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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 10632
Device Problems Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Event Description
It was reported that foreign material was found on the device.A 3.00 x 48 synergy drug-eluting stent was selected for treatment.However, during preparation, a piece of metal sticking out of the stent was noticed.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Event Description
It was reported that foreign material was found on the device.A 3.00 x 48 synergy drug-eluting stent was selected for treatment.However, during preparation, a piece of metal sticking out of the stent was noticed.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy ous mr 3.00 x 48 mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts from the distal stent region were noted to be lifted and pulled distally.The undamaged stent outer diameter was measured 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.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.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 Key10885966
MDR Text Key219154713
Report Number2134265-2020-16295
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 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/08/2021
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0024294168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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