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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 10607
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date since event date was not provided.Device is a combination product.
 
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, when it was removed for predilation, the struts were deformed.No further information available.
 
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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 Key10312271
Report Number2134265-2020-09741
Device Sequence Number3462747
Product Code NIQ
UDI-Device Identifier08714729840398
UDI-Public08714729840398
Combination Product (Y/N)N
Initial Reporter StateMI
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 Other
Type of Report Initial
Report Date (Section B) 07/22/2020
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 Date10/28/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0024727595
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2020
Initial Report FDA Received Date07/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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