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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 Failure to Advance (2524)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/06/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that procedural delay was encountered.The target lesion was located in a coronary artery.A 3.00 x 38 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion.It took a while to try to cross the lesion which made the case go longer.No complications nor injuries were reported.No further information available.
 
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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 Key10763150
Report Number2134265-2020-14730
Device Sequence Number3336239
Product Code NIQ
UDI-Device Identifier08714729840411
UDI-Public08714729840411
Combination Product (Y/N)N
Initial Reporter StateSD
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/30/2020
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 Expiration Date08/06/2022
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0025854556
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/13/2020
Initial Report FDA Received Date10/30/2020
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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