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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 Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/30/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in a calcified coronary artery.A 3.50 x 16 synergy drug-eluting stent was selected for use.However, prior to placement inside the vessel, it was noted that the stent dislodged from the balloon.The procedure was completed with a new synergy stent.There were no patient complications nor injuries 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 Key10283678
Report Number2134265-2020-08987
Device Sequence Number16860074
Product Code NIQ
UDI-Device Identifier08714729840121
UDI-Public08714729840121
Combination Product (Y/N)N
Initial Reporter StateTX
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 Nurse
Type of Report Initial
Report Date (Section B) 07/16/2020
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 Date01/26/2022
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0025171790
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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