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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 10618
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.Vascular access obtained via the right radial artery.The 90% stenosed, 14x2.25mm, concentric, de novo target lesion with a bend of more than or equal to 90 degrees was located in the severely tortuous and moderately calcified left circumflex artery.After engaging a 6f guide catheter coaxially and crossing a non-bsc wire, pre-dilatation was performed with a 1.5mm maverick balloon.A 2.25x16mm synergy drug-eluting stent was then advanced but failed to cross.Dilatation was performed again with the maverick balloon and upon attempting to re-insert the device, it was noted that the stent strut was damaged.The procedure was completed with a 2.25x16mm promus elite stent.No patient complications were reported and the patient was stable.
 
Manufacturer Narrative
Device is a combination product.Device was evaluated by mfr: synergy ous mr 2.25 x 16 mm stent delivery system was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from the proximal region of the stent were noted to be lifted from their crimped position and pulled proximally.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and the proximal balloon cone was noted to be bunched.The balloon wings were however wrapped and evenly folded and no signs of positive pressure were noted.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.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.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.Vascular access obtained via the right radial artery.The 90% stenosed, 14x2.25mm, concentric, de novo target lesion with a bend of more than or equal to 90 degrees was located in the severely tortuous and moderately calcified left circumflex artery.After engaging a 6f guide catheter coaxially and crossing a non-bsc wire, pre-dilatation was performed with a 1.5mm maverick balloon.A 2.25x16mm synergy drug-eluting stent was then advanced but failed to cross.Dilatation was performed again with the maverick balloon and upon attempting to re-insert the device, it was noted that the stent strut was damaged.The procedure was completed with a 2.25x16mm promus elite stent.No patient complications were reported and the patient was stable.
 
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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 Key9529418
MDR Text Key177151563
Report Number2134265-2019-16268
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
Report Date 02/14/2020
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 Date12/17/2019
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0022306401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/31/2020
Supplement Dates FDA Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
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