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

Model Number	H7493942816400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole occurred.The target lesion was located in the coronary artery.A 26 encore inflator device was inserted.A 4.00 x 16mm synergy megatron? drug-eluting stent was advanced and attempted to inflate but no pressure was achieved by the inflator device.The stent was subsequently removed.However, upon inflation outside the patient, a distal shaft hole was noticed.The procedure was completed with another synergy megatron des.There were no patient complications reported, and the patient has fully recovered.
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.
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.Investigation results: device analysis findings: the device was disposed and will not be returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established as it is most likely that due to the absence of the returned device and insufficient information regarding device handling and procedural conditions, a definitive cause cannot be established, and no further investigation required at this time.
Event or Problem Description
It was reported that shaft hole occurred.The target lesion was located in the coronary artery.A 26 encore inflator device was inserted.A 4.00 x 16mm synergy megatron? drug-eluting stent was advanced and attempted to inflate but no pressure was achieved by the inflator device.The stent was subsequently removed.However, upon inflation outside the patient's body, a distal shaft hole was noticed.The procedure was completed with another synergy megatron des.There were no patient complications reported, and 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: 24344775
• Report Number: 2124215-2026-08484
• Device Sequence Number: 15911812
• Product Code: NIQ
• UDI-Device Identifier: 08714729985624
• UDI-Public: (01)08714729985624(17)270526(10)36692563
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/14/2026

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 Model Number: H7493942816400
• Device Catalogue Number: H7493942816400
• Device Lot Number: 0036692563
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 05/26/2025
• 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
• Patient Sex: Unknown