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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number UNK776
Device Problem Occlusion Within Device (1423)
Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 01/21/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: the complaint device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
Same case as mdr id 2134265-2017-00814 and 2134265-2017-00815. It was reported that myocardial infarction and stent thrombosis occurred. The target lesions were located in the circumflex artery and right coronary artery (rca). Two synergy¿ drug-eluting stents were implanted in the circumflex and one synergy¿ drug-eluting stent was implanted in the rca. During the procedure, the patient was given angiomax. The procedure was completed and the patient went to recovery. However, an hour later, the patient displayed st segment elevation myocardial infarction and all three stents had thrombosed. Another synergy stent was then implanted to treat the thrombosis and the patient was discharged on plavix. There were no further patient complications reported and the patient's status was fine.
 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6313297
MDR Text Key66859292
Report Number2134265-2017-00823
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK776
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 Received01/23/2017
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: 02/08/2017 Patient Sequence Number: 1
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