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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 10663
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 16 x 3.00 promus premier select drug-eluting stent was advanced but could not track down the lesion and was damaged.The device was removed and the procedure was completed with a different device.No known patient complications were reported.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 16 x 3.00 promus premier select drug-eluting stent was advanced but could not track down the lesion and was damaged.The device was removed and the procedure was completed with a different device.No known patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.
 
Manufacturer Narrative
Device evaluated by mfr.: a p select ous mr 16 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped 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 signs of distal tip damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section 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.The target lesion was located in the left anterior descending artery.A 16 x 3.00 promus premier select drug-eluting stent was advanced but could not track down the lesion and was damaged.The device was removed and the procedure was completed with a different device.No known patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery and the patient's status was stable.
 
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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 Key10099319
MDR Text Key193109926
Report Number2134265-2020-07127
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,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2021
Device Model Number10663
Device Catalogue Number10663
Device Lot Number0023949585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Date Manufacturer Received10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight82
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