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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 Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.
 
Event Description
It was reported that shaft tear occurred.The target lesion was located in a coronary vessel.A 2.25x28mm synergy stent was advanced to treat the lesion.However, resistance was encountered and when the device was continued to be pushed, the shaft got kinked and eventually got torn.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that shaft tear occurred.The target lesion was located in a coronary vessel.A 2.25x28mm synergy stent was advanced to treat the lesion.However, resistance was encountered and when the device was continued to be pushed, the shaft got kinked and eventually got torn.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr.: synergy ous mr 2.25 x 28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (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 no signs of damage.A visual and tactile examination of the hypotube found a break 26.7cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.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 Key8174343
MDR Text Key130680378
Report Number2134265-2018-64384
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 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/25/2020
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0022752919
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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