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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 85% stenosed, 38mm x 4.0mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery (rca).A 4.00 x 38 synergy drug-eluting stent was advanced for treatment.However, the stent rubbed against the lesion when crossing the proximal end of rca and the stent struts were lifted up.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 4.00 x 38mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the mid-section lifted and pulled.The undamaged crimped stent outer diameter was measured 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 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 85% stenosed, 38mm x 4.0mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery (rca).A 4.00 x 38 synergy drug-eluting stent was advanced for treatment.However, the stent rubbed against the lesion when crossing the proximal end of rca and the stent struts were lifted up.The procedure was completed with another of the 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 Key11084326
MDR Text Key224075305
Report Number2134265-2020-18516
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 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0025188365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received12/28/2020
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight79
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