FDA Adverse Event Injury Summary report: N

SYNERGY XD

MDR report key: 20858289 · Received December 5, 2024

Report

Report Number
2124215-2024-76851
Event Type
Injury
Date Received
December 5, 2024
Date of Event
January 9, 2024
Report Date
April 8, 2026
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NIQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AGENT IDE IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2023, THE SUBJECT PRESENTED WITH MYOCARDIAL INFARCTION. A 2.5 MM X 12 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE SAPHENOUS VEIN GRAFT (SVG)-DIAGONAL GRAFT AND A 2.25 MM X 16 MM SYNERGY DES WAS IMPLANTED IN THE SVG-RAMUS GRAFT. ON (B)(6) 2024, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH CHEST PAIN. AT THE TIME OF EVENT THE SUBJECT WAS ON CLOPIDOGREL, WHICH WAS CONTINUED. BASED ON THE SYMPTOMS AND BIOMARKER ELEVATION THE SUBJECT WAS DIAGNOSED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (MI) AND WAS RECOMMENDED FOR CARDIOLOGY CONSULTATION. THE LOCATION OF THE MI WAS NOT IDENTIFIABLE, AND THE MI WAS CLASSIFIED AS NON-Q-WAVE MI. ON (B)(6) 2024, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2024, DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED 70% STENOSIS AT THE DIAGONAL GRAFT AND 90% IN-STENT RESTENOSIS (ISR) AT THE RAMUS GRAFT. THE SUBJECT WAS RECOMMENDED FOR REVASCULARIZATION. INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION REVEALED UNDER EXPANSION OF THE PREVIOUSLY PLACED 2.25 MM X 16 MM SYNERGY DES AT THE SVG-RAMUS GRAFT. THE 90% ISR AT THE SVG-RAMUS GRAFT WAS TREATED WITH A NON-BOSTON SCIENTIFIC (NON-BSC) 2.25 MM X 15 MM STENT. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE SUBJECT WAS DISCHARGED WITH DAPT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1296660 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 69 YR Male Required Intervention| H