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

Model Number	H7493942832350
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation and removal difficulty occurred.A percutaneous coronary intervention (pci) was performed on a moderately calcified right coronary artery (rca).A 3.50 x 32mm synergy megatron was advanced to the lesion, the balloon was inflated one time at 12 atmospheres for 8 to 10 seconds, and was deployed in the rca.However, the balloon would not deflate.A double negative was performed using a 3-way but it did not do much and the device had to be removed with a lot of effort.The procedure was completed with this device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
Event or Problem Description
It was reported that deflation and removal difficulty occurred.A percutaneous coronary intervention (pci) was performed on a moderately calcified right coronary artery (rca).A 3.50 x 32mm synergy megatron was advanced to the lesion, the balloon was inflated one time at 12 atmospheres for 8 to 10 seconds, and was deployed in the rca.However, the balloon would not deflate.A double negative was performed using a 3-way but it did not do much and the device had to be removed with a lot of effort.The procedure was completed with this device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that after the stent was implanted, the balloon took a lot of time to deflate and when it was finally able to be removed it was noted to be deformed.
Event or Problem Description
It was reported that deflation and removal difficulty occurred.A percutaneous coronary intervention (pci) was performed on a moderately calcified right coronary artery (rca).A 3.50 x 32mm synergy megatron was advanced to the lesion, the balloon was inflated one time at 12 atmospheres for 8 to 10 seconds, and was deployed in the rca.However, the balloon would not deflate.A double negative was performed using a 3-way but it did not do much and the device had to be removed with a lot of effort.The procedure was completed with this device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that after the stent was implanted, the balloon took a lot of time to deflate and when it was finally able to be removed it was noted to be deformed.It was further reported that resistance was encountered only while withdrawing the stent delivery system into the 7f guide catheter.It was noted that more than a minute was allowed for balloon deflation before pulling back the device and that there was an attempt to deflate the balloon manually with a 20 cc syringe.There was always contrast inside of the balloon, a mix of 85% saline and 15% of contrast, which allowed visualization under fluoroscopy.The stent was confirmed to have been deployed, and well implanted.

• 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: 12511092
• Report Number: 2134265-2021-11929
• Device Sequence Number: 14431560
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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: H7493942832350
• Device Lot Number: 0026505660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 10/11/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/30/2021; 10/13/2021
• Patient Sequence Number: 1