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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 10607
Medical Device Problem Codes Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that removal difficulties were encountered and stent damage occurred.The target lesion was located in the right coronary artery.A 3.50x38mm synergy ii drug-eluting stent was advanced for treatment.However, when pulling out the stent through a 7 fr non-bsc guide extension catheter, the stent was stuck.The devices were pulled out and the stent was found bended off the balloon.The procedure was completed with another synergy stent of the same size.No patient complications were reported and the patient's status was stable.
 
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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 Key10219873
Report Number2134265-2020-08088
Device Sequence Number3233753
Product Code NIQ
UDI-Device Identifier08714729840428
UDI-Public08714729840428
Combination Product (Y/N)N
Initial Reporter StateSD
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) 07/01/2020
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 Date11/03/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0024755141
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2020
Initial Report FDA Received Date07/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
7 FR TRAPLINER GUIDE CATHETER
Patient Age47 YR
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