MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10623

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

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)

Event Date 02/15/2023

Event Type  Death  

Event Description

Synergy china registry.It was reported that unstable angina and acute non-st segment elevation myocardial infarction occurred.In (b)(6) 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 100% stenosis and was 56 mm long, with a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with unstable angina and was hospitalized for further evaluation and treatment.Medication was given and angiography without revascularization was performed to treat the event.Seven days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was considered to be recovering/resolving.In (b)(6) 2023, the subject was diagnosed with acute non-st segment elevation myocardial infarction and was hospitalized for further evaluation and treatment.Target vessel revascularization and non-target vessel revascularization were performed, and medication was given to treat the event.Six days later, the event was considered to be recovered and resolved and the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry it was reported that unstable angina and acute non-st segment elevation myocardial infarction occurred.In november 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 100% stenosis and was 56 mm long, with a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In february 2023, the subject was diagnosed with unstable angina and was hospitalized for further evaluation and treatment.Medication was given and angiography without revascularization was performed to treat the event.Seven days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was considered to be recovering/resolving.In march 2023, the subject was diagnosed with acute non-st segment elevation myocardial infarction and was hospitalized for further evaluation and treatment.Target vessel revascularization and non-target vessel revascularization were performed, and medication was given to treat the event.Six days later, the event was considered to be recovered and resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that in march 2023, the subject presented with unstable angina.Cardiac enzymes were measured, and the subject was diagnosed with myocardial infarction.Four days later, coronary angiography revealed 100% stenosis in the proximal left anterior descending (lad) extending up to middle left anterior descending (lad) which was treated with percutaneous coronary intervention.Post treatment, the residual stenosis was 0%.

Event Description

Synergy china registry.It was reported that unstable angina and acute non-st segment elevation myocardial infarction occurred.In november 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 100% stenosis and was 56 mm long, with a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In february 2023, the subject was diagnosed with unstable angina and was hospitalized for further evaluation and treatment.Medication was given and angiography without revascularization was performed to treat the event.Seven days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was considered to be recovering/resolving.In march 2023, the subject was diagnosed with acute non-st segment elevation myocardial infarction and was hospitalized for further evaluation and treatment.Target vessel revascularization and non-target vessel revascularization were performed, and medication was given to treat the event.Six days later, the event was considered to be recovered and resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that in march 2023, the subject presented with unstable angina.Cardiac enzymes were measured, and the subject was diagnosed with myocardial infarction.Four days later, coronary angiography revealed 100% stenosis in the proximal left anterior descending (lad) extending up to middle left anterior descending (lad) which was treated with percutaneous coronary intervention.Post treatment, the residual stenosis was 0%.In sep 2023, the subject was diagnosed with acute left heart failure and was hospitalized on the same day.Medication was given to treat the event.Fourteen days after the subject was discharged on aspirin and clopidogrel.The outcome of the event was considered to be recovering and resolving.Three days after the subject was discharged the subject died.The primary cause of death was heart failure.It is unknown if an autopsy was performed.

Event Description

Synergy china registry: it was reported that unstable angina and acute non-st segment elevation myocardial infarction occurred.In (b)(6) 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 100% stenosis and was 56 mm long, with a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with unstable angina and was hospitalized for further evaluation and treatment.Medication was given and angiography without revascularization was performed to treat the event.Seven days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was considered to be recovering/resolving.In (b)(6) 2023, the subject was diagnosed with acute non-st segment elevation myocardial infarction and was hospitalized for further evaluation and treatment.Target vessel revascularization and non-target vessel revascularization were performed, and medication was given to treat the event.Six days later, the event was considered to be recovered and resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that in (b)(6) 2023, the subject presented with unstable angina.Cardiac enzymes were measured, and the subject was diagnosed with myocardial infarction.Four days later, coronary angiography revealed 100% stenosis in the proximal left anterior descending (lad) extending up to middle left anterior descending (lad) which was treated with percutaneous coronary intervention.Post treatment, the residual stenosis was 0%.In (b)(6) 2023, the subject was diagnosed with acute left heart failure and was hospitalized on the same day.Medication was given to treat the event.Fourteen days later the subject was discharged on aspirin and clopidogrel.The outcome of the event was considered to be recovering and resolving.Three days after the subject was discharged from the hospital the subject died.The primary cause of death was heart failure.It is unknown if an autopsy was performed.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17962102
• MDR Text Key: 326005447
• Report Number: 2124215-2023-53379
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0029631778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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): Required Intervention; Death
• Patient Age: 65 YR
• Patient Sex: Female