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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 10623
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 80% stenosed, 38mm x 3.0 target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 3.00 x 38 synergy stent was advanced for treatment.However, the proximal part of the stent rubbed against the proximal left anterior descending artery and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent damage occurred.The 80% stenosed, 38mm x 3.0 target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 3.00 x 38 synergy stent was advanced for treatment.However, the proximal part of the stent rubbed against the proximal left anterior descending artery and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluation by mfr.: a synergy ous mr 3.00 x 38mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts in the very proximal region were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within max 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 tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along 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 Key11086509
MDR Text Key224120621
Report Number2134265-2020-18526
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 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2022
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0025195466
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight79
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