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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 0028634762
Device Problems Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The non-totally occluded, 5.00 x 10mm, eccentric target lesion was located in the moderately tortuous and moderately calcified unprotected left main artery.Following vascular access via the radial artery, a 6f guide catheter was placed and pre-dilation performed.A 5.00 x 12mm synergy megatron drug eluting stent was advanced for treatment and was successfully implanted in the lesion.The balloon was fully deflated without any difficulty.However, during removal, the balloon got buckled and stuck in the guide catheter.The shaft broke during the attempt to pull the balloon inside the guide.The procedure was completed with this device and there were no patient complications reported.
 
Event Description
It was reported that shaft break occurred.The non-totally occluded, 5.00 x 10mm, eccentric target lesion was located in the moderately tortuous and moderately calcified unprotected left main artery.Following vascular access via the radial artery, a 6f guide catheter was placed and pre-dilation performed.A 5.00 x 12mm synergy megatron drug eluting stent was advanced for treatment and was successfully implanted in the lesion.The balloon was fully deflated without any difficulty.However, during removal, the balloon got buckled and stuck in the guide catheter.The shaft broke during the attempt to pull the balloon inside the guide.The procedure was completed with this device and there were no patient complications reported.
 
Manufacturer Narrative
The synergy megatron mr ous 5.00 x 12mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the balloon identified that the balloon was bunched at its distal end.There was a large build-up of blood inside the balloon.A microscopic examination of the balloon material identified no tears or holes.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the distal extrusion confirmed a shaft break at approximately 26.7 cm proximal from distal tip.Multiple kinking was also identified along the extrusion.The stent was deployed and was not returned.A visual and microscopic examination identified no damage to the tip section.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15890473
MDR Text Key307104626
Report Number2124215-2022-50121
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 03/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2023
Device Lot Number0028634762
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2022
Initial Date FDA Received11/30/2022
Supplement Dates Manufacturer Received03/24/2023
Supplement Dates FDA Received03/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
Patient SexMale
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