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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 10632
Device Problem Premature Activation (1484)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.Event date: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
 
Event Description
It was reported that stent partially deployment occurred.The physician was unable to place a 2.50 x 48 synergy drug-eluting stent because the stent was partially deployed.No patient complications were reported.
 
Event Description
It was reported that stent partially deployment occurred.The physician was unable to place a 2.50 x 48 synergy drug-eluting stent because the stent was partially deployed.No patient complications were reported.Device evaluated by mfr.: a visual examination of the stent found that on the first proximal row, stent struts were lifted.There was no sign of stent partial deployment and no sign of positive pressure applied to the balloon.The undamaged crimped stent od (outer diameter) was measured within maximum crimped stent profile measurement.Stent damage most likely occurred during advancing attempts.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 damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile 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.
 
Manufacturer Narrative
Device is a combination product.Event date: the event date was note reported.The first date of the month of the aware date was entered as an estimate.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 02:58 pm ct.The report number is being corrected from: 2134265-2018-64405 to: 2134265-2018-62918.
 
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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 Key8085804
MDR Text Key127859453
Report Number2134265-2018-62918
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
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/13/2019
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0022162440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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