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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 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angina (1710)
Event Date 12/10/2020
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that stenocardia occurred. In (b)(6) 2020, the subject was referred to cardiac catheterization and the index procedure was performed. The target lesion 1 was located in the distal right coronary artery (rca) with 90% stenosis and was 12 mm long, with a reference vessel diameter of 3. 0 mm. The target lesion 1 was treated with pre-dilatation and placement of a 3. 00 mm x 16 mm synergy stent system. Following this, post-dilatation was performed with 10% residual stenosis. Five days later, subject was discharged on aspirin and clopidogrel. In (b)(6) 2020, the subject presented to the hospital for stenocardia. Medication was given to treat the event. At the time of reporting, the outcome of the event was considered to be not recovered and not resolved.
 
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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 Key13664864
MDR Text Key286924602
Report Number2134265-2022-01546
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 Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/24/2020
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0023855618
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2019
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: 03/03/2022 Patient Sequence Number: 1
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