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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0025449727
Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
It was reported that failure to cross the lesion and shaft break occurred.A 4.50 x 20mm synergy megatron was advanced but would not cross the lesion.It was noted that the stent was broken.The procedure was completed.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Correction: b5: describe event or problem: from: it was reported that failure to cross the lesion and shaft break occurred.To: it was reported that failure to cross a lesion and a stent break occurred.H6: from: break (1069) to: material deformation (a0406).
 
Event Description
It was reported that failure to cross the lesion and stent break occurred.A 4.50 x 20mm synergy megatron was advanced but would not cross the lesion.It was noted that the stent was broken.The procedure was completed.No patient complications were reported in relation to this event.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11267322
MDR Text Key229897358
Report Number2134265-2021-01115
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Lot Number0025449727
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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