FDA Adverse Event Injury Summary report: N

SYNERGY XD

MDR report key: 19110728 · Received April 15, 2024

Report

Report Number
2124215-2024-22724
Event Type
Injury
Date Received
April 15, 2024
Date of Event
February 11, 2022
Report Date
April 15, 2024
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NIQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AGENT IDE. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2017, 80% ISR AND 90% ISR WAS NOTED AT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND MID RCA RESPECTIVELY. THE LESIONS WERE SUCCESSFULLY TREATED WITH A 3.00 MM X 10.00 MM NON-BOSTON SCIENTIFIC (BSC) BALLOON AND A 3.00 MM X 38.00 MM SYNERGY STENT, RESULTING IN 30% RESIDUAL STENOSIS. ON (B)(6) 2022, THE SUBJECT PRESENTED TO THE HOSPITAL, COMPLAINING CHEST BURNING AND DISCOMFORT (EQUIVALENT TO STABLE ANGINA), WHICH WERE SIMILAR TO PRIOR EPISODES. TWO DAYS LATER, THE CARDIAC CATHETERIZATION REVEALED 60% ISR AT THE PROXIMAL AND MID RCA. ON (B)(6) 2022, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR THE AGENT IDE STUDY. THE TARGET LESION WAS LOCATED AT THE PROXIMAL LEFT CIRCUMFLEX (LCX) AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 3.0 MM. THE TARGET LESION WAS PREDILATED USING A 3.00 MM X 15 MM BALLOON RESULTING IN 20% RESIDUAL STENOSIS AND TIMI FLOW 3. FOLLOWING PRE-DILATION, THE LESION WAS SUCCESSFULLY TREATED WITH A 3.5 MM X 20 MM NC QUANTUM APEX STUDY DEVICE WITH 10% RESIDUAL STENOSIS AND TIMI FLOW 3. THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL AND ASPIRIN. ON (B)(6) 2024, THE SUBJECT STARTED EXPERIENCING SYMPTOMS OF SHORTNESS OF BREATH WITH EXERTION, CHEST PAIN AND FATIGUE. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED THAT THE 80% STENOSIS AT THE 3.0 MM X 38 MM SYNERGY DRUG ELUTING STENT, 60% STENOSIS AT THE PROXIMAL RCA, 80% STENOSIS AT THE DISTAL RCA AND 90% STENOSIS AT PROXIMAL LCX. THE SUBJECT WAS DIAGNOSED WITH WORSENING CORONARY ARTERY STENOSIS AND AORTIC STENOSIS. ON (B)(6) 2024, THE SUBJECT WAS HOSPITALIZED AND RECOMMENDED FOR CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). CABG WAS PERFORMED WITH SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL BRANCH. IN ADDITION, CABG WAS PERFORMED AT THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND SVG TO POSTERIOR DESCENDING ARTERY (PDA). ON (B)(6) 2024, THE EVENTS WERE CONSIDERED TO BE RESOLVED/RECOVERED AND THE SUBJECT WAS DISCHARGED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1893290 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 70 YR Male Required Intervention| H