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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 10603
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/23/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the circumflex artery.Three synergy drug-eluting stents with sizes 2.75 x 20, 2.75x28mm, 3.0x16mm were simultaneously used for treatment.However, it was noted that the stent struts flared for all devices while trying to enter the artery.The devices were removed and the procedure was completed with another synergy stent.No known 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 Key10419357
Report Number2134265-2020-10228
Device Sequence Number11777186
Product Code NIQ
UDI-Device Identifier08714729840169
UDI-Public08714729840169
Combination Product (Y/N)N
Initial Reporter StateOH
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) 08/18/2020
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 Date03/25/2021
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0023589319
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2020
Initial Report FDA Received Date08/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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