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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 9552
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 28 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, the tip of the stent strut was lifted up.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: promus premier ous mr 28 x 2.50mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts in the proximal and middle region were found to be lifted from their crimped position and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and no issues were noted.The balloon wings were wrapped and evenly folded and no signs of positive pressure were noted.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 and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
 
Event Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 28 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, the tip of the stent strut was lifted up.The procedure was completed with another of same device.There were no patient complications nor injuries 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
MDR Report Key11240898
MDR Text Key229102087
Report Number2134265-2021-00833
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
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/12/2022
Device Model Number9552
Device Catalogue Number9552
Device Lot Number0025632473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
Patient Weight65
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