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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 10620
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified proximal right coronary artery.After deploying a 3.50x24mm synergy drug-eluting stent, an nc quantum balloon catheter was advanced for post-dilation.However upon removal of the balloon, it was noticed that half of the stent came out together with the balloon.Another synergy stent was then used, overlapping the remaining half that was left in the artery and the procedure was completed.No further patient complications were reported and the patient was discharged in stable condition.
 
Event Description
It was reported that stent fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified proximal right coronary artery.After deploying a 3.50x24mm synergy drug-eluting stent, an nc quantum balloon catheter was advanced for post-dilation.However upon removal of the balloon, it was noticed that half of the stent came out together with the balloon.Another synergy stent was then used, overlapping the remaining half that was left in the artery and the procedure was completed.No further patient complications were reported and the patient was discharged in stable condition.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the stent delivery system was not returned for analysis.The damaged stent was returned on a pig-tail mandrel with stent protector.An examination (visual and via scope) of the stent found the entire length of the stent damaged and stretched.There was no evidence that the stent had fractured.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 Key8499152
MDR Text Key141449075
Report Number2134265-2019-03591
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 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/10/2019
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0022283970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON CATHETER: NC QUANTUM; BALLOON CATHETER: NC QUANTUM; BALLOON CATHETER: NC QUANTUM
Patient Outcome(s) Required Intervention;
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