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

Model Number	H7493926020300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Myocardial Infarction (1969); Restenosis (4576)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2019, a 2.50 mm x 20 mm synergy drug eluting stent (des) was implanted in the mid left anterior descending artery (lad) and a 3.00 mm x 20 mm synergy drug eluting stent (des) was implanted in the proximal lad.On (b)(6) 2025, the subject started experiencing symptoms associated with unstable angina.At the time of the event the subject was on aspirin and ticagrelor.Coronary angiography revealed 50 to 60% in stent restenosis (isr) at the lad.On (b)(6) 2025, the subject was diagnosed with unstable angina and was admitted to hospital for further evaluation and treatment.Tte revealed 50-55% lvef.On (b)(6) 2025, the 100% stenosis at the left main was treated with a des and balloon angioplasty catheter.Target vessel revascularization was also preformed and the left circumflex artery was stented.Post revascularization, the residual stenosis was 0% and timi flow was 3.The event was considered as resolved and subject was discharged.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.B2 outcomes attrib to adv event: corrected.
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2019, a 2.50 mm x 20 mm synergy drug eluting stent (des) was implanted in the mid left anterior descending artery (lad) and a 3.00 mm x 20 mm synergy drug eluting stent (des) was implanted in the proximal lad.On (b)(6) 2025, the subject started experiencing symptoms associated with unstable angina.At the time of the event the subject was on aspirin and ticagrelor.Coronary angiography revealed 50 to 60% in stent restenosis (isr) at the lad.On (b)(6) 2025, the subject was diagnosed with unstable angina and was admitted to hospital for further evaluation and treatment.Tte revealed 50-55% lvef.On (b)(6) 2025, the 100% stenosis at the left main was treated with a des and balloon angioplasty catheter.Target vessel revascularization was also performed and the left circumflex artery was stented.Post revascularization, the residual stenosis was 0% and timi flow was 3.The event was considered as resolved and subject was discharged.It was further reported that on (b)(6) 2025, the subject started experiencing symptoms associated with chest pain.On (b)(6) 2025, the subject presented to hospital with chest pain and was hospitalized for further evaluation and treatment.Based on the symptoms and diagnostics, the subject was diagnosed with myocardial infarction.

• Brand Name: SYNERGY?
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21933308
• Report Number: 2124215-2025-26819
• Device Sequence Number: 8714734
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: (01)08714729840176
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: H7493926020300
• Device Catalogue Number: H7493926020300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 06/24/2026
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: Black Or African American