.Anemia.Delirium.Deconditioning.Etiology of acute renal failure probably secondary to sepsis ongoing infections.Will place hemodialysis catheter and start continuous renal replacement therapy.(b)(6) 2014: (b)(6) medical center.Lab.Lower respiratory culture, bacterial: final: staphylococcus aureus: methicillin resistant.(b)(6) 2014: (b)(6) medical center.(b)(6), mbbs.Radiology-abdomen 2 views portable.Indication: abdominal distention.Findings: mild dilation of the colon.No obvious dilated small bowel loops.Impression: no free air under right hemidiaphragm.Left hemidiaphragm is excluded.Elevated left hemidiaphragm seen on chest x-ray from same day.Possible colonic ileus.(b)(6) 2014: (b)(6) medical center.(b)(6), mbbs.Radiology-ct abdomen/pelvis with contrast.Indication: bowel obstruction.Impression: colonic pneumatosis involving the entire right colon with inflammatory fat stranding and some fluid along the right paracolic gutter.Small amount of gas in the mesenteric veins as described.Findings are highly concerning for colonic ischemia and surgical consult is recommended.Mild gaseous distention of the remainder of the colonic loops may be related to ileus.No small bowel dilatation or obstruction.Interval decrease in size of cystic pancreatic lesions along the anterior aspect of the pancreatic head and neck which may represent resolving pseudocysts.Atelectatic changes in lung bases.Mild hepatomegaly.Patent portal vein.Small bilateral inguinal hernias containing fat.(b)(6) 2014: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Consultation.General surgery.Complaint of dilated bowel sepsis who is hospitalized for respiratory failure and sepsis secondary to pneumonia and chronic respiratory disease from a paralyzed left diaphragm has begun to worsen over past 24 hours.Was noted to have high residuals on tube feeds and placed to low wall suction and obtained greater than 1 liter of nasogastric output.Had significant rise in white blood count as well as need for restarting on pressors.Abdominal x-ray demonstrated significant bowel distention.Weight 327 lb 9.7 oz.Exam: abdomen no hernias, tender, distended, rigid.Impression/plan: respiratory failure and possible intra-abdominal process.Stat ct.Possible or today.(b)(6) 2014: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: pneumatosis.Postoperative diagnosis: necrosis of the right colon.Procedure performed: exploratory laparotomy, extended right colectomy, mucous fistula, and ileostomy.Surgeon: (b)(6) , md.Assistant: dr.(b)(6) and dr.(b)(6) , md.Estimated blood loss: about 500 ml.The patient received 2 units ffp, 2 units packed red blood cells, and multiple units of crystalloid resuscitation.Indications: mr.(b)(6) is a 36-year-old gentleman who had presented to the icu 10 days prior to the surgery.He had been treated with multiple antibiotics for presumed pneumonia.He continued to deteriorate clinically, and on the day that we saw him, he was acidotic, his white count had almost tripled, his renal function had failed, and he was requiring some pressure support in order to maintain perfusion.His abdomen was distended on exam, though it was difficult because he is morbidly obese and given the fact that he only had the prior umbilical hernia as an intra-abdominal surgery, we felt that ct scan would be warranted so we would know what we would be operating on.Ct scan obtained showed that he had pneumatosis of the right colon.He was immediately taken to the operating room as an emergency case.Procedure: ¿after being transferred from the icu directly to the or, anesthesia was induced, a time-out was called.A very extended midline incision was made from the xiphoid to pubis.Upon entering the peritoneum carefully under direct visualization, there was a large amount of colonic distention.We could clearly see that the transverse colon was very distended and on the right side it was very dusky.We put in retractors and were able to quickly see that the right colon was incredibly compromised.We could not visualize safely the white line of toldt because of the patient¿s habitus and colonic distention.We felt that by continuing to manipulate this incredibly distended, friable, necrotic bowel we could cause numerous perforations.So, we made a controlled perforation on the anterior surface of the transverse colon and decompressed the bowel.We closed this defect with a pursestring suture.This allowed us greater mobility with the colon.We then took down the white line of toldt carefully.We clearly identified the duodenum and mobilized the colon off of it safely.As we examined the small bowel, the ileocecal valve and the rest of the small intestines looked grossly normal.There was no ischemia, no other lesions.It should be noted too, that while the colon was very distended and necrotic; however, there were no areas of perforation and there was no abscess or murky fluid.When we started to mobilize the transverse colon we did have significant difficulty.The patient had a known pancreatic cyst, which was abutting his transverse colon mesentery.It was incredibly difficult to dissect the transverse colon free.His proximal transverse colon was not viable, and so we knew we were going to ligate it there, but the mucous fistula we needed to dissect this free in order to mature the mucous fistula.Using a combination of electrocautery and metzenbaum scissors, we were able to finally free up a significant portion of the transverse colon mesentery without compromising the middle colic artery.Satisfied with that, we turned our attention to the right colon.After mobilizing the right colon off the peritoneal attachments, we transected it at the level of the ileocecal valve and the proximal portion of the transverse colon.We took the mesentery using the ligasure device.The mesentery was very thick and friable, so we spent a good deal of time dissecting it free from its retroperitoneal attachments and achieving good hemostasis.Satisfied, we then also looked at the distal ileum, where we freed up as many peritoneal reflections as we could in order to take the tension off of what would become out ileostomy.The patient¿s habitus again was very difficulty [sic].He had 6 cm of subcutaneous fat, and he also was significantly challenging.Satisfied with our mobilization of both the distal small bowel and the mucous fistula we then copiously irrigated the abdomen.We looked at the left colon, which was viable.We looked at the stomach and gallbladder and all these organs seemed grossly normal.We then elected to bring out the ostomy to the skin.First we started with the mucous fistula.We identified what we felt was the rectus muscle and made a skin incision roughly 2 cm circular incision, and then dissected down to anterior sheath of the rectus where we made a cruciate incision using electrocautery.We split the muscles and then opened the posterior sheath and peritoneum.Once open, we delivered the distal colon that was going to be the mucous fistula through, ensured that it did have a minimal amount of tension.We readdressed any epiploica and/or peritoneal attachments carefully.This tissue again was very friable, and we were afraid of devascularizing his entire mucous fistula.Once we felt we had enough to mature a mucous fistula, we placed a bowel clamp over it and turned our attention to the ileostomy.This was a far easier maturation.After making a skin incision and a subcutaneous tunnel we made the incision on the rectus sheath, split the muscle and opened the posterior sheath and peritoneum.In both the ileostomy and the fistula, we made sure that we had stretched the fascial opening so we could easily insert two fingers.Satisfied that we had both the ileostomy and the mucous fistula out, we then closed the abdomen primarily using three 0 looped maxon.The incision was very long, and the patient having that much fat on his abdominal wall, we wanted to be sure that would take some of the tension off.We discussed potentially using retention sutures; however, given his abdominal wall and habitus, we felt this might be more morbid and the risk benefit was not worth it.Once his fascia was closed primarily, we place lap sponges on the skin to cover the wound, and we matured the mucous fistula and the ileostomy using interrupted 2-0 vicryl.Satisfied that the blood supply looked good to the ileostomy, it was bruised but it was pink and viable, the mucous fistula was very bruised but we attributed this to most of our manipulation and there was a minimal amount of tension on the mucous fistula.Satisfied we then place the ostomy appliances, took of [sic] the towels from the abdominal incision and placed wet kerlix.At the close of the procedure all sharp, instrument, and sponge counts were correct x2.The patient tolerated the procedure and went to the icu in critical condition.¿.(b)(6) 2014: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Progress notes.Does not follow commands this am.Exam: abdomen obese, firm, elastic dressing in place, absent bowel sounds.Impression/plan: status post resection of right hemicolon and colectomy from ischemic bowel on empiric antibiotic coverage.Acute respiratory failure, very complicated now with volume overload, sepsis, pneumonia in left lower lobe, elevated left diaphragm.Weaning propofol to attempt to awaken.Not dose-optimizing sedation at request of surgical consultants given fear of dehiscence.Ischemic bowel, status post resection of right hemicolon and colostomy.Methicillin resistant staphylococcus aureus pneumonia/tracheitis, vancomycin restarted.Septic shock, on doripenem, flagyl, vancomycin, norepinephrine.Normocytic anemia, hemoglobin dropped from 10 to 8 today.Sinus tachycardia/atrial arrhythmia.Acidosis, mixed metabolic and respiratory.(b)(6) 2014: (b)(6) medical center.Lab.Lower respiratory culture, bacterial: stahylococcus aureus: methicillin resistant.(b)(6) 2014: (b)(6) medical center.(b)(6) , mbbs.Radiology-abdomen 2 views portable.Indication: ischemic bowel status/post resection.Findings: there is an air-filled appearance of the stomach.Otherwise, abdomen is relatively gasless.Impression: previously visualized air-filled colon is no longer seen.Findings could either represent resolved ileus or may be a fluid-filled appearance of the bowel which may not be visualized on radiographs.(b)(6) 2014: (b)(6) medical center.(b)(6) , md; (b)(6) , md.Progress notes.Patient with worsening respiratory status overnight with increase in ventilatory requirement and vasopressors.Weight 338 lb 10 oz.Exam: abdomen mildly distended, ileostomy healthy with stool in bag, midline wound with vacuum-assisted closure in place, mucous fistula appears viable but with sloughing mucosa.Impression/plan: septic shock secondary to ischemic bowel; now with increasing leukocytosis and need for vasopressors, would consider repeat ct abdomen/pelvis with contrast.Hold tube feeds; discontinue imodium.Continue broad spectrum antibiotics.Acute blood loss anemia; hemoglobin overall stable.Acute respiratory failure.Acute renal failure continue continuous renal replacement therapy.Severe protein calorie malnutrition.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis with contrast.Indication: rule out intraabdominal perforation, obstruction or possible cause of compartment syndrome.Findings: postsurgical changes from partial small bowel resection with right abdominal wall ileostomy.Postsurgical changes also noted from right hemicolectomy with left abdominal mucous fistula.Trace abdominal and pelvic free fluid.Open ventral abdominal wall wound defect at midline.Bilateral fat-containing inguinal hernias.Impression: post surgical changes from right hemicolectomy, right abdominal wall ileostomy and left abdominal wall mucous fistula.No bowel obstruction.No pneumatosis or pneumoperitoneum.Trace abdominal ascites.Distended gallbladder with layering hyperattenuating material which may represent sludge or small stones.No definite wall thickening.This could be further assessed with right upper quadrant ultrasound as clinically warranted.Hepatomegaly.Cystic lesions adjacent to pancreas, again possible representing pseudocysts.(b)(6) 2014: (b)(6) medical center.(b)(6), mbbs.Radiology-ultrasound abdomen right upper quadrant liver gallbladder.Indication: obstructive jaundice r/o common bile duct obstruction.Impression: hepatomegaly with slightly increased echotexture which could be related to fatty infiltration or liver parenchymal disease.No gross focal liver lesions.Patent portal vein.Over distended gallbladder with some sludge layering in the gallbladder neck.A dilated duct seen adjacent to the gallbladder with stones and debris.This may represent a dilated redundant cystic duct or a dilated common bile duct.No convincing evidence to suggest acute cholecystitis.No ascites in right upper abdomen.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Radiology-biliary percutaneous transhepatic cholangiogram.Indications: unspecified vascular insufficiency of intestine.Findings: gallbladder is markedly distended.Approximately 250 ml of bile was removed.No evidence of intrahepatic biliary dilatation.Impression: successful placement of cholecystostomy drain.(b)(6) 2014: (b)(6) medical center.(b)(6), md.Procedure note.Pre-procedure diagnosis: acalculous cholecystitis.Post-procedure diagnosis: acalculous cholecystitis.Indication for procedure: suspected acalculous cholecystitis.Procedure name/description: percutaneous cholecystostomy drain placement.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® bio-a® tissue reinforcement 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 states: ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly(glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ 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.The instructions for use warn: ¿the gore® bio-a® tissue reinforcement is not designed to be a load-bearing prosthesis and is therefore not recommended for the permanent bridging of fascial defects.¿ 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.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: 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® bio-a® tissue reinforcement 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 states: ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly(glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ 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.The instructions for use warn: ¿the gore® bio-a® tissue reinforcement is not designed to be a load-bearing prosthesis and is therefore not recommended for the permanent bridging of fascial defects.¿ 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.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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