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

Model Number	H7493942824450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The tight lesion was located in the calcified coronary artery.A shockwave was used to pretreat the lesion, followed by predilatation with a 3.5x12 nc emerge balloon catheter.A 4.50 x 24mm synergy megatron drug-eluting stent was then selected for treatment.However, during the initial inflation at 5 atmospheres for about 2 seconds, the balloon ruptured.The procedure was successfully completed with a non-boston scientific device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 4.50 x 24mm was returned for analysis.A visual and tactile inspection identified no issues with the hypotube shaft.No stent was returned for analysis.Due to the stent was not returned, a review of the manufacturing stent profile data was performed, and the maximum stent od of units released of this batch was 0.0539-inch within max crimped stent profile measurement.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified a pinhole in the balloon.A pinhole was located in the balloon material at 1mm proximal to the distal markerband.Bumper tip showed signs of distal tip damage.A microscopic examination of the markerbands identified no damage.A leakage testing was performed.The device was attached to an encore inflation unit.A pinhole was located in the balloon material above the proximal markerband when inflating to rated burst pressure of 16 atmospheres.The encore device was verified before and after use using the druck gauge.
Event or Problem Description
It was reported that balloon rupture occurred.The tight lesion was located in the calcified coronary artery.A shockwave was used to pretreat the lesion, followed by predilatation with a 3.5x12 nc emerge balloon catheter.A 4.50 x 24mm synergy megatron drug-eluting stent was then selected for treatment.However, during the initial inflation at 5 atmospheres for about 2 seconds, the balloon ruptured.The procedure was successfully completed with a non-boston scientific device, and 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: 21798380
• Report Number: 2124215-2025-21616
• Device Sequence Number: 15575427
• Product Code: NIQ
• UDI-Device Identifier: 08714729985716
• UDI-Public: (01)08714729985716(17)260403(10)33852444
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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): 06/16/2025

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: 04/03/2026
• Device Model Number: H7493942824450
• Device Catalogue Number: H7493942824450
• Device Lot Number: 0033852444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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