• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10673
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device is a combination product.
 
Event Description
It was reported that stent damage occured and the procedure was cancelled. Vascular access was obtained via radial artery. The 90% stenosed, 16mm x 3. 5mm, concentric, de novo, target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery. After pre-dilation with 3. 00mm balloon catheter, a 20 x 3. 50 promus elite drug-eluting stent was advanced but failed to cross lesion and the stent strut got damaged. The device was removed and the procedure was cancelled. No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMUS ELITE
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 Key10471234
MDR Text Key204917131
Report Number2134265-2020-11113
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/13/2022
Device Model Number10673
Device Catalogue Number10673
Device Lot Number0025079624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-