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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was advanced for treatment.However, it was noted during withdrawal that the shaft extension broke.The device was removed and the procedure was completed.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 2.25 x 20mm stent delivery system (sds) was returned for analysis.The device was returned without the stent attached.The balloon cones were reviewed, and they were in a deflated state.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a break located at 1mm distal to the distal end of the strain relief as well as 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 shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was advanced for treatment.However, it was noted during withdrawal that the shaft extension broke.The device was removed and the procedure was completed.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 Key10446121
MDR Text Key204182781
Report Number2134265-2020-10800
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 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/09/2020
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0023510348
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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