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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 Problems Fracture (1260); Activation Failure (3270); Migration (4003)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event - estimated based on aware date of (b)(6) 2021.
 
Event Description
It was reported that stent insufficient apposition and migration occurred.A percutaneous coronary intervention was being performed on a lesion in the right coronary artery (rca).A 4.00mm x 24mm synergy megatron stent was misplaced at the rca ostium.No further intervention was performed at that time.Six months after implantation, the physician decided to remove part of the synergy megatron stent.A 4.0mm non-compliant balloon was passed through the stent from the side close to the rca ostium and flipped to the side.The proximal half of the stent was then grabbed by an ensnare 12-20mm and pulled into a 7f guiding catheter.The proximal half of the stent broke loose due to its two link design.The ostial part of the vessel was reinforced with a new 4.5mm x 12mm synergy megatron perfectly placed at the rca ostium.
 
Event Description
It was reported that stent insufficient apposition and migration occurred.A percutaneous coronary intervention was being performed on a lesion in the right coronary artery (rca).A 4.00mm x 24mm synergy megatron stent was misplaced at the rca ostium.No further intervention was performed at that time.Six months after implantation, the physician decided to remove part of the synergy megatron stent.A 4.0mm non-compliant balloon was passed through the stent from the side close to the rca ostium and flipped to the side.The proximal half of the stent was then grabbed by an ensnare 12-20mm and pulled into a 7f guiding catheter.The proximal half of the stent broke loose due to its two link design.The ostial part of the vessel was reinforced with a new 4.5mm x 12mm synergy megatron perfectly placed at the rca ostium.It was later reported that the event was 100% due to implanting failure and not a material complaint.It was noted that the physician decided to resolve the implanting failure six months after the implantation by removing part of the megatron.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
B3: date of event - estimated based on aware date of (b)(6) 2021.Device/media analysis: the device was not returned for analysis and is not expected to return as the device was disposed.Two angio images with text description were attached to the complaint record.Per text:the ostial flush- what does not fit is made to fit.A synergy megatron 4.0/24 des was misplaced at the rca ostium hanging half way into the aorta.After 3 months the stent was passed through the cells from the side close to the rca ostium and flipped to the side by a 4.0 nc balloon, the proximal half of the stent broke loose due to its two link design and the ostial part of the vessel was reinforced with a new megatron 4.5/12 perfectly placed at the rcs ostium.The first image appears to show the synergy megatron 4.0x24 deployed at the rca ostium and extending into the aorta.The second image appears to show an inflated dilation balloon which had been placed through the side of the deployed stent and into the ostium as described in the text.
 
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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 Key11207164
MDR Text Key227928820
Report Number2134265-2021-00454
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
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 Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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