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

Model Number	H7493942820500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 20mm synergy megatron? drug-eluting stent was successfully deployed.However, upon removal of the catheter, it was noticed that the shaft of the balloon was broken.The device was removed.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 20mm synergy megatron? drug-eluting stent was successfully deployed.However, upon removal of the catheter, it was noticed that the shaft of the balloon was broken.The device was removed.No patient complications were reported.It was further reported via medwatch mw5175460 that the target lesion was located in the right renal artery.Following deployment, the stent balloon was inflated and subsequently became stuck in a 6f non-boston scientific guiding catheter.A piece of the balloon was broken off in the hypotube.The broken piece was successfully removed from the patient.Another sheath was placed in the right femoral artery.The patient remained stable throughout the procedure and was transferred to the post-care unit.

• 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: 23052883
• Report Number: 2124215-2025-63209
• Device Sequence Number: 9504107
• Product Code: NIQ
• UDI-Device Identifier: 08714729985686
• UDI-Public: (01)08714729985686(17)260605(10)34246305
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2026
• Device Model Number: H7493942820500
• Device Catalogue Number: H7493942820500
• Device Lot Number: 0034246305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 06/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female