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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 10601
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Used the first date of the month of the aware date as no event date was provided.Device is a combination product.
 
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a coronary artery.A 2.25 x 12mm synergy stent was deployed for treatment.However, upon removal it was observed that the stent balloon was stuck and it requires too much force to remove.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 Key8454110
Report Number2134265-2019-02997
Device Sequence Number13788435
Product Code NIQ
UDI-Device Identifier08714729840022
UDI-Public08714729840022
Combination Product (Y/N)N
Initial Reporter StateLA
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) 03/26/2019
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 Date10/10/2020
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0022816961
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2019
Initial Report FDA Received Date03/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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