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

Model Number	H7493942828500
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 28 mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, a non-boston scientific (bsc) guide extension was used and it was found that it does not have a large inner lumen which led the stent had difficulty to delivered through the lesion.The shaft was broken within the guide extension.The device was simply removed, and the procedure was completed with the original device without any patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device synergy megatron mr us 5.00 x 28mm stent delivery system was returned to the complaint investigation site (cis).Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified multiple kinks along the length of the hypotube shaft.The distal shaft was separated at the port exchange and was returned stuck inside a guide catheter.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The stent was not returned as it had been delivered.Bumper tip showed no signs of distal tip damage.The allegation in the complaint is confirmed.
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 28mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, a non-boston scientific (bsc) guide extension was used and it was found that it does not have a large inner lumen which led the stent had difficulty to delivered through the lesion.The shaft was broken within the guide extension.The device was simply removed, and the procedure was completed with the original device without any patient complications reported.

• 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: 21684122
• Report Number: 2124215-2025-17887
• Device Sequence Number: 21037723
• Product Code: NIQ
• UDI-Device Identifier: 08714729985761
• UDI-Public: (01)08714729985761(17)250904(10)32441038
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 09/04/2025
• Device Model Number: H7493942828500
• Device Catalogue Number: H7493942828500
• Device Lot Number: 0032441038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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 Sex: Unknown