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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10621
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the middle to distal end of left circumflex coronary artery.A following pre-dilatation, a 3.50x28mm synergy ii drug eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion after reaching proximal end and it was noticed that the stent strut was lifted.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.
 
Event Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the middle to distal end of left circumflex coronary artery.A following pre-dilatation, a 3.50x28mm synergy ii drug eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion after reaching proximal end and it was noticed that the stent strut was lifted.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.It was further reported that the lesion was mildly tortuous and mildly calcified.
 
Manufacturer Narrative
(b5) describe event or problem: updated to include additional information on lesion details.(d2) date of event: updated the event date from 07jan2021 to (b)(6) 2020.
 
Manufacturer Narrative
(b5) describe event or problem: updated to include additional information on lesion details.(d2) date of event: updated the event date from (b)(6) 2021 to (b)(6) 2020.Device evaluated by mfr: synergy ous mr 3.50 x 28mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with mid-section struts lifted.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks and a break 104.5cm distal to the distal end of the strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the middle to distal end of left circumflex coronary artery.A following pre-dilatation, a 3.50x28mm synergy ii drug eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion after reaching proximal end and it was noticed that the stent strut was lifted.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.It was further reported that the lesion was mildly tortuous and mildly calcified.It was further reported that the device was removed intact from the patient's body and the shaft broke accidentally during packaging.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11184603
MDR Text Key227544028
Report Number2134265-2021-00403
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,distri
Type of Report Initial,Followup,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/02/2022
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0025036658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age48 YR
Patient Weight59
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