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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0026740495
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Event Description
It was reported that stent damage and entrapment occurred.The target lesion was located in mildly tortuous and moderately calcified mid left main and left anterior descending (lad) artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilatation, however, during the procedure the shaft kinked and when the device was removed, a fracture was noted 10cm into the balloon.Another nc emerge balloon was used.A 8 x 4.00 promus elite mr drug-eluting stent was then introduced, but it became stuck in the guide catheter.When the device was pulled back, the stent was noted to be frayed.All devices were removed from the body and the procedure completed with another of the same stent.There were no patient complications.
 
Manufacturer Narrative
The promus elite ous mr 8 x 4.00 mm stent delivery system (sds) was returned for analysis.The distal to mid stent struts were lifted from their crimped positioned and pulled proximally.An accurate outer diameter measure of the stent could not be obtained therefore a review of the manufacturing stent profile data was performed and the stent od at the time of manufacture 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 tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found multiple kinking damages to the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage and entrapment occurred.The target lesion was located in mildly tortuous and moderately calcified mid left main and left anterior descending (lad) artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilatation, however, during the procedure the shaft kinked and when the device was removed, a fracture was noted 10cm into the balloon.Another nc emerge balloon was used.A 8 x 4.00 promus elite mr drug-eluting stent was then introduced, but it became stuck in the guide catheter.When the device was pulled back, the stent was noted to be frayed.All devices were removed from the body and the procedure completed with another of the same stent.There were no patient complications.
 
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Brand Name
PROMUS ELITE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14255042
MDR Text Key290442525
Report Number2134265-2022-05017
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/03/2022
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 Date07/25/2022
Device Lot Number0026740495
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2022
Initial Date FDA Received04/29/2022
Supplement Dates Manufacturer Received06/02/2022
Supplement Dates FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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