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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 Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.A promus premier ous mr 28 x 3.00mm stent delivery system was returned for analysis with the product mandrel inserted through distal tip.A visual examination of the stent found signs of stent damage.Stent struts at the distal end of the stent were lifted and pulled from their crimped position.The undamaged stent outer diameter was measured and the result is 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 signs of distal tip 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.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 25-may-2020.It was reported that advancing difficulties were encountered.The diffused target lesion was located in the severely calcified mid to distal left anterior descending artery.A 28 x 3.00 promus premier drug-eluting stent was introduced but could not be advanced to the lesion.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.
 
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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 Key10182546
MDR Text Key196067847
Report Number2134265-2020-07191
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 06/22/2020
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 Date04/23/2021
Device Model Number9552
Device Catalogue Number9552
Device Lot Number0023756988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2020
Initial Date FDA Received06/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
Patient Weight60
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