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The event occurred in (b)(6) as part of (b)(6) clinical study: elunir ridaforolimus eluting coronary stent system high bleeding risk (hbr) - (b)(6) study.
On (b)(6) 2019 the subject was admitted to the hospital with acute coronary syndrome and st-elevation myocardial infarction (stemi).
Coronary angiography showed a diseased vessel in the rca/rpda/rpl.
Index procedure was on (b)(6) 2019 with implantation of an elunir stent (lot# lnrce00337) to the proximal rca and a second stent (lot# lnrce00225) to the distal rca, both target lesions.
On (b)(6) 2019, approximately 4 days post index procedure, the subject experienced chest pain and on admission was found to be in complete av block with st elevation in ii, ii, avf (stemi).
The subject underwent emergent pci with angiography showing 100% stenosis of mid rca.
Ivus showed the proximal portion of the 3.
5x38mm stent (lot# lnrce00337) was under deployed.
Thrombus was also seen.
The event is associated only with the proximal rca implanted stent, size 3.
5x38mm (lot# lnrce00337).
Actions taken following the event were as follows: infusion of intracoronary glycoprotein iib/iiia (gp iib/iiib) inhibitor was initiated.
An export catheter was used but only minimal thrombus was aspirated.
The subject received additional gp iib/iiib.
Coronary revascularization to the mid rca with pre-dilatation and drug eluting balloon to the stent was performed.
The stenosis resolved to 0% with restoration of coronary flow.
The subject converted from complete heart block to sinus tachycardia with resolution of st elevation.
(related sae#2- inferior st segment elevation myocardial infarction).
The subject received a loading dose of ticagrelor 180 mg.
He was previously on dapt (clopidogrel and aspirin) and this was switched to ticagrelor plus aspirin.
Post procedure troponin was 602 ng/l (1130 ng/l on (b)(6) 2019 from a previous hospital discharge).
On (b)(6) 2019 ekg showed inferior q-wave and t-wave inversion.
The subject was also noted to have bibasilar crepitus.
He was started on furosemide 40 mg daily and bisoprol was increased to 5 mg daily post mi.
On (b)(6) 2019 his echocardiogram showed moderate ejection fraction between 40-45%.
His furosemide was discontinued and was discharged home on (b)(6) 2019.
Patient outcome: recovered.
The investigator considered the event of stent thrombosis and consequent inferior stemi severe, not related to the procedure, related to the device and resolved on (b)(6) 2019.
Initial assessment by (b)(6) medical reviewer: stent thrombosis of the right coronary artery possibly related to the device and the procedure.
It will be confirmed by the cec and review of the angiographic data.
It was anticipated but will be referred to the cec.
Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that the tevent is related to study device.
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