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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 H7493942820350
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Event Description
It was reported that removal difficulties and damage occurred.A 3.50 x 20mm synergy megatron drug-eluting stent was selected for use in the percutaneous coronary intervention (pci) procedure of the severely tortuous and moderately calcified ostial circumflex(cx) and left main(lm) artery.A synergy megatron was deployed in the lm and ostial cx.After the stent was implanted, the physician attempted to remove the balloon, however the balloon was unable to be removed through the guide.The balloon was inflated and deflated several times but the balloon could not be removed.The balloon was fully deflated, the physician removed the guide catheter, guidewire and the balloon all together by pulling the guide catheter with it.It was noticed the balloon looked compressed in the middle.The procedure was completed with this device.There were no patient complications reported.
 
Event Description
It was reported that removal difficulties and damage occurred.A 3.50 x 20mm synergy megatron drug-eluting stent was selected for use in the percutaneous coronary intervention (pci) procedure of the severely tortuous and moderately calcified ostial circumflex(cx) and left main(lm) artery.A synergy megatron was deployed in the lm and ostial cx.After the stent was implanted, the physician attempted to remove the balloon, however the balloon was unable to be removed through the guide.The balloon was inflated and deflated several times but the balloon could not be removed.The balloon was fully deflated, the physician removed the guide catheter, guidewire and the balloon all together by pulling the guide catheter with it.It was noticed the balloon looked compressed in the middle.The procedure was completed with this device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: a 3.50 x 20mm synergy megatron stent delivery system (sds) device was received for analysis.The device was returned the stent was detached from the balloon.The stent was successfully implanted in the patient.The balloon cones were reviewed, and the balloon was bunched.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found shaft polymer extrusion damage and a kink 4.5 cm proximal to the distal tip of the device.The balloon was inflated to rated burst pressure of 16atm without issue.The balloon inflated and held pressure and deflated in 5 seconds.The inflation device was verified before and after use using druck pressure gauge.A recommended 0.014" guidewire could not be loaded due to the inner lumen damage.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key14875983
MDR Text Key302360955
Report Number2134265-2022-07400
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985655
UDI-Public08714729985655
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/15/2022
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 Model NumberH7493942820350
Device Lot Number0028708774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/10/2022
Initial Date FDA Received06/30/2022
Supplement Dates Manufacturer Received07/28/2022
Supplement Dates FDA Received08/15/2022
Was Device Evaluated by Manufacturer? Yes
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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