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

Device Problem Obstruction of Flow (2423)

Patient Problems Myocardial Infarction (1969); Restenosis (4576)

Event Date 06/16/2023

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The patient was being treated for immediate non-st-elevation myocardial infarction (nstemi).The vascular access site was obtained via right radial artery.The target lesion was located in distal to ostial left anterior descending artery (lad).The lesion was previously treated with three drug-eluting stents resulted in 90% ostial in-stent-restenosis with tmi 3 flow in proximal lad.After a 6f non-boston scientific (bsc) guide catheter was engaged coaxially and a non-bsc guidewire was crossed the lesion.Percutaneous coronary intervention (pci) was successfully performed in ostial lad and old balloon angioplasty was done using a 3.00mm x 12mm and 4.0 x 12mm nc balloon catheters, and a 3.5mm x 10mm and 4.0 x 10mm cutting balloons followed by a 3.5 x 20mm drug-eluting balloon.Following the procedure, ivus showed a minimal stent area of 6.1mm2.No patient complications were reported, and patient fully recovered.

Manufacturer Narrative

A4: weight: 82.5 kg.

• 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: 17785506
• MDR Text Key: 323890955
• Report Number: 2124215-2023-48045
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 79 YR