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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided. The promus premier ous mr 28 x 3. 00 mm stent delivery system was returned for analysis. A visual examination of the stent found that the stent was damaged on proximal stent struts with struts lifted. The undamaged crimped stent outer diameter was measured and the result was within the maximum crimped stent profile measurement. A visual examination of the tip showed no signs of damage. 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 tactile examination found no issues with the hypotube shaft. A visual and tactile examination of the outer lumen and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft. No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 23-sep-2021. It was reported that the device was defective. A 28 x 3. 00 promus premier drug-elutign stent was selected for use. However, it was noted that the device was defective. No other information was provided. However, returned device analysis revealed stent damage.
 
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Brand NamePROMUS PREMIER
Type of DeviceSTENT, 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 Key12583018
MDR Text Key274951779
Report Number2134265-2021-12319
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/12/2018
Device Model Number9552
Device Catalogue Number9552
Device Lot Number0019853176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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