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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 Difficult to Advance (2920)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/15/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified diagonal branch.After pre-dilation was performed with a 2x12mm emerge balloon catheter.A 2.25 x 12 and a 2.50 x 16 synergy drug-eluting stents were selected for use; but, during insertion, the stents lose wire access.The stents were completely removed from the patient's body.The physician decided not to proceed and aborted the procedure.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 Key10362997
Report Number2134265-2020-09779
Device Sequence Number11417483
Product Code NIQ
UDI-Device Identifier08714729840022
UDI-Public08714729840022
Combination Product (Y/N)N
Initial Reporter StateCA
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) 08/04/2020
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 Date10/22/2021
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0024687499
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/15/2020
Initial Report FDA Received Date08/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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