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

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Agent ide study.It was reported that a myocardial infarction occurred.On (b)(6) 2024, the subject was diagnosed with accelerating angina.On the same day, 80% in stent restenosis from mid right coronary artery (rca) into distal rca was treated with laser atherectomy, 2.50 mm x 12 mm and 2.50 mm x 15 mm emerge monorail balloons, a 3.50 mm x 10 mm wolverine cutting monorail balloon and a non-boston scientific balloon.An 100% acute occlusion of the right posterior descending artery (rpda) was noticed and the subject experienced chest pain.A culotte technique bifurcation percutaneous coronary intervention (pci) was attempted, but optimization of the bifurcation with kissing balloons failed due to difficulty in delivering.The rpda was then treated with 2.50 mm x 12 mm and 2.50 mm x 15 mm emerge balloons, a 3.50 mm x 30 mm nc emerge balloon, a 2.50 mm x 20 mm synergy stent and non-boston scientific balloons.Post treatment of the rpda lesion, the lesion from the mid rca to second right posterolateral artery (rpl) was treated with a 3.50 mm x 48 mm synergy stent, 3.50 mm x 30 mm, 3.50 mm x 15 mm, 2.50 mm x 12 mm, 3.00 mm x 15 mm, 4.00 mm x 20 mm and 4.00 mm x 15 mm nc emerge balloons, a 4.0 mm x 24 mm synergy megatron stent, and non-boston scientific balloons.The subject was noted with good flow.Post revascularization, the residual stenosis was unknown with thrombolysis in myocardial infarction (timi) flow of 3.On (b)(6) 2024, the subject was discharged on dapt.On (b)(6) 2024, the subject presented to the emergency department with complaints of ongoing right sided chest pain, shortness of breath associated with activity and continued chest discomfort since cardiac stent placement on (b)(6) 2024.Two nitroglycerine were administered.On the same day, lab test revealed elevated troponin i, consistent with protocol definition of myocardial infarction.Based on the symptoms and biomarker elevation, the subject was diagnosed with myocardial infarction during follow up period.The location of myocardial infarction was not identifiable and was not a q wave mi.On (b)(6) 2024, the event was considered to be resolved/recovered.

• Brand Name: SYNERGY MEGATRON
• 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: 19054415
• MDR Text Key: 339553678
• Report Number: 2124215-2024-20870
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White