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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 H7493926028350
Device Problems Occlusion Within Device; Inadequacy of Device Shape and/or Size
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative

Device is combination product. Device evaluated by mfr: the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause user preference issue as the user is dissatisfied with the function, performance, or appearance of the product. (b)(4).

 
Event Description

It was reported that stent thrombosis occurred and the patient experienced chest pain and st segment elevation. The patient presented with myocardial infarction. The 5. 0mm target lesion was located in a coronary artery. A 3. 50 x 28mm synergy ii was implanted to treat the lesion. After the procedure, while the patient was in the holding area, the patient experienced chest pain and st segment elevations. The patient was brought back to the catheter laboratory and physician took a picture of the vessel. It was noted that there was an acute stent thrombosis with the implanted 3. 5x28mm synergy stent. The actual vessel artery size was 5. 0mm; therefore the 3. 50 synergy stent was undersized. The physician then placed a 4. 0x32mm synergy stent and post dilated it with a 5. 0x20 nc quantum balloon catheter. 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 Key6500168
Report Number2134265-2017-03093
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/19/2017
Device MODEL NumberH7493926028350
Device Catalogue Number39260-2835
Device LOT Number0020115170
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 Received03/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2017
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: 04/18/2017 Patient Sequence Number: 1
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