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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 10609
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 as there was no date provided.Device is a combination product.
 
Event or Problem Description
It was reported that stent damage occurred.After a synergy stent was deployed in the proximal portion of the vessel, a 3.50x12mm synergy stent was advanced but failed to cross the previously deployed stent.The device was removed and the stent appeared to be damaged.No patient complications were reported.
 
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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 Key9213614
Report Number2134265-2019-12416
Device Sequence Number11410340
Product Code NIQ
UDI-Device Identifier08714729840541
UDI-Public08714729840541
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
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) 10/21/2019
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 Date12/04/2020
Device Model Number10609
Device Catalogue Number10609
Device Lot Number0023080407
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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