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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 10663
Device Problems Fracture (1260); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that stent fracture occurred. A 16 x 3. 00 promus premier select stent was advanced. On x-ray it was noticed that the medial portion of the stent was not laying on the balloon correctly. The stent was removed and a fracture was observed. The procedure was completed with another of the same device. There were no patient complications. The patient was fine.

 
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Brand NamePROMUS PREMIER SELECT
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 Key10652016
MDR Text Key210617389
Report Number2134265-2020-13417
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/13/2021
Device MODEL Number10663
Device Catalogue Number10663
Device LOT Number0023662266
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/2019
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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