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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 Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 2.50 x 48 synergy drug-eluting stent was advanced to treat the lesion.However, the stent was unable to advance through a watchdog device.The stent was removed intact and manually from the patient's body and it was noted that the stent was damaged.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.A 2.50 x 48 synergy drug-eluting stent was advanced to treat the lesion.However, the stent was unable to advance through a watchdog device.The stent was removed intact and manually from the patient's body and it was noted that the stent was damaged.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 2.50 x 48 mm stent delivery system (sds) was returned for analysis together with the customer's 6f guidecatheter, haemostatic valve attached to the guidecatheter a guideliner extension guidecatheter and guidewire.An examination the crimped stent found stent damage.Stent struts from the distal stent region 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 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 shaft found multiple kinks along the length of the hypotube.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found multiple kinks along the length of the shaft polymer extrusion.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 Key11238898
MDR Text Key229096862
Report Number2134265-2021-00441
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 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/27/2022
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0026282891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Date Manufacturer Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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