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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 10606
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as there was no date provided.
 
Event or Problem Description
It was reported that stent damage occurred.A 4.00 x 32mm synergy ii des was selected for use; however, before entering the body, it was noticed that the stent was damaged.The procedure was completed with a new stent.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 Key8386042
Report Number2134265-2019-01828
Device Sequence Number13550578
Product Code NIQ
UDI-Device Identifier08714729840374
UDI-Public08714729840374
Combination Product (Y/N)N
Initial Reporter StateMO
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) 03/04/2019
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 Date02/22/2019
Device Model Number10606
Device Catalogue Number10606
Device Lot Number21800170
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2019
Initial Report FDA Received Date03/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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