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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 H7493941832220
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/07/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 30% stenosed target lesion was located in the moderately calcified left anterior descending.The 2.25 x 32 mm synergy xd drug-eluting stent was used for treatment.However, during insertion, the proximal edge of the stent was kinked.The procedure was completed successfully with another 2.25 x 32 mm synergy xd drug-eluting stent.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 Key11682436
Report Number2134265-2021-04964
Device Sequence Number3617480
Product Code NIQ
UDI-Device Identifier08714729980766
UDI-Public08714729980766
Combination Product (Y/N)Y
Initial Reporter StateNC
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 Physician
Type of Report Initial
Report Date (Section B) 04/16/2021
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 Date12/14/2022
Device Model NumberH7493941832220
Device Lot Number0026555988
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/07/2021
Initial Report FDA Received Date04/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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