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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10600
Medical Device Problem Codes Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/06/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in a moderately tortuous and moderately calcified coronary artery.A 2.25 x 8 synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent did not cross the lesion and was too damaged to be used as the stent struts were lifted.No complications were reported and the patient status was stable.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12196442
Report Number2134265-2021-09285
Device Sequence Number11660291
Product Code NIQ
UDI-Device Identifier08714729839965
UDI-Public08714729839965
Combination Product (Y/N)Y
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/20/2021
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
Operator of Device Health Professional
Device Expiration Date01/06/2022
Device Model Number10600
Device Catalogue Number10600
Device Lot Number0025057959
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2021
Initial Report FDA Received Date07/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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