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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941828220
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 08/30/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 2.25 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion even after multiple attempts and the stent was found to be mangled.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
SYNERGY XD
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12477027
Report Number2134265-2021-11669
Device Sequence Number3714274
Product Code NIQ
UDI-Device Identifier08714729980759
UDI-Public08714729980759
Combination Product (Y/N)Y
Initial Reporter StateWI
Initial Reporter CountryUS
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 Nurse
Type of Report Initial
Report Date (Section B) 09/15/2021
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 Date11/18/2022
Device Model NumberH7493941828220
Device Lot Number0026428019
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/03/2021
Initial Report FDA Received Date09/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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