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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
Model Number H7493942816450
Device Problems Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Additional information: b5: it was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.E1: (b)(6).E3: physician.
 
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.It was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.
 
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.It was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: synergy megatron mr us 4.50 x 16mm stent delivery system (sds), catheter was returned for analysis, the following attributes were examined: stent profile: no stent was returned, the stent was implanted in the patient.Balloon profile: the balloon cones were reviewed, and no issues were noted.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of distal tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a shaft break at the site of the wire exchange port.No other issues were identified during analysis.
 
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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
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 Key14242568
MDR Text Key290453346
Report Number2134265-2022-04930
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985631
UDI-Public08714729985631
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,Followup,Followup
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/12/2022
Device Model NumberH7493942816450
Device Lot Number0027195888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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