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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
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: the date of event is unknown.Boston scientific became aware of the event on (b)(6) 2021.Therefore a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
 
Event Description
It was reported that a stent fracture occurred.A percutaneous coronary intervention (pci) was performed on the right coronary artery (rca) ostium.After non boston scientific guidewires crossed the lesion, a 4.5 x 8 nc emerge was advanced to predilate the target lesion at 13 atmospheres for 20 seconds.Following predilitation, a 4.00 x 24 synergy megatron was advanced to the target lesion, inflated at 14 atmospheres for 30 seconds, and deployed.Following stent deployment, a 4.5 x 12 nc emerge was advanced to post dilate the target lesion and was inflated at 14 atmospheres for 20 seconds.A stent fracture was noted.Another synergy megatron was deployed to cover the fracture and successfully complete the procedure.No further patient complications were reported in relation to this event.
 
Manufacturer Narrative
B3: date of event: the date of event is unknown.Boston scientific became aware of the event on 16feb2021.Therefore a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
 
Event Description
It was reported that a stent fracture occurred.A percutaneous coronary intervention (pci) was performed on the right coronary artery (rca) ostium.After non boston scientific guidewires crossed the lesion, a 4.5 x 8 nc emerge was advanced to predilate the target lesion at 13 atmospheres for 20 seconds.Following predilitation, a 4.00 x 24 synergy megatron was advanced to the target lesion, inflated at 14 atmospheres for 30 seconds, and deployed.Following stent deployment, a 4.5 x 12 nc emerge was advanced to post dilate the target lesion and was inflated at 14 atmospheres for 20 seconds.A stent fracture was noted.Another synergy megatron was deployed to cover the fracture and successfully complete the procedure.No further patient complications were reported in relation to this event.It was further reported that 60 to 80% stenosed target lesion, with moderate angulation, was located in the mildly calcified and moderately tortuous proximal rca.A semi complaint balloon was used to prepare the lesion.Post dilation, the lesion was 30 to 60 percent stenosed.It was noted that the fracture occurred at the time of implant.It was noted during angio, a non boston scientific stent visualization tool was used to identify the fracture.The patient was reported to be good following the procedure.
 
Manufacturer Narrative
B3: date of event: the date of event is unknown.Boston scientific became aware of the event on (b)(6) 2021.Therefore a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.Media evaluated by mfr:the device was not returned for analysis and is not expected to return as the device was implanted.3 photos from the angiographic procedure were provided and reviewed by medial safety.The first digital subtraction still image show a stent with an apparent gap in scaffolding in its proximal portion.Stent material appears continuous in the superior and inferior margins of the stent.The stent is shown deployed on a bend traversed by 2 guidewires.Two markerbands consistent with a balloon catheter (but shorter than the stent delivery balloon are seen within the stent as well.The proximal marker band appears adjacent to the scaffold gap.The second subtracted still image shows increased density in the midportion of the stent consistent with deployment of a stent within a stent.The scaffolding gap is no longer evident.The stent is still traversed by 2 guidewires, two balloon catheter markerbands and the guide catheter tip are evident as well.The 3rd still image is an angiogram likely following the first stent deployment.There is a band of haziness in a tortuous bend that appears consistent with the scaffold gap.
 
Event Description
It was reported that a stent fracture occurred.A percutaneous coronary intervention (pci) was performed on the right coronary artery (rca) ostium.After non boston scientific guidewires crossed the lesion, a 4.5 x 8 nc emerge was advanced to predilate the target lesion at 13 atmospheres for 20 seconds.Following predilitation, a 4.00 x 24 synergy megatron was advanced to the target lesion, inflated at 14 atmospheres for 30 seconds, and deployed.Following stent deployment, a 4.5 x 12 nc emerge was advanced to post dilate the target lesion and was inflated at 14 atmospheres for 20 seconds.A stent fracture was noted.Another synergy megatron was deployed to cover the fracture and successfully complete the procedure.No further patient complications were reported in relation to this event.It was further reported that 60 to 80% stenosed target lesion, with moderate angulation, was located in the mildly calcified and moderately tortuous proximal rca.A semi complaint balloon was used to prepare the lesion.Post dilation, the lesion was 30 to 60 percent stenosed.It was noted that the fracture occurred at the time of implant.It was noted during angio, a non boston scientific stent visualization tool was used to identify the fracture.The patient was reported to be good following the procedure.
 
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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 Key11386322
MDR Text Key233793560
Report Number2134265-2021-02170
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,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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