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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 H7493941824250
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/11/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified circumflex artery.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for use.However, the proximal shaft broke while trying to advance the stent.The location of the fracture was outside of the patient.The device was completely removed by pulling out the distal part and the procedure was completed with another of the same device.There were no patient complications 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 Key11797847
Report Number2134265-2021-05898
Device Sequence Number3854779
Product Code NIQ
UDI-Device Identifier08714729980827
UDI-Public08714729980827
Combination Product (Y/N)Y
Initial Reporter StateWY
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) 05/10/2021
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 Date11/02/2022
Device Model NumberH7493941824250
Device Lot Number0026344299
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/22/2021
Initial Report FDA Received Date05/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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