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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493942832350
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Event 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 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 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.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12511092
MDR Text Key272660215
Report Number2134265-2021-11929
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985778
UDI-Public08714729985778
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2021
Device Model NumberH7493942832350
Device Lot Number0026505660
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2021
Patient Sequence Number1
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