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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 10618
Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 3.50 x 16 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.When the device was removed, the edge was found to be lifted.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.A 3.50 x 16 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.When the device was removed, the edge was found to be lifted.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 3.50 x 16 stent delivery system was returned for analysis.Examination of the stent under microscope found stent damage.Stent strut in the distal end lifted from the crimped stent position.The undamaged stent outer diameter was measured using snap gauge and the result is within maximum 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.Examination of the tip found no tip damage.Examination of the hypotube found no issues.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.
 
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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 Key11073665
MDR Text Key224314167
Report Number2134265-2020-18484
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,distri
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/02/2021
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0024286298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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