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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 10666
Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)
Patient Problems 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 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications reported.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery.A 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications reported.It was further reported that the lesion was 70% stenosed, mildly tortuous and moderately calcified.The shaft was bent while advancing the stent shaft.After removal, the physician attempted to straighten the device but the shaft broke.
 
Manufacturer Narrative
Device evaluated by mfr.: promus premier select ous mr 28 x 2.75 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with proximal to mid-section struts bunched proximally.The undamaged crimped stent outer diameter 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 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.A 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications reported.It was further reported that the lesion was 70% stenosed, mildly tortuous and moderately calcified.The shaft was bent while advancing the stent shaft.After removal, the physician attempted to straighten the device but the shaft broke.
 
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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 Key11100012
MDR Text Key224529919
Report Number2134265-2020-18617
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/08/2021
Device Model Number10666
Device Catalogue Number10666
Device Lot Number0024123296
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
Patient Weight74
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