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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 10600
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Event date: unknown.
 
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.After a guide wire was advanced in the lesion.A 2.50 x 12mm synergy ii drug-eluting stent (des) and a 3.00 x 8mm synergy ii des were noted to be defective.When the physician advanced the said stents on the wire, he noted that the stents were slightly bent and he felt that it would not cross well.The physician implanted three stents and the procedure was completed.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 Key7840685
Report Number2134265-2018-60695
Device Sequence Number16478399
Product Code NIQ
UDI-Device Identifier08714729839996
UDI-Public08714729839996
Combination Product (Y/N)N
Initial Reporter StateTN
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) 09/02/2018
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 Date06/06/2020
Device Model Number10600
Device Catalogue Number10600
Device Lot Number0022227216
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date09/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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