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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 02/11/2022
Event Type  Injury  
Event Description
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.
 
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Brand Name
SYNERGY XD
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 Key19110728
MDR Text Key340232851
Report Number2124215-2024-22724
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/15/2024
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/15/2024
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 Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age70 YR
Patient SexMale
Patient RaceWhite
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