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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 10602
Medical Device Problem Codes Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that deflation failure and removal difficulties were encountered.A 3.50 x 16mm synergy ii drug-eluting stent was advanced and deployed.However, during removal of the delivery system, due to deflation issues the balloon flared/winged and telescoped which deformed the tip of the guide catheter.The physician had to remove all the devices and put in a new guide catheter for post-dilatation and the procedure was completed.No patient complications were reported and the patient was fine.
 
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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 Key9623213
Report Number2134265-2020-00302
Device Sequence Number503894
Product Code NIQ
UDI-Device Identifier08714729840121
UDI-Public08714729840121
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/23/2020
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 Date06/17/2021
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0023997660
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/06/2020
Initial Report FDA Received Date01/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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