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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 10665
Device Problems Material Deformation (2976); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.Date of event: date of event is unknown.The event was reported to bsc on (b)(6) 2019.A date of (b)(6) 2019 has been entered for the date of the event to indicate that the event occurred on an unknown date in (b)(6) 2019.
 
Event Description
It was reported that difficulty placing a stent and stent strut damage occurred.After predrilling the right coronary artery (rca), a 24 x 2.50 promus premier select was advanced, but was not able to be placed.After removing the device from the patient, it was noticed that the stent struts were bent.It was noted that the bent stent struts occurred due to resistance felt during the procedure.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be stable.
 
Manufacturer Narrative
Device is a combination product.B3: date of event: date of event is unknown.The event was reported to bsc on (b)(6) 2019.A date of (b)(6) 2019 has been entered for the date of the event to indicate that the event occurred on an unknown date in (b)(6) 2019.Device evaluated by mfr: the promus premier select stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified proximal stent damage.Proximal stent struts were found to be lifted and pulled distally.The proximal stent damage (lifted and bent back distally) is consistent with the proximal end of the stent coming into contact with a resistance upon withdrawal.The outer diameter of the undamaged crimped stent was measured using snap gauge and was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination found that there was no damage to the tip.
 
Event Description
It was reported that difficulty placing a stent and stent strut damage occurred.After predrilling the right coronary artery (rca), a 24 x 2.50 promus premier select was advanced, but was not able to be placed.After removing the device from the patient, it was noticed that the stent struts were bent.It was noted that the bent stent struts occurred due to resistance felt during the procedure.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be 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 Key8817820
MDR Text Key151927920
Report Number2134265-2019-08575
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 09/11/2019
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 Date01/27/2021
Device Model Number10665
Device Catalogue Number10665
Device Lot Number0023294473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2019
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/23/2019
Supplement Dates Manufacturer Received08/20/2019
Supplement Dates FDA Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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