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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 10619
Device Problem Fracture (1260)
Patient Problem Ischemia (1942)
Event Date 12/23/2021
Event Type  Injury  
Event Description
It was reported that slow flow occurred. The target lesion was located in the calcified left main (lm) to left anterior descending artery (lad). Following predilatation, a 3. 50 x 20 synergy stent was deployed at nominal pressure. The lesion was post dilated with a 4 x 8mm balloon, and with a proximal optimisation technique (pot) in the lm at nominal 12 atmospheres, but slow flow and a fracture in the proximal end of the stent was noted. Another stent was deployed to cover the fracture. Post stent deployment, the flow was good. Post dilatation was performed with a 4 x 8mm balloon, and the procedure was completed. No further patient complications resulted in relation to this event, and the patient was reported to be good and stable post procedure.
 
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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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13184788
MDR Text Key283394992
Report Number2134265-2021-16537
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0027665042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
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