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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 Arrhythmia (1721); Bradycardia (1751); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 04/22/2019
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 aspirin, heparin and brilinta. The target lesion was located in the right coronary artery. A 4. 00x24mm synergy ii drug-eluting stent was implanted 6 minutes after administration of weight based heparin and brilinta given 3 minutes after stent placement. However, follow-up electrocardiogram showed st- segment elevation 57 minutes following stent placement. The patient was sent back to lab and it was noted that the implanted stent was occluded. A second stent was placed, integrilin and angiomax were started and completed the procedure. The patient was transferred to intensive care unit and was discharged with no further patient complications reported. Follow-up clinic visit stated that the patient was noted to have sinus bradycardia with first- degree atrioventricular block and evidence of inferior infarct.
 
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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 Key8754434
MDR Text Key149829083
Report Number2134265-2019-06938
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 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/18/2020
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0022718218
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 Manufactured09/19/2018
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: 07/02/2019 Patient Sequence Number: 1
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