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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 H7493926012220
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Complete Heart Block (2627)
Event Date 08/15/2017
Event Type  Death  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id# 2134265-2017-08798 & 2134265-2017-09177. It was reported that fourteen days after stent implantation, the patient presented with st elevated myocardial infarction (stemi), third degree heart block, thrombosis and died one day post re-intervention. The target lesion was located in the mid right coronary artery (rca). A 2. 25 x 12 synergy stent and a 2. 25 x 16 synergy stent were implanted in the distal rca and the physician was attempting to deliver another 2. 25 x 12 synergy stent, however, difficulty advancing in the mid rca was noted. As the physician was pulling the stent back into the guide catheter, resistance was felt and as he continue to pull back he noticed the stent stayed in the ostium of the rca and the shaft continued to pull back. When the delivery system was out of the body, he realized that the distal 8 inches of the shaft were broken off, part in the artery and part in the guide catheter. A non bsc guide extension catheter was positioned into the area and was used to re-capture the broken shaft and pull it out. The dislodged stent was deployed against the wall in the right ostial artery. After this, a dissection was noted in the rca. The vessel could not be re-wired and the patient was sent to bypass surgery. The surgery went well and the patient was doing very well. Fourteen days later, the patient presented with stemi and third degree heart block. In the cath lab, it was noted that the saphenous vein graft was full of thrombus. Three non-bsc stents were placed in the saphenous vein graft and at the end of the procedure there was a timi 1 flow down the vessel. Patient was brought upstairs to her room in a "critically ill" status and died the following morning. The cause of death was acute hemorrhage. The physician does not believe the patient death is related to the synergy stents.
 
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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 Key6857719
MDR Text Key85765840
Report Number2134265-2017-09176
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 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493926012220
Device Catalogue Number39260-1222
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 Received08/15/2017
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: 09/12/2017 Patient Sequence Number: 1
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