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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 10621
Device Problems Material Rupture (1546); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture and stent damage occurred.A 3.50 x 28 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the balloon ruptured and the stent was deformed.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no information was provided.
 
Event Description
It was reported that balloon rupture and stent damage occurred.A 3.50 x 28 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the balloon ruptured and the stent was deformed.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no information was provided.Device evaluated by mfr.: synergy ous mr 3.50 x 28 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the proximal stent region were noted to be lifted from their crimped position 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 length of 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.The device was loaded without issues on a 0.014 inch test guidewire.The device was functionally tested with an encore inflation device being attached to the inflation hub and the balloon was inflated without issues and held pressure to 16 atm.A vacuum was pulled using the encore device and the balloon delated fully within 15 seconds.The encore device was verified before and after the procedure.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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key13385434
MDR Text Key284879345
Report Number2134265-2022-00804
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/07/2022
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 Date02/24/2023
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0026918725
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received09/02/2022
Supplement Dates FDA Received09/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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