|
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) 1997: (b)(6) medical center.[signature illegible], pac; g.[illegible], md.History and physical.Height 5¿9¿, weight 210.Bilateral low back pain with radiation down legs.History of lumbar facet injection, epidural steroid injections, lysis of adhesions, myelotomy, lumbar laminectomy x3.Exam: abdomen; soft, nontender, benign.Moderate paresthesia right lateral thigh.Impression: failed back syndrome.Past laminectomy syndrome.Lumbar radiculopathy.Status post lysis of epidural adhesions.Hypertension, reflux esophagitis.Status post epidural steroid injections.Status post lumbar facet injection.Plan: dorsal column stimulator trial.¿ (b)(6) 1997: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: chronic low back pain.Postoperative diagnosis: chronic low back pain.Anesthesia: general.Name of operation: permanent implantation of a dorsal column stimulator.Estimated blood loss: less than 20 cc.¿ (b)(6) 1997: (b)(6) medical center.Implant record.Medtronic implantable pulse generator, medtronic extension kit.Implant: right upper quadrant.¿ (b)(6) 2000: (b)(6) medical center.(b)(6), pa-c; (b)(6) , md.History and physical.38-year-old followed by us for several years for chronic back pain.Spinal cord stimulator implant (b)(6) 1997, originally had good coverage with pain control, stimulator no longer providing good relief especially on left.Currently taking methadone for pain relief.History of hypertension, he claims history of ulcer disease as well as fast heart rate.Permanently disabled, married.Impression/plan: chronic pain with minimal coverage of spinal cord stimulator.Proceed with dual placement of electrodes and synergy system.¿ (b)(6) 2001: (b)(6) hospital.(b)(6) , md.Radiology ¿ ct abdomen with & without contrast.Indication: abdominal pain.Findings: lung bases clear, heart normal in size with left ventricular contour.Prominent pericardial fat pad.Liver and spleen normal in contour and homogeneous.Mild diffuse hepatic fatty change.Stomach mildly distended with oral contrast and air.Metal surgical clips present in midepigastric region suggesting previous fundoplication.Patient is status post cholecystectomy.Pancreas, adrenals, kidneys, and retroperitoneum normal in contour.Bowel loops normal in lumen caliber.Prominent periumbilical hernia containing mesenteric fat and bowel loops.Mesenteric fat and vascular structures otherwise normal in contour and attenuation.Impression: moderately large (5-cm) periumbilical hernia containing mesenteric fat and bowel loops.Mild diffuse colonic constipation with no bowel distention or obstruction identified.Changes status post cholecystectomy and post-surgical changes suggesting previous fundoplication around ge junction.Mild diffuse hepatic fatty change.¿ (b)(6) 2001: (b)(6) hospital.(b)(6), md.Radiology ¿ x-ray barium swallow/upper gi with air contrast.Indication: abdominal pain.Barium swallow: findings: the patient swallowed barium without difficulty.Normal triggering of oropharyngeal component.Valleculae and piriform sinuses distend normally.No aspiration demonstrated.Cervical and thoracic esophagus distend normally with a small sliding hiatal hernia.Intermittent ge reflux into lower thoracic esophagus demonstrated in supine position.Impression: small sliding hiatal hernia with intermittent ge reflux into the lower thoracic esophagus in the supine position.Otherwise normal barium swallow.Upper gastrointestinal study: findings: preliminary kub shows air and mild amount of stool in multiple scattered and clustered nondistended loops of large and/or small bowel in mid and upper abdomen and overlying pelvis.Small amount of residual stool and contrast material present in sigmoid colon and rectum.Indwelling epidural pain control device with wire leads overlying the thoracolumbar spine noted.Patient swallowed barium and crystals without difficulty.Cervical and thoracic esophagus, stomach, duodenal bulb, and duodenum distend normally with no focal mucosal ulceration, mass lesion or gastric outflow obstruction.Moderate diffuse prominence of gastric fundal mucosal folds.Small sliding hiatal hernia with intermittent ge reflux into the lower thoracic esophagus.Proximal small bowel loops, in so far as seen, are normal in caliber, mucosal pattern and distribution.Impression: moderate diffuse superficial gastritis.Small sliding hiatal hernia with intermittent ge reflux into the lower thoracic esophagus in the supine position.¿ (b)(6) 2001: (b)(6) hospital.(b)(6), md.Radiology ¿ us abdominal complete.Indication: abdominal pain.Impression: findings suggest diffuse hepatic fatty change or other hepatic infiltrative process with mild hepatomegaly.Otherwise normal abdominal ultrasound.¿ (b)(6) 2003: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Operation performed: laparoscopic repair of the incisional hernia.- procedure: ¿under general endotracheal anesthesia and sterile technique, three trochars [sic] were placed along the left anterior abdominal line and two on the right anterior abdominal line.Entry was made with the optiview system in the left upper quadrant.Pneumoperitoneum was carried out with carbon dioxide.Dense multiple adhesions of omentum and small bowel were attached in the hernia sack and these were taken down sharply with the harmonic scalpel and scissors.A portion of the colon was also attached at the upper portion of the defect and this was taken down.There was one area that was near the colon itself, which the harmonic scalpel had taken down.Pressure on either side of the colon revealed no defect of encroachment on the lumen of the colon; however, a 2-0 ethibond suture was passed in a limbered fashion over the questionable area and sutured to cover the area.A 4 x 6 piece of mesh was brought into the abdomen after being cigarette rolled and unrolled.It was noted that it was not large enough to cover the defect.Therefore a 7 x 9 inch piece of mesh was brought to the field.Suture were placed in the 3, 6, 9, and 12 o¿clock positions.This was rolled and passed into the abdomen and unrolled.Using the transporter, the sutures were grabbed in the 3, 6, 9, and 12 o¿clock positions around the defect itself and a tacking gun was used to tack the mesh in place, taking care to put the smooth expanded polytetrafluorethylene surface against the abdominal cavity.Hemostasis was obtained.The defect was entirely covered and the mesh was intact and secured in areas.Trochars [sic] were removed.The pneumoperitoneum was deflated and the defects were closed with 4-0 vicryl and injected with 20 ml of 0.5% marcaine plain.The patient tolerated the procedure well and was sent to recovery in stable condition.All counts were correct.¿ ¿ (b)(6) 2006: (b)(6) hospital.(b)(6), md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: possible ventral hernia.Findings: lung bases unremarkable.Unenhanced imaging of abdomen demonstrates multiple surgical clips at gastroesophageal junction.No calcified gallstones.No renal calculi.Postcontrast imaging of abdomen demonstrates normal liver, gallbladder, pancreas, spleen, adrenal glands, and kidneys.Abdominal aorta of normal caliber.No peritoneal adenopathy.Postsurgical changes noted in anterior abdominal wall.Midline upper abdominal ventral hernia with maximum transverse dimension of approximately 10 cm.This hernia contains bowel loops and fat.No evidence of obstruction or incarceration.No free fluid in pelvis.Mild bladder wall thickening, may be related to distention.Impression: large midline, recurrent ventral hernia, as described.Hernia extends from the level of the upper pole region of the kidneys to the level of the iliac crest.¿ (b)(6) 2006: (b)(6) hospital.Inpatient hospitalization.- (b)(6) 2006: (b)(6) hospital.(b)(6) , do.History and physical.Admitted, cramping abdominal pain, began (b)(6) followed by vomiting and fever yesterday.Had normal bowel movement last night.Had this pain before, but would resolve within 24 hours.Exam: abdomen; soft, faint bowel sounds, however there is a nasogastric tube in place, tender right mid hernia.Impression/plan: abdominal pain with history of herniorrhaphy.- (b)(6) 2006: (b)(6) hospital.(b)(6) , md.Radiology ¿ abdomen 2 view.Indication: abdomen distended.Findings: several air-fluid levels on upright film.No distended loops of bowel.No actual luminal gas.Surgical clips from prior hernia repair.Impression: no acute abnormality.- (b)(6) 2006: (b)(6) hospital.(b)(6) , md.Radiology ¿ us gallbladder/pelvis/liver/pancreas.Indication: abdominal pain, nausea, vomiting.Impression: difficult examination due to patient¿s large body habitus.Cannot rule out possibility of small stones, no evidence of any ductal dilation seen, no evidence of fluid in abdomen.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.Review of the manufacturing 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.
|
