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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 10622
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2022
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 19-dec-2022.It was reported that crossing difficulties were encountered.The patient presented with myocardial infarction and underwent percutaneous transluminal coronary angioplasty.The 72% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The physician engaged the lesion with a 3.5 ebu guide catheter and a non-boston scientific (bsc) guidewire was crossed.Following pre-dilatation with a non-bsc balloon, a 3.00 x 32 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed, and another synergy drug-eluting stent was used.The procedure was completed with a good timi 3 flow and no patient complications were reported.However, returned device analysis revealed a shaft break.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 3.00 x 32mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.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 and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a shaft break 90 cm distal to the distal end of the strain relief and multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 3.00 x 32mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.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 and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a shaft break 90 cm distal to the distal end of the strain relief and multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.B5 describe event or problem updated.
 
Event Description
Reportable based on device analysis on 19dec2022 it was reported that difficulty crossing lesion occurred.The 72% stenosed target lesion was located in moderately tortuous and moderately calcified left anterior descending artery.A 3.00 x 32 synergy drug eluting stent was selected for use.However, during procedure, the stent didn't cross the lesion.The device was removed, and the procedure was completed with another of same device.There were no patient complication nor injuries reported.However, returned device analysis identified a shaft break.It was further reported that the shaft did not break during procedure.The shaft broke during the transit.
 
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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
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 Key16048779
MDR Text Key308005365
Report Number2124215-2022-55038
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
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 01/02/2023
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 Date10/07/2023
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0028211145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2022
Initial Date FDA Received12/26/2022
Supplement Dates Manufacturer Received12/29/2022
Supplement Dates FDA Received01/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON CATHETER: NC TREK; BALLOON CATHETER: NC TREK; GUIDE CATHETER: 3.5 EBU; GUIDE CATHETER: 3.5 EBU; GUIDEWIRE: BMW; GUIDEWIRE: BMW
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