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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 Known Impact Or Consequence To Patient (2692)
Date of Event 12/03/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery.Following pre-dilation was performed with a 2.5x12mm balloon catheter, a 2.75 x 12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent strut got peeled off.No patient complications nor injuries 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 Key8223316
Report Number2134265-2018-64865
Device Sequence Number263757
Product Code NIQ
UDI-Device Identifier08714729840527
UDI-Public08714729840527
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
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) 01/07/2019
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 Date02/14/2019
Device Model Number10609
Device Catalogue Number10609
Device Lot Number0021781491
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2018
Initial Report FDA Received Date01/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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