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

Model Number	H7493942816500
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	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties and a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an 85% stenosed mid right coronary artery (rca).A 5.00 x 16mm synergy megatron was selected for treatment due to the vessel being 5.5mm large.The lesion was predilated and the stent was advanced and successfully deployed at 11 atmospheres for 20 seconds in the rca.Following stent deployment, the stent balloon was pulled at a double negative pressure, and the balloon was attempted to be removed.However, the balloon got hung up in the proximal part of the 6fr jr4 non boston scientific guide catheter.Another attempt to pull negative and pull the balloon out with great force was attempted, but the shaft of the balloon broke.It was noted that vacuum was held during withdrawal until the fracture occurred.It was noted that the target lesion was not tortuous, but the right subclavian vessel that the user was working through was very tortuous.Everything (guide catheter, wire, and balloon) was removed out of the patient.It was noticed that the balloon was still stuck in the tip of the guide, and that the balloon was fully deflated.The shaft break was noticed to be just proximal to the balloon.It was noted that there was no obvious damage observed other than the shaft fracture, and after the fact of stent deployment.The procedure was successfully completed and no patient complications resulted in relation to this event.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a synergy megatron mr us 5.00 x 16mm stent delivery system catheter.A visual and tactile examination of the hypotube shaft found multiple kinks and multiple hypotube breaks.The first hypotube break was located just distal to the strain relief and the second break was located 1cm distal to the wire exchange port.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found multiple kinks along the shaft polymer extrusion.Device analysis found that the device was broken at multiple locations, multiple hypotube and shaft polymer extrusion kinks were also noted.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention (pci) was performed on an 85% stenosed mid right coronary artery (rca).A 5.00 x 16mm synergy megatron was selected for treatment due to the vessel being 5.5mm large.The lesion was predilated and the stent was advanced and successfully deployed at 11 atmospheres for 20 seconds in the rca.Following stent deployment, the stent balloon was pulled at a double negative pressure, and the balloon was attempted to be removed.However, the balloon got hung up in the proximal part of the 6fr jr4 non boston scientific guide catheter.Another attempt to pull negative and pull the balloon out with great force was attempted, but the shaft of the balloon broke.It was noted that vacuum was held during withdrawal until the fracture occurred.It was noted that the target lesion was not tortuous, but the right subclavian vessel that the user was working through was very tortuous.Everything (guide catheter, wire, and balloon) was removed out of the patient.It was noticed that the balloon was still stuck in the tip of the guide, and that the balloon was fully deflated.The shaft break was noticed to be just proximal to the balloon.It was noted that there was no obvious damage observed other than the shaft fracture, and after the fact of stent deployment.The procedure was successfully completed and no patient complications resulted in relation to this event.It was further reported that the balloon was bound up at the distal end of the guide.

• 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: 14548633
• Report Number: 2134265-2022-06180
• Device Sequence Number: 17800424
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: 08714729985648
• 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): 06/10/2022

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: 01/10/2023
• Device Model Number: H7493942816500
• Device Lot Number: 0028748691
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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