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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/27/2019
Type of Reportable Event Serious Injury
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 the circumflex artery.A 2.25 x 12 synergy drug-eluting stent was advanced for treatment.However, while trying to cross through stent struts, the stent came off the balloon.The procedure was completed with another of the same device.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 Key9206013
Report Number2134265-2019-12580
Device Sequence Number305351
Product Code NIQ
UDI-Device Identifier08714729840022
UDI-Public08714729840022
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0023973111
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/27/2019
Initial Report FDA Received Date10/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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