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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 0031178009
Device Problems Difficult to Remove (1528); Material Deformation (2976); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2023
Event Type  Injury  
Manufacturer Narrative
E1: initial reporter phone: (b)(6).
 
Event Description
It was reported that removal difficulty occurred, requiring an additional device.The 80% stenosed target lesion was located in the non-tortuous and severely calcified proximal circumflex artery.The vessel had a departure angle of approximately 90 degrees followed by a further curve towards 70 degrees.A 4.00 x 20mm synergy megatron stent balloon was inserted, inflated and the stent was positioned.Following deflation at 15 atmospheres for 15 seconds, it was difficult to remove the synergy megatron delivery balloon.The synergy megatron delivery balloon was inflated and deflated several times, eventually allowing removal.The proximal synergy megatron stent segment was damaged at retraction, but optimized during a proximal optimization technique (pot).Following removal, it was noted the delivery balloon was not completely deflated.The procedure was completed and there were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.Examination of the stent delivery system noted the stent was not returned.The balloon was inflated to 16 atmospheres using the inflation aid and deflated without issue.No other device issues were identified during returned product analysis.
 
Event Description
It was reported that removal difficulty occurred, requiring an additional device.The 80% stenosed target lesion was located in the non-tortuous and severely calcified proximal circumflex artery.The vessel had a departure angle of approximately 90 degrees followed by a further curve towards 70 degrees.A 4.00 x 20mm synergy megatron stent balloon was inserted, inflated and the stent was positioned.Following deflation at 15 atmospheres for 15 seconds, it was difficult to remove the synergy megatron delivery balloon.The synergy megatron delivery balloon was inflated and deflated several times, eventually allowing removal.The proximal synergy megatron stent segment was damaged at retraction, but optimized during a proximal optimization technique (pot).Following removal, it was noted the delivery balloon was not completely deflated.The procedure was completed and there were no patient complications reported.
 
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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 Key18246864
MDR Text Key329488859
Report Number2124215-2023-68155
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0031178009
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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