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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 H7493941816450
Medical Device Problem Code Difficult to Remove (1528)
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 removal difficulties were encountered.The 80% stenosed target lesion was located in a non-tortuous and moderately calcified vessel.A 4.50 x 16mm synergy xd drug-eluting stent was advanced to treat the lesion.However, after deploying the stent, the fully deflated balloon was difficult to withdraw from the stent.The balloon was removed by pulling back on catheter shaft.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 Key11735655
Report Number2134265-2021-04967
Device Sequence Number17251663
Product Code NIQ
UDI-Device Identifier08714729981190
UDI-Public08714729981190
Combination Product (Y/N)Y
Initial Reporter StateMS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 04/27/2021
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 Date01/04/2023
Device Model NumberH7493941816450
Device Lot Number0026599594
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/07/2021
Initial Report FDA Received Date04/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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