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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 H7493941828250
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/11/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 95% stenosed target lesion was located in the non-tortuous and non-calcified first obtuse marginal artery.A 2.50 x 28mm synergy xd drug-eluting stent was advanced for treatment.Inflation was performed at 16 atmospheres for 15 seconds.However, during withdrawal, it was noticed that the balloon felt like it was sticking to the inside of the stent and was difficult to remove.The balloon was fully deflated and was able to be removed intact.The procedure was completed with the original 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 Key11614875
Report Number2134265-2021-03460
Device Sequence Number19622967
Product Code NIQ
UDI-Device Identifier08714729980834
UDI-Public08714729980834
Combination Product (Y/N)Y
Initial Reporter StateMI
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) 04/05/2021
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 NumberH7493941828250
Device Lot Number0026429956
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/11/2021
Initial Report FDA Received Date04/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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