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

Model Number 10619

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Synergy china registry.It was reported that the patient experienced coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the middle left anterior descending artery (lad) with 90% stenosis was 19 mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilation and placement of a 3.00 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin, ticagrelor and other medication.In (b)(6) 2024, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Coronary angiography was performed with non-target vessel revascularization and the event was treated medically.Six days later, the event was considered to be recovered/resolved and the subject was discharged.

Manufacturer Narrative

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

Event Description

Synergy china registry.It was reported that the patient experienced coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the middle left anterior descending artery (lad) with 90% stenosis was 19 mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilation and placement of a 3.00 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin, ticagrelor and other medication.In (b)(6) 2024, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Coronary angiography was performed with non-target vessel revascularization and the event was treated medically.Six days later, the event was considered to be recovered/resolved and the subject was discharged.It was further reported that the event occurred in november 2020, not in january 2024 as previously reported.Angiography without revascularization was performed and no other action was taken to treat the event.Three days later, the subject was discharged.A year later the event was considered to be recovered and resolved.It was noted that there was 40% stenosis in the middle of the study stent.

Event Description

Synergy china registry.It was reported that the patient experienced coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the middle left anterior descending artery (lad) with 90% stenosis was 19 mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilation and placement of a 3.00 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin, ticagrelor and other medication.In (b)(6) 2024, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Coronary angiography was performed with non-target vessel revascularization and the event was treated medically.Six days later, the event was considered to be recovered/resolved and the subject was discharged.It was further reported that the event occurred in (b)(6) 2020, not in (b)(6) 2024 as previously reported.Angiography without revascularization was performed and no other action was taken to treat the event.Three days later, the subject was discharged.A year later the event was considered to be recovered and resolved.It was noted that there was 40% stenosis in the middle of the study stent.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Correction: h6 patient code: restenosis added.

• 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: 19101534
• MDR Text Key: 340100708
• Report Number: 2124215-2024-22450
• 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
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0023299302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female