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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10604
Medical Device Problem Codes Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This device is a combination product.Event date was not reported and approximated (b)(6) 2020.
 
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24 synergy drug-eluting stent was advanced for treatment, but failed to cross the lesion.The device was pulled out of the body; however, it was noted that the stent struts were bent.The procedure was later completed.There were no patient complications nor injuries reported and the patient was stable.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9792279
Report Number2134265-2020-02615
Device Sequence Number2330626
Product Code NIQ
UDI-Device Identifier08714729840237
UDI-Public08714729840237
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P150003
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) 03/05/2020
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 Date09/11/2021
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0024466198
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/13/2020
Initial Report FDA Received Date03/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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