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

Model Number	H7493942816500
Medical Device Problem Codes	Deflation Problem (1149); Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
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 occurred.The target lesion was located in the right coronary artery.Following normal preparation, a 5.00 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After the stent balloon was inflated at nominal pressure, the balloon was deflated; however, it got stuck within the stent and had to pull hard to get the balloon out.Multiple attempts were made to deflate and pull the device, but the balloon remained stuck in the stent.Additional force was applied and the guide catheter was pulled out along with the balloon.A new guide catheter and an alternate device were used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis cannot be performed.Device history record (dhr) 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 as well as unavailability of the device for analysis.After the stent balloon was inflated at nominal pressure, the balloon was deflated; however, it got stuck within the stent and had to pull hard to get the balloon out.Multiple attempts were made to deflate and pull the device, but the balloon remained stuck in the stent.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located in the right coronary artery.Following normal preparation, a 5.00 x 16mm synergy megatron drug-eluting stent was advanced for treatment.After the stent balloon was inflated at nominal pressure, the balloon was deflated; however, it got stuck within the stent and had to pull hard to get the balloon out.Multiple attempts were made to deflate and pull the device, but the balloon remained stuck in the stent.Additional force was applied and the guide catheter was pulled out along with the balloon.A new guide catheter and an alternate device were used to complete the procedure.There were no patient complications.It was further reported that the target lesion was moderately tortuous and severely calcified.The stent was successfully deployed, and the balloon deflated slowly.

• 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: 24731803
• Report Number: 2124215-2026-17298
• Device Sequence Number: 16014730
• 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): 09/10/2026

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: H7493942816500
• Device Catalogue Number: H7493942816500
• Device Lot Number: 0035355636
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• 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: 04/09/2026; 08/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/04/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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
• Patient Sex: Unknown