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It was reported to gore that on (b)(6) 2018, the patient underwent aortic stent placement using two gore® excluder® aaa endoprostheses to treat an ¿aortic blockage.¿ according to the complaint, "the stent that was placed in [the patient] was much too large and collapsed, causing (b)(6) dollars for further medical treatment.Also causing permanent damage to [the patient¿s] left leg and foot and extensive long term health issues." the complaint alleges that "at the follow up appointment with dr.(b)(6) on (b)(6) 2018, dr.(b)(6) told [the patient and her husband] that he had never seen anything like this.[the patient] had clots on both femoral arteries and multiple clots throughout her legs.He said there was nothing to do at this point to repair it, and to push herself to walk farther and do more and that she would be on blood thinners the rest of her life.Dr.(b)(6) did not want to see her back in his office for a follow up visit for 6 months.He offered a referral to a vein clinic and that appointment was also 6 months out." it was reported that since her (b)(6) 2018 follow up appointment, the patient has seen multiple additional vascular surgeons, and has undergone six surgeries to address ¿clots on both femoral arteries.¿ the patient stated she does not have any additional details regarding the reported follow-up appointments and additional surgical procedures.Additional details regarding the patient¿s clinical course were ascertained from the gore associate present at the implanting procedure and are as follows: it was reported that on (b)(6) 2018, the patient was implanted with two gore® excluder® aaa endoprostheses to treat occlusive disease, including thromboembolism, of the abdominal aorta.The trunk-ipsilateral component was reportedly advanced from the right side and implanted as planned.A decision was reportedly made to implant an iliac extender component (pll161007/15537790) instead of a contralateral leg component because the patient¿s common iliac arteries were small (measurement not available).According to the report, the distal end of the iliac extender component could not extend far enough into the common iliac artery without compromising proximal device overlap with the trunk-ipsilateral component (overlap was reported to be ~2 cm).According to the report, a follow-up examination on an unknown date showed the iliac extender component was impinged at the aortic bifurcation.It was reported that on an unknown date, an additional procedure was performed a balloon expandable stent was implanted to treat the device impingement.According to the report, device patency was restored, and the patient tolerated the procedure.Medical records for the implant procedure, the patient¿s postoperative clinical course, and the reported additional procedures were requested but have not been provided.
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H6: added patient codes 2550, 1994, and 1984 (used for left common iliac and bilateral femoral artery occlusions).H6: upon review of medical records received, device and conclusion coding remains unchanged.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: progress notes dated (b)(6) 2018 indicate the patient presented to the hospital with a chief complaint of blue toe syndrome.The records state: ¿46 year old woman who comes today for evaluation of painful 1st and 4th toes.Onset of pain was acute about 30 days ago.At the same time, she developed bluish discoloration.This has worsened since then.No fever.Mild claudication in both legs.Long standing history of smoking (30 years, at least 10 cigarettes/day).She also has history of coronary artery disease, with healed myocardial infarction, as well as chronic systolic heart failure.¿ the (b)(6) 2018 progress notes state: ¿ct angiogram of aorta: large near occlusive thrombus in distal abdominal aorta, with associated atherosclerosis of the native arteries.¿ ¿assessment: 46 year old woman with atherosclerosis of the abdominal aorta with near occlusive thrombus, and small non healing ulcer in left 1st toe.This has caused distal arterial embolization into the left 1st and 4th toes.Options for management discussed including continuation of medical management with or without anticoagulation or an intervention.Decision made to proceed with intervention.Will offer endograft stent as attempt to exclude this large thrombus, which is the source of embolization.¿ actual ct angiogram images have not been received.The (b)(6) 2018 progress notes continue: ¿plan: await result of cardiac nuclear stress test to determine her risk of perioperative coronary ischemia.Then, if ok, schedule patient for endograft stent placement in abdominal aorta and possible both common iliac arteries.¿ ¿risks, alternatives and benefits of procedure were explained to the patient.All questions answered.Consent obtained.Risks include death, bleeding, infection, stroke, renal failure, embolization, edema, nerve damage, possible reoperation, thrombosis, embolization, limb loss, among others.Patient understands and is willing to proceed.¿ stress test records dated (b)(6) 2018 indicate the patient underwent a nuclear stress test as part of pre-operative evaluation.The stress test records state: ¿conclusion: 1) probably abnormal nuclear stress test.2) reversible perfusion defect that is relatively small but is quite definite, at the tip of the apex.3) suggestion of a larger partially reversible perfusion defect of the inferior wall.This is suggested, but this is [sic] not quite reach diagnostic significance with regard to as defined by the quantitative algorithm.Nonetheless, i believe it is suggested.4) normal ejection fraction wall motion.¿ history and physical records dated (b)(6) 2018 state the patient ¿¿is quite limited in her ability to do activities.She is barely able to walk due to her symptoms of claudication.She does still continue to smoke, although she is interested in smoking cessation.She has smoked for well over 25 years.She states she does not ever smoke more than a pack a day.Usually about a half a pack.She has documented dyslipidemia.¿ history and physical notes dated (b)(6) 2018 state: ¿initial assessment and plan: 1) preoperative assessment prior to undergoing endograft repair of near occlusive thrombus in the distal abdominal aorta with associated atherosclerosis of the native arteries.The patient had abnormal noninvasive risk assessment suggestive of possible multivessel ischemia.I recommended the patient undergo a coronary angiogram and possible percutaneous intervention if indicated.2) ongoing tobacco abuse.We did start the patient on chantix starter and continuation pack.3) history of near occlusive thrombus of the distal abdominal aorta.The patient does need possible endograft placed.4) longstanding history of hypothyroidism.5) dyslipidemia, on statin therapy.6) history of alcohol consumption.No prior history of alcohol withdrawal symptoms.¿ operative records dated (b)(6) 2018 indicate the patient underwent ¿1) placement of covered stent in abdominal aorta.2) placement of covered stents in bilateral common iliac arteries.3) advancement of tip of catheter from both common femoral arteries to abdominal aorta.4) radiological supervision and interpretation of placement of stent in abdominal aorta.5) ultrasound guidance for identification of bilateral common femoral arteries, with real time guidance for access of bilateral common femoral arteries, with documentation and report.¿ operative records dated (b)(6) 2018 state: ¿ultrasound was used to identify bilateral common femoral arteries.Under ultrasound guidance, we obtained access with needle, followed by 0.035 inch guidewires.Then, we advanced a 6-french sheath bilaterally and performed preclosure with perclose devices x2 for each common femoral artery.Eight-french sheaths were then exchanged and then we advanced kumpe catheters, which allowed us to advance 0.035 inch lunderquist guidewires from both common femoral arteries to the descending thoracic aorta.Then, a 12-french sheath was advanced from the left common femoral artery to abdominal aorta and a 16- french sheath was advanced from the right common femoral artery to abdominal aorta.A 5-french pigtail marker catheter was advanced then from the left common femoral artery to abdominal aorta.We obtained abdominal aortic angiogram.¿ actual ultrasound images have not been received.The (b)(6) 2018 operative records continue: ¿we then used a main body gore excluder endoprosthesis, reference number rlt231212, serial number (b)(4).This was deployed in the abdominal aorta below the renal artery takeoff and extended down into the left common iliac artery.Then, another stent was placed in the right common iliac artery to complete the modular bifurcated prosthesis.This was a contralateral limb gore excluder device, reference number pll161007, serial number (b)(4).This covered the left common iliac artery.As stated above, the main body extending from the abdominal aorta into the right common iliac artery.Reliant balloon was then advanced for angioplasty post deployment as well as 10 mm balloon for kissing balloon angioplasty at the level of the aortic bifurcation.¿ the records confirm two gore® excluder® aaa endoprostheses (rlt231212/17360522 and pll161007/15537790) were used during the procedure.¿ operative records dated (b)(6) 2018 further state: ¿we finally advanced a straight marker catheter from the right common femoral artery to abdominal aorta and obtained abdominal aortic angiogram that showed no evidence of stenosis.No evidence of endoleaks.No evidence of contrast extravasation.¿ findings: ¿severe atherosclerosis of the native aorta with near occlusion secondary to combination of thrombus and atherosclerosis in the infrarenal abdominal aorta as well as bilateral common iliac arteries, proximally.At the end of the procedure, no residual stenosis was observed.¿ discharge summary dated (b)(6) 2018 indicates the patient was admitted to the hospital on (b)(6) 2018 for ¿severe atherosclerosis of infrarenal abdominal aorta with near occlusion¿ and ¿severe stenosis of bilateral iliac arteries.¿ principal discharge diagnosis was the same.The records state: ¿[the patient] presented to (b)(6) medical center on (b)(6) 2018.On that day she underwent elective placement of covered stents of her infrarenal abdominal aorta and bilateral iliac stents through percutaneous bilateral groin access.Following deployment and dilation of these stents, access sites at the groin were dosed with percutaneous closure devices and sandbags were applied for 30 minutes.On post-operative day 1, her bilateral groin sites are soft, and free of hematoma.She had an uneventful course overnight.Her foley catheter was removed today, she tolerated her diet, and she was discharged home in stable condition.¿ images from the procedure have not been received.Progress notes dated (b)(6) 2018 indicate the patient presented for follow-up after endovascular repair on (b)(6) 2018.The records state: ¿subjective: bilateral leg weakness when walking.¿ ¿physical examination, extremities: unable to palpate pulses in both feet or popliteal arteries.Capillary refill is less than 3 seconds in all toes.Both feet are slightly cool to palpation.Incision: small incisions in both groins are healed.¿ progress notes dated (b)(6) 2018 continue: ¿she now has new thrombus formation with associated claudication in both legs.Options for management discussed including anticoagulation.Endovascular therapy, open surgery or hybrid procedure.Decision made to continue with anticoagulation and claudication rehabilitation.Patient has no rest pain, ulcers or gangrene.Prior episode of toe embolization now almost healed in left foot.I answered all questions she and her husband had.We also discussed the possibility that she has a hypercoagulable disorder.I offered her referral to hematology or to another cardiovascular surgeon for second opinion.She declined.¿ ed provider notes dated (b)(6) 2018 indicate the patient presented to the emergency department with a chief complaint of extremity weakness.The records state the patient ¿¿is a 46 y.O.Female who presents to the ed as a transfer from (b)(6) where she was seen through the emergency department with a chief complaint of lower extremity weakness.Patient reports that she started to have numbness in her left foot after taking off an ingrown toe several months ago.She then developed blue toe syndrome, and was found to have significant aortic stenosis or thrombus.Patient underwent surgery on 02/27/2018 where she had an aortic bifemoral stent placed, and (b)(6) [sic].She never really had any improvement in her symptoms since her surgery.¿ the (b)(6) 2018 ed provider notes state: ¿patient reports that her foot is pale and has pain with ambulating.Patient reports that she experiences left extremity weakness, and difficulties in walking upstairs.She was evaluated at (b)(6), and referred here to sacred heart for further evaluation and management of her symptoms.Patient received a shot of lovenox while in the ed.Patient reports a social history of tobacco abuse.Patient denies any cardiac history.¿ record states that on (b)(6) 2018 in (b)(6), ¿¿patient underwent surgical management of severe atherosclerosis of the aorta with near occlusion secondary to combination of thrombus and atherosclerosis in the infrarenal abdominal aorta as well as bilateral femoral iliac arteries proximally.¿ the ed provider notes dated (b)(6) 2018 continue: ¿physical exam, musculoskeletal: weak but symmetric range of motion in all major joints as she is examined on the exam table, was not witnessed eat up and walk [sic] or ambulate.¿ ¿final impression: 1) aortic stenosis, severe secondary to aortic thrombus.2) bilateral leg weakness.3) claudication of both lower extremities.4) status post vascular surgery -aortobifem endograft treatment.¿ history and physical records dated (b)(6) 2018 indicate the patient was admitted to the hospital on the same day for iliac artery thrombosis and acute limb ischemia.The records state: ¿assessment and plan: acute limb ischemia with 2 weeks history of bilateral feet rest pain and numbness of toe (svs acute limb ischemia class 1).There is bilateral iliac artery thrombosis: r external iliac and common femoral and l common iliac and the left limb of aortic graft.Both lower extremities are not eminently threatened.There is doppler signals on r pt and lat.Plan to admit, iv heparin, aortic and bilateral iliac angiogram and possible thrombectomy/thrombolysis tomorrow.¿ the history and physical records dated (b)(6) 2018 state: ¿[the patient] is a 46 y.O.Female patient¿seen today for ischemic rest pain and short distance claudication.She has history of blue toe syndrome due to distal abdominal aorta mural thrombus, possibly the source of her atheroembolims.She underwent placement of gore excluder aortic endograft as threatment [sic] for aortic mural thrombus in outside facility by ct surgeon at end of (b)(6) 2018.Post op she reported persistent rest pain and short distance claudication.¿ the (b)(6) 2018 history and physical records continue: ¿cta on (b)(6) 2018 showed occlusion of her bilateral common iliac artery and left limb of the endograft.She follow up with her surgeon in id and was told nothing to be done.She couldn't tolerate the pain and present to (b)(6) in (b)(6) and evaluated by vascular surgeon there.I was contacted by [the vascular surgeon] and she is subsequently transferred here for further management.¿ social history: ¿she reports that she quit smoking about 3 months ago.Her smoking use included cigarettes.She has a 375.00 pack-year smoking history.She has never used smokeless tobacco.She reports that she does not drink alcohol or use drugs.¿ history and physical records dated (b)(6) 2018 indicate report from cta performed on (b)(6) 2018 as follows: ¿indication: atherosclerosis of left leg.¿ ¿technique: cta abdomen and bilateral lower extremities with iv contrast.¿ ¿findings: the abdominal aorta is normal in caliber contour and signal.There has been interval placement of an aortic bi-iliac stent graft.The left common iliac artery is completely occluded.There is reconstitution by left internal iliac anastomosis.There is a focal filling defect in the left common femoral artery image number 140 suggesting thrombus.Additionally there is complete occlusion of the right external iliac artery approximately 1 cm beyond the bifurcation with reconstitution at the level of the inguinal canal.The bilateral distal common femoral arteries, superficial femoral arteries, popliteal arteries appear normal.Normal three - vessel runoff noted to the bilateral feet.The neck soft tissues appear unremarkable.Osseous structures are normal for age.¿ the history and physical records dated (b)(6) 2018 continue: ¿impression [from cta performed on (b)(6) 2018 ]: interval placement of an aortic-bi-iliac stent graft.Complete occlusion of the left common iliac artery.There is reconstitution of the left external iliac artery by the left internal iliac anastomosis.Focal filling defect in left common femoral artery image number 140 is consistent with intraluminal thrombus.Complete occlusion of the right external iliac approximately 1 cm beyond the bifurcation with reconstitution at the level of the inguinal canal.Normal caliber contour of the bilateral common femoral, superficial femoral and popliteal arteries within normal three-vessel runoff to the bilateral feet.¿ operative records dated (b)(6) 2018 state: ¿46 year old female presents with acute limb ischemia with 2 weeks history of bilateral feet rest pain and numbness of toe (svs acute limb ischemia class 1).There is bilateral iliac artery thrombosis: r external iliac and common femoral and l common iliac and the left limb of aortic endograft.Plan for aortic and bilateral iliac angiogram and possible thrombectomy/thrombolysis.¿ findings: ¿1) aorta-bilateral iliac endograft placed in outside facility.2) thrombosed left iliac limb and common iliac artery.Reconstituted flow to left external iliac and internal iliac artery.Patent left common femoral artery.3) thrombosed right external iliac artery and proximal common femoral artery.4) residual thrombi in bilateral iliac arteries.¿ the operative records dated (b)(6) 2018 indicate the patient underwent: ¿1) us guided access of bilateral common femoral arteries.2) placement of catheter in aorta and aortogram and bilateral iliac angiogram.3) catheter based thrombolysis of bilateral iliac artery with angiojet (20 mg tpa and powerpulse mode).4) catheter based mechanical thrombectomy of bilateral iliac artery.5) initiation of continuous tpa infusion in bilateral iliac artery vis unifuse catheters.¿ pre-operative/post-operative diagnosis: ¿atherosclerosis of native artery in lower extremity with ischemic rest pain, bilateral.¿ the (b)(6) 2018 operative records state: ¿under ultrasound guidance i accessed bilateral common femoral artery in retrograde fashion with micropuncture kit.It was noted that the right common femoral artery is nearly occluded from thrombus.I placed 4 fr x 10 ml sheath in bilateral common femoral artery in retrograde direction.Then using 0.035 glidewire supported by (b)(6) i was able to cross the occluded right external iliac artery and left common iliac artery as well as left iliac limb of the aaa endograft.I placed a flushing catheter in distal aorta and performed aortogram.She received 5000 unit heparin based on her weight.¿ the (b)(6) 2018 operative records continue: ¿the 4 fr sheath was exchanged to 8 fr sheath bilaterally.I percolated the thrombosed bilateral iliac artery and the left iliac limb graft with a total of 20 mg tpa using powerpulse mode of angiojet.On-table thrombolysis was performed.Then residual thrombus was removed with catheter based mechanical thrombectomy using angiojet.Postthrombolysis and thrombectomy angiogram used significant residual thrombus.I placed one unifuse infusion catheter in bilateral iliac artery (30 cm infusion length on left side and 20 cm on right side).Continuous tpa infusion was initiated through the unifuse catheters and 200 unit of heparin was infused through the side arm of each sheaths.The catheters and sheaths were sutured with sutures and tapes.Patient tolerated procedure well.No immediately complication.She has monophasic doppler signals on pt on right foot and at on left foot.¿ physician assessment and plan notes dated (b)(6) 2018 state: ¿active hospital problems: iliac artery thrombosis (bilateral), tobacco dependence, blue toe syndrome of left lower extremity, atherosclerotic ulcer of aorta, and ischemic rest pain of lower extremity.¿ the (b)(6) 2018 assessment and plan notes state: ¿on the am of 3/21, pt suddenly developed svt.She rc'd adenosine 6mg followed by 12mg followed by bolus dose of amiodarone after which she converted to sr.Ekg completed/reviewed and no acute st changes.Pt had no cp or dyspnea w/ event and had a slight dip in her blood pressure w/ the arhythmia.Icu called to bedside and consulted for this reason.Pt did appear dry, lytes pending and was volume resuscitated w/ ll lr w/ good response.¿ progress notes dated (b)(6) 2018 state: ¿i have seen and examined the patient.I agree with the assessment and plan.Rest pain resolved.Tolerated thrombolysis overnight.No groin hematoma.Sensory and motor functions intact.No evidence of compartment syndrome.Pt doppler signals on both feet.Plan for thrombolysis check and possible intervention.¿ operative records dated (b)(6) 2018 state: ¿46 year old female presents with acute limb ischemia with rest pain due to thrombosis of bilateral iliac artery and aortic endoprosthesis.She was initiated on tpa thrombolysis on (b)(6) 2018 , this is lysis day 2.Plan for aortogram and pelvic angiogram to evaluate outcome of thrombolysis.¿ findings: ¿1) interval resolution of right external iliac artery thrombosis.2) short segment right common femoral artery occlusion, unchanged.Flow is reconstituted to distal common femoral.3) thrombosis of the native segment of distal left common iliac artery.The left iliac limb of aortic endograft is still occluded right limb of aortic endograft is patent.Left common femoral artery is patent.The operative records dated (b)(6) 2018 indicate the patient underwent ¿1) aortogram and pelvic angiogram for thrombolysis evaluation.2) lntravascular ultrasound of bilateral common iliac arteries and abdominal aorta.3) balloon angioplasty of bilateral common iliac in kissing fashion (8x20 mm balloon, abbott).4) continuation of tpa infusion and thrombolysis via ekos catheter.¿ pre-operative/post-operative diagnoses: ¿embolism and thrombosis of iliac artery.Thrombosis of aortic endoprothesis.¿ continued on attachment.Attachment: [st237628.Zip].
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H6: code 4112 ¿ please refer to summary below for imaging evaluation results.H6: updated conclusion codes.Imaging evaluation summary - angiographic and computed tomographic (ct) images were received by gore from the facility and an imaging evaluation was performed.Reconstruction from pre-operative ct study dated (b)(6) 2018 illustrated a flow lumen narrowing.The diameter immediately distal to the left renal artery appeared to be 15.0mm, and the diameter 16mm distal to the left renal artery appears to be 14.6mm.An axial image from ct dated 1/22/18 illustrated thrombus being present in the aortic flow lumen.This image also showed the flow lumen narrowing to 4.99mm x 13.0mm.A procedural angiographic image dated (b)(6) 2018 illustrated a patent abdominal aorta with patent bilateral common and external iliac arteries.Axial images from post-operative ct study dated revealed what appeared to be an occluded left contralateral limb.These images also showed occlusion of the left common and right external iliac arteries.An axial image from post-operative ct study dated (b)(6) 2018 illustrated that the previous occluded left contralateral limb had been resolved.A 3d reconstruction image on the same date showed that the previous right external and left common iliac artery occlusions had been resolved.It should be noted that the gore® excluder® aaa endoprosthesis instructions for use provides the following indications for use: ¿the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: adequate iliac / femoral access infrarenal aortic neck treatment diameter range of 19 ¿ 32 mm and a minimum aortic neck length of 15 mm proximal aortic neck angulation = 60° iliac artery treatment diameter range of 8 ¿ 25 mm and iliac distal vessel seal zone length of at least 10 mm.¿ the gore® excluder® aaa endoprosthesis instructions for use states that ¿key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.¿ furthermore, the gore® excluder® aaa endoprosthesis instructions for use states that adverse events that may occur and/or require intervention include, but are not limited to arterial or venous thrombosis.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 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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