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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 10606
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code Thrombosis (2100)
Date of Event 10/05/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that acute stent thrombosis occurred.A 4.00 x 32 synergy ii drug-eluting stent was implanted for treatment.However, stent thrombosis occurred within the hour after leaving the procedure room.The patient had the therapeutic range for activated clotting time during the case as well as plavix or brillanta and aspirin medications on board.The patient was brought into the lab and the stent thrombosis was removed.No further patient complications were reported and the patient's status 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 Key10830810
Report Number2134265-2020-15491
Device Sequence Number14179091
Product Code NIQ
UDI-Device Identifier08714729840374
UDI-Public08714729840374
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/12/2020
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 Date08/06/2021
Device Model Number10606
Device Catalogue Number10606
Device Lot Number0024287250
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2020
Initial Report FDA Received Date11/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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