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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 0025940250
Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: the date of the event is unknown.Bsc became aware of the event on 09 december 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.
 
Event Description
It was reported that stent damage occurred.A 3.50 x 24mm synergy megatron stent was used to treat a target lesion, but a strut dislodged.The procedure was completed and no patient complications were reported in relation to this event.
 
Manufacturer Narrative
B3: date of event: update from (b)(6) 2020 to (b)(6) 2020.
 
Event Description
It was reported that stent damage occurred.A 3.50 x 24mm synergy megatron stent was used to treat a target lesion, but a strut dislodged.The procedure was completed and no patient complications were reported in relation to this event.It was further reported that a strut from the stent dislodged when crossing a calcareous spur in the patient.A second device had to be used to perform the intervention.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
B3: date of event: update from (b)(6) 2020 to (b)(6) 2020.Device evaluated by mfr: a synergy megatron mr ous 3.50 x 24mm stent delivery system was returned.A visual examination of the stent found stent damage.Stent struts from the mid-section of the stent were noted to be lifted and pulled distally.The undamaged stent outer diameter was measured using snap gauge and the result is within maximum crimped stent profile measurement.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.No other issues were identified.
 
Event Description
It was reported that stent damage occurred.A 3.50 x 24mm synergy megatron stent was used to treat a target lesion, but a strut dislodged.The procedure was completed and no patient complications were reported in relation to this event.It was further reported that a strut from the stent dislodged when crossing a calcareous spur in the patient.A second device had to be used to perform the intervention.No patient complications were reported in relation to this event.A synergy megatron mr ous 3.50 x 24mm stent delivery system was returned.A visual examination of the stent found stent damage.Stent struts from the mid-section of the stent were noted to be lifted and pulled distally.The undamaged stent outer diameter was measured using snap gauge and the result is within maximum crimped stent profile measurement.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.No other issues were identified.
 
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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
MDR Report Key11018514
MDR Text Key222038582
Report Number2134265-2020-17753
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/24/2022
Device Lot Number0025940250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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