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

Model Number	H7493942816500
Medical Device Problem Codes	Material Rupture (1546); Failure to Unfold or Unwrap (1669); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported vis medsun (b)(4) that balloon rupture occurred requiring additional surgery.The patient presented for a right heart percutaneous, patent ductus arteriosus, stenting procedure.The 5.00 x 16mm synergy megatron was advanced for treatment.During the procedure, the stent delivery system balloon ruptured resulting in a lack of deployment of the stent.The stent remained im the left subclavian artery.The patient became severely cyanotic and was emergently transferred to the operating room for life saving intervention.The patient was returned to the operating room for removal of the retained stent and for vascular rep.
Additional Manufacturer Narrative
B3 date of event was estimated based on reported event date of july 2025.
Event or Problem Description
It was reported vis medsun (b)(4) that balloon rupture occurred requiring additional surgery.The patient presented for a right heart percutaneous, patent ductus arteriosus, stenting procedure.The 5.00 x 16mm synergy megatron was advanced for treatment.During the procedure, the stent delivery system balloon ruptured resulting in a lack of deployment of the stent.The stent remained im the left subclavian artery.The patient became severely cyanotic and was emergently transferred to the operating room for life saving intervention.The patient was returned to the operating room for removal of the retained stent and for vascular rep.
Additional Manufacturer Narrative
B3 date of event was estimated based on reported event date of july 2025.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 wasnot 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 traced to intentional off-label, unapproved, or contraindicated use as the use of this coronary stent to attempt to treat patent ductus arteriosus.Per instructions for use the synergy megatron is a coronary stent system, intended to treat coronary artery stenosis, however per information provided this synergy megatron device was selected treat patent ductus arteriosus which is an abnormal connection between the aorta and the pulmonary artery and not a coronary artery.

• 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: 24675410
• Report Number: 2124215-2026-16090
• Device Sequence Number: 10108841
• Product Code: NIQ
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493942816500
• Device Catalogue Number: H7493942816500
• Device Lot Number: 0035355636
• Was Device Available for Evaluation?: No
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 28 LB
• Patient Race: Black Or African American