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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/14/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 3.00x38mm promus element plus drug-eluting stent was selected for use.However, during preparation, the shaft was found to be fractured into two at the portion just after the stent.The procedure was completed with a different device.No patient complications reported and the patient's status was stable.
 
Event Description
It was reported that shaft break occurred.A 3.00x38mm promus element plus drug-eluting stent was selected for use.However, during preparation, the shaft was found to be fractured into two at the portion just after the stent.The procedure was completed with a different device.No patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: promus element plus,mr,ous 3.00x38mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was within max 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 no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a break at 109.6cm distal to the distal end of the strain relief.No other issues were identified during analysis.
 
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 Key10791349
MDR Text Key214753617
Report Number2134265-2020-15028
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/14/2022
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0025067121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
-
-