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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
Device Problem Obstruction of Flow (2423)
Patient Problems Atrial Fibrillation (1729); Thrombosis/Thrombus (4440)
Event Date 07/07/2022
Event Type  Injury  
Event Description
It was reported that acute thrombosis and atrial fibrillation occurred.The target lesion was located in the left anterior descending (lad) artery.A non-boston scientific (bsc) stent was implanted in the distal lad and a 2.25 synergy drug-eluting stent was implanted in the proximal lad.However, angiogram showed acute stent thrombosis in lad with an unknown cause.The patient fibrillated and was shocked back into rhythm.The procedure was completed by placing another 2.25 stent in the proximal lad.No further patient complications reported.The patient recovered and was discharged.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15095405
MDR Text Key296503625
Report Number2134265-2022-07990
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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