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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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery.A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery (rca).A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the midly tortuous and moderately calcified rca.The patient's status was stable.
 
Manufacturer Narrative
B5 - describe event or problem updated.F10 - patient code updated.
 
Manufacturer Narrative
Device evaluated by mfr.: promus select ous mr 32 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Struts in various locations along the stent length were noted to be lifted fom the crimped profile.The undamaged stent outer diameter was measured by snap gauge and the result is 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 examination of the bumper tip showed no signs of 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 calcified right coronary artery (rca).A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the midly tortuous and moderately calcified rca.The patient's status is 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 Key11095793
MDR Text Key224398217
Report Number2134265-2020-18595
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 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/07/2022
Device Model Number10667
Device Catalogue Number10667
Device Lot Number0025718146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
Patient Weight74
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