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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
Device Problem Obstruction of Flow (2423)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 11/15/2021
Event Type  Injury  
Event Description
(b)(6) clinical study. It was reported that in-stent restenosis occurred. On (b)(6) 2017, a synergy drug eluting stent was implanted to treat the target lesion located in the mid right coronary artery (rca) and proximal rca. On (b)(6) 2021, the subject was presented with unstable anginal (braunwald classification ib) and was referred for the agent ide study. The index procedure was performed on the same day. Cardiac catherization revealed 90% in-stent restenosis at mid rca lesion with timi flow of 3. Following pre-dilation, the lesion was treated with a 3. 50 mm x 20 mm study balloon successfully with 0% residual stenosis and timi flow of 3. On the same day, the subject was discharged with aspirin and prasugrel.
 
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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 Key14116201
MDR Text Key289315693
Report Number2134265-2022-04326
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
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
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 Treatment Data
Date Received: 04/14/2022 Patient Sequence Number: 1
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