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

Model Number	H7493942816450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Additional information: b5: it was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.E1: (b)(6).E3: physician.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.It was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an ostial lesion.A 4.50 x 16mm synergy megatron was inserted, but a mid shaft fracture occurred.The device was removed, and the procedure was successfully completed.No patient complications were reported in relation to this event.It was further reported that the target lesion was located in the left main (lm) artery.The shaft break occurred while trying to remove the device.The shaft break occurred due to the shaft was trapped behind the aortic valve up against the wall of the aorta.The shaft was trapped up against the wall of the guide and was pulled out of the patient.No patient complications resulted in relation to this event and the patient was reported to be good post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy megatron mr us 4.50 x 16mm stent delivery system (sds), catheter was returned for analysis, the following attributes were examined: stent profile: no stent was returned, the stent was implanted in the patient.Balloon profile: the balloon cones were reviewed, and no issues were noted.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of distal tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a shaft break at the site of the wire exchange port.No other issues were identified during analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14242568
• Report Number: 2134265-2022-04930
• Device Sequence Number: 4887723
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 05/23/2022

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: 04/12/2022
• Device Model Number: H7493942816450
• Device Lot Number: 0027195888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 05/20/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/18/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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