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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926016300
Device Problem Occlusion Within Device (1423)
Patient Problems ST Segment Elevation (2059); Thrombosis (2100)
Event Date 02/11/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: the complaint device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. 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
It was reported that stent thrombosis occurred. The patient presented with an inferior st-elevation myocardial infarction. The target lesion was located in the proximal right coronary artery (rca). The lesion was predilated with a 2. 5 x 15 emerge¿ balloon catheter and a 3. 00 x 16 synergy ii stent was implanted. No post dilatation was performed. The patient was stable and was sent to the floor at the end of the procedure. However, approximately one hour later, st elevation was noted. The patient was found to have thrombus present in the proximal rca stent. A non bsc aspiration catheter was used to treat the thrombosis, then followed by a 3. 00 nc emerge¿ balloon catheter. Intravascular ultrasound was performed to obtain image. Then a 3. 5x15mm emerge¿ balloon was used for post dilation and the procedure was completed. No further patient complications were reported and the patient's status was stable.
 
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Brand NameSYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key6375341
MDR Text Key68963878
Report Number2134265-2017-01594
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
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2017
Device Model NumberH7493926016300
Device Catalogue Number39260-1630
Device Lot Number0019784635
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 Received02/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2016
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: 03/03/2017 Patient Sequence Number: 1
Treatment
BALLOON: 2.5X15 EMERGE (PREDILATION)
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