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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.
 
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Brand NameSYNERGY MEGATRON
Type of DeviceCORONARY 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 Key12511092
MDR Text Key272660215
Report Number2134265-2021-11929
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were 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
Device Expiration Date12/02/2021
Device Model NumberH7493942832350
Device Lot Number0026505660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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