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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 Consequences Or Impact To Patient (2199)
Date of Event 04/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The event date was note reported.The first date of the month of the aware date was entered as an estimate.Device is a combination product.
 
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a tortuous and calcified vessel.Following pre-dilatation with a 2.5 x 15mm apex balloon catheter, a 3.00 x 20 synergy drug-eluting stent was advanced for treatment but failed to cross.Upon removal, it was noted that the stent developed a burr.There were no patient complications 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 Key10086845
Report Number2134265-2020-06974
Device Sequence Number2465103
Product Code NIQ
UDI-Device Identifier08714729840176
UDI-Public08714729840176
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/26/2020
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 Date10/09/2021
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0024609759
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/27/2020
Initial Report FDA Received Date05/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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