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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10674
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr.: promus elite ous mr 24 x 3.00 stent delivery system was returned for analysis.A visual examination of the stent found a damaged stent - stent struts from the distal end of the stent were lifted and pulled distally.The undamaged stent outer diameter was measured and the result was within maximum 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 multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 23-sep-2020.It was reported that crossing difficulties were encountered and shaft kink occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 24 x 3.00 promus elite drug-eluting stent was advanced for treatment, but failed to cross the lesion even after several attempts and the catheter got kinked.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed stent damage.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
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 Key10662293
MDR Text Key211311285
Report Number2134265-2020-13514
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 10/12/2020
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 Date10/08/2020
Device Model Number10674
Device Catalogue Number10674
Device Lot Number0022807156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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