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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 H7493941832270
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/16/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.The 2.75 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent looked like it was partly off the delivery system and damaged.The procedure was completed with another of the same device.There were no patient complications nor injuries 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 Key12521448
Report Number2134265-2021-12028
Device Sequence Number4221026
Product Code NIQ
UDI-Device Identifier08714729980926
UDI-Public08714729980926
Combination Product (Y/N)Y
Initial Reporter StateTX
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) 09/23/2021
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 Date01/26/2023
Device Model NumberH7493941832270
Device Lot Number0026759312
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/16/2021
Initial Report FDA Received Date09/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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