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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 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.The 85% stenosed, 2.25x16mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.25x16mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the tip of the stent struts were lifted due to severe tortuosity.The device was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that stent damage occurred.The 85% stenosed, 2.25x16mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.25x16mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the tip of the stent struts were lifted due to severe tortuosity.The device was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ous mr 2.25 x 16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found damage to the stent.The mid-section of the stent was damaged with stent struts deformed and pulled in a distal direction.The undamaged crimped stent outer diameter was measured and the result was within max 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 and microscopic examination of the bumper tip showed 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.No other issues were identified during the product analysis.
 
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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 Key8197769
MDR Text Key131476961
Report Number2134265-2018-64648
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 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2019
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0021650731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight76
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