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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 Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/01/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occurred.Following pre-dilatation with a 2.5x20mm balloon catheter, a 2.75 x 38 synergy drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent was damaged.No patient complications nor injuries 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 Key11433388
Report Number2134265-2021-02922
Device Sequence Number3523234
Product Code NIQ
UDI-Device Identifier08714729840404
UDI-Public08714729840404
Combination Product (Y/N)Y
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/08/2021
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 Date12/18/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0025002746
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/01/2021
Initial Report FDA Received Date03/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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