MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Agent ide study.It was reported that worsening chest pain, thrombosis, myocardial infarction and in-stent restenosis occurred.In (b)(6) 2017, prior to index procedure, the lcx was noted with severe in-stent restenosis at left circumflex (lcx) artery was treated with 2.5 mm x 8 mm synergy stent.In (b)(6) 2019, percutaneous transluminal coronary angioplasty (ptca) and brachytherapy was performed to treat the in-stent restenosis (isr) at lcx.In (b)(6) 2021, the subject presented with stable angina.Heparin or antithrombotic medications were administered at the time of index procedure.The target lesion was located in the distal lcx and was 25 mm long with a reference vessel diameter of 2.5 mm.The target lesion was predilated using 3.00 mm x 12 mm balloon.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 12 mm emerge balloon with 0% residual stenosis and timi flow of 3.On the following day, post index procedure, the subject had mild mid anterior chest discomfort.The subject was discharged with aspirin and clopidogrel on the same day.In (b)(6) 2022, the subject was diagnosed with worsening cardiac chest pain and was hospitalized on the same day for further evaluation and treatment.During the course of hospitalization, the subject underwent left heart catheterization with laser atherectomy and ptca to left coronary artery (lca); the event was also treated with medications.The distal lcx was revascularized.Three days later, the event was considered recovered/resolved and the subject was discharged on clopidogrel.Two weeks later, the subject presented to the hospital with worsening chest pain due to cardiac non-st segment elevation myocardial infarction (nstemi).The subject was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with target lesion thrombosis and myocardial infarction.Coronary enzymes were noted to be elevated.Percutaneous coronary intervention was performed to treat re-stenosis at the distal lcx.Following predilation with a non-compliant balloon, a 3.50 x 8mm non-boston scientific drug eluting stent was placed.The event was considered resolved with sequelae and the subject was discharged on the same medication.

Event Description

Agent ide study.It was reported that worsening chest pain, thrombosis, myocardial infarction and in-stent restenosis occurred.In february 2017, prior to index procedure, the lcx was noted with severe in-stent restenosis at left circumflex (lcx) artery was treated with 2.5 mm x 8 mm synergy stent.In february 2019, percutaneous transluminal coronary angioplasty (ptca) and brachytherapy was performed to treat the in-stent restenosis (isr) at lcx.In august 2021, the subject presented with stable angina.Heparin or antithrombotic medications were administered at the time of index procedure.The target lesion was located in the distal lcx and was 25 mm long with a reference vessel diameter of 2.5 mm.The target lesion was predilated using 3.00 mm x 12 mm balloon.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 12 mm emerge balloon with 0% residual stenosis and timi flow of 3.On the following day, post index procedure, the subject had mild mid anterior chest discomfort.The subject was discharged with aspirin and clopidogrel on the same day.In march 2022, the subject was diagnosed with worsening cardiac chest pain and was hospitalized on the same day for further evaluation and treatment.During the course of hospitalization, the subject underwent left heart catheterization with laser atherectomy and ptca to left coronary artery (lca); the event was also treated with medications.The distal lcx was revascularized.Three days later, the event was considered recovered/resolved and the subject was discharged on clopidogrel.Two weeks later, the subject presented to the hospital with worsening chest pain due to cardiac non-st segment elevation myocardial infarction (nstemi).The subject was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with target lesion thrombosis and myocardial infarction.Coronary enzymes were noted to be elevated.Percutaneous coronary intervention was performed to treat re-stenosis at the distal lcx.Following predilation with a non-compliant balloon, a 3.50 x 8mm non-boston scientific drug eluting stent was placed.The event was considered resolved with sequelae and the subject was discharged on the same medication.It was further reported that in march 2022, 99% in stent re-stenosis from the proximal to distal lcx was initially treated with a 2 mm x 20 mm non compliant (nc) balloon.Post which the lesion was treated with laser atherectomy and a 3 mm x 15 mm scoring balloon.The lesion was then successfully post dilated with a 2.5 mm x 20 mm nc non-boston scientific balloon resulting in 40% stenosis with timi flow 3.When the subject returned two weeks later, percutaneous coronary intervention was performed to treat 80% re-stenosis at the distal lcx.Post revascularization 0% stenosis was noted.

Event Description

Agent ide study.It was reported that worsening chest pain, thrombosis, myocardial infarction and in-stent restenosis occurred.In (b)(6) 2017, prior to index procedure, the lcx was noted with severe in-stent restenosis at left circumflex (lcx) artery was treated with 2.5 mm x 8 mm synergy stent.In (b)(6) 2019, percutaneous transluminal coronary angioplasty (ptca) and brachytherapy was performed to treat the in-stent restenosis (isr) at lcx.In (b)(6) 2021, the subject presented with stable angina.Heparin or antithrombotic medications were administered at the time of index procedure.The target lesion was located in the distal lcx and was 25 mm long with a reference vessel diameter of 2.5 mm.The target lesion was predilated using 3.00 mm x 12 mm balloon.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 12 mm emerge balloon with 0% residual stenosis and timi flow of 3.On the following day, post index procedure, the subject had mild mid anterior chest discomfort.The subject was discharged with aspirin and clopidogrel on the same day.In (b)(6) 2022, the subject was diagnosed with worsening cardiac chest pain and was hospitalized on the same day for further evaluation and treatment.During the course of hospitalization, the subject underwent left heart catheterization with laser atherectomy and ptca to left coronary artery (lca); the event was also treated with medications.The distal lcx was revascularized.Three days later, the event was considered recovered/resolved and the subject was discharged on clopidogrel.Two weeks later, the subject presented to the hospital with worsening chest pain due to cardiac non-st segment elevation myocardial infarction (nstemi).The subject was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with target lesion thrombosis and myocardial infarction.Coronary enzymes were noted to be elevated.Percutaneous coronary intervention was performed to treat re-stenosis at the distal lcx.Following predilation with a non-compliant balloon, a 3.50 x 8mm non-boston scientific drug eluting stent was placed.The event was considered resolved with sequelae and the subject was discharged on the same medication.It was further reported that in (b)(6) 2022, 99% in stent re-stenosis from the proximal to distal lcx was initially treated with a 2 mm x 20 mm non-compliant (nc) balloon.Post which the lesion was treated with laser atherectomy and a 3 mm x 15 mm scoring balloon.The lesion was then successfully post dilated with a 2.5 mm x 20 mm nc non-boston scientific balloon resulting in 40% stenosis with timi flow 3.When the subject returned two weeks later, percutaneous coronary intervention was performed to treat 80% re-stenosis at the distal lcx.Post revascularization 0% stenosis was noted.It was further reported that on (b)(6) 2017 a 4.00 x 16mm synergy stent was implanted to treat the left anterior descending artery (lad).On (b)(6) 2022, the subject presented complaints of worsening substernal pressure like chest pain radiating to left neck and jaw.Sublingual nitroglycerin was given, that mildly decreased the chest pain from 8/10 to 2/10, along with imdur, which was ongoing at the time of admission.On examination, the subject was having shortness of breath, nausea, diaphoresis and mild epigastric discomfort.The chest pain again started to increase and was worse with exertion.The subject was diagnosed with chest pain with acute coronary syndrome and acute inferior stemi.The lad had 50% stenosis at the mid and 40% at the distal segment.Intravenous heparin drip and nitro paste drip with morphine was given as part of the procedure.The subject was on clopidogrel at the time of the event.On (b)(6) 2022, the subject presented emergently with worsening chest pain, which was not relieved by nitroglycerin.It was reported that the subject had experienced palpitation episodes at home with heart rate ranging from 40-186.On examination, the subject was having chest pain, occasional diaphoresis and shortness of breath.Eliquis was switched to lovenox for paroxysmal atrial fibrillation.On (b)(6) 2023, angiography revealed the lad at 15% stenosis of the previously placed stent at the ostial to distal segment.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15810161
• MDR Text Key: 303791765
• Report Number: 2124215-2022-47105
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 01/13/2023
• Supplement Dates FDA Received: 12/08/2022; 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White