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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
Lot Number 0027612324
Device Problems Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent angioplasty.The 4.50mm x 8mm, eccentric target lesion was located in the moderately tortuous and moderately calcified unprotected left main artery.After obtaining vascular access via the radial artery, a 6f guide catheter was placed and pre-dilatation was performed.A 4.50 x 8mm synergy megatron drug-eluting stent was advanced for treatment.The stent was deployed and implanted after the second inflation at 24 atmospheres.The balloon was completely deflated after approximately 20-40 seconds without any difficulty.However, upon withdrawal, the balloon buckled and got stuck as it was being pulled into the guide catheter.It was noted that the device was not intact upon removal.The procedure was completed with this device.No patient complications and the patient status was stable.
 
Manufacturer Narrative
Updated: b5.Describe event or problem and e1: initial reporter email.B3.Date of event: corrected from 11/19/2022 to 11/21/2022.D6a.Implant date: corrected from 11/19/2022 to 11/21/2022.
 
Event Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent angioplasty.The 4.50mm x 8mm, eccentric target lesion was located in the moderately tortuous and moderately calcified unprotected left main artery.After obtaining vascular access via the radial artery, a 6f guide catheter was placed and pre-dilatation was performed.A 4.50 x 8mm synergy megatron drug-eluting stent was advanced for treatment.The stent was deployed and implanted after the second inflation at 24 atmospheres.The balloon was completely deflated after approximately 20-40 seconds without any difficulty.However, upon withdrawal, the balloon buckled and got stuck as it was being pulled into the guide catheter.It was noted that the device was not intact upon removal.The procedure was completed with this device.No patient complications and the patient status was stable.It was further reported that the shaft of the device broke, 2-3 cm from the hub.It was removed with support of another balloon.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15890340
MDR Text Key307662484
Report Number2124215-2022-49654
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/21/2023
Device Lot Number0027612324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER: 6F CORDIS; GUIDE CATHETER: 6F CORDIS; GUIDEWIRE: 0.14; GUIDEWIRE: 0.14; INFLATION DEVICE: 6F MEDTRONIC EBU; INFLATION DEVICE: 6F MEDTRONIC EBU
Patient Age47 YR
Patient SexMale
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