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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Model Number 24653 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Thrombosis (2100); Thrombosis/Thrombus (4440)
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| Event Date 09/16/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).Date of birth: year 1949.
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Event Description
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It was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the mid superficial femoral artery (sfa) of the right leg.The target lesion had a 5.1mm and 4.9mm reference vessel diameter, proximally and distally respectively, and a total length of 80mm visually estimated.The target lesion was 100% occluded and was crossed through the true lumen.Pre-dilatation was performed using one balloon.One 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon and 0% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019, the patient was diagnosed with stent thrombosis and sfa occlusion.The patient was admitted to the hospital on (b)(6) 2019 for a wire-guided embolectomy in the right sfa.The event was reported as recovered and resolved as of (b)(6) 2019.
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Event Description
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It was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the mid superficial femoral artery (sfa) of the right leg.The target lesion had a 5.1mm and 4.9mm reference vessel diameter, proximally and distally respectively, and a total length of 80mm visually estimated.The target lesion was 100% occluded and was crossed through the true lumen.Pre-dilatation was performed using one balloon.One 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon and 0% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019, the patient was diagnosed with stent thrombosis and sfa occlusion.The patient was admitted to the hospital on (b)(6) 2019 for a wire-guided embolectomy in the right sfa.The event was reported as recovered and resolved as of (b)(6) 2019.
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Manufacturer Narrative
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Patient identifier: (b)(6).Date of birth: year 1949.
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Event Description
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It was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the mid superficial femoral artery (sfa) of the right leg.The target lesion had a 5.1mm and 4.9mm reference vessel diameter, proximally and distally respectively, and a total length of 80mm visually estimated.The target lesion was 100% occluded and was crossed through the true lumen.Pre-dilatation was performed using one balloon.One 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon and 0% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019, the patient was diagnosed with stent thrombosis and sfa occlusion.The patient was admitted to the hospital on october 4, 2019 for a wire-guided embolectomy in the right sfa.The event was reported as recovered and resolved as of (b)(6) 2019.It was further reported there was stent thrombosis on both legs.On (b)(6) 2019, 727 days post index procedure, the patient presented with symptoms of claudication consistent with a paod (peripheral arterial occlusive disease) stage iib, particularly in the calves from past two weeks (per edc).The patient's pain-free walking distance was noted to be less than 100 meters.On (b)(6) 2019, the subject presented as an outpatient, since severe pain was noted in both calves, when climbing stairs, and at the upper leg on the dorsal side.The pain occurred after walking approx.50 to 100 meters.On physical examination, popliteal and peripheral pulses were not palpable and both feet were cool hence, sensitivity disorder of both forefeet were confirmed.Duplex ultrasound revealed occlusion of the superficial femoral artery through the stent.No flow was seen on the right.The patient was suggested to re-visit on october 1, for further discussion at vascular surgery clinic.On (b)(6) 2019, the patient re-visited as an outpatient and duplex ultrasound of both limbs revealed occluded sfa stents in both sides, close to the outflow and only still monophasic popliteal flows was noted on both sides.Abi on the right was 0.5.Treadmill test revealed severe pulling in both calves after 48 minutes and pain increased after 53 minutes of the test.Based on the diagnostic findings, the patient was recommended for embolectomy on both right and left limb and advised to continue aspirin.On (b)(6) 2019, the patient was hospitalized for planned treatment.On physical examination, foot pulses were not palpable with certainty on either side.Per source, paod stage was iib on both sides (right and left limb) due to sfa occlusion on both sides.On the same day, 745 days posy index procedure, 100% stenosis in the right ostial to mid sfa (target lesion) which was 200 mm long with a reference vessel diameter of 5 mm was initiated with embolectomy treatment however, embolectomy was not successful with a size 3 french fogarty catheter as this could not be introduced into the stent.Therefore, the occluded stent was passed with a terumo wire.A wire-guided embolectomy catheter was fed forward and the intraluminal position was monitored.Then, a thrombectomy of the stent and the proximal sfa was performed in several passes.Old and fresh thrombotic material was extracted.Post treatment, residual stenosis was 0%.Follow-up angiography on the left limb revealed higher grade in-stent restenosis in left sfa stent which was implanted during index procedure.Fresh and old thrombotic material was noted; hence embolectomy was performed with 3 french fogarty catheter in several passes and dilation was performed using drug-eluting impact admiral balloon 5 mm x 60 mm.On (b)(6) 2019, the event was considered recovered/ resolved.On (b)(6) 2019, the patient was discharged on the same day in a good general state with clopidogrel and xarelto for 6months.The patient was recommended for follow-up and ultrasound monitoring in 6 months.Additionally, monitoring of the retention parameters due to restricted renal function as well as the electrolytes was advised.
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Manufacturer Narrative
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Patient identifier: (b)(6).Date of birth: year 1949.
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Manufacturer Narrative
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Patient identifier: (b)(6).Date of birth: year 1949.
|
| |
|
Event Description
|
|
It was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the mid superficial femoral artery (sfa) of the right leg.The target lesion had a 5.1mm and 4.9mm reference vessel diameter, proximally and distally respectively, and a total length of 80mm visually estimated.The target lesion was 100% occluded and was crossed through the true lumen.Pre-dilatation was performed using one balloon.One 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon and 0% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019, the patient was diagnosed with stent thrombosis and sfa occlusion.The patient was admitted to the hospital on (b)(6) 2019 for a wire-guided embolectomy in the right sfa.The event was reported as recovered and resolved as of (b)(6) 2019.It was further reported there was stent thrombosis on both legs.On (b)(6) 2019, 727 days post index procedure, the patient presented with symptoms of claudication consistent with a paod (peripheral arterial occlusive disease) stage iib, particularly in the calves from past two weeks (per edc).The patient's pain-free walking distance was noted to be less than 100 meters.On (b)(6) 2019, the subject presented as an outpatient, since severe pain was noted in both calves, when climbing stairs, and at the upper leg on the dorsal side.The pain occurred after walking approx.50 to 100 meters.On physical examination, popliteal and peripheral pulses were not palpable and both feet were cool hence, sensitivity disorder of both forefeet were confirmed.Duplex ultrasound revealed occlusion of the superficial femoral artery through the stent.No flow was seen on the right.The patient was suggested to re-visit on (b)(6) for further discussion at vascular surgery clinic.On (b)(6) 2019, the patient re-visited as an outpatient and duplex ultrasound of both limbs revealed occluded sfa stents in both sides, close to the outflow and only still monophasic popliteal flows was noted on both sides.Abi on the right was 0.5.Treadmill test revealed severe pulling in both calves after 48 minutes and pain increased after 53 minutes of the test.Based on the diagnostic findings, the patient was recommended for embolectomy on both right and left limb and advised to continue aspirin.On (b)(6) 2019, the patient was hospitalized for planned treatment.On physical examination, foot pulses were not palpable with certainty on either side.Per source, paod stage was iib on both sides (right and left limb) due to sfa occlusion on both sides.On the same day, 745 days posy index procedure, 100% stenosis in the right ostial to mid sfa (target lesion) which was 200 mm long with a reference vessel diameter of 5 mm was initiated with embolectomy treatment however, embolectomy was not successful with a size 3 french fogarty catheter as this could not be introduced into the stent.Therefore, the occluded stent was passed with a terumo wire.A wire-guided embolectomy catheter was fed forward and the intraluminal position was monitored.Then, a thrombectomy of the stent and the proximal sfa was performed in several passes.Old and fresh thrombotic material was extracted.Post treatment, residual stenosis was 0%.Follow-up angiography on the left limb revealed higher grade in-stent restenosis in left sfa stent which was implanted during index procedure.Fresh and old thrombotic material was noted; hence embolectomy was performed with 3 french fogarty catheter in several passes and dilation was performed using drug-eluting impact admiral balloon 5 mm x 60 mm.On (b)(6) 2019, the event was considered recovered/ resolved.On (b)(6) 2019, the patient was discharged on the same day in a good general state with clopidogrel and xarelto for 6months.The patient was recommended for follow-up and ultrasound monitoring in 6 months.Additionally, monitoring of the retention parameters due to restricted renal function as well as the electrolytes was advised.It was further reported that on (b)(6) 2017, baseline angiography analysis by core lab, performed in right mid sfa, revealed mild calcification with absence of thrombus, ulceration and aneurysm.Inflow tract patency was not shown.On (b)(6) 2019, additional angiography by core lab at right ostial, proximal and mid sfa revealed patent outflow, with in-stent restenosis pattern as occlusion, with absence of aneurysm.Post procedure, the subject was noted with warm legs and was in a stable cardiovascular state.
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