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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 10617
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 12/03/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 12mm in length target lesion was located in the moderately tortuous and mildly calcified 2.75mm in diameter mid left anterior descending artery.A 2.75 x 12 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.However, the stent struts were found to be lifted up.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
 
Event Description
It was reported that stent damage occurred.The 12mm in length target lesion was located in the moderately tortuous and mildly calcified 2.75mm in diameter mid left anterior descending artery.A 2.75 x 12 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.However, the stent struts were found to be lifted up.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy ous mr 2.75 x 12mm stent delivery system was returned for analysis.An examination of the crimped stent identified mid-section stent damage with the stent struts lifted from the crimped profile.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found multiple kinks.A examination of the shaft polymer extrusion found no issues.An examination of the tip found no signs of damage.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 Key11241267
MDR Text Key229101208
Report Number2134265-2021-00900
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 04/08/2021
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 Date12/14/2020
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0024005070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
Patient Weight82
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