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

Lot Number	0032127287
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that stent fracture occurred.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified vessel.When the 4.50 x 16mm synergy megatron mr drug eluting stent was inserted to treat the target lesion, resistance was felt in the guide catheter.The stent was removed in one piece and analyzed.The device appeared fractured mid stent, so a new megatron was used to complete the procedure.There were no patient complications.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20344485
• Report Number: 2124215-2024-61202
• Device Sequence Number: 7895614
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/01/2024

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: 07/10/2025
• Device Lot Number: 0032127287
• 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: 09/13/2024
• Initial Report FDA Received Date: 10/01/2024
• Date Device Manufactured: 07/11/2023
• 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