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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 10621
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 99% stenosed, eccentric, de novo target lesion was located in the severely calcified artery.The lesion contained >=90 degrees bend.Following pre-dilation, a 2.25 x 28 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and found the tip of the stent itself was deformed.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 2.25 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured using snap gauge and the result was 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 found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section 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.The 99% stenosed, eccentric, de novo target lesion was located in the severely calcified artery.The lesion contained >=90 degrees bend.Following pre-dilation, a 2.25 x 28 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and found the tip of the stent itself was deformed.The procedure was completed with another of same device.There were no patient complications reported and the patient 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 Key11241108
MDR Text Key229109568
Report Number2134265-2021-00899
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 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2021
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0024897503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2021
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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