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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10667
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.While outside the patient and while unpacking a 32 x 2.50 promus premier select stent, it was noticed that the stent was damaged.The procedure was completed successfully with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: a 32 x 2.50mm promus premier select stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the mid stent region were noted to be lifted from their crimped position and pulled distally.The undamaged 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 shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.While outside the patient and while unpacking a 32 x 2.50 promus premier select stent, it was noticed that the stent was damaged.The procedure was completed successfully with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.
 
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Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10304167
MDR Text Key199855809
Report Number2134265-2020-09601
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10667
Device Catalogue Number10667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Date Manufacturer Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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