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

Model Number	H7493942832500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The patient underwent angiogram of the target lesion located in the non-tortuous mid to distal right coronary artery.A 5.00 x 32mm synergy megatron was advanced and deployed for treatment.However, during withdrawal, the hypotube broke just proximal to the balloon and remained inside the patient.A new stent was placed to pin the balloon fragment onto another stent to avoid migration.No patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem updated.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent angiogram of the target lesion located in the non-tortuous mid to distal right coronary artery.A 5.00 x 32mm synergy megatron was advanced and deployed for treatment.However, during withdrawal, the hypotube broke just proximal to the balloon and remained inside the patient.A new stent was placed to pin the balloon fragment onto another stent to avoid migration.No patient complications were reported.It was further reported that the device deflation period before removal was underdetermined but it was fully deflated with no visible contrast on fluoro.

• 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: 17290020
• Report Number: 2124215-2023-33875
• Device Sequence Number: 12143459
• Product Code: NIQ
• UDI-Device Identifier: 08714729985808
• UDI-Public: 08714729985808
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: H7493942832500
• Device Lot Number: 0030836947
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown