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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 10605
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code Thrombosis (2100)
Date of Event 10/30/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent thrombosis occurred.The target lesion was located in a coronary artery.A 2.50 x 28 synergy drug-eluting stent was placed for treatment.However, it was noted that the stent became clotted off.The activated clotting time was above 300 and the clot formed during the time of the 2nd stent placement.The procedure was completed and no patient complications were reported and the patient was unharmed.
 
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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 Key10870960
Report Number2134265-2020-16058
Device Sequence Number2549361
Product Code NIQ
UDI-Device Identifier08714729840275
UDI-Public08714729840275
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) 11/19/2020
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 Date01/14/2021
Device Model Number10605
Device Catalogue Number10605
Device Lot Number0023221296
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/02/2020
Initial Report FDA Received Date11/19/2020
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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