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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 Entrapment of Device (1212); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/24/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Event date: event date was approximated based on reported information and aware date.Device is a combination product.
 
Event or Problem Description
It was reported that stent dislodgement occurred.A 4.00x38mm synergy ii drug-eluting stent was advanced for treatment.However, it was noted that the stent became stuck in the guidezilla extension guide catheter.When the device was pulled out, it came off the stent delivery system.The dislodged stent was retrieved and another 4.0x38mm stent was used to complete the procedure.No patient complications were reported and the patient's status was okay.
 
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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 Key8073403
Report Number2134265-2018-62925
Device Sequence Number244471
Product Code NIQ
UDI-Device Identifier08714729840435
UDI-Public08714729840435
Combination Product (Y/N)N
Initial Reporter StateWI
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) 11/15/2018
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 Date06/13/2020
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0022272374
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2018
Initial Report FDA Received Date11/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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