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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
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 removal difficulty and shaft break occurred requiring additional intervention.The target lesion was located in a mildly tortuous coronary artery.After pre dilation of the lesion, a 5.00 x 20mm synergy megatron? drug-eluting stent was deployed.During withdrawal of the balloon catheter, it was observed that the balloon would not exit the stent.Inflation of the balloon to 8 atm was performed, after which deflation and another attempt to withdraw were made.The balloon still could not be removed from the stent into a non-boston scientific guide catheter.Additional inflations were performed two or three more times to remove all contrast from the balloon.Partial withdrawal was then achieved, and the balloon was advanced approximately halfway into the guide catheter, however; the stent shaft fractured within the guide catheter.Snaring was used to remove all the fragments and the procedure was completed.No patient complications were reported.The patient has fully recovered.

• 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: 25520936
• Report Number: 2124215-2026-32040
• Device Sequence Number: 13265461
• Product Code: NIQ
• UDI-Device Identifier: 08714729985686
• UDI-Public: (01)08714729985686(17)270908(10)37497178
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 07/20/2026

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 Model Number: H7493942820500
• Device Catalogue Number: H7493942820500
• Device Lot Number: 0037497178
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/20/2026
• Date Device Manufactured: 09/08/2025
• 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 Sex: Unknown