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

Model Number	H7493942832350
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured, and removal difficulties occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.Following pre-dilatations with 3.00 non-boston scientific balloon catheters, a 3.50 x 32mm synergy megatron drug-eluting stent was advanced in a 6f non-boston scientific (bsc) guide catheter with two wires and a 2.00 x 20 balloon, but it failed to advance the lesion.The stent was removed and noted to be intact.The 2.00 x 20 balloon was removed, and the stent was successfully delivered again across the lesion.However, following the initial inflation at 3-4 atmospheres for minimal seconds, and during deployment, the balloon ruptured.The deflation was instantaneous as the balloon ruptured.Contrast was seen on the angiography, and blood came back into the insufflator.When the balloon was removed, it would not retract back into the non-bsc guide.Subsequently, the balloon was removed in one piece by deep seating the non-bsc guide into the vessel.The 1.50 x 8mm, 2.00 x12mm, and 2.50 x12mm balloon catheters were delivered and the stent was fully expanded, post-dilated with a 3.50 x15 non-compliant balloon.No patient complications were 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: 22075394
• Report Number: 2124215-2025-28421
• Device Sequence Number: 9362984
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: (01)08714729985778(17)260527(10)34260317
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/22/2025

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: 05/27/2026
• Device Model Number: H7493942832350
• Device Catalogue Number: H7493942832350
• Device Lot Number: 0034260317
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 05/27/2024
• 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