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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thrombosis (2100); Sudden Cardiac Death (2510)
Event Date 08/23/2018
Event Type  Death  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that subacute thrombosis and death occurred. The de novo target lesion was located in the left anterior descending artery. The 2. 75 x 16 mm synergy stent was implanted successfully and was considered well positioned and well apposed. There was no vessel dissection or perforation. The patient was under observation for nine days and after that the patient died suddenly of cardiac arrest.
 
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that subacute thrombosis and death occurred. The de novo target lesion was located in the left anterior descending artery. The 2. 75 x 16 mm synergy stent was implanted successfully and was considered well positioned and well apposed. There was no vessel dissection or perforation. The patient was under observation for nine days and after that the patient died suddenly of cardiac arrest it was further reported that lesion was 80-90% stenosed with mild tortuosity and mild calcification. Chest pain lead to the discovery of the thrombosis. The thrombosis was under physician observation. The patient was on standard antiplatelet therapy.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7914297
MDR Text Key121882246
Report Number2134265-2018-61283
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/29/2019
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0021381248
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2018 Patient Sequence Number: 1
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