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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9548
Device Problems Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
Event Type  malfunction  
Event Description
It was reported that the stent moved on balloon and stent damage occurred.Vascular access was obtained via radial artery.The 12x3.50mm, concentric and de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and mildly calcified ostial left anterior descending artery.After a choice floppy guidewire and a non-boston scientific guide catheter crossed the lesion, pre-dilatation was peformed with a non-boston scientific balloon catheter.A 12 x 3.50 promus premier drug-eluting stent was advanced; however, the stent failed to cross the lesion.The stent was deformed and moved from the balloon.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: promus premier ous mr 12 x 3.50mm stent delivery system (sds) was returned for analysis.An examination of the crimped stent found the stent moved on the balloon, with distal stent struts pulled distally over the tip of the device.The crimped stent outer diameter measured during manufacture 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 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 hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.An attempt was made to load a recommended guide catheter but it could not be loaded through the tip due to the damaged stent covering the tip.No other issues were identified during the product analysis.
 
Event Description
It was reported that the stent moved on balloon and stent damage occurred.Vascular access was obtained via radial artery.The 12x3.50mm, concentric and de novo target lesion with a bend of <=45 degrees was located in the mildly tortuous and mildly calcified ostial left anterior descending artery.After a choice floppy guidewire and a non-boston scientific guide catheter crossed the lesion, pre-dilatation was peformed with a non-boston scientific balloon catheter.A 12 x 3.50 promus premier drug-eluting stent was advanced; however, the stent failed to cross the lesion.The stent was deformed and moved from the balloon.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
PROMUS PREMIER
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 Key11272326
MDR Text Key230042036
Report Number2134265-2021-01163
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2021
Device Model Number9548
Device Catalogue Number9548
Device Lot Number0023258681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE WIRE: CHOICE FLOPPY; GUIDE WIRE: CHOICE FLOPPY; GUIDE WIRE: CHOICE FLOPPY
Patient Age70 YR
Patient SexMale
Patient Weight95 KG
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