Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ELEMENT PLUS; 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 ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9394
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
It was reported that improper labeling was encountered.A 3.50x38mm promus element plus drug eluting stent was selected for use.However, it was noted that the batch lot number of the outer package was different from the inner package.There were no patient complications reported.
 
Event Description
It was reported that improper labeling was encountered.A 3.50x38mm promus element plus drug eluting stent was selected for use.However, it was noted that the batch lot number of the outer package was different from the inner package.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and the complaint report of a difference between the labels of the carton and the pouch can be confirmed as an unopened foil pouch detailing batch # 25196159 on its label was found within an open carton detailing batch # 25431185 on its label.The blue closure tab of this carton was found to have been opened.No damage was noted to the carton or the label.An unopened foil pouch was found inside the opened carton.No damage was noted on the pouch or the pouch label.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROMUS ELEMENT PLUS
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11653219
MDR Text Key245093210
Report Number2134265-2021-04005
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/19/2022
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0025431185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Date Manufacturer Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-