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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 Material Deformation (2976)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 3.50 x 24 synergy drug-eluting stent was selected for used.However, during unpacking the surface of the stent strut was not smooth.The procedure was completed with another of the same device.There were no patient complications reported and that the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: a synergy ous mr 3.50 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.Struts along the proximal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is 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 and microscopic 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.A 3.50 x 24 synergy drug-eluting stent was selected for used.However, during unpacking the surface of the stent strut was not smooth.The procedure was completed with another of the same device.There were no patient complications reported and that the patient's status 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 Key11186785
MDR Text Key227522819
Report Number2134265-2021-00412
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 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
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 Number10620
Device Catalogue Number10620
Device Lot Number0025201634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2021
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight79
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