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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)].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: (b)(6) regional medical center.[signature illegible].Emergency department visit.Severe sudden onset testicular pain, unable to urinate.Has not taken medications for months due to lack of money.Severe pain left abdomen; has not happened before.Positive vomiting with pain.Left lower quadrant tenderness; positive large hernia, mild distention.Left testicle tenderness, no masses or enlargement.Impression: renal lithiasis.(b)(6) 2010: onrad, inc.(b)(6), md.Radiology ¿ ct angiogram abdomen/pelvis.Findings: a large ventral hernia with a wide opening and no evidence of obstruction.Impression: 6.8 cm infrarenal abdominal aortic aneurysm present.Status post endovascular repair with aortobiliac stents in position.No evidence of acute dissection or hemorrhage.Large ventral hernia.(b)(6) 2010: (b)(6) regional medical center.(b)(6), md.Consultation.¿back pain¿, also felt dizzy and weak when he stands up.1 week of heaviness in chest with some radiation to left arm.Feels like abdominal pain is separate from back pain.Surgical history: ventral incisional hernia repair with mesh 2008, abdominal aortic aneurysm repair with stent (b)(6) 2008, abdominal wall hernia repair with mesh 2008.First surgery was to repair an abdominal wall hernia (baseball sized).Developed pneumonia while hospitalized, tore mesh, so a second exploratory laparotomy was performed to repair the initial hernia surgery.Social: current smoker: about 1 pack/day x 40 years.Abdomen: large ventral incisional hernia, reducible 14 cm x 14 cm, no erythema.Old healed midline incision, no pulsatile mass palpable.Ct abdomen/pelvis: 6.8 cm aneurysm of native abdominal aortal.Evidence of prior endovascular repair with aorto-bi-iliac stents present.Diverticulosis.Large ventral hernia, non-obstructed.Impression/plan: (b)(6) male with significant cardiovascular disease presenting with acute onset of back pain.Ct showed stable 6.8 cm aorta aneurysm with stent in place.Lost insurance and has been taking no medications but aspirin for 6 months.Also reports 1 week of anginal pain; concern for unstable angina.Back pain unlikely secondary to aneurysm, may be nephrolithiasis.Currently has abdominal pain and leukocytosis.Check lipase and blood culture.No surgery at this time.Will need follow up outpatient with general surgery for hernia repair.(b)(6) 2010: (b)(6) regional medical center.(b)(6).Office notes.Abdominal aortic aneurysm repair-pain in area of incision left side with increased pain with palpation; small nodule along incision line.Norco prescription ran out; has tried not to take it, but feels he may need again.Distended abdomen with hernia repair with mesh.Refill norco.(b)(6) 2010: (b)(6) regional medical center.(b)(6).Office notes.Complains of left abdominal surgical pain and right abdominal pain.¿a lot of pain at left incision site.¿ off norco x 2 weeks.Positive nausea, no constipation or emesis.Abdomen: multiple bulges.Impression/plan: abdominal aortic aneurysm repair, open in 2008.Endovascular leak status post open aortoiliac reconstruction (b)(6) 2010.Abdominal pain right side chronic, likely secondary to ventral hernia.Left side likely incisional pain.Increased pain causing blood pressure to be elevated.Norco as needed for pain, abdomen x-ray.(b)(6) 2010: (b)(6) regional medical center.(b)(6) md.Office notes.Follow up.Patient unable to get labs and abdominal x-ray; chronic abdominal pain surgical area.Unable to get ct abdomen/pelvis check for abdominal aortic aneurysm repair-abdominal pain after surgery.Medical history: hiatal hernia.Social: no tobacco.Abdomen tender throughout, deformity from hernia.Impression/plan: abdominal pain right lower quadrant possible secondary to hernia-abdomen x-ray.Abdominal pain mid upper quadrant-check abdominal aortic aneurysm repair versus hernia pain.Ct abdomen/pelvis-ultrasound abdomen.No more pain medication unless patient does ultrasound or ct.Hypertension-not at goal; control pain.(b)(6) 2010: (b)(6) regional medical center.(b)(6) md.Radiology ¿ ct abdomen/pelvis with and without intravenous contrast.Indication: abdominal aortic aneurysm, status post open repair, abdominal pain.Impression: 1) redemonstration of abdominal aortic aneurysm stents without definite endoleak identified.Decrease in size of aortic aneurysm, now measuring 3.7 cm.Mild periaortic fat stranding.2) no other evidence of acute intraabdominal or intrapelvic abnormality.3) stable large abdominal wall hernia.(b)(6) 2010: (b)(6) regional medical center.(b)(6) md.Office notes.Right coronary artery stent (b)(6) 2010; here for follow up.Still complains of abdominal pain; ¿burning¿ like someone is ¿grabbing¿ his abdomen.Medication: plavix.Tender throughout abdomen.Positive abdominal hernia.Impression: abdominal pain likely secondary to abdominal hernia.Status post abdominal aortic aneurysm repair; ct-positive hernia.Watch for signs/symptoms of strangulation.Norco as needed.(b)(6) 2010: (b)(6) regional medical center.[illegible signature]; (b)(6).Office notes.History of hypertension, coronary artery disease, myocardial infarction x 2, abdominal aortic aneurysm repair status post repair (b)(6), hyperlipidemia, status post right coronary artery stent (b)(6), here for follow up.Continue to complain of abdominal pain, ¿burning¿ in surgical area, worse when standing up.Occasional nausea.Height 5¿7, weight (b)(6).Medications: plavix.No tobacco, alcohol or drugs.Abdomen exam: soft, non-tender, non-distended, palpable abdominal hernia with positive tenderness to palpation.Ultrasound (b)(6) 2010: [illegible] without leaking, stable large abdominal wall hernia.Impression/plan: 1) chronic abdominal pain: follow up with surgery (b)(6) 2010; watch for signs/symptoms of strangulation.Norco as needed.Abdominal pain ¿ mesh migrated, no evidence of incarcerated bowel; [illegible] expedite surgery consult for mesh revision, etc.(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Office notes.Complains of abdominal hernia x 1 year.Has extensive cardiac history.Reported increased pain to right lower quadrant/left lower quadrant with movement and food.Seen by internal medicine on (b)(6) 2010 for possible mesh migration with no evidence of incarcerated bowel; referred to surgery for possible hernia repair.Tobacco: 1 ½ pack/day x 40 years; quit 2 years ago.Abdomen: bowel sounds positive, tender to palpation right and left lower quadrants.Large ventral mass protrusion.Impression/plan: sac trigger injection-immediate result.Return to clinic 4 weeks.May need repeat trigger injection.Will need laparoscopic ventral hernia repair in future but for now need to lose 10-15 lbs.(b)(6) 2011:(b)(6) regional medical center.(b)(6) md.Office notes.Still has a lot of pain and recently started to notice lower extremity cramping.Uses norco for pain.Followed by general surgery and vascular surgery.Abdomen: surgical scar and protuberant [illegible].Impression/plan: abdominal pain secondary to incisional hernia.No sign of incarceration or strangulation.Follow up with general surgery, continue norco as needed.Coronary artery disease status post stent placement.Hypertension controlled.Bilateral lower extremity cramping likely secondary to peripheral vascular disease.Continue plavix, no aspirin, follow up with vascular surgery.(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Office notes.Follow up trigger injections.No current complaints, ¿just usual abdominal pain.¿.Abdomen: firm along mass, pain to palpation at lower abdomen, right lower quadrant scar.Pain mostly right quadrant.Impression/plan: trigger point completely resolved pain.Pain of hernia in middle, reducible.Palpable mesh edge.Plan for laparoscopic versus open ventral hernia repair with meh (b)(6) 2011.(b)(6) 2011: (b)(6) regional medical center.[signature illegible].History and physical.Presents to clinic with history of myocardial infarction, abdominal aortic aneurysm, previous hernia, hypertension, elevated cholesterol status post trigger injection.Complains of pain most in right abdomen quadrant; pain getting progressively worse in right quadrant.Pre-existing cardiac history.No complaints of pain at this time.Denies nausea/vomiting, constipation, diarrhea.Consented for laparoscopy hernia repair with mesh.Abdomen: firm, large mass with scar from previous surgeries.Cardiac: previous percutaneous coronary intervention, history of angina within 30 days, hypertension requiring medication.Vascular: revascularization for peripheral vascular disease history.[nurse reviewer note: missing page 4 of 4.] (b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Radiology ¿ chest x-ray.Indication: preoperative.Impression: moderate pulmonary hyperinflation suggesting possible chronic obstructive pulmonary disease.(b)(6) 2011: (b)(6) regional medical center.[signature illegible].Anesthesia notes.Medications: aspirin.Plavix-quit 7 days ago.Wt.166 lbs.Asa class: 3.Implant procedure: laparoscopic ventral hernia repair with mesh for recurrent hernia.Implant: gore® dualmesh® plus biomaterial [1dlmcp07/8132814, cut to 25 x 28 cm] implant date: (b)(6) 2011 (hospitalization (b)(6) 2011).(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Operative report.First assistant: (b)(6) md.Level of involvement: (b)(6) md was present and scrubbed throughout the entire procedure.Preoperative diagnosis: recurrent ventral incisional hernia.Postoperative diagnosis: recurrent ventral incisional hernia.Indications for surgery: see preoperative diagnosis.Findings at surgery: a large hernia sac with old mesh, which was completely separated from the hernia.A large hernia sac.No enterotomies were created.At least a 4 cm underlay overlap on the hernia edge.Operative procedure: ¿informed consent was obtained.The patient was taken to the operating room.The patient was placed in the supine position on the operating table and general endotracheal anesthesia was administered.A foley catheter was inserted.The patient¿s abdomen was then prepped and draped in standard sterile fashion including use of an ioban.Preoperative antibiotics were given.A local anesthesia was infused in the left upper quadrant and veress needle was inserted at palmer¿s point.Position was confirmed with saline meniscus test.The co2 was inspected as the patient¿s abdomen was allowed to insufflate to 15 mmhg without complications.Incision was then made inferior to veress needle insertion site and 5 mm trocar was inserted.The 5 mm 30 degree laparoscope was inserted.There were no noted injuries from veress needle insertion.On usual surveillance of the abdomen there were multiple adhesions to the anterior abdominal wall and anterior abdominal wall mesh including bowel.There was noted a large hernia defect as well as a previous mesh that had completely separated from the hernia itself.Three additional trocars were inserted along the left flank on 12 mm along the middle of the flank and two 5 mm left lower quadrant.All trocars were inserted under direct visualization.Using atraumatic grasper and endo shears the adhesions were carefully taken down along the hernia.There were no enterotomies created.The harmonic scalpel was used to take down the omentum.All adhesions were lysed and this took approximately 1-1/2 hours.The entire circumference of the hernia was completely free of adhesions.We then planned to use a dual mesh.The hernia edges were then measured at approximately 13 x 14 cm along the skin.We used approximately at least a 4 cm overlap of the hernia edge in the planning the use of mesh.The size of the mesh was then cut to fit our desired overlay of the hernia defect.It was approximately 25 x 28 cm in size.The mesh was marked and 1-0 vicryl suture was tied and the tails were kept even.The mesh was rolled over a grasper and placed into the abdomen through the 12 mm port.The mesh was then opened and laid in the directions previously marked.Using suture passer four corners of the mesh were tacked up to the anterior abdominal wall vicryl the vicryl sutures.These were then tagged with kelly clamps.In between these four marked areas additional interrupted vicryls were placed with use of suture passer.The mesh was then brought up to anterior abdominal wall where it was noted to lay flat.Then using a pro tacker the additional edges of the mesh were tacked to the anterior abdominal wall in interrupted fashion.Several areas were tacked up with vicryl suture using a suture passer.During this time that the mesh was placed the abdominal wall pressure was turned down to approximately 8 mmhg.The abdomen and underlying bowel was examined and there was no noted enterotomy or bleeding noted from veress needle insertion site.All sutures were tied down and cut.The 12 mm trocar site was closed with 1-0 vicryl suture.The abdomen was then allowed to collapse and all co2 was removed.The trocars were then removed.The patient was then flattened.The abdomen was cleaned and dried.All port sites were closed with staples.The small stab incisions in the abdomen the skin was closed with steri-strips.The patient was then awakened in the operating room, extubated and was taken to recovery in stable condition.¿ anesthesia: general endotracheal.Drain and packs: none.Complications: none.Classification of wound: clean.Postoperative condition and disposition: stable; post anesthesia care unit.Estimated blood loss and blood replaced: 30 ml.No blood replaced.Medications and /or iv fluids: preop clindamycin 900 mg iv.Prognosis, immediate and remote: good.Specimens to the laboratory and / or pathology: none.(b)(6) 2011: (b)(6) regional medical center.(b)(6).Postoperative note.Preoperative diagnosis: recurrent ventral incisional hernia.Postoperative diagnosis: same.Operation: laparoscopic ventral hernia repair with mesh (for recurrent hernia).Findings: large hernia sac with old mesh completely separated from hernia mesh.Large hernia sac.No enterotomy.4 cm underlay overlap hernia edge.Estimated blood loss: 30 ml.Drains/packing: none.Complication: none.Postoperative condition: stable.Disposition: pacu.Prognosis (immediate/remote): good/good.Wound classification: clean.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp07.Lot batch code: 8132814.W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp07/8132814) was implanted during the procedure.Relevant medical information: (b)(6) 2011: (b)(6) regional medical center.[signature illegible].Discharge summary.Admission date: (b)(6) 2011.Principal diagnosis: incisional ventral hernia.Operation: laparoscopic ventral hernia repair with mesh for recurrent hernia.Summary: came to clinic with complaints of right abdominal pain that had been worsening.Taken for laparoscopic repair of ventral hernia with mesh.Tolerated procedure well; however, pain control was an issue postoperatively.Admitted to floor; received intravenous pain control and dvt prophylaxis.Developed worsening abdominal pain secondary to ileus; however, this resolved on its own under careful observation.Kub was done and showed no obstruction.Upon discharge, was passing gas and tolerating oral diet.Discharge home.Activity as tolerated; no lifting more than 10 lbs., regular diet.Follow up surgery clinic in 1 week.(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Office notes.Status post ventral hernia repair.Complaining of significant postoperative pain.States requiring 2 norco every 4 hours.Normal bowel movements, no nausea/vomiting.Denies lifting anything, can walk 2-3 blocks per day.No other complaints.Abdomen: laparoscopic incision sites healing well.Right abdomen bulging around repaired hernia site.Plan: abdominal binder, fentanyl patch, norco prescription.Return to clinic in 2 weeks.(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Office notes.Follow up.Overall doing better than before.Complains of abdominal pain.Had ventral hernia repair on (b)(6) 2011 and is followed by general surgery.Scheduled to discuss hernia revision next week.Impression/plan: ventral hernia, now with abdominal pain at surgical site.Follow up with surgery clinic.Pain control with hydrocodone.(b)(6) 2011: (b)(6) regional medical center.(b)(6) md.Office notes.Status post incisional hernia repair.Abdomen: positive bowel sounds, nondistended, tender, midline ventral hernia.Impression: healed, decreased pain, eating well.Return to clinic as needed.(b)(6) 2011: (b)(6), usn.Radiology ¿ ct abdomen/pelvis.Indication: lower abdominal pain with blood in semen.Findings [included]: soft tissues: surgical mesh is seen along the anterior aspect of the peritoneum within the superior aspect of the abdominal wall.Impression: 1) a 4.6 cm abdominal aortic aneurysm containing thrombus.Bilateral iliac artery stents are present.It is unclear whether the patient has had a prior surgical repair of this aneurysm.Comparison with prior studies would be helpful to evaluate for stability.No active extravasation of contrast or retroperitoneal fluid seen to suggest acute rupture.2) 7-mm the [sic] juxta pleural nodule within the lingula.Smaller nodule about the right major fissure which may represent an intrapulmonary lymph node.Comparison with old studies would be helpful to determine stability of the nodule within the lingula.If not available, consider ct chest to further evaluate on a routine basis.3) 30% anterior wedging of the l1 vertebral body.This is of uncertain chronicity.If available, comparison with old studies would be helpful to determine acuity.(b)(6) 2011: (b)(6).Office notes.Seen for calcified prostate, prostatitis, hematospermia.Weight (b)(6)., bmi 24.28.Past surgical history: this past february had abdominal aortic aneurysm repair with mesh.No tobacco use.(b)(6) 2011: (b)(6).Office notes.Wt.(b)(6), bmi 25.84.Follow up hematospermia and pelvic pain.No abdominal pain and states last abdominal aortic aneurysm repair done with mesh not visible on ct.Pelvic discomfort has resolved.Impression/plan: prostatitis: resolved.(b)(6) 2011.(b)(6).Office notes.Seen for chest pain.History coronary artery disease status post myocardial infarction percutaneous intervention 2002; second acute coronary syndrome and stent in 2006; repair of abdominal aortic aneurysm 2010 and reports elective stent placement prior to surgery.Has exertional angina for years; has complaints of palpitations.Tobacco: 30 pack years; quit 2010.No alcohol.Current medications: aspirin, plavix.Impression: coronary artery disease, hypertension, hyperlipidemia, palpitations.(b)(6) 2012: (b)(6), staff.History and physical.Presents with abdominal pain, nausea and vomiting.Pain described as feeling like he had been punched in the stomach; pain very severe.Past medical history: chronic obstructive pulmonary disease ¿ not taking any meds and without symptoms; deep vein thrombosis in groin.Surgical history: ventral hernia repair ¿ complicated by bowel adhesions to mesh requiring further surgical intervention (3 total during that admission) 2010/2011.Smoking: <1 pack/day; 30 pack year history; quit in 2010 but occasionally smokes if out with friends.Weight (b)(6).Abdomen exam: normal bowel sounds, tender to palpation primarily periumbilical and epigastric, no rebound tenderness, firm from mesh, but non-distended, no tenderness to percussion.Ct abdomen: evidence of prior ventral hernia repair.Multiple moderately distended loops of small bowel are present.Early mechanical small bowel obstruction is possible.Impression/plan: past medical history ventral hernia repair with mesh complicated by bowel adhesions now presenting with acute onset abdominal pain, elevated white blood cells.Multiple abdominal surgeries and large area of mesh; also, with abdominal aortic aneurysm stenting with previous leak.Admit, intravenous fluids, nothing by mouth, blood pressure control, pain/nausea control with morphine and zofran, repeat ct abdomen/pelvis in the morning, deep vein thrombosis prophylaxis with lovenox, hold oral meds.(b)(6) 2012: (b)(6).Radiology ¿ acute abdomen series, 3 views.Impression: mild subsegmental atelectasis left lung base.Large bulla right apex.Small bowel gaseous distention in left mid-abdomen.Possibility of a partial small bowel obstruction cannot be excluded.Vascular stents.Prior hernia surgery.(b)(6) 2012: (b)(6).Radiology ¿ ct abdomen/pelvis with oral contrast.Indication: severe abdomen pain.Rule out small bowel obstruction.Impression: mildly distended segments of contrast filled small bowel with air-fluid levels in the lower left abdomen and pelvis.The ileum is of normal size; findings consistent with some degree of small bowel obstruction.Point of transition or obstruction not well delineated.Status post repair of ventral wall hernia with a mesh.Bilateral iliac covered stents and mild abdominal aortic aneurysm measuring up to 3.9 cm.Nasogastric tube in stomach.Mild bilateral lower lobe infiltrated and minimal bibasilar atelectasis or scar.Calcified granuloma left lower lobe.Mild colonic diverticulosis without evidence of diverticulitis.(b)(6) 2012:(b)(6), staff.Discharge summary.Admission date: (b)(6) 2012.Discharge diagnosis: constipation.Presented with abdominal pain, nausea/vomiting; abdomen tender to palpation primarily periumbilical and epigastric, firm from mesh, but non-distended.Admitted to rule out small bowel obstruction with significant epigastric/periumbilical pain with acute onset 5 hours prior.Final diagnosis is constipation.Hospital course: initially admitted through the emergency room for concerns of small bowel obstruction.Had three large bowel movements 1st day admission.Felt immediate resolution of pain after.Nasogastric tube pulled; started on regular diet and tolerated.On exam, abdomen soft, nontender, nondistended.Discharged home; follow up in surgery clinic in 2 weeks.Instructions: bowel regimen with polyethylene glycol x 7 days.Docusate sodium twice daily until follow up appointment.(b)(6) 2012: (b)(6).Office notes.Follow up after hospital admission on (b)(6) for what was initially believed to be a small bowel obstruction but was likely increased pain above baseline due to constipation in setting of abdomen with multiple prior surgeries.Released after large bowel movement with assistance from laxatives relieved pain.Afterwards, he was placed on miralax daily and colace.No return of pain that prompted him to go to ed.Has baseline midline supraumbilical pain.Current med: plavix.Height 5¿7, weight (b)(6), bmi 27.09.Abdomen exam: not distended.Abdominal tenderness baseline tenderness to palpation over mesh of midline abdomen above umbilicus.No evidence of herniation.Impression/plan: 1) chronic constipation: improved; high fiber diet and intermittent use of colace and miralax.2) abdominal pain: improved and has returned to baseline which is related to mesh in periumbilical region.Pain exacerbation at presentation was related to constipation.3) aneurysm of abdominal aorta: no evidence of graft failure on prior imaging.(b)(6) 2013: (b)(6).Radiology ¿ ct chest with contrast.Findings: status post anterior abdominal wall hernia repair.Impression: no evidence of aortic dissection.Slight interval enlargement of a 2.3 cm saccular aneurysm at the aortic arch.Stable appearance of aortoiliac stent graft for abdominal aortic aneurysm.Extensive emphysematous changes of the lungs.(b)(6) 2013: (b)(6), staff.History and physical.Complains of right-sided neck and arm pain that started yesterday.Denies recent illness.Abdomen: soft, nontender, normal bowel sounds, midline ventral scar, left-sided ¿j¿ shaped scar lower abdomen, 6cm bruise left lower abdomen.Impression/plan: rule out trans-ischemic attack.Admit.Consult neurology.(b)(6) 2013: (b)(6) md.Consultation.Right upper extremity weakness.Several days ago, after reaching for an item, noticed he couldn¿t grab something due to weakness.Denies numbness.Started noticing pain later, starting gradually.Starts from right neck through shoulder, posterior upper arm and lateral forearm to just below elbow.Pain is constant, 10/10.Given valium, norco, dilaudid; didn¿t help.Cervical fusion about 30 years ago.Surgical history: ventral hernia repair x3.Medications: aspirin, plavix.Gastrointestinal: denies pain, diarrhea, constipation, but had nausea/vomiting with the pain.Impression: cervicalgia.Limb weakness: acute onset of right upper extremity weakness in setting of severe neck pain which worsens with various head positions.This argues against etiology such as stroke; more concerned with acute disc herniation or vascular dissection.Did appear to have a trigger point with a dermal cyst which should be further evaluated.Recommendations: mri cervical spine, mra/ct-a carotid.Consider medrol if no contraindications.Consider gabapentin, titrating to relief.Consider at least temporarily scheduling narcotic relief and/or patient-controlled analgesia as patient reports inadequate pain relief.Evaluate cyst over right trapezius.(b)(6)2013: (b)(6), staff.Discharge summary.Admission date: (b)(6) 2013.Discharge diagnosis: cervical spinal stenosis with radiculopathy, right.Admitted to rule out trans-ischemic attack.Seen by neurology.Hospital stay complicated by pain control; pain only improved with intravenous morphine.Started on a steroid burst (2/5 days at discharge), neurontin, oxycontin and amitriptyline.Will see neurosurgery as outpatient.(b)(6) 2013: (b)(6).Office notes.Seen for right upper extremity cervical radiculopathy, right hand weakness.Weight (b)(6), bmi 28.19.Impression: cervical spondylosis.Surgical decompression recommended.Stop aspirin and plavix on (b)(6) 2013.(b)(6) 2013: [facility ni].[provider ni].Prescription.Methylprednisolone (medrol dosepak).(b)(6) 2013: [facility ni].(b)(6).Procedure report ¿ left heart catheterization/percutaneous intervention.Resolute drug-eluting stent successfully deployed right coronary artery with excellent results.Left coronary system free of disease.(b)(6) 2013: (b)(6).Radiology ¿ ct, cta abdomen.Indication: aortic abdominal stent with difficulty passing proximal guidewire during recent cath.Findings [included]: surgical mesh is seen within the anterior abdomen consistent with prior hernia repair.Impression: 1) surgical changes consistent with prior abdominal aortic aneurysm repair with additional stents of the limbs of the bypass graft extending to the common iliac arteries are present and grossly unchanged from prior exam.These findings include a small kink of the posterior right limb with soft tissue density narrowing the lumen, likely on the basis of intimal hyperplasia.Kinking is also identified within the anterior left limb without significant flow-limiting stenosis.Overall, the stents appear well opacified with contrast suggesting gross patency.2) mild stable dilatation of the infrarenal aorta measuring approximately 3.6 cm.3) recommend follow up ct to ensure resolution of the worsening area of atelectasis versus consolidation within the right lung base.(b)(6) 2013: [facility ni].(b)(6), lcdr mc.Discharge summary.Date of admission: (b)(6) 2013.Discharged to home.Discharge diagnosis: chest pain, hypertension, hyperlipidemia, neuropathy, history of coronary artery disease status post percutaneous coronary intervention and stent.Procedure: cta of abdominal aortic-no dissection, chronic appearing thrombus, small stent stenosis at graft site; appears non-critical.Hospital course: admitted for evaluation of substernal chest pain 3 days after stent placement in right coronary artery.Initially treated with nitroglycerin and morphine; pain decreased.Admitted to intensive care unit on heparin, morphine and nitroglycerin drip.Chest pain determined to be unlikely ischemic in etiology.At time of discharge, afebrile and hemodynamically stable, tolerating food, ambulating, voiding and stooling appropriately.New medications: oxycontin ir, tylenol as needed.Continue aspirin, plavix.Follow up cardiology clinic.
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H6: updated health effect.H6: updated investigation finding.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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.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.¿ 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 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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