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

Model Number	H7493942828350
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 3.50 x 28mm synergy megatron was advanced for treatment.However, when inserting the megatron into the guide, the shaft snapped in half at the middle of the delivery system.The pieces were removed with no issues and the procedure was completed with a new device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy megatron mr us 3.50 x 28mm was returned for analysis.A visual and microscopic examination of the crimped stent identified no damages.The stent was securely crimped on the balloon.The balloon cones were reviewed, and no issues were noted.There was no evidence of any positive pressures having been applied to the balloon.A visual and microscopic examination of the bumper tip showed no damage.The device was received in two sections as a result of a break in the hypotube.The break was located at 81cm distal to the distal end of the strain relief.An examination of the break site identified no issues with the device which could have contributed to the break.Both sections of the hypotube were kinked at various locations along both sections of the break.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no damages.No other issues were identified during analysis.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 3.50 x 28mm synergy megatron was advanced for treatment.However, when inserting the megatron into the guide, the shaft snapped in half at the middle of the delivery system.The pieces were removed with no issues and the procedure was completed with a new device.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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16765597
• Report Number: 2124215-2023-18384
• Device Sequence Number: 17668633
• Product Code: NIQ
• UDI-Device Identifier: 08714729985730
• UDI-Public: 08714729985730
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 06/02/2023

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: 10/19/2023
• Device Model Number: H7493942828350
• Device Lot Number: 0030442125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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