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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 H7493926038300
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.   (b)(4). 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 investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.   (b)(4).

 
Event Description

Same case as mdr# 2134265-2018-06593, 2134265-2018-06594, and 2134265-2018-06595. It was reported that stent damage occurred. The target lesion was located in the left anterior descending artery (lad) extending to the left circumflex artery (lcx). A 3. 00 x 38mm synergy ii drug-eluting stent (des) was advanced but failed to cross the lesion and was removed from the patient. The physician noticed the patient becoming unstable. A non-bsc left ventricular assist device was placed and chest compressions started. The same 3. 00 x 38mm synergy ii des was selected for re-use and the physician noted that the stent struts were flared. The physician pressed the stent struts back onto the balloon but when the device was advanced using a guidezilla¿ ii guide extension catheter, the stent came off the balloon in the guidezilla. Both were removed together. A guidezilla¿ ii guide extension catheter was advanced and three synergy ii des were placed, two stents in the lad and one in the lcx, to compete the procedure. Later that day the patient died. The physician did not consider the death related to any of the devices.

 
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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 Key7665061
MDR Text Key113285069
Report Number2134265-2018-05796
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP150003
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 06/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/15/2019
Device MODEL NumberH7493926038300
Device Catalogue Number39260-3830
Device LOT Number0021913317
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 Received06/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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