MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 07/12/2021

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that vasospasm occurred.In (b)(6) 2021, the index procedure was performed and heparin or antithrombotic medication gp iib/iiia inhibitor were administered.The subject, on a prior regimen of aspirin (>= 72 hours) at the time of index procedure, and loading dose of 300 mg of clopidogrel was given prior to the procedure.The target lesion was located at the mid left anterior descending (lad) was 24 mm long with a reference vessel diameter was 3.00 mm.The target lesion was predilated with 3.00 mm x 30 mm balloon with 30% residual stenosis.Following pre-dilation, the lesion was treated with 3.00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis.Post dilation was not performed.On the following day, the subject was noted with chest pain.Electrocardiogram (ecg) revealed st & t wave abnormality, prolonged qt and t wave inversion evident in anterolateral leads, indicating anterolateral ischemia.Also, elevation of ck-mb was noted to be consistent with protocol definition of myocardial infarction (mi).The subject was diagnosed with mi, which had led to prolongation of index hospitalization.The diagnosis of mi was based on symptoms of chest pain and biomarker elevation.The location of myocardial infarction was not identifiable and was not q wave mi.The next day, an ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads.Other findings were similar to previous ecg performed.The event was treated medically.However, the subject had repeated episodes of angina, hence the decision for revascularization was made.The antiplatelet medication during the hospitalization was unknown.Five days later, coronary angiography revealed 90% in-stent restenosis at the mid lad-1 (target lesion) and 50% in-stent stenosis at mid lad-2 (target lesion) with 90% stenosed side branch in 2nd diagonal.Distal lad was 70% stenosed and 100% stenosis in left circumflex (lcx) artery at the 1st obtuse marginal.On the same day, pre-dilation was performed using multiple balloon inflations in the mid to distal lad, using 3.0 x 2mm emerge balloon catheter.Post inflation, 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.A non-boston scientific (bsc) guide wire was then placed into the 2nd diagonal and sequential balloon dilation was performed with emerge and mini trek to treat the lesions.Furthermore, percutaneous coronary angioplasty with an agent balloon catheter was performed to treat the 90% stenosis at mid lad and distal lad.Post revascularization, 10% residual stenosis with timi flow 3 was noted.The 2nd diagonal with 90% stenosis was also revascularized using balloon angioplasty.Post revascularization, 40% residual stenosis with timi flow 3 was noted.On the following day, the event was considered to be recovered and resolved.The subject was discharged on the same day.

Event Description

Agent ide clinical study it was reported that vasospasm occurred.In (b)(6) 2021, the index procedure was performed and heparin or antithrombotic medication gp iib/iiia inhibitor were administered.The subject, on a prior regimen of aspirin (>= 72 hours) at the time of index procedure, and loading dose of 300 mg of clopidogrel was given prior to the procedure.The target lesion was located at the mid left anterior descending (lad) was 24 mm long with a reference vessel diameter was 3.00 mm.The target lesion was predilated with 3.00 mm x 30 mm balloon with 30% residual stenosis.Following pre-dilation, the lesion was treated with 3.00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis.Post dilation was not performed.On the following day, the subject was noted with chest pain.Electrocardiogram (ecg) revealed st & t wave abnormality, prolonged qt and t wave inversion evident in anterolateral leads, indicating anterolateral ischemia.Also, elevation of ck-mb was noted to be consistent with protocol definition of myocardial infarction (mi).The subject was diagnosed with mi, which had led to prolongation of index hospitalization.The diagnosis of mi was based on symptoms of chest pain and biomarker elevation.The location of myocardial infarction was not identifiable and was not q wave mi.The next day, an ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads.Other findings were similar to previous ecg performed.The event was treated medically.However, the subject had repeated episodes of angina, hence the decision for revascularization was made.The antiplatelet medication during the hospitalization was unknown.Five days later, coronary angiography revealed 90% in-stent restenosis at the mid lad-1 (target lesion) and 50% in-stent stenosis at mid lad-2 (target lesion) with 90% stenosed side branch in 2nd diagonal.Distal lad was 70% stenosed and 100% stenosis in left circumflex (lcx) artery at the 1st obtuse marginal.On the same day, pre-dilation was performed using multiple balloon inflations in the mid to distal lad, using 3.0 x 2mm emerge balloon catheter.Post inflation, 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.A non-boston scientific (bsc) guide wire was then placed into the 2nd diagonal and sequential balloon dilation was performed with emerge and mini trek to treat the lesions.Furthermore, percutaneous coronary angioplasty with an agent balloon catheter was performed to treat the 90% stenosis at mid lad and distal lad.Post revascularization, 10% residual stenosis with timi flow 3 was noted.The 2nd diagonal with 90% stenosis was also revascularized using balloon angioplasty.Post revascularization, 40% residual stenosis with timi flow 3 was noted.On the following day, the event was considered to be recovered and resolved.The subject was discharged on the same day.It was further reported that in (b)(6) 2021, the subject was diagnosed with non-st elevation myocardial infarction.The baseline ecg revealed sinus rhythm with t wave abnormality, lateral ischemia with st depression in the anterior lead.During the index procedure, a non-bsc guide wire was placed in the native distal lad artery.The target lesion was predilated with multiple balloon inflations.Following pre-dilation, final balloon angioplasty was performed using 3.00 mm x 30 mm nc quantum apex (poba).Post balloon dilation, final angiographic results revealed better expansion of the previously placed stents in the mid lad artery with distal spasm in lad and was treated with nitroglycerin.The event was considered to be recovered and resolved on the same day.One day post index procedure, the subject was noted with persistent exertional chest pain and nitroglycerin 10 mcg/min was given.Nitroglycerin was increased to 20 mcg/min, anti-anginal medication dosing was increased, and amlodipine 2.5 mg was added to medically manage the recurring angina.Two days post index procedure, ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads and 1st degree atrioventricular (av) block.Even though medications were adjusted, the subject continued to have repeated episodes of angina hence the decision for revascularization was made.Five days post index procedure, an ecg revealed st and t wave abnormality and anterolateal ischemia.Additionally, diagnostic angiography revealed right coronary artery (rca) 100% occlusion and patent (right ventricle) rv marginal branch with collaterization of the obtuse marginal (om)/left system.The saphenous vein graft to the r-pda(right posterior descending artery) was patent.The left internal mammary artery (lima) to the lad had multiple stents with recurrent in-stent restenosis and evidence of recoil.The first stented region of the mid lad (target lesion) was 50% stenosed with adjacent 90% stenotic lesion in the ostial second diagonal branch.The second stented region of the mid lad (target lesion) was 90% stenosed.The distal lad was 70% stenosed.There was 100% stenosis at the 1st om.Multiple balloon inflations were then performed using emerge 3.0 x 20 mm balloon from mid to distal lad.Post inflation, the 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.Intracoronary nitroglycerine was administered.A non-bsc guide wire was then placed into the 2nd diagonal branch and 90% stenosis was treated with sequential balloon dilations performed at the diagonal ostium with a non-bsc balloon.Following this, simultaneous kissing balloon angioplasty was performed at 2nd diagonal using 3 mm emerge balloon and 2 mm non-bsc balloon.Post revascularization of 2nd diagonal, 40% residual stenosis with timi flow 3 was noted.Percutaneous coronary angioplasty with a 3.0 x 30 mm agent drug coated balloon (crossover) was performed to treat the 90% in-stent restenosis at mid lad and distal lad (target vessel revascularization (tvr).Post revascularization of mid lad and distal lad, 10% residual stenosis with timi flow 3 was noted.The following day, nitroglycerin was weaned off and the subject was ambulating without any chest pain.The event was considered to be recovered and resolved and the subject was discharged home in stable condition on aspirin and clopidogrel.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12411694
• MDR Text Key: 269520318
• Report Number: 2134265-2021-10563
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR