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

Model Number	H7493942832350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Angina (1710); Vasoconstriction (2126); Restenosis (4576)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that restenosis and stent fracture occurred.On (b)(6)2021, in stent restenosis occurred at proximal right coronary artery (rca), it was successfully treated with a 3.50 mm x 32 mm synergy megatron drug eluting stent.On (b)(6) 2022, 99% in stent restenosis noted at proximal rca with stent fracture.On (b)(6) 2022, coronary angiography revealed 99% in-stent restenosis at proximal rca, was noted with neointimal hyperplasia and stent recoil.Heparin or other antithrombotic medication were administered at the time of index procedure.The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours) at the time of index procedure.The target lesion was located at the proximal rca and was 7 mm long with a reference vessel diameter was 4.0 mm.The target lesion was pre-dilated with a 2.00 mm x 15 mm balloon with 30% residual stenosis and timi flow of 3.The target lesion was treated with a 4.00 mm x 12 mm nc emerge study device successfully with 15% residual stenosis and timi 3.The patient was discharged on aspirin and clopidogrel.In (b)(6) 2024, the patient was noted with symptoms associated with angina during length of walk for which nitroglycerine was administered.At the time of the event, the patient was on aspirin and clopidogrel.On (b)(6) 2025, the patient presented to the hospital for follow up, ecg was performed which revealed sinus rhythm with premature atrial complexes.Medication was given to treat the event.On (b)(6) 2025, the patient presented to the hospital for cardiac catheterization.Diagnostic coronary angiography revealed that 100% in stent restenosis at proximal rca was noted with neointimal hyperplasia and stent recoil which was predilated and treated with multiple balloons.The residual stenosis was noted as 5% with timi flow 3.Re-treatment of the target lesion was planned on a later day.On (b)(6) 2025, the patient presented to the hospital for the planned cardiac catheterization.Diagnostic coronary angiography revealed that 50% in stent restenosis at the proximal rca, which was treated with a 4.00 mm x 6 mm wolverine cutting balloon, a 2.50 mm x 21 mm non-bsc balloon and a 4.00 mm x 30 mm agent dcb balloon which got ruptured.Diagnostic coronary angiography also revealed 70% stenosis at the proximal left anterior descending (lad), the non-target lesion was treated with a 3.00 mm x 33 mm non-bsc drug eluting stent followed by post dilated with a 3.50 mm x 15 mm non-bsc balloon successfully.The residual stenosis was noted as 25% with timi 3.The next day, the event was considered to be resolved with sequelae.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that restenosis and stent fracture occurred.On (b)(6) 2021, in stent restenosis occurred at proximal right coronary artery (rca), it was successfully treated with a 3.50 mm x 32 mm synergy megatron drug eluting stent.On (b)(6) 2022, 99% in stent restenosis noted at proximal rca with stent fracture.On (b)(6) 2022, coronary angiography revealed 99% in-stent restenosis at proximal rca, was noted with neointimal hyperplasia and stent recoil.Heparin or other antithrombotic medication were administered at the time of index procedure.The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours) at the time of index procedure.The target lesion was located at the proximal rca and was 7 mm long with a reference vessel diameter was 4.0 mm.The target lesion was pre-dilated with a 2.00 mm x 15 mm balloon with 30% residual stenosis and timi flow of 3.The target lesion was treated with a 4.00 mm x 12 mm nc emerge study device successfully with 15% residual stenosis and timi 3.The patient was discharged on aspirin and clopidogrel.In (b)(6) 2024, the patient was noted with symptoms associated with angina during length of walk for which nitroglycerine was administered.At the time of the event, the patient was on aspirin and clopidogrel.On (b)(6) 2025, the patient presented to the hospital for follow up, ecg was performed which revealed sinus rhythm with premature atrial complexes.Medication was given to treat the event.On (b)(6) 2025, the patient presented to the hospital for cardiac catheterization.Diagnostic coronary angiography revealed that 100% in stent restenosis at proximal rca was noted with neointimal hyperplasia and stent recoil which was predilated and treated with multiple balloons.The residual stenosis was noted as 5% with timi flow 3.Re-treatment of the target lesion was planned on a later day.On (b)(6) 2025, the patient presented to the hospital for the planned cardiac catheterization.Diagnostic coronary angiography revealed that 50% in stent restenosis at the proximal rca, which was treated with a 4.00 mm x 6 mm wolverine cutting balloon, a 2.50 mm x 21 mm non-bsc balloon and a 4.00 mm x 30 mm agent dcb balloon which got ruptured.Diagnostic coronary angiography also revealed 70% stenosis at the proximal left anterior descending (lad), the non-target lesion was treated with a 3.00 mm x 33 mm non-bsc drug eluting stent followed by post dilated with a 3.50 mm x 15 mm non-bsc balloon successfully.The residual stenosis was noted as 25% with timi 3.The next day, the event was considered to be resolved with sequelae.

• Brand Name: SYNERGY MEGATRON?
• Common Device Name: 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21741125
• Report Number: 2124215-2025-19092
• Device Sequence Number: 4007355
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: (01)08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493942832350
• Device Catalogue Number: H7493942832350
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4 MM X 30 MM AGENT DCB BALLOON - BSC; 4 MM X 30 MM AGENT DCB BALLOON - BSC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White