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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arteriosclerosis/ Atherosclerosis (4437)
Event Date 07/29/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that atherosclerosis occurred. In (b)(6) 2020, the subject presented with unstable angina and was referred for catheterization. The index procedure was performed on the same day. The target lesion 1 was located in the left main coronary artery (lmca) extending up to the mid left anterior descending (lad) artery with 99% stenosis and was 45 mm long and a reference vessel diameter of 3. 5 mm. Target lesion 1 was treated with placement of 3. 5 mm x 24 mm and 3. 00 mm x 28 mm synergy stent systems, and pre-dilatation was not performed. Following this, post-dilatation was performed with 99% residual stenosis. On the following day, the left ventricular ejection fraction (lvef) measured was 68%. Four days later, subject was discharged on ticagrelor and other antiplatelet medication. In (b)(6) 2021, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. Coronary angiography without revascularization was performed to treat the event. Two days later, the subject was discharged and the event was considered recovering and resolving.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12556498
MDR Text Key274112867
Report Number2134265-2021-11767
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/13/2020
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0023997297
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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