MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON?; CORONARY DRUG-ELUTING STENT

Model Number	H7493942812500
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon removal difficulty occurred.The 90% stenosed target lesion was located in the severely calcified coronary artery.A 5.00 mm x 12 mm synergy megatron coronary drug-eluting stent monorail was selected for use.During withdrawal, it was noted that the balloon would not pull back all the way into the guide catheter.The physician tried to inflate/deflate balloon multiple times of 3-4 atm to try to get the balloon to rewrap, but still unable to withdraw.There was a visible damage on the balloon shoulder, it will not fully deflate.Physician decided to remove the whole system including the sds, guidewire, guide catheter and had to remove the femoral sheath as the balloon would not come out from the guide catheter.Furthermore, the tip of the guide catheter was flared as a result of trying to remove the sds.The rota drive floppy guidewire was able to be removed from the device outside the patient.The procedure was completed with original device.
Additional Manufacturer Narrative
H6: device codes: removed code.
Event or Problem Description
It was reported that balloon removal difficulty occurred.The 90% stenosed target lesion was located in the severely calcified coronary artery.A 5.00mm x 12mm synergy megatron coronary drug-eluting stent monorail was selected for use.During withdrawal, it was noted that the balloon would not pull back all the way into the guide catheter.The physician tried to inflate/deflate balloon multiple times of 3-4 atm to try to get the balloon to rewrap, but still unable to withdraw.There was a visible damage on the balloon shoulder, it will not fully deflate.Physician decided to remove the whole system including the sds, guidewire, guide catheter and had to remove the femoral sheath as the balloon would not come out from the guide catheter.Furthermore, the tip of the guide catheter was flared as a result of trying to remove the sds.The rota drive floppy guidewire was able to be removed from the device outside the patient.The procedure was completed with original device.It was further reported that the procedure was first started off with using a 7f mach1 vl3.5sh guide, but it did not fit well with the patient anatomy.The physician exchanged that guide for 7f mach1 vl3sh guide catheter that was used for the entire procedure until the physician removed everything as a whole from the body.The megatron des was implanted successfully.The balloon was bigger and had more contrast in the indeflator solution.It was deflated for at least 10 seconds with 2 negative pull backs on the balloon before trying to remove the sds system.
Additional Manufacturer Narrative
H6: device codes: removed code device evaluated by manufacturer: the device was returned for analysis.Visual examination identified the stent was not attached.A visual and tactile examination identified no issues along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section noted the extrusion was stretched.Bumper tip showed no signs of distal tip damage.Balloon cones were reviewed.The balloon was pulled in a distally and bunched at the distal section.The inner lumen was detached (starting from 12.1cm from the bumper tip with a length of 8.9cm) but contained within outer lumen.Proximal markerband was pulled proximally from proximal balloon cone.No issues with the distal markerband.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon removal difficulty occurred.The 90% stenosed target lesion was located in the severely calcified coronary artery.A 5.00mm x 12mm synergy megatron coronary drug-eluting stent monorail was selected for use.During withdrawal, it was noted that the balloon would not pull back all the way into the guide catheter.The physician tried to inflate/deflate balloon multiple times of 3-4 atm to try to get the balloon to rewrap, but still unable to withdraw.There was a visible damage on the balloon shoulder, it will not fully deflate.Physician decided to remove the whole system including the sds, guidewire, guide catheter and had to remove the femoral sheath as the balloon would not come out from the guide catheter.Furthermore, the tip of the guide catheter was flared as a result of trying to remove the sds.The rota drive floppy guidewire was able to be removed from the device outside the patient.The procedure was completed with original device.It was further reported that the procedure was first started off with using a 7f mach1 vl3.5sh guide, but it did not fit well with the patient anatomy.The physician exchanged that guide for 7f mach1 vl3sh guide catheter that was used for the entire procedure until the physician removed everything as a whole from the body.The megatron des was implanted successfully.The balloon was bigger and had more contrast in the indeflator solution.It was deflated for at least 10 seconds with 2 negative pull backs on the balloon before trying to remove the sds system.

• Brand Name: SYNERGY MEGATRON?
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22472590
• Report Number: 2124215-2025-44577
• Device Sequence Number: 18118919
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: (01)08714729985600(17)260416(10)33943955
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2026
• Device Model Number: H7493942812500
• Device Catalogue Number: H7493942812500
• Device Lot Number: 0033943955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Race: Black Or African American