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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 09/04/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 2.25 x 20mm synergy ii drug-eluting stent was selected for use.After the device was flushed and prepped, it was tried to advance onto the wire.However, it was noticed that the stent was damaged.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 2.25 x 20 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the mid stent region were noted to be lifted from their crimped position and pulled distally.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found a kink measured at 210 mm distal to the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.A 2.25 x 20mm synergy ii drug-eluting stent was selected for use.After the device was flushed and prepped, it was tried to advance onto the wire.However, it was noticed that the stent was damaged.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10544105
MDR Text Key207332866
Report Number2134265-2020-12840
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2021
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0024627449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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