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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 0032293610
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
It was reported that difficulty removal occurred.The 90% stenosed target lesion was located in the severely tortuous and mildly to non-calcified right coronary artery (rca).A 4.50 x 20mm synergy megatron drug-eluting stent (des) was advanced for treatment.During the procedure, a synergy megatron des was placed in the mid-rca along with a non-boston scientific guide extension (ge) catheter.However, when attempting to remove the stent, the stent balloon couldn't be inserted back into the guiding catheter.Subsequently, despite various attempts, including inflating to 1-2 atmospheres and deflating the guide catheter, the stent balloon remained stuck.The physician suggested that advancing the ge after stent placement and before complete deflation might have caused deformation, preventing reinsertion into the ge.Additionally, the steep angle between the proximal and mid-rca could have contributed to the problem.Ultimately, the entire system had to be removed due to the persistent issue.The procedure was completed with a different device, and no patient complications were reported.
 
Event Description
It was reported that difficulty removal occurred.The 90% stenosed target lesion was located in the severely tortuous and mildly to non-calcified right coronary artery (rca).A 4.50 x 20mm synergy megatron drug-eluting stent (des) was advanced for treatment.During the procedure, a synergy megatron des was placed in the mid-rca along with a non-boston scientific guide extension (ge) catheter.However, when attempting to remove the stent, the stent balloon couldn't be inserted back into the guiding catheter.Subsequently, despite various attempts, including inflating to 1-2 atmospheres and deflating the guide catheter, the stent balloon remained stuck.The physician suggested that advancing the ge after stent placement and before complete deflation might have caused deformation, preventing reinsertion into the ge.Additionally, the steep angle between the proximal and mid-rca could have contributed to the problem.Ultimately, the entire system had to be removed due to the persistent issue.The procedure was completed with a different device, and no patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy megatron mr ous 4.50 x 20mm was returned for analysis.A visual and tactile examination identified the device was received in two sections as a result of a break which had occurred in the hypotube.The break was located at the base of the strain relief.A microscopic examination of the break site identified no issues with the actual hypotube which could have contributed to the break.Multiple kinks were noted along the hypotube.A visual, tactile and microscopic examination identified the entire distal extrusion was severely stretched and flattened.A microscopic examination of distal extrusion identified clear evidence that excessive tensile forces had been applied to the device.This was evident in the stretching and bunching noted along the extrusion.A microscopic examination of the balloon identified no tears or holes in the balloon.The balloon was deflated but was not refolded.The device was received with the guidewire, used by the customer, loaded through the tip and wire lumen of the device.Due to the stretching that was evident along the distal extrusion, the inner/wire lumen was stretched down onto the guidewire which prevented the movement of the device over the wire.The outer diameter of the wire was measured at 0.014inch size wire.It was possible to pass the device through the 6 french size guide catheter that was received with the device.No other damages were noted along the device.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18965653
MDR Text Key338558827
Report Number2124215-2024-16100
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032293610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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