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 Angina (1710); Thrombosis/Thrombus (4440)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Synergy china registry: it was reported that the patient experienced unstable angina pectoris.In (b)(6) 2019, the subject presented with unstable angina and referred for cardiac catheterization.The target lesion was located in the middle right coronary artery (rca) with 80% stenosis was 29 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilation and placement of a 2.50 mm x 32 mm synergy stent system.Following post-dilation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with stable angina pectoris and was hospitalized for further treatment.Coronary angiography and percutaneous coronary intervention were performed, and medication was given to treat the event.Two days later, the event was considered to be recovered/resolved and the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry.It was reported that the patient experienced unstable angina pectoris.In (b)(6) 2019, the subject presented with unstable angina and referred for cardiac catheterization.The target lesion was located in the middle right coronary artery (rca) with 80% stenosis was 29 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilation and placement of a 2.50 mm x 32 mm synergy stent system.Following post-dilation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with stable angina pectoris and was hospitalized for further treatment.Coronary angiography and percutaneous coronary intervention were performed, and medication was given to treat the event.Two days later, the event was considered to be recovered/resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that in (b)(6) 2023, post index procedure, angiography revealed that the target lesion was located in the proximal right coronary artery (rca) with 70% stenosis extended up to middle rca which revealed stent thrombosis and was treated with percutaneous coronary intervention.Following post-intervention, the residual stenosis was 0%.Additionally, medication was given to treat the event.Two days later, the event was considered to be recovered/resolved and the subject was discharged.

• 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: 18573273
• MDR Text Key: 333623935
• Report Number: 2124215-2024-03484
• 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
• Report Date: 04/17/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023325130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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: 62 YR
• Patient Sex: Male