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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10604
Device Problem Obstruction of Flow (2423)
Patient Problems ST Segment Elevation (2059); Thrombosis (2100)
Event Date 03/27/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that acute stent thrombosis and st-segment elevation occurred. The patient was given tenecteplase (tnkase) and brilinta. The target lesion was located in the right coronary artery (rca). A 3. 50x24mm synergy ii drug-eluting stent was implanted 80 minutes after administration of tnkase. However, electrocardiogram showed st- segment elevation 67 minutes after stent placement. The patient was sent back to lab and it was noted that the implanted stent in the rca was 100%occluded due to a thrombus from undetermined site. Additional heparin was given and a stent was placed and the procedure was completed. The patient was reported with mild depressed right ventricular function. No further patient complications were reported.
 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8749526
MDR Text Key149678997
Report Number2134265-2019-06934
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0023040349
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 Received06/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2018
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: 07/01/2019 Patient Sequence Number: 1
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