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

Model Number	H7493942820500
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent balloon removal difficulty occurred.A percutaneous coronary intervention was being performed on a 90% stenosed, mildly calcified and mildly tortuous lesion in the proximal right coronary artery.The lesion was pre-dilated with a balloon catheter.A 5.00 x 20mm synergy megatron drug-eluting stent was delivered using a 7f guidezilla ii extension catheter.While removing the stent balloon and attempting to keep the guide engaged, the physician sensed some resistance with the balloon and the guidezilla ii.The physician kept attempting to remove the stent balloon while keeping the guide engaged but was unable to do so.The balloon would not pass through the guidezilla ii after deploying the stent.Both the stent balloon and guidezilla ii had to be removed together as one unit.The procedure was able to be continued.The 0.014 inch guidewire was never removed and the physician was able to post dilate the stents and complete the procedure without complications.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11488259
• Report Number: 2134265-2021-03349
• Device Sequence Number: 3804237
• Product Code: NIQ
• UDI-Device Identifier: 08714729985686
• UDI-Public: 08714729985686
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 12/02/2021
• Device Model Number: H7493942820500
• Device Lot Number: 0026517130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1