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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 H7493926038250
Device Problems Bent (1059); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported that stent damage occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 2.50 x 38 synergy ii drug-eluting stent was advanced to treat the lesion.However, while trying to enter a 5.5fr non-bsc guide extension catheter, the stent got interfered within the guide catheter and a stent strut was lifted.The procedure was completed with another 2.50 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient was doing great.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy ii us mr 2.50 x 38mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified distal stent damage.Distal stent rows 1-3 were damaged with stent struts lifted and pulled proximally.The undamaged crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.The balloon cones were reviewed and no damage was noted to the balloon.The wings of the distal balloon cone were tightly wrapped and evenly folded.The proximal balloon cone folds were bunched in appearance.It did not appear that the balloon had been to positive pressure.A visual and tactile examination found a hypotube kink 470 mm distal from the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion revealed no issues.The device was loaded on a 0.014'' guide wire without issue or resistance.A visual and microscopic examination of the tip identified no tip damage.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
 
Event Description
It was reported that stent damage occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 2.50 x 38 synergy ii drug-eluting stent was advanced to treat the lesion.However, while trying to enter a 5.5fr non-bsc guide extension catheter, the stent got interfered within the guide catheter and a stent strut was lifted.The procedure was completed with another 2.50 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient was doing great.
 
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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 Key7583085
MDR Text Key110583625
Report Number2134265-2018-05026
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840398
UDI-Public08714729840398
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 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/22/2019
Device Model NumberH7493926038250
Device Catalogue Number39260-3825
Device Lot Number0021792729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2018
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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