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

Model Number	H7493942824350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with angina and was being treated for percutaneous coronary intervention (pci).The target lesion was moderately calcified vessel.A 3.00 x 28mm synergy xd and a 3.50 x 24mm synergy megatron drug-eluting stents were advanced for treatment.However, during insertion of both stents through guideliner, the mid shaft of both synergy megatron stent broke.The whole devices were pulled and removed from the patient.A non-bsc devices were used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with angina and was being treated for percutaneous coronary intervention (pci).The target lesion was moderately calcified vessel.A 3.00 x 28mm synergy xd and a 3.50 x 24mm synergy megatron drug-eluting stents were advanced for treatment.However, during insertion of both stents through guideliner, the mid shaft of both synergy megatron stent broke.The whole devices were pulled and removed from the patient.A non-bsc devices were used to complete the procedure.No patient complications were reported.It was further reported that a 6 french guide catheter with a 6 french guideliner were used during insertion of the stents.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16229833
• Report Number: 2124215-2023-02269
• Device Sequence Number: 17515491
• Product Code: NIQ
• UDI-Device Identifier: 08714729985693
• UDI-Public: 08714729985693
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/07/2023

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: 07/18/2023
• Device Model Number: H7493942824350
• Device Lot Number: 0029847045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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