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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10621
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/17/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is a combination product.
 
Event or Problem Description
It was reported that a stent damage occurred.The target lesion was located in the right coronary artery.A 5.00 x 28 synergy ii drug-eluting stent was advanced through a 6f guidezilla ii guide extension catheter.However, the stent struts were damaged by the guidezilla.The physician has been advised that a 4.5/5.0 will not advanced through a 6f guidezilla ii.The device was removed and another 5.0 stent was advanced and completed the procedure.No patient complications were reported and the patient's status was stable.
 
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Brand Name
SYNERGY
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8734215
Report Number2134265-2019-07341
Device Sequence Number19476173
Product Code NIQ
UDI-Device Identifier08714729973461
UDI-Public08714729973461
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P150003/S039
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/26/2019
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 Date11/04/2020
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0022909123
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2019
Initial Report FDA Received Date06/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
6FR GUIDEZILLA II
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