MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON?; coronary drug-eluting stent

Model Number	H7493942824500
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device issues occurred requiring additional intervention.The target lesion was located in the tortuous and heavily calcified right coronary artery.After placement of two guide catheters and two guidewires, pre-dilatation was performed using multiple balloons.A 5.00 x 24mm synergy megatron drug-eluting stent (des) was introduced but after the stent was implanted, deflation issues occurred, multiple negative deflations were performed, however, when removing the catheter from the stent, the catheter broke off inside the patient and had to be retrieved with a snare.The procedure was completed with an alternate device.There were no patient complications and the patient fully recovered.
Event or Problem Description
It was reported that device issues occurred requiring additional intervention.The target lesion was located in the tortuous and heavily calcified right coronary artery.After placement of two guide catheters and two guidewires, pre-dilatation was performed using multiple balloons.A 5.00 x 24mm synergy megatron drug-eluting stent (des) was introduced but after the stent was implanted, deflation issues occurred, multiple negative deflations were performed, however, when removing the catheter from the stent, the catheter broke off inside the patient and had to be retrieved with a snare.The procedure was completed with an alternate device.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not 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 based on the available information.It was reported that device issues occurred requiring additional intervention.Multiple negative deflations were performed, however, when removing the catheter from the stent, the catheter broke off inside the patient and had to be retrieved with a snare.As per ifu the user should allow a minimum of 30 seconds for larger balloon to achieve completed deflation.Without the additional information or analysis of the device a clear conclusion of the deflation issue cannot be established.The break within the catheter was likely caused by an excessive force having been applied during removal attempts.

• 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 ; +1(612)875-7234
• MDR Report Key: 24715424
• Report Number: 2124215-2026-16977
• Device Sequence Number: 17583249
• Product Code: NIQ
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: H7493942824500
• Device Catalogue Number: H7493942824500
• Device Lot Number: 0036663882
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 08/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/13/2026; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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 Age: 78 YR
• Patient Sex: Male