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

Model Number 10622

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

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)

Event Date 09/18/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

Synergy china registry: it was reported that acute left ventricular failure occurred that required additional intervention.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 70 mm long, with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 x 38 mm and 3.50 x 38 mm synergy china stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal left anterior descending artery (lad) extending up to middle lad with 95% stenosis and was 30 mm long, with a reference vessel diameter of 3.0 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy china stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Five days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the patient was diagnosed with acute left ventricular failure and was hospitalized on the same day for further treatment.In (b)(6) 2023, the patient was referred for coronary angiography which revealed 99% stenosis in the middle lad.The 99% stenosis which had the previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization,).Medication was also given to treat the event.Post intervention, the residual stenosis was noted to be 10%.Seven days later, the subject was discharged on aspirin and ticagrelor.The event was considered to be recovering/resolving.

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

Synergy china registry.It was reported that acute left ventricular failure occurred that required additional intervention.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 70 mm long, with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 x 38 mm and 3.50 x 38 mm synergy china stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal left anterior descending artery (lad) extending up to middle lad with 95% stenosis and was 30 mm long, with a reference vessel diameter of 3.0 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy china stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Five days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the patient was diagnosed with acute left ventricular failure and was hospitalized on the same day for further treatment.In (b)(6) 2023, the patient was referred for coronary angiography which revealed 99% stenosis in the middle lad.The 99% stenosis which had the previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization,).Medication was also given to treat the event.Post intervention, the residual stenosis was noted to be 10%.Seven days later, the subject was discharged on aspirin and ticagrelor.The event was considered to be recovering/resolving.It was further reported that in (b)(6) 2023, the subject presented with symptoms of ischemia and was diagnosed with myocardial infarction (mi).An electrocardiogram (ecg) was performed and cardiac enzymes were noted to be elevated consistent with protocol definition of mi.Location of mi was anterior (septal) and was non-q wave mi.

Manufacturer Narrative

E1 initial reporter address: (b)(6).

Event Description

Synergy china registry.It was reported that acute left ventricular failure occurred that required additional intervention.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 70 mm long, with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 x 38 mm and 3.50 x 38 mm synergy china stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal left anterior descending artery (lad) extending up to middle lad with 95% stenosis and was 30 mm long, with a reference vessel diameter of 3.0 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy china stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Five days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the patient was diagnosed with acute left ventricular failure and was hospitalized on the same day for further treatment.In (b)(6) 2023, the patient was referred for coronary angiography which revealed 99% stenosis in the middle lad.The 99% stenosis which had the previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization,).Medication was also given to treat the event.Post intervention, the residual stenosis was noted to be 10%.Seven days later, the subject was discharged on aspirin and ticagrelor.The event was considered to be recovering/resolving.It was further reported that in (b)(6) 2023, the subject presented with symptoms of ischemia and was diagnosed with myocardial infarction.

• 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: 18509177
• MDR Text Key: 332870265
• Report Number: 2124215-2024-00126
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023602808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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: 65 YR
• Patient Sex: Male