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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 H7493926016250
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50 x 16 synergy ii stent was advanced to treat the lesion.The stent was successfully deployed; however, upon removing the delivery system, it was noted that the shaft was cracked.The procedure was completed with no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent was not returned for analysis.As per complaint report the stent was deployed at the targeted lesion during the procedure.The balloon cones were reviewed and the balloon folds appeared opened.It was evident that the balloon was subjected to positive pressure and a vacuum was pulled.Presence of a red substance which appeared to be blood was also observed inside the balloon body.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.Hypotube kinks most likely occurred due to forces that were applied on the delivery system during handling of the device.A visual and tactile examination of the extrusion found a longitudinal inner and outer shaft polymer extrusion tear which was stretching for 58 mm distal from the guidewire exchange port; the core wire was observed to be exposed by the tear.No other issues were identified during the product analysis.A review of the manufacturing process was carried out as part of the analysis.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50 x 16 synergy ii stent was advanced to treat the lesion.The stent was successfully deployed; however, upon removing the delivery system, it was noted that the shaft was cracked.The procedure was completed with no patient complications reported.
 
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Brand Name
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of Device
BIODEGRADABLE 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 Key6808492
MDR Text Key83217559
Report Number2134265-2017-08306
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840091
UDI-Public(01)08714729840091(17)20180425(10)20576834
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 Physician
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/25/2018
Device Model NumberH7493926016250
Device Catalogue Number39260-1625
Device Lot Number20576834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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