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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 Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the coronary vessel.A 2.50x38mm synergy drug-eluting stent was advanced to treat the lesion.However, during advancing, the shaft was kinked and broke at about 15cm from the hub, outside the patient's body.The device was removed and the procedure was completed with a 2.50x28mm synergy stent.No patient complications 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 Key9215670
Report Number2134265-2019-12544
Device Sequence Number398559
Product Code NIQ
UDI-Device Identifier08714729840398
UDI-Public08714729840398
Combination Product (Y/N)N
Initial Reporter StateTN
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) 10/21/2019
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 Model Number10607
Device Catalogue Number10607
Device Lot Number0024082525
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/02/2019
Initial Report FDA Received Date10/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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