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

Model Number	H7493942812500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 12mm synergy megatron drug-eluting stent was advanced to treat the lesion.However, it was noticed that balloon was fractured inside the patient's body.The procedure was complete with the original device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 12mm synergy megatron drug-eluting stent was advanced to treat the lesion.However, it was noticed that balloon was fractured inside the patient's body.The procedure was complete with the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy megatron mr us 5.00 x 12mm stent delivery system, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.The device was returned attached to a guidewire and guide catheter.Multiple kinks were noted along the hypotube shaft.Visual examination of the polymer extrusion identified a break at the port exchange, a kink directly after the the proximal makerband and stretching along the entire length of the polymer extrusion.No stent was attached to the balloon.Balloon cones were reviewed and was subjected to positive pressure.Blood was inside the balloon.Microscopic examination of the polymer extrusion identified a break at the port exchange, a kink directly after the the proximal makerband and stretching along the entire length of the polymer extrusion.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.

• 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: 16877940
• Report Number: 2124215-2023-21015
• Device Sequence Number: 5718196
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: 08714729985600
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 08/08/2023
• Device Model Number: H7493942812500
• Device Lot Number: 0029995433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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